Comparative Study of the Effects of Combined Oral Contraceptives in Hemostatic Variables

PubMed Central

Stocco, Bianca; Fumagalli, Helen F.; Franceschini, Silvio A.; Martinez, Edson Z.; Marzocchi-Machado, Cleni M.; de Sá, Marcos Felipe S.; Toloi, Maria Regina T.

2015-01-01

Abstract Thrombotic risk is associated with the estrogen dose and type of progestin in combined oral contraceptives. Studies published since 1990 showed that third-generation progestins have larger risk to contribute to thrombosis development than the second-generation. However, there are conflicts in the literature regarding the thrombotic risk associated to the drospirenone progestin. So, this study aimed to evaluate the effects of 3 formulations of contraceptives containing ethinylestradiol (EE) (20 and 30 μg) combined with drospirenone versus levonorgestrel combined with EE (30 μg) in hemostatic parameters. This cross-sectional study included 70 healthy women between 18 and 30 years, BMI 19 to 30 kg/m2, not pregnant, non-smokers, and users or non-users (control) of contraceptives for a minimum period of 6 months. The following parameters were assessed: prothrombin time (PT), Factor VII, activated partial thromboplastin time (aPTT), Factor XII, fibrinogen, Factor 1 + 2, Protein C, Protein S, antithrombin, D-dimers, and plasminogen activator inhibitor-1. Significant alterations were found in PT, aPTT, fibrinogen, D-dimers, and protein S, all favoring a state of hypercoagulation for contraceptive containing DRSP/20EE. Both contraceptives containing DRSP/30EE and LNG/30EE promoted changes that favor the hypercoagulability in the coagulant variable PT and in the anticoagulant variables Protein S and Protein C, respectively. We suggest that the progestin drospirenone can contribute to an inadequate balance among procoagulant, anticoagulant, and fibrinolytic factors, since that the contraceptive containing the lowest dose of estrogen and drospirenone (DRSP/20EE) caused a higher number of hemostatic changes. PMID:25634167

Effect of progestin vs. combined oral contraceptive pills on lactation: A double-blind randomized controlled trial

PubMed Central

Espey, Eve; Ogburn, Tony; Leeman, Larry; Singh, Rameet; Schrader, Ronald

2013-01-01

Objective To estimate the effect of progestin-only vs. combined hormonal contraceptive pills on rates of breastfeeding continuation in postpartum women. Secondary outcomes include infant growth parameters, contraceptive method continuation and patient satisfaction with breastfeeding and contraceptive method. Methods In this randomized controlled trial, postpartum breastfeeding women who desired oral contraceptives were assigned to progestin-only vs. combined hormonal contraceptive pills. At two and eight weeks postpartum, participants completed in-person questionnaires that assessed breastfeeding continuation and contraceptive use. Infant growth parameters including weight, length and head circumference were assessed at eight weeks postpartum. Telephone questionnaires assessing breastfeeding, contraceptive continuation and satisfaction were completed at 3-7 weeks and 4 and 6 months. Breastfeeding continuation was compared between groups using Cox proportional hazards regression. Differences in baseline demographic characteristics and in variables between the two intervention groups were compared using chi-square tests, Fisher’s Exact test, or two-sample t-tests as appropriate. Results Breastfeeding continuation rates, contraceptive continuation, and infant growth parameters did not differ between users of progestin-only and combined hormonal contraceptive pills. Infant formula supplementation and maternal perception of inadequate milk supply were associated with decreased rates of breastfeeding in both groups. Conclusions Choice of combined or progestin-only birth control pills administered two weeks postpartum did not adversely affect breastfeeding continuation. PMID:22143258

Effect of exenatide on the pharmacokinetics of a combination oral contraceptive in healthy women: an open-label, randomised, crossover trial

PubMed Central

2012-01-01

Background Consistent with its effect on gastric emptying, exenatide, an injectable treatment for type 2 diabetes, may slow the absorption rate of concomitantly administered oral drugs resulting in a decrease in maximum concentration (Cmax). This study evaluated the drug interaction potential of exenatide when administered adjunctively with oral contraceptives, given their potential concomitant use. Methods This trial evaluated the effect of exenatide co-administration on single- and multiple-dose pharmacokinetics of a combination oral contraceptive (ethinyl estradiol [EE] 30 μg, levonorgestrel [LV] 150 μg [Microgynon 30®]). Thirty-two healthy female subjects participated in an open-label, randomised, crossover trial with 3 treatment periods (oral contraceptive alone, 1 hour before exenatide, 30 minutes after exenatide). Subjects received a single dose of oral contraceptive on Day 8 of each period and QD doses on Days 10 through 28. During treatment periods of concomitant usage, exenatide was administered subcutaneously prior to morning and evening meals at 5 μg BID from Days 1 through 4 and at 10 μg BID from Days 5 through 22. Single- (Day 8) and multiple-dose (Day 22) pharmacokinetic profiles were assessed for each treatment period. Results Exenatide did not alter the bioavailability nor decrease daily trough concentrations for either oral contraceptive component. No substantive changes in oral contraceptive pharmacokinetics occurred when oral contraceptive was administered 1 hour before exenatide. Single-dose oral contraceptive administration 30 minutes after exenatide resulted in mean (90% CI) Cmax reductions of 46% (42-51%) and 41% (35-47%) for EE and LV, respectively. Repeated daily oral contraceptive administration 30 minutes after exenatide resulted in Cmax reductions of 45% (40-50%) and 27% (21-33%) for EE and LV, respectively. Peak oral contraceptive concentrations were delayed approximately 3 to 4 hours. Mild-to-moderate nausea and vomiting were the

The combined oral contraceptive pill containing drospirenone and ethinyl estradiol plus levomefolate calcium.

PubMed

Rapkin, Rachel B; Creinin, Mitchell D

2011-10-01

Neural tube defects are the second most common congenital anomaly in the United States, although their incidence may be decreased by periconception folic acid supplementation. A new oral contraceptive containing drospirenone and ethinyl estradiol plus levomefolate calcium was formulated to decrease the risk of neural tube defects in pregnancies conceived while taking or shortly after discontinuing this pill. Because of its novelty, very few studies have been performed to evaluate the efficacy, side effects and safety related to contraception, premenstrual dysphoric disorder and acne; therefore, literature evaluating similar contraceptives without levomefolate is reviewed. Additionally, we review studies evaluating the addition of levomefolate calcium to oral contraceptives containing 3 mg drospirenone and either 20 or 30 μg ethinyl estradiol. To date, no study has been performed to evaluate the effect this new oral contraceptive has on reducing the incidence of neural tube defects. This new pill has similar contraceptive efficacy, side effect, safety and benefits profile to other drospirenone-containing contraceptives. While also approved to prevent neural tube defects, no studies validate this claim and physician time is better spent counseling women, regardless of contraceptive choice, on the importance of folic acid supplementation during the child-bearing years.

No interacting influence of lavender oil preparation silexan on oral contraception using an ethinyl estradiol/levonorgestrel combination.

PubMed

Heger-Mahn, Doris; Pabst, Günther; Dienel, Angelika; Schläfke, Sandra; Klipping, Christine

2014-12-01

Silexan is an oral Lavender oil preparation with proven anxiolytic efficacy. Given the high prevalence of anxiety and restlessness in younger women, oral contraceptives and Silexan will likely be co-administered. A double-blind, randomised, 2-period crossover study was performed to investigate the effects of Silexan on the pharmacokinetics and pharmacodynamics of Microgynon(®), a combination oral contraceptive containing ethinyl estradiol 0.03 mg (EE) and levonorgestrel 0.15 mg (LNG) in healthy, fertile, adult females. During 2 consecutive cycles of 28 days, oral contraception was given for 21 days combined with 1 × 160 mg/day Silexan or placebo. Plasma concentration-time profiles of EE and LNG were obtained on day 18 ± 1 up to 24 h after dosing. The primary outcome measure was the area under the concentration-time curve over a dosing interval of τ = 24 h (AUCτ) for EE and LNG plasma levels. An interaction with Silexan was formally excluded if the 90 % confidence interval for the AUCτ ratio during co-administration with Silexan or placebo was included within the range of 0.80-1.25. Secondary outcomes included EE and LNG peak concentration (C max) and time to C max (t max), follicle size, endometrial thickness, the Hoogland score, and serum levels of estradiol, progesterone, and sex hormone-binding globulin. A total of 24 women (mean age 27.3 years; mean body mass index 22.2 kg/m(2)) participated. The confidence intervals for the EE and LNG AUCτ and C max ratios fell within the pre-specified limits, indicating no interaction (point estimates [Silexan/placebo] AUCτ EE 0.97, LNG 0.94; C max EE 0.99, LNG 0.96). For LNG, t max was slightly delayed. No secondary outcome indicated any impairment of contraceptive efficacy. Co-administration of Silexan did not affect the efficacy of a combination oral contraceptive containing EE and LNG and was well tolerated.

Progestin and estrogen potency of combination oral contraceptives and endometrial cancer risk.

PubMed

Maxwell, G L; Schildkraut, J M; Calingaert, B; Risinger, J I; Dainty, L; Marchbanks, P A; Berchuck, A; Barrett, J C; Rodriguez, G C

2006-11-01

Using data from a case-control study of endometrial cancer, we investigated the relationship between the progestin and estrogen potency in combination oral contraceptives (OCs) and the risk of developing endometrial cancer. Subjects included 434 endometrial cancer cases and 2,557 controls identified from the Cancer and Steroid Hormone (CASH) study. OCs were classified into four categories according to the individual potencies of each hormonal constituent (high versus low estrogen or progestin potency). Logistic regression was used to evaluate associations between endometrial cancer risk and combination OC formulations. With non-users as the referent group, use of OCs with either high potency progestin [odds ratio for endometrial cancer (OR)=0.21, 95% confidence interval (CI)=0.10 to 0.43] or with low potency progestin (OR=0.39, 95% CI=0.25 to 0.60) were both associated with a decreased risk of endometrial cancer. Overall high progestin potency OCs did not confer significantly more protection than low progestin potency OCs (OR=0.52, 95% CI=0.24 to 1.14). However, among women with a body mass index of 22.1 kg/m2 or higher, those who used high progestin potency oral contraceptives had a lower risk of endometrial cancer than those who used low progestin potency oral contraceptives (OR=0.31, 95% CI=0.11 to 0.92) while those with a BMI below 22.1 kg/m2 did not (OR=1.36, 95% CI=0.39 to 4.70). The potency of the progestin in most OCs appears adequate to provide a protective effect against endometrial cancer. Higher progestin-potency OCs may be more protective than lower progestin potency OCs among women with a larger body habitus.

Oral contraceptives in polycystic ovary syndrome.

PubMed

Helvaci, N; Yildiz, B O

2014-09-01

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of women of reproductive age and combined oral contraceptives (OCs) are often the first-line treatment of the syndrome by improving hyperandrogenism and regulating menstrual cycles. Oral contraceptives have some cardiovascular and metabolic effects that varies among different formulations depending upon the dose and type of the both estrogen and progestin components. These cardiometabolic effects of OCs raise some concerns about their long-term use in PCOS, but available data suggest that the benefits outweigh the risks. More studies are needed to clarify the safety of long-term use of OCs in PCOS.

Use of and access to oral and injectable contraceptives in Brazil

PubMed Central

Farias, Mareni Rocha; Leite, Silvana Nair; Tavares, Noemia Urruth Leão; Oliveira, Maria Auxiliadora; Arrais, Paulo Sergio Dourado; Bertoldi, Andréa Dâmaso; Pizzol, Tatiane da Silva Dal; Luiza, Vera Lucia; Ramos, Luiz Roberto; Mengue, Sotero Serrate

2016-01-01

contraceptives from SUS. Monophasic combined oral contraceptives were the most frequently reported (71.6%) and low-level levonorgestrel + ethinylestradiol combination accounted for 38.7% of them. The most frequently reported medicines are included in the Relação Nacional de Medicamentos Essenciais (RENAME – National List of Essential Medicines. CONCLUSIONS Most women aged 15 to 49 who reported using contraceptives had access to the medicine and use monophasic combined oral contraceptives of appropriate efficiency and safety purchased by direct payment, mainly from retail pharmacies. PMID:27982384

Use of combined oral contraceptives and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases

PubMed Central

Coupland, Carol; Hippisley-Cox, Julia

2015-01-01

Objective To investigate the association between use of combined oral contraceptives and risk of venous thromboembolism, taking the type of progestogen into account. Design Two nested case-control studies. Setting General practices in the United Kingdom contributing to the Clinical Practice Research Datalink (CPRD; 618 practices) and QResearch primary care database (722 practices). Participants Women aged 15-49 years with a first diagnosis of venous thromboembolism in 2001-13, each matched with up to five controls by age, practice, and calendar year. Main outcome measures Odds ratios for incident venous thromboembolism and use of combined oral contraceptives in the previous year, adjusted for smoking status, alcohol consumption, ethnic group, body mass index, comorbidities, and other contraceptive drugs. Results were combined across the two datasets. Results 5062 cases of venous thromboembolism from CPRD and 5500 from QResearch were analysed. Current exposure to any combined oral contraceptive was associated with an increased risk of venous thromboembolism (adjusted odds ratio 2.97, 95% confidence interval 2.78 to 3.17) compared with no exposure in the previous year. Corresponding risks associated with current exposure to desogestrel (4.28, 3.66 to 5.01), gestodene (3.64, 3.00 to 4.43), drospirenone (4.12, 3.43 to 4.96), and cyproterone (4.27, 3.57 to 5.11) were significantly higher than those for second generation contraceptives levonorgestrel (2.38, 2.18 to 2.59) and norethisterone (2.56, 2.15 to 3.06), and for norgestimate (2.53, 2.17 to 2.96). The number of extra cases of venous thromboembolism per year per 10 000 treated women was lowest for levonorgestrel (6, 95% confidence interval 5 to 7) and norgestimate (6, 5 to 8), and highest for desogestrel (14, 11 to 17) and cyproterone (14, 11 to 17). Conclusions In these population based, case-control studies using two large primary care databases, risks of venous thromboembolism associated with combined oral

The effect of a combination therapy with myo-inositol and a combined oral contraceptive pill versus a combined oral contraceptive pill alone on metabolic, endocrine, and clinical parameters in polycystic ovary syndrome.

PubMed

Minozzi, Massimo; Costantino, Demetrio; Guaraldi, Claudia; Unfer, Vittorio

2011-11-01

Compare the effects of a combined contraceptive pill (OCP) in combination with myo-inositol (MI) on endocrine, metabolic, and clinical parameters in patients with polycystic ovary syndrome (PCOS). One hundred fifty-five patients with PCOS were enrolled in this prospective, open-label clinical study. Patients were assigned to receive oral treatment with OCP alone (estradiol (EE) 30 μg/gestodene 75 μg) or in combination with myo-inositol 4 g/die, for 12 months. OCP plus MI therapy resulted in a higher reduction of FG score compared with OCP alone therapy. The combined therapy (OCP plus MI) significantly decreased hyperinsulinaemia, by positively affecting the fasting insulin and glucose levels and homeostasis model assessment-insulin resistance parameters, while no significant changes were observed in the OCP group. Androgens serum levels decreased in both groups, but significantly more in the combined therapy group. The lipid profile was improved in the combined therapy group, by reducing low-density lipoprotein cholesterol levels and enhancing high-density lipoprotein cholesterol levels. Our data show that a combination of combined contraceptive pill and MI may be more effective in controlling endocrine, metabolic, and clinical profile in patients with PCOS than OCP alone, and may reduce insulin levels and insulin resistance. Hence, combined treatment may become a more effective long-term therapeutic choice for controlling PCOS symptoms.

Maintaining physiological testosterone levels by adding dehydroepiandrosterone to combined oral contraceptives: I. Endocrine effects.

PubMed

Coelingh Bennink, Herjan J T; Zimmerman, Yvette; Laan, Ellen; Termeer, Hanneke M M; Appels, Nicole; Albert, Adelin; Fauser, Bart C J M; Thijssen, Jos H H; van Lunsen, Rik H W

2017-11-01

To determine whether adding dehydroepiandrosterone to combined oral contraceptives (COCs) maintains physiological levels of free testosterone. A randomized, double-blind, placebo-controlled, two-way crossover study conducted in 81 healthy women (age range: 20-35 years; Body mass index (BMI) range: 18-35 kg/m 2 ) using oral contraceptives. Androgens, sex hormone-binding globulin (SHBG), estradiol (E2) and estrone (E1) were measured, and free testosterone and the free testosterone index were calculated. Subjects discontinued oral contraceptive use for at least one menstrual cycle before being randomized to receive five cycles of ethinyl estradiol (EE) combined with either levonorgestrel (EE/LNG group) or drospirenone (EE/DRSP group) together with either dehydroepiandrosterone (DHEA) (50 mg/day orally) or placebo. Subsequently, all subjects crossed over to the other treatment arm for an additional five cycles. Both COCs decreased the levels of all androgens measured. Significant decreases (p<.05) were found with EE/LNG and EE/DRSP for total testosterone (54.5% and 11.3%, respectively) and for free testosterone (66.8% and 75.6%, respectively). Adding DHEA to the COCs significantly increased all androgens compared to placebo. Moreover, including DHEA restored free testosterone levels to baseline values in both COC groups and total testosterone levels to baseline in the EE/LNG group and above baseline in the EE/DRSP group. SHBG concentrations were significantly higher with EE/DRSP compared to EE/LNG (p<.0001). The addition of DHEA did not affect the levels of SHBG. Taking COCs reduces total and free testosterone levels and increases SHBG concentrations. By coadministration with DHEA, physiological levels of total and free testosterone are restored while using EE/LNG. With EE/DRSP, only the free testosterone level is normalized by DHEA coadministration. A daily oral dose of 50-mg DHEA maintains physiological free and total testosterone levels in women who are using an EE

Evaluation of lipid profile in adolescents during long-term use of combined oral hormonal contraceptives.

PubMed

Guazzelli, Christina Aparecida Falbo; Lindsey, Prescilla Chow; de Araújo, Fabio Fernando; Barbieri, Márcia; Petta, Carlos Alberto; Aldrighi, Jose Mendes

2005-02-01

The study evaluated the effects of the long-term use of a combined oral hormonal contraceptive containing 30 microg ethinyl estradiol and 75 microg gestodene in adolescents. Thirty-three volunteers, aged from 14 to 19 years, who used the oral contraceptive for three consecutive years, were studied. Evaluation of total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides was made before use and after 1, 2 and 3 years. During the 3-year study period, total cholesterol, HDL-C, LDL-C and triglyceride levels were significantly higher than previous measurements, but average values did not exceed the normal range. Compared to the first year, the second- and third-year cholesterol, HDL-C, LDL-C and triglyceride levels were not significantly different.

A study on utilization of oral contraceptives in the City of Zagreb (2008-2010).

PubMed

Zelić-Kerep, Ana; Stimac, Danijela; Ozić, Sanja; Zivković, Kresimir; Zivković, Nikica

2014-06-01

Main aim of this study is to quantify and analyze the utilization and utilization trends of oral hormonal contraceptives in the City of Zagreb, 2008-2010, and to propose potential interventions, if necessary. Data gathered from Zagreb pharmacies were assessed by Anatomical Therapeutic Chemical Classification of drugs and Daily Defined Dose methodology. An alarming decrease in total utilization of hormonal contraceptives by 76% from 2008-2009 was found as the main result of this study. A major decrease by 95.5% in utilization of G03AB04 subgroup, sequential combined oral contraceptives, was noted in the year 2009. The subgroup G03AC0, progesterone-only pill group, showed a stable trend, and it became the most utilized subgroup in 2010, due to the decrease in utilization of both fixed and sequential combined oral contraceptives. Utilization of oral contraceptives in Croatia is not regulated adequately, since such dynamics in utilization can occur unnoticed. Measures need to take place in order to improve this situation. Proposed measures include organized farmacovigilance, prescription based on guidelines, and strict screening for risk factors in women seeking oral contraception. More research is required in Croatia to understand the pattern of utilization of hormonal contraceptives and to find the true cause of decrease in utilization of oral contraceptives.

Oral contraceptives and neuroactive steroids.

PubMed

Rapkin, Andrea J; Biggio, Giovanni; Concas, Alessandra

2006-08-01

A deregulation in the peripheral and brain concentrations of neuroactive steroids has been found in certain pathological conditions characterized by emotional or affective disturbances, including major depression and anxiety disorders. In this article we summarize data pertaining to the modulatory effects of oral contraceptive treatment on neuroactive steroids in women and rats. Given that the neuroactive steroids concentrations are reduced by oral contraceptives, together with the evidence that a subset of women taking oral contraceptives experience negative mood symptoms, we propose the use of this pharmacological treatment as a putative model to study the role of neuroactive steroids in the etiopathology of mood disorders. Moreover, since neuroactive steroids are potent modulators of GABA(A) receptor function and plasticity, the treatment with oral contraceptives might also represent a useful experimental model to further investigate the physiological role of these steroids in the modulation of GABAergic transmission.

History of oral contraception.

PubMed

Dhont, Marc

2010-12-01

On the 50th birthday of the pill, it is appropriate to recall the milestones which have led to its development and evolution during the last five decades. The main contraceptive effect of the pill being inhibition of ovulation, it may be called a small miracle that this drug was developed long before the complex regulation of ovulation and the menstrual cycle was elucidated. Another stumbling block on its way was the hostile climate with regard to contraception that prevailed at the time. Animal experiments on the effect of sex steroids on ovulation, and the synthesis of sex steroids and orally active analogues were the necessary preliminaries. We owe the development of oral contraceptives to a handful of persons: two determined feminists, Margaret Sanger and Katherine McCormick; a biologist, Gregory Pincus; and a gynaecologist, John Rock. Soon after the introduction of the first pills, some nasty and life-threatening side effects emerged, which were due to the high doses of sex steroids. This led to the development of new preparations with reduced oestrogen content, progestins with more specific action, and alternative administration routes. Almost every decade we have witnessed a breakthrough in oral contraception. Social and moral objections to birth control have gradually disappeared and, notwithstanding some pill scares, oral contraceptives are now one of the most used methods of contraception. Finally, all's well that ends well: recent reports have substantiated the multiple noncontraceptive health benefits paving the way for a bright future for this 50-year-old product.

[Arterial diseases in women using combined hormonal contraceptives].

PubMed

Novotná, M; Unzeitig, V; Novotný, T

2002-05-01

To determine the association between myocardial infarction and cerebral stroke and use of combined oral contraceptives. Review of literature. Department of Obstetrics and Gynaecology, Hospital of Merciful Brothers, Brno, Czech Republic. Identification of methodologically sound studies able to address the topic. Studies were identified by Medline database search. Five the most recent and important studies were the main source of information (Oxford Family Planning Association Contraception Study 1984, Royal College of General Practitioners' Study 1994, WHO Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception 1996, 1997, Transnational Study on Oral Contraceptives and the Health of Young Women 1997, Myocardial Infarction and Oral Contraceptives Study, 1997). Generally there was no evidence of a significantly increased risk of arterial wall disease in healthy non smoked users younger than 35 years. No difference between second and third generation oral contraceptives on risk of arterial wall disease were found. In the most of cases of myocardial infarction or stroke one or more risk factor were identified. Two of the most relevant risk factors are smoking and the absence of blood pressure control. The risk of arterial cardiovascular system diseases seems not to be increased at no-risk users (healthy non-smoker younger than 35 years).

Higher risk of venous thrombosis associated with drospirenone-containing oral contraceptives: a population-based cohort study

PubMed Central

Gronich, Naomi; Lavi, Idit; Rennert, Gad

2011-01-01

Background: Combined oral contraceptives are a common method of contraception, but they carry a risk of venous and arterial thrombosis. We assessed whether use of drospirenone was associated with an increase in thrombotic risk relative to third-generation combined oral contraceptives. Methods: Using computerized records of the largest health care provider in Israel, we identified all women aged 12 to 50 years for whom combined oral contraceptives had been dispensed between Jan. 1, 2002, and Dec. 31, 2008. We followed the cohort until 2009. We used Poisson regression models to estimate the crude and adjusted rate ratios for risk factors for venous thrombotic events (specifically deep vein thrombosis and pulmonary embolism) and arterial thromboic events (specifically transient ischemic attack and cerebrovascular accident). We performed multivariable analyses to compare types of contraceptives, with adjustment for the various risk factors. Results: We identified a total of 1017 (0.24%) venous and arterial thrombotic events among 431 223 use episodes during 819 749 woman-years of follow-up (6.33 venous events and 6.10 arterial events per 10 000 woman-years). In a multivariable model, use of drospirenone carried an increased risk of venous thrombotic events, relative to both third-generation combined oral contraceptives (rate ratio [RR] 1.43, 95% confidence interval [CI] 1.15–1.78) and second-generation combined oral contraceptives (RR 1.65, 95% CI 1.02–2.65). There was no increase in the risk of arterial thrombosis with drospirenone. Interpretation: Use of drospirenone-containing oral contraceptives was associated with an increased risk of deep vein thrombosis and pulmonary embolism, but not transient ischemic attack or cerebrovascular attack, relative to second- and third-generation combined oral contraceptives. PMID:22065352

Comparative effects of a contraceptive vaginal ring delivering a nonandrogenic progestin and continuous ethinyl estradiol and a combined oral contraceptive containing levonorgestrel on hemostasis variables.

PubMed

Rad, Mandana; Kluft, Cornelis; Ménard, Joël; Burggraaf, Jacobus; de Kam, Marieke L; Meijer, Piet; Sivin, Irving; Sitruk-Ware, Regine L

2006-07-01

This study aimed to compare the effects on hemostasis variables of a contraceptive vaginal ring with those of an oral contraceptive. Twenty-three and 22 healthy premenopausal women were randomized to the contraceptive vaginal ring (150 microg Nestorone and 15 microg ethinyl estradiol) or Stediril 30 during 3 cycles. Analysis of covariance was performed with baseline values as covariate. The contraceptive vaginal ring changed most hemostasis variables similarly but raised (95% confidence intervals of percent treatment differences) Factor VIIt (28% to 49%), extrinsic activated protein C resistance (14% to 65%), and sex hormone-binding globulin (117% to 210%) and lowered Protein S (-32% to -16%) and the global activated partial thromboplastin time-based activated protein C resistance (-12% to -2%) more than the oral contraceptive. The contraceptive vaginal ring affected some measured hemostasis variables and sex hormone-binding globulin differently from the oral contraceptive, most likely because of difference in androgenicity of the progestins. The results suggest that the contraindications for oral contraceptive use would also apply to the tested contraceptive vaginal ring.

Ocular complications of oral contraceptives.

PubMed

Wood, J R

1977-01-01

The systemic side effects of oral contraceptives are mentioned, and the incidence and variety of ocular complications are discussed. Experimental studies on the ocular effects of oral contraceptives in laboratory animals have shown only increased permeability of the lens and possibly vascular dilatation. Numerous case reports, however, have been published which describe neuroophthalamic, vascular, retinal and macular, aqueous humor dynamic, cornea and contact lense, lens, color vision, and other miscellaneous effects. These reports are reviewed as are the 6 reported prospective studies. These prospective studies reveal only changes in kerotometry readings. Thus the large number of case reports may represent a low overall incidence or may be normal findings in the population as a whole or may be caused by other systemic factors. Until multicenter prospective studies provide definitive guidelines, the risk associated with oral contraceptive use must be kept in its proper perpsective and ocular histories should contain information on oral contraceptive use.

Correlates of oral contraception continuation.

PubMed

Ewer, P A; Gibbs, J O

1971-05-01

A sample of 139 predominantly black, young, low-income patients who had accepted oral contraception at a publicly supported family planning clinic has been analyzed for correlates of oral contraception continuation. Interviews were conducted 10-12 months after the clinic visit; at this time 38% of the patients continued taking oral contraceptives. It was found that patients with the highest continuation rates were 18-24 years old, in the 2-3 parity group, living with their husbands, had low-parity mothers, and were able to fill prescriptions in less time with more convenient methods of transportation. Discontinuers tended to have high-parity mothers, live with parents or head their own households, and to be in the 13-17 or 25-45 year old age groups. Fear of long-term use of oral contraceptives and perceived side effects appeared to be implicated in discontinuation. The rate of discontinuation may be associated with irregular coital experience and less consistent exposure to pregnancy.

A randomized double-blind trial of two low dose combined oral contraceptives.

PubMed

Bounds, W; Vessey, M; Wiggins, P

1979-04-01

Fifty-five women using Loestrin-20 (20 microgram ethinyl oestradiol and 1 mg norethisterone acetate) as an oral contraceptive have been compared with a like number using Microgynon-30 (30 microgram ethinyl oestradiol and 150 microgram levonorgestrel) in a randomized, double-blind trial. Despite the small sample size, the main finding in the trial is clear-cut; Loestrin-20 provides poor cycle control and is thus less acceptable as an oral contraceptive than Microgynon-30. Although there is also a suggestion that Loestrin-20 may be less effective than Microgynon-30, the difference in the accidental pregnancy rates is not statistically significant.

Pharmacodynamics of combined estrogen-progestin oral contraceptives: 1. Effects on metabolism.

PubMed

Bastianelli, Carlo; Farris, Manuela; Rosato, Elena; Brosens, Ivo; Benagiano, Giuseppe

2017-03-01

The risk-benefit profile of any pharmacologic agent must be evaluated against risks connected with the events to be avoided. This is especially true in the case of hormonal contraception, not intended to combat a disease. Over the six decades during which their use has progressively expanded, the risk-benefit profile of combined oral contraceptives (COC) has substantially changed, with new combinations, dosages and mode of administration appearing on the market. Area covered: In a series of articles, recent information on the complex issue of COC risks and benefits will be reviewed in the hope of providing an updated picture. The present article reviews metabolic changes occurring during use of modern combinations of estrogens (ethinyl estradiol, estradiol, estradiol valerate and estetrol) and new progestins (desogestrel, gestodene, dienogest, drospirenone, nomegestrol acetate), often compared to classic compounds, such as levonorgestrel. Three categories of metabolic effects in healthy women are detailed: on carbohydrates, lipid and bone mineral content. Expert commentary: Overall, the picture is reassuring: the new generations of progestins are basically devoid of androgenic, estrogenic or glucocorticoid related side-effects. This should result in an improved safety profile, although past history teaches us that that large comparative and surveillance studies are required before firm conclusions can be drawn. At any rate, available evidence indicates that metabolic effects of third and fourth generation progestins, especially when they are combined with natural estrogens, are minimal and, if used in healthy women, should not cause concern.

A prospective randomized trial comparing low-dose ethinyl estradiol and drospirenone 24/4 combined oral contraceptive vs. ethinyl estradiol and drospirenone 21/7 combined oral contraceptive in the treatment of hirsutism.

PubMed

Oner, Gokalp; Muderris, Iptisam Ipek

2011-11-01

A prospective randomized trial was conducted to compare the clinical efficacy of two oral contraceptives containing drospirenone in the treatment of hirsutism in women. Fifty women with moderate to severe hirsutism were recruited. Three women were lost to follow-up. Twenty-four patients received oral 0.03 mg ethinyl estradiol and 3 mg drospirenone 21/7 regimen (Group 1) for 6 months. Another group of 23 patients received oral 0.02 mg ethinyl estradiol and 3 mg drospirenone 24/4 regimen (Group 2) for 6 months. Hirsutism was assessed after 6 months using the Ferriman-Gallwey (F-G) scoring system. Hormonal levels after 6 months of both therapies were compared with baseline values and each other. An improvement in the F-G scores for hirsutism (mean±SD) was observed in Group 1 (17.3±5.2 to 8.7±2.5, p<.001) and in Group 2 (17.5±4.8 to 7.9±2.8, p<.001). Pre- and post-treatment hirsutism scores were comparable between the groups (p>.05). Total and free testosterone levels decreased significantly after the therapy in both groups. The sex hormone-binding globulin levels increased significantly in both groups during the 6-month period. The treatment of hirsutism with both combined oral contraceptives (COCs) containing drospirenone offered comparable effects and was well tolerated. Copyright © 2011 Elsevier Inc. All rights reserved.

Efficacy and safety of metformin or oral contraceptives, or both in polycystic ovary syndrome.

PubMed

Yang, Young-Mo; Choi, Eun Joo

2015-01-01

Polycystic ovary syndrome (PCOS) is an endocrinopathy that affects approximately 10% of reproductive-aged women throughout their lives. Women with PCOS present with heterogeneous symptoms including ovulatory dysfunction, hyperandrogenism, and polycystic ovaries. Therefore, lifelong individualized management should be considered. Pharmacological agents commonly used to manage the symptoms are metformin and oral contraceptive pills. Although these medications have been beneficial in treating PCOS symptoms, their efficacy and safety are still not entirely elucidated. This study aimed to report the efficacy and safety of metformin, oral contraceptives, or their combination in the treatment of PCOS and to define their specific individual roles. A literature search of original studies published in PubMed and Scopus was conducted to identify studies comparing metformin with oral contraceptives or evaluating the combination of both in PCOS. Eight clinical trials involving 313 patients were examined in the review. The intervention dosage of metformin ranged from 1,000 to 2,000 mg/d and that of oral contraceptives was ethinylestradiol 35 µg and cyproterone acetate 2 mg. Lower body mass index was observed with regimens including metformin, but increased body mass index was observed in monotherapy with oral contraceptives. Administration of metformin or oral contraceptives, especially as monotherapy, had a negative effect on lipid profiles. In addition, there are still uncertainties surrounding the effects of metformin or oral contraceptives in the management of insulin level, although they improved total testosterone and sex hormone-binding globulin levels. In the included studies, significant side effects due to metformin or oral contraceptives were not reported. The clinical trials suggest that metformin or oral contraceptives are at least patient convenient, efficacious, and safe for the treatment of PCOS. However, well-designed, prospective, long-term, large

Efficacy and safety of metformin or oral contraceptives, or both in polycystic ovary syndrome

PubMed Central

Yang, Young-Mo; Choi, Eun Joo

2015-01-01

Background Polycystic ovary syndrome (PCOS) is an endocrinopathy that affects approximately 10% of reproductive-aged women throughout their lives. Women with PCOS present with heterogeneous symptoms including ovulatory dysfunction, hyperandrogenism, and polycystic ovaries. Therefore, lifelong individualized management should be considered. Pharmacological agents commonly used to manage the symptoms are metformin and oral contraceptive pills. Although these medications have been beneficial in treating PCOS symptoms, their efficacy and safety are still not entirely elucidated. This study aimed to report the efficacy and safety of metformin, oral contraceptives, or their combination in the treatment of PCOS and to define their specific individual roles. Methods A literature search of original studies published in PubMed and Scopus was conducted to identify studies comparing metformin with oral contraceptives or evaluating the combination of both in PCOS. Results Eight clinical trials involving 313 patients were examined in the review. The intervention dosage of metformin ranged from 1,000 to 2,000 mg/d and that of oral contraceptives was ethinylestradiol 35 µg and cyproterone acetate 2 mg. Lower body mass index was observed with regimens including metformin, but increased body mass index was observed in monotherapy with oral contraceptives. Administration of metformin or oral contraceptives, especially as monotherapy, had a negative effect on lipid profiles. In addition, there are still uncertainties surrounding the effects of metformin or oral contraceptives in the management of insulin level, although they improved total testosterone and sex hormone-binding globulin levels. In the included studies, significant side effects due to metformin or oral contraceptives were not reported. Conclusion The clinical trials suggest that metformin or oral contraceptives are at least patient convenient, efficacious, and safe for the treatment of PCOS. However, well

A primer on the hormone-free interval for combined oral contraceptives.

PubMed

Hauck, Brian A; Brown, Vivien

2015-01-01

The dosing, schedules, and other aspects of combined oral contraceptive (COC) design have evolved in recent years to address a variety of issues including short- and long-term safety, bleeding profiles, and contraceptive efficacy. In particular, several newer formulations have altered the length of the hormone-free interval (HFI), in order to minimize two key undesired effects that occur during this time: hormone-withdrawal-associated symptoms (HWaS) and follicular development. This primer reviews our current understanding of the key biological processes that occur during the HFI and how this understanding has led to changes in the dosing and schedule of newer COC formulations. In brief, HWaS are common, underappreciated, and a likely contributor to COC discontinuation; because of this, shortening the HFI and/or supplementing with estrogen during the progestin-free interval may provide relief from these symptoms and improve adherence. A short HFI (with or without estrogen supplementation) may also help maintain effective follicular suppression and contraceptive efficacy, even when the overall dose of estrogen throughout the cycle is low. Taken together, the available data about HWaS and follicular activity during the HFI support the rationale for recent COC designs that use a low estrogen dose and a short HFI. The availability of a variety of COC regimens gives physicians a range of choices when selecting the most appropriate COC for each woman's particular priorities and needs.

The combined use of oral medroxyprogesterone acetate and methyltestosterone in a male contraceptive trial programme.

PubMed

Bain, J; Rachlis, V; Robert, E; Khait, Z

1980-04-01

A male contraceptive trial was undertaken in 23 men using a combination of oral medroxyprogesterone acetate (MPA) and oral methyltestosterone (MeT). The men were divided into four groups according to varying drug dosages and were followed for 15 months (control - 3 months, treatment - 6 months, follow-up - 6 months). The parameters assessed included sperm count and motility, serum gonadotropins and sex steroids, and several biochemical and hematological tests. A questionnaire dealing with side-effects and changes in sexual function was administered intermittently. Although sperm count was suppressed (most dramatically at the highest drug doses, MPA 20mg,MeT 20mg), it was not suppressed to infertile levels. Sperm motility was unaltered; LH was modestly suppressed, FSH was not suppressed; testosterone was suppressed even at low doses; dihydrotestosterone responses were inconsistent. No significant biochemical abnormalities or side-effects occurred although some men experienced mild transient acne, gynecomastia and decreased testicular size. We conclude that in the doses used in this trial, the combination of MPA and MeT is not effective for male contraceptive, purposes and that higher doses may induce severe and undesirable side-effects.

Combined oral contraceptive treatment for bleeding complaints with the etonogestrel contraceptive implant: a randomised controlled trial.

PubMed

Hou, Melody Y; McNicholas, Colleen; Creinin, Mitchell D

2016-10-01

Estimate symptom improvement rate of women with bleeding complaints using the etonogestrel contraceptive implant when started on continuous combined oral contraceptives (COC). We conducted a double-blinded randomised controlled trial of women reporting troublesome bleeding related to their etonogestrel contraceptive implant and desiring intervention. Participants received continuous COCs or placebo for four weeks to evaluate self-reported bleeding improvement at four weeks. Participants could continue study treatment or prescribed COCs for another eight weeks if desired. We planned to enroll 130 participants between two sites (80% power to detect a 20% effect size at a 0.05 significance level, with 10% loss to follow up). We closed the study after enrolling 26 participants due to recruitment futility. All women on COCs and 75% of placebo users reported bleeding improvement at four weeks (p = 0.09), with 92% and 42%, respectively, reporting significant improvement (p = 0.03). The median number of days until bleeding stopped for at least four days in COC and placebo users was 1 day (range 1-9) and 4.5 days (range 1-28), respectively (p = 0.63). Eight (75%) COC and five (42%) placebo users opted to continue study treatment (p = 0.41). Despite bleeding improvement, women who desired implant removal at enrollment were more likely to re-request removal than those who initially considered other interventions (3 of 5 [60%] vs 1 of 17 [6%], p = 0.03). Although women who have troublesome bleeding while using the contraceptive implant may experience improvement with no treatment over 4 weeks, women using COCs are more likely to report significant improvement. Clinicaltrials.gov registration number: NCT01963403.

[Individualization of low-dose oral contraceptives. Pharmacological principles and practical indications for oral contraceptives].

PubMed

Cianci, A; De Leo, V

2007-08-01

water retention, weight gain and arterial hypertension often associated with oral contraceptive use. Recent comparative studies recorded weight loss that stabilized after 6 months of treatment with drospirenone/EE. Overweight women may therefore benefit from the formulation with 20 microg EE, whereas the formulation with at least 30 microg EE should be more appropriate for underweight women. Women with slight to moderate acne, the formulation with 30 microg EE has been found to be as effective as 2 mg cyproterone acetate combined with 35 micrig EE (Diane). Menstrual cycle characteristics, however, remain the main factor determining the choice of formulation. Randomised control studies comparing the new formulation with others containing second or third generation progesterones have found similar efficacy in cycle control and incidence of spotting. From this point of view, it is not advisable to prescribe more than 30 microg EE (Yasmin or Yasminelle) for women with normal menstrual cycles, whereas in cases of hypomenorrhea and/or amenorrhea at least this dose of EE plus drospirenone may be used. Women with hypermenorrhea run the risk of spotting if an inappropriate drug is chosen. A solution is to use 30 microg EE/drospirenone from day 5 of the cycle. To control so-called minor side-effects, the dose of EE must be appropriate. In women with premenstrual tension a dose of at least 30 microg EE associated with drospirenone reduces or even prevents symptoms. On the other hand, in cases of chronic headache or headache as a side-effect of oral contraceptive use, a lower dose of estrogen is beneficial, and doses below 20 microg may be used. Although the progesterone component is not considered to affect headache, good results have been obtained with drospirenone, the antimineralcorticoid effects of which reduce blood pressure and improve symptoms. Formulations with 20 microg EE and drospirenone are particularly indicated in women with pre-existing mastodynia, fibrocystic

Therapeutic, prophylactic, untoward, and contraceptive effects of combined oral contraceptives: catholic teaching, natural law, and the principle of double effect when deciding to prescribe and use.

PubMed

Casey, Murray Joseph; Salzman, Todd A

2014-01-01

Combined oral contraceptives (COC) have been demonstrated to have significant benefits for the treatment and prevention of disease. These medications also are associated with untoward health effects, and they may be directly contraceptive. Prescribers and users must compare and weigh the intended beneficial health effects against foreseeable but unintended possible adverse effects in their decisions to prescribe and use. Additionally, those who intend to abide by Catholic teachings must consider prohibitions against contraception. Ethical judgments concerning both health benefits and contraception are approached in this essay through an overview of the therapeutic, prophylactic, untoward, and contraceptive effects of COC and discussion of magisterial and traditional Catholic teachings from natural law. Discerning through the principle of double effect, proportionate reason, and evidence gathered from the sciences, medical and moral conclusions are drawn that we believe to be fully compliant with good medicine and Catholic teaching.

Oral contraceptives and benign breast disease.

PubMed

Hislop, T G; Threlfall, W J

1984-08-01

In 1980 a questionnaire was mailed to 726 nurses who had previously entered a study of breast disease in the late 1940s and 1950s; 665 responded. Between the ages of 30 to 49 years, 137 reported detecting their first signs of benign breast disease and 76 reported receiving their first biopsy for these signs. Long-term oral contraceptive usage reduced the risk of developing signs of benign breast disease and the risk of biopsy for these signs. The potential bias due to the effect of prior benign breast disease on the prescribing practices for oral contraceptives was minimized by considering oral contraceptive usage prior to detecting the first signs of benign breast disease.

Evaluation of effects of an oral contraceptive containing ethinylestradiol combined with drospirenone on adrenal steroidogenesis in hyperandrogenic women with polycystic ovary syndrome.

PubMed

De Leo, Vincenzo; Morgante, Giuseppe; Piomboni, Paola; Musacchio, Maria Concetta; Petraglia, Felice; Cianci, Antonio

2007-07-01

To investigate whether the administration of an oral contraceptive containing the new antiandrogenic drospirenone is associated with reduced adrenal androgen synthesis in hyperandrogenic women with diagnosis of polycystic ovary syndrome. Drospirenone, an analogue of spironolactone and aldosterone antagonist, is a novel progestin under clinical development that is similar to the natural hormone progesterone, combining potent progestogenic with antimineralocorticoid and antiandrogenic activities. Prospective study. Healthy volunteers in University Department of Obstetrics and Gynecology. Fifteen women ages 18 to 28 years with the diagnosis of polycystic ovary syndrome. Three months of contraceptive use (30 mcg ethinylestradiol, 3 mg drospirenone). An adrenocorticotropic hormone test was performed before and after the study. Adrenal production of cortisol was unchanged after therapy with oral contraceptives. An interesting observation was reduced basal concentrations of androgens such as androstenedione, dehydroepiandrosterone sulfate, testosterone, and free testosterone during therapy. The ratios of the areas of substrates to products before and after oral contraceptive administration were compared for differences in 17alpha-hydroxylase (17-hydroxyprogesterone/progesterone) and 17,20-lyase (androstenedione/17-hydroxyprogesterone); activities were significantly reduced, indicating a reduction in the activities of these enzymes. The present results show for the first time that oral contraceptives containing drospirenone affect adrenal steroidogenesis by reducing synthesis and release of androgens in response to adrenocorticotropic hormone, leaving adrenal production of cortisol unchanged.

An overview of the development of combined oral contraceptives containing estradiol: focus on estradiol valerate/dienogest

PubMed Central

Fruzzetti, Franca; Trémollieres, Florence; Bitzer, Johannes

2012-01-01

Natural estrogens such as estradiol (E2) or its valerate ester (E2V) offer an alternative to ethinyl estradiol (EE). E2-containing combined oral contraceptives (COCs) have demonstrated sufficient ovulation inhibition and acceptable contraceptive efficacy. However, earlier formulations were generally associated with unacceptable bleeding profiles. Two E2V-containing preparations have been approved to date for contraceptive use: E2V/cypro-terone acetate (CPA) (Femilar®; only approved in Finland and only in women >40 years or women aged 35–40 years in whom a COC containing EE is not appropriate) and E2V/dienogest (DNG; Qlaira®/Natazia®). The objective of the current review is to provide an overview of the development of COCs containing natural estrogen, highlighting past issues and challenges faced by earlier formulations, as well as the current status and future directions. The majority of information to date pertains to the development of E2V/DNG. PMID:22468839

Oral contraceptive use changes brain activity and mood in women with previous negative affect on the pill--a double-blinded, placebo-controlled randomized trial of a levonorgestrel-containing combined oral contraceptive.

PubMed

Gingnell, Malin; Engman, Jonas; Frick, Andreas; Moby, Lena; Wikström, Johan; Fredrikson, Mats; Sundström-Poromaa, Inger

2013-07-01

Most women on combined oral contraceptives (COC) report high levels of satisfaction, but 4-10% complain of adverse mood effects. The aim of this randomized, double-blinded, placebo-controlled trial was to investigate if COC use would induce more pronounced mood symptoms than placebo in women with previous history of COC-induced adverse mood. A second aim was to determine if COC use is associated with changes in brain reactivity in regions previously associated with emotion processing. Thirty-four women with previous experience of mood deterioration during COC use were randomized to one treatment cycle with a levonorgestrel-containing COC or placebo. An emotional face matching task (vs. geometrical shapes) was administered during functional magnetic resonance imaging (fMRI) prior to and during the COC treatment cycle. Throughout the trial, women recorded daily symptom ratings on the Cyclicity Diagnoser (CD) scale. During the last week of the treatment cycle COC users had higher scores of depressed mood, mood swings, and fatigue than placebo users. COC users also had lower emotion-induced reactivity in the left insula, left middle frontal gyrus, and bilateral inferior frontal gyri as compared to placebo users. In comparison with their pretreatment cycle, the COC group had decreased emotion-induced reactivity in the bilateral inferior frontal gyri, whereas placebo users had decreased reactivity in the right amygdala. COC use in women who previously had experienced emotional side effects resulted in mood deterioration, and COC use was also accompanied by changes in emotional brain reactivity. These findings are of relevance for the understanding of how combined oral contraceptives may influence mood. Placebo-controlled fMRI studies in COC sensitive women could be of relevance for future testing of adverse mood effects in new oral contraceptives. Copyright © 2012 Elsevier Ltd. All rights reserved.

Adherence to oral contraception in women on Category X medications.

PubMed

Steinkellner, Amy; Chen, William; Denison, Shannon E

2010-10-01

Over 6% of women become pregnant when taking teratogenic medications, and contraceptive counseling appears to occur at suboptimal rates. Adherence to contraception is an important component in preventing unwanted pregnancy and has not been evaluated in this population. We undertook a pharmacy claims-based analysis to evaluate the degree to which women of childbearing age who receive Category X medications adhere to their oral contraception. We evaluated the prescription medication claims for over 6 million women, age 18-44 years, with prescription benefits administered by a pharmacy benefits manager. Women with 2 or more claims for a Category X medication and 2 or more claims for oral contraception were evaluated in further detail. Adherence to oral contraception was measured by analyzing pharmacy claims. Multivariable logistic regression was performed to identify factors associated with adherence. There were 146,758 women of childbearing age who received Category X medications, of which 26,136 also took oral contraceptive medication. Women who received Category X medications were prescribed oral contraception (18%) at rates similar to others of childbearing age (17%). Women prescribed both Category X and oral contraception demonstrated adherence similar to the overall population. Age, class of Category X medication, number of medications, prescriber's specialty, and ethnicity correlated with lower adherence rates. Despite added risk associated with unintended pregnancy, many women who receive Category X medications have refill patterns suggesting nonadherence to oral contraception. Compared with all women age 18-44 years, women receiving teratogenic medications do not have better adherence to oral contraception. Copyright © 2010 Elsevier Inc. All rights reserved.

Breast cancer among young U.S. women in relation to oral contraceptive use.

PubMed

White, E; Malone, K E; Weiss, N S; Daling, J R

1994-04-06

While most studies have found no association between oral contraceptive use and breast cancer, several studies of younger women have reported an association with long-term oral contraceptive use. PURPOSE. We studied the relationship of patterns of oral contraceptive use to breast cancer risk among younger women. These women have had oral contraceptives available their entire reproductive lives and are now entering the breast cancer-prone years. A population-based, case-control study of breast cancer was conducted in three counties in western Washington State among women born in 1945 or later, ages 21-45. Case patients were 747 women with breast cancer diagnosed in 1983-1990 and identified through the Seattle-Puget Sound Surveillance, Epidemiology, and End Results cancer registry. Control subjects were 961 women identified by random-digit telephone dialing. Subjects were interviewed in person, using pictures of brands of oral contraceptives and calendars of life events as recall aids. There was no increased incidence of breast cancer associated with ever having used oral contraceptives. Because only 8% of this cohort had never used oral contraceptives, short-term users (< 1 year) were combined with never users as the reference group for further analyses. A small increased risk of breast cancer was associated with long duration of oral contraceptive use (odds ratio for > or = 10 years = 1.3; 95% confidence interval [CI] = 0.9-1.9; P for trend = .03), particularly among women aged 35 years or younger (odds ratio for > or = 10 years = 1.7; 95% CI = 0.9-3.1). Breast cancer was also modestly related to oral contraceptive use early in reproductive life (odds ratio for use within 5 years of menarche = 1.3; 95% CI = 1.0-1.8; P for trend = .04) and to use of high-progestin-potency oral contraceptives for at least 1 year (odds ratio = 1.5; 95% CI = 1.1-2.1). These associations were adjusted for age, age at menarche, term pregnancy, induced abortion, and family history of

Discriminant analysis of the metabolic effects of a new combined contraceptive vaginal ring containing Nestorone/EE vs. a second-generation oral contraceptive containing levonorgestrel/EE.

PubMed

Rad, Mandana; Burggraaf, Jacobus; de Kam, Marieke L; Cohen, Adam F; Kluft, Cornelis

2012-09-01

Discriminant analysis (DA) was performed on data of two combined hormonal contraceptives (CHC) differing in estrogen ratio to explore whether a combination of variables rather than a single variable distinguishes CHCs better. Data were used of a parallel study in premenopausal women treated for three cycles (21 days on, 7 days off) with a contraceptive vaginal ring delivering Nestorone and ethinyl estradiol (EE) or an oral contraceptive containing levonorgestrel and EE. DA was performed on the change from baseline (CFB) and the end-of-treatment values at 3 months for lipids, sex-hormone binding globulin (SHBG), C-reactive protein, angiotensinogen, blood pressure and hemostasis variables, and on the hemostasis variables only. For the complete set, the CFB for factor VII (FVII), SHBG and plasminogen (PLG), or end-of-treatment SHBG- and FVII level discriminated the treatments best. Maximal discrimination for the hemostasis data was by CFB for FVII and PLG or end-of-treatment FVII level. DA identifies differences between CHCs and may provide information on the factors associated with thrombotic risk. Copyright © 2012 Elsevier Inc. All rights reserved.

A combined oral contraceptive affects mucosal SHIV susceptibility factors in a pigtail macaque model

PubMed Central

Ostergaard, Sharon Dietz; Butler, Katherine; Ritter, Jana M.; Johnson, Ryan; Sanders, Jeanine; Powell, Nathaniel; Lathrop, George; Zaki, Sherif R.; McNicholl, Janet M.; Kersh, Ellen N.

2015-01-01

Background Injectable hormonal contraception may increase women’s risk of HIV acquisition, and can affect biological risk factors in animal models of HIV. We established, for the first time, a model to investigate whether combined oral contraceptives (COC) alter SHIV susceptibility in macaques. Methods Seven pigtail macaques were administered a monophasic levonorgestrel (LNG)/ethinyl estradiol (EE) COC at 33% or 66% of the human dose for 60 days. Menstrual cycling, vaginal epithelial thickness and other SHIV susceptibility factors were monitored for a mean of 18 weeks. Results Mean vaginal epithelial thicknesses was 290.8 μm at baseline and 186.2 μm during COC (p=0.0141, Mann Whitney test). Vaginal pH decreased from 8.5 during to 6.5 post- treatment (0.0176 two-tailed t-test). Measured microflora was unchanged. Conclusions COC caused thinning of the vaginal epithelium and vaginal pH changes, which may increase SHIV susceptibility. 0.033 mg LNG + 0.0066 mg EE appeared effective in suppressing ovulation. PMID:25536296

21 CFR 310.501 - Patient package inserts for oral contraceptives.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Patient package inserts for oral contraceptives... Patient package inserts for oral contraceptives. (a) Requirement for a patient package insert. The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the...

21 CFR 310.501 - Patient package inserts for oral contraceptives.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Patient package inserts for oral contraceptives... Patient package inserts for oral contraceptives. (a) Requirement for a patient package insert. The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the...

21 CFR 310.501 - Patient package inserts for oral contraceptives.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Patient package inserts for oral contraceptives... Patient package inserts for oral contraceptives. (a) Requirement for a patient package insert. The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the...

Cancers in Australia in 2010 attributable to and prevented by the use of combined oral contraceptives.

PubMed

Jordan, Susan J; Wilson, Louise F; Nagle, Christina M; Green, Adele C; Olsen, Catherine M; Bain, Christopher J; Pandeya, Nirmala; Whiteman, David C; Webb, Penelope M

2015-10-01

To estimate the proportion and number of cancers occurring in Australia in 2010 attributable to combined oral contraceptive pill (OCP) use. We estimated the population attributable fraction (PAF) for cancers causally associated with combined OCP use (breast, cervix), and the proportion of endometrial and ovarian cancers prevented (prevented fraction [PF]). We used standard formulae incorporating prevalence of combined OCP use in the Australian population, relative risks of cancer associated with this exposure and cancer incidence. An estimated 105 breast and 52 cervical cancers (0.7% and 6.4% of each cancer, respectively) in Australia in 2010 were attributable to current use of combined OCP. Past combined OCP use was estimated to have prevented 1,032 endometrial and 308 ovarian cancers in 2010, reducing the number of cancers that would otherwise have occurred by 31% and 19%, respectively. A small proportion of breast and cervical cancers is attributable to combined OCP use; OCP use is likely to have prevented larger numbers of endometrial and ovarian cancers. Women seeking contraceptive advice should be told of potential adverse effects, but should also be told that - along with reproductive health benefits - combined OCP use can reduce long-term risks of ovarian and endometrial cancers. © 2015 The Authors.

Are oral emergency contraceptives a safe and effective form of long-term birth control?

PubMed

Kraus, Connie; Hooper-Lane, Christopher

2017-10-01

Yes, but not as effective as some other methods. Annual pregnancy rates in women using pericoital levonorgestrel 150 mcg to 1 mg range from 4.9% to 8.9%; menstrual irregularity is the most common adverse effect (strength of recommendation [SOR]: B, Cochrane review of lower-quality trials). In women younger than 35 years who have sexual intercourse 6 or fewer times per month, correct and consistent use of pericoital levonorgestrel 1.5 mg results in an annual pregnancy rate of 11% (SOR: B, one large prospective, open-label trial). Pericoital contraception is less effective than long-acting reversible contraceptives (annual pregnancy rates of 0.05%-0.8%) or perfect use of combined oral contraceptives (0.3% annual pregnancy rate), but similar to, or better than, typical use of combined oral contraception (9%) and condoms (18%).

A randomized comparative trial of a combined oral contraceptive and azelaic acid to assess their effect on sleep quality in adult female acne patients.

PubMed

Albuquerque, Rachel Gimenes; da Rocha, Marco Alexandre Dias; Hirotsu, Camila; Hachul, Helena; Bagatin, Edileia; Tufik, Sergio; Andersen, Monica Levy

2015-12-01

Several studies have reported an increase in the prevalence of adult female acne. This subtype of acne presents particular characteristics, and can be triggered by several factors such as smoking, stress, the use of oily cosmetics and even by poor sleep. Sleep quality is related to well-being and the maintenance of body homeostasis. In addition, several skin diseases present a bidirectional relationship with sleep, demonstrating an important connection between skin and the central nervous system. With this in mind, we aimed to compare the effect of two types of treatment for adult female acne (azelaic acid or a combined oral contraceptive) on sleep quality and on concentrations of stress hormones. Also, we proposed to assess the correlation of sleep and hormonal parameters with acne severity. In order to do this, 32 women underwent a clinical evaluation, completed the Pittsburgh Sleep Quality Index (PSQI) questionnaire and had their blood collected for hormone assays. These procedures were performed at baseline and after 6 months of treatment. At baseline there were no differences between the groups in terms of body mass index, age, acne severity and hormone concentrations. Results showed that both treatments demonstrated effectiveness but that women treated with azelaic acid presented a better sleep quality after the treatment compared to baseline and to the group treated with the combined oral contraceptive. The combined oral contraceptive group presented an increase in cortisol and a decrease in free testosterone concentration in relation to baseline. These data suggest that both azelaic acid and combined oral contraceptive are effective in the treatment of adult female acne but, azelaic acid seems to be a more suitable option for those women who may benefit from a better subjective sleep quality.

Effect of oral contraceptive agents on nutrients: II. Vitamins.

PubMed

Prasad, A S; Oberleas, D; Moghissi, K S; Stryker, J C; Lei, K Y

1975-04-01

Clinical, biochemical and nutritional data were collected from a large population of women using oral contraceptive agents. Higher incidence of abnormal clinical signs related to malnutrition were observed in the lower (B) as compared to the higher (A) socioeconomic groups, and also in the nonsupplemented groups as compared to the supplemented groups in the B subjects. As a rule the intake of oral contraceptive agent subjects of vitamin A, C, B6 and folic acid did not differ from that of the controls As expected, subjects from the supplemented groups had higher intake of vitamin A, C, B6, thiamin, riboflavin and folic acid, and A groups had higher intake of vitamin C, B6, riboflavin and folic acid. Increased plasma vitamin A and decreased carotene levels were observed in oral contraceptive agent users. In general oral contraceptive agents had little or no effect on plasma ascorbic acid. Urinary excretion of both thiamin and riboflavin in subjects using oral contraceptive agents were lower in A groups. Erythrocyte folate and plasma pyridoxal phosphate was decreased in A groups due to oral contraceptive agents. Subjects who took supplements had higher levels of plasma vitamin A, ascorbic acid and folate. But urinary thiamin and riboflavin were higher only in group A subjects who took supplements.

An ethinyl estradiol-levonorgestrel containing oral contraceptive does not alter cytochrome P4502C9 in vivo activity.

PubMed

Cherala, Ganesh; Pearson, Jacob; Maslen, Cheryl; Edelman, Alison

2014-03-01

Oral contraceptives have been in wide use for more than 50 years. Levonorgestrel, a commonly employed progestin component of combined oral contraceptives, was implicated in drug-drug interactions mediated via CYP2C9. Although in vitro studies refuted this interaction, there are no confirmatory in vivo studies. In the current study, we examined the phenotypic status of CYP2C9 using low-dose (125 mg) tolbutamide before and after oral contraceptive use in reproductive age women. Blood was collected 24 hours after the tolbutamide oral dose was administered, plasma was isolated, and tolbutamide concentration (C24) was measured using liquid chromatography-mass spectrometry. The natural logarithm of tolbutamide C24, a metric for CYP2C9 phenotype, was found to be equivalent (within 80%-125% equivalency boundaries) before and after oral contraceptive use. In conclusion, levonorgestrel-containing oral contraceptives, the most commonly used form of oral contraception, do not affect the status of the CYP2C9 enzyme. This suggests that it is safe to co-administer levonorgestrel-containing oral contraceptives and CYP2C9 substrates, which include a wide array of drugs.

An Ethinyl Estradiol-Levonorgestrel Containing Oral Contraceptive Does Not Alter Cytochrome P4502C9 In Vivo Activity

PubMed Central

Pearson, Jacob; Maslen, Cheryl; Edelman, Alison

2014-01-01

Oral contraceptives have been in wide use for more than 50 years. Levonorgestrel, a commonly employed progestin component of combined oral contraceptives, was implicated in drug–drug interactions mediated via CYP2C9. Although in vitro studies refuted this interaction, there are no confirmatory in vivo studies. In the current study, we examined the phenotypic status of CYP2C9 using low-dose (125 mg) tolbutamide before and after oral contraceptive use in reproductive age women. Blood was collected 24 hours after the tolbutamide oral dose was administered, plasma was isolated, and tolbutamide concentration (C24) was measured using liquid chromatography–mass spectrometry. The natural logarithm of tolbutamide C24, a metric for CYP2C9 phenotype, was found to be equivalent (within 80%–125% equivalency boundaries) before and after oral contraceptive use. In conclusion, levonorgestrel-containing oral contraceptives, the most commonly used form of oral contraception, do not affect the status of the CYP2C9 enzyme. This suggests that it is safe to coadminister levonorgestrel-containing oral contraceptives and CYP2C9 substrates, which include a wide array of drugs. PMID:24368832

Combined hormonal contraceptive (CHC) use among obese women and contraceptive effectiveness: a systematic review.

PubMed

Dragoman, Monica V; Simmons, Katharine B; Paulen, Melissa E; Curtis, Kathryn M

2017-02-01

To evaluate from the literature whether combined hormonal contraception (CHC), including combined oral contraception pills (COCs), transdermal patch, vaginal ring or combined injectables, have different effectiveness or failure rates by body weight or body mass index (BMI). We searched PubMed and the Cochrane Library databases for all articles in all languages published between inception and February 2016, for evidence relevant to body weight or BMI, CHC use and contraceptive effectiveness. The quality of each individual study was assessed using the system for evaluating evidence developed by the United States Preventive Services Task Force. From 2874 articles, we identified 15 reports for inclusion, all of fair to poor quality. Fourteen studies measured the association of obesity status and contraceptive failure among COC users. Three fair quality and one poor quality study reported increased COC failure among a heterogeneous population of overweight and obese women compared with normal weight women, while eight fair quality and two poor quality studies did not find an association. Two fair quality studies reported on contraceptive transdermal patches. One pooled analysis described a higher proportion of pregnancies among women using the patch who weighed ≥90 kg; another secondary analysis suggested BMI>30 was associated with increased failure. No studies directly compared contraceptive effectiveness using the combined vaginal ring or combined injectable. Current available evidence addressing the risk of CHC failure in obese compared to normal weight women is limited to fair and poor quality studies. Studies of COCs show mixed results, though absolute differences in COC failure by body weight and BMI are small. Based on limited evidence, it appears that increasing body weight and BMI may contribute to decreasing contraceptive patch effectiveness. Copyright © 2017. Published by Elsevier Inc.

Pharmacists' knowledge and interest in developing counseling skills relating to oral contraceptives.

PubMed

Amin, Mohamed E K

2016-04-01

Possessing correct therapeutic information on oral contraceptives is an important prerequisite for the provision of sound advice to women who are using these products. This study examines Egyptian pharmacists' knowledge of pharmacotherapeutic aspects of oral contraceptives as well as interest in developing skills in providing counseling on oral contraceptive pills. Community pharmacies throughout Alexandria, Egypt. A cross-sectional survey was self-administered by a random sample of community pharmacists in Alexandria, Egypt. Five multiple choice questions likely to arise when counseling women on oral contraceptives were constructed. Questions covered compatibility with breastfeeding, precautions, health risks and managing missed pills of oral contraceptives. Using ordered logistic regression, a model was estimated to predict pharmacists' interest in developing skills in providing counseling on oral contraceptives. Pharmacists' aggregate scores for knowledge questions and pharmacists' interest in developing skills in providing counseling on oral contraceptive pills. Of the 181 approached pharmacists, 92 % participated. Twenty one pharmacists (13 %) did not know the correct answer to any question, 122 (73 %) answered one-two correctly, 23 (14 %) answered three-four correctly. No pharmacist answered all five questions correctly. For pharmacists' interest in developing skills in providing counseling on oral contraceptives, the percentage values for answers were: not interested at all (10.2 %), slightly interested (27.0 %), somewhat interested (23.4 %), interested (30.0 %) and extremely interested (9.6 %). Pharmacists' interest in developing skills in providing counseling on oral contraceptives was significantly associated with the number of women who requested advice from the pharmacists on oral contraceptives (OR 1.54, CI 1.24-1.91). In terms of the learning method of preference, percentage values for answers were: attending a workshop (4 %), online course (18

Oral contraceptives and the risk of gallbladder disease: a comparative safety study

PubMed Central

Etminan, Mahyar; Delaney, Joseph A.C.; Bressler, Brian; Brophy, James M.

2011-01-01

Background Recent concerns have been raised about the risk of gallbladder disease associated with the use of drospirenone, a fourth-generation progestin used in oral contraceptives. We conducted a study to determine the magnitude of this risk compared with other formulations of oral contraceptives. Methods We conducted a retrospective cohort study using the IMS LifeLink Health Plan Claims Database. We included women who were using an oral contraceptive containing ethinyl estradiol combined with a progestin during 1997–2009. To be eligible, women had to have been taking the oral contraceptive continuously for at least six months. We computed adjusted rate ratios (RRs) for gallbladder disease using a Cox proportional hazards model. In the primary analysis, gallbladder disease was defined as cholecystectomy; in a secondary analysis, it was defined as hospital admission secondary to gallbladder disease. Results We included 2 721 014 women in the cohort, 27 087 of whom underwent surgical or laparoscopic cholecystectomy during the follow-up period. Compared with levonorgestrel, an older second-generation progestin, a small, statistically significant increase in the risk of gallbladder disease was associated with desogestrel (adjusted RR 1.05, 95% confidence interval [CI] 1.01–1.09), drospirenone (adjusted RR 1.20, 95% CI 1.16–1.26) and norethindrone (adjusted RR 1.10, 95% CI 1.06–1.14). No statistically significant increase in risk was associated with the other formulations of oral contraceptive (ethynodiol diacetate, norgestrel and norgestimate). Interpretation In a large cohort of women using oral contraceptives, we found a small, statistically significant increase in the risk of gallbladder disease associated with desogestrel, drospirenone and norethindrone compared with levonorgestrel. However, the small effect sizes compounded with the possibility of residual biases in this observational study make it unlikely that these differences are clinically

Communication about Contraception and Knowledge of Oral Contraceptives amongst Norwegian High School Students.

ERIC Educational Resources Information Center

Hansen, Thomas; Skjeldestad, Finn Egil

2003-01-01

Examines communication about contraception and specific knowledge of oral contraceptives (OCs) in a sample of Norwegian high school students. More females than males discussed contraception at least monthly. Discussions were predominantly held with peers and not adults. Females were far more knowledgeable about OCs than males. The most significant…

Progestin-Only Oral Contraceptives

MedlinePlus

... oral contraceptives are a very effective method of birth control, but they do not prevent the spread of ... on another day, use a backup method of birth control (such as a condom and/or a spermicide) ...

The effect of oral contraception on cardiometabolic risk factors in women with elevated androgen levels.

PubMed

Krysiak, Robert; Gilowska, Małgorzata; Okopień, Bogusław

2017-02-01

In unselected reproductive-aged women, use of combined estrogen-progestin oral contraceptive pills has been linked with an increased risk of vascular disease. The aim of this study was to investigate the effect of oral contraception on cardiometabolic risk factors in a population of women with hyperandrogenism. The study included 16 untreated women with elevated testosterone levels and 15 matched healthy women who were then treated with oral contraceptive pills containing ethinyl estradiol (30μg) and drospirenone (3mg). Plasma lipids, glucose homeostasis markers, circulating levels of androgens, uric acid, high-sensitivity C-reactive protein (hsCRP), fibrinogen and homocysteine, as well as urinary albumin-to-creatinine ratio (UACR) were assessed at baseline and after 12 weeks of treatment. Compared to healthy women, women with elevated androgen levels showed increased plasma levels of hsCRP, fibrinogen and homocysteine, as well as a higher value of UACR. Oral contraception reduced androgen levels only in hyperandrogenic women. In healthy women, ethinyl estradiol plus drospirenone increased plasma levels of insulin, hsCRP, fibrinogen and homocysteine, while in women with elevated androgen levels their effect was limited only to a small increase in hsCRP. Our results suggest that a deteriorating effect of oral contraceptive pills containing ethinyl estradiol and drospirenone in hyperandrogenic women is weaker than in healthy young women and that ethinyl estradiol/drospirenone combination therapy may be safely used in the former group of patients. Copyright © 2016. Published by Elsevier Urban & Partner Sp. z o.o.

[Cholestatic icterus due to oral contraceptives].

PubMed

Pestel, M; Lambert, C; Jeanmougin, M

1973-03-01

A case report of cholestatic jaundice in a 25 year old woman, who had had jaundice at age 4 years, and had taken Stediril (a combined oral contraceptive) for 1 month, implicates either the pill or a possibly hereditary hyperlipidemia. The jaundice developed in 2 weeks with vomiting, epigastric pain, anorexia, then discolored urine and feces, and intense pruritus. On hospitalization the patient had moderate bilirubinemia (56 mg/1), low alkaline phosphatase (13 U.K.) and slightly high serum glutamate pyruvate transaminase (270 U.W.). There were elevated serum cholesterol (3 gm/1), triglycerides (2.05 gm/1), total lipids (10.6 gm/1), and a definitely increased pre-beta lipoprotein, suggesting hyperlipidemia type IV (Frederickson classification). Liver biopsy showed fibrosis of the portal spaces lymphocytic infiltration, canalicular and intrahepatocytic thrombi. On laparoscopy the liver had a regular lower border, normal volume color and surface. Albumin, prothrombin and flocculation tests were normal. The patient's jaundice lasted about 1 month, then liver function slowly improved, although pruritus remained intense. Probably this jaundice was due to oral contraceptives, in a patient predisposed either by jaundice in childhood or endogenous hyperlipidemia.

Efficacy of the low-dose combined oral contraceptive chlormadinone acetate/ethinylestradiol: physical and emotional benefits.

PubMed

Heskamp, Marie-Luise S; Schramm, Georg A K

2010-01-01

This study investigated the effects of the low-dose combined oral contraceptive (COC) 2.0 mg chlormadinone acetate (CMA)/0.03 mg ethinylestradiol (EE) (Belara, Balanca) on cycle-related physical and emotional disorders in women >or=25 years of age. A prospective, non-interventional, observational study of 3772 women over six cycles was conducted in 303 office-based gynecological centers throughout Germany. CMA/EE provided high contraceptive efficacy with a Pearl index of 0 (95% confidence interval=0.00-0.22) and was generally well tolerated, with no statistically significant weight changes during the observation period (p=.147). CMA/EE intake resulted in a statistically significant improvement in cycle-related physical and emotional symptoms, with a 67% overall reduction in sum score for number and intensity of cycle-related symptoms per patient. The results of this study in women >or=25 years of age support previous findings that 2.0 mg CMA/0.03 mg EE is an effective low-dose COC, with an excellent tolerability profile, with the additional benefits of significantly reducing both cycle-related physical and emotional symptoms (pcontraceptive treatment. Further research is warranted.

Contraceptive use in the Nordic countries.

PubMed

Lindh, Ingela; Skjeldestad, Finn E; Gemzell-Danielsson, Kristina; Heikinheimo, Oskari; Hognert, Helena; Milsom, Ian; Lidegaard, Øjvind

2017-01-01

The aim was to compare contraceptive use in the Nordic countries and to assess compliance with recommendations from the European Medicines Agency regarding the use of combined oral contraception containing low-dose estrogen and levonorgestrel, norethisterone or norgestimate. Data on hormonal contraceptive prescriptions and sales figures for copper intrauterine devices were obtained from national databases and manufacturers in Denmark, Finland, Iceland, Norway and Sweden in 2010-2013. Contraceptive use was highest in Denmark (42%) and Sweden (41%), followed by Finland (40%). Combined oral contraception was the most used method in all countries, with the highest use in Denmark (26%). The second most used method was the levonorgestrel-releasing intrauterine system, with the highest use in Finland (15%) and ≈10% in the other countries. Copper intrauterine devices (7%) and the progestin-only pill (7%) were most often used in Sweden. Combined oral contraception use decreased with increasing age and levonorgestrel-releasing intrauterine system and progestin-only pills use increased. The use of long-acting reversible methods of contraception (=levonorgestrel-releasing intrauterine system, copper intrauterine devices, and implants) increased with time and was highest in Sweden (20%) and Finland (18%). The highest use of European Medicines Agency recommended combined oral contraception was in Denmark, increasing from 13 to 50% between 2010 and 2013. In Finland, recommended combined oral contraception remained below 1%. Contraceptive use was highest in Denmark and Sweden, levonorgestrel-releasing intrauterine system use was highest in Finland and all long-acting methods were most common in Sweden. The use of combined oral contraception recommended by the European Medicines Agency was highest in Denmark. © 2016 Nordic Federation of Societies of Obstetrics and Gynecology.

Oral contraceptives may alter the detection of emotions in facial expressions.

PubMed

Hamstra, Danielle A; De Rover, Mischa; De Rijk, Roel H; Van der Does, Willem

2014-11-01

A possible effect of oral contraceptives on emotion recognition was observed in the context of a clinical trial with a corticosteroid. Users of oral contraceptives detected significantly fewer facial expressions of sadness, anger and disgust than non-users. This was true for trial participants overall as well as for those randomized to placebo. Although it is uncertain whether this is an effect of oral contraceptives or a pre-existing difference, future studies on the effect of interventions should control for the effects of oral contraceptives on emotional and cognitive outcomes. Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

Randomized comparison of bleeding patterns in women using a combined contraceptive vaginal ring or a low-dose combined oral contraceptive on a menstrually signaled regimen.

PubMed

Weisberg, Edith; Merki-Feld, Gabriele S; McGeechan, Kevin; Fraser, Ian S

2015-02-01

To compare bleeding patterns for 12 months continuous use of a contraceptive ring [contraceptive vaginal ring (CVR)] and pill [combined oral contraceptive (COC)] on a menstrually signaled regimen and the effectiveness of 4 days "treatment withdrawal" to stop bleeding. Women, 66 to each group, were randomized to continuous use of a CVR (15 mcg ethinyl estradiol/150 mcg etonogestrel) or a low-dose pill (20 mcg ethinyl estradiol/100 mcg levonorgestrel) for 360 days on a menstrually signaled regimen. Bleeding/spotting days, daily use of ring or pill, was recorded. Endpoint was the total number of bleeding/spotting days for each method over four 90-day reference periods (RP) plus the analysis of bleeding patterns using modified World Health Organization criteria. There was a reduction in the mean (±S.D.) number of bleeding/spotting days from RP1 (CVR 14.2±10; pill 16.6±10.9) to RP4 (CVR 8.8±9.6; pill 8.8±9.1). Fifteen percent of CVR and 4% COC users experienced amenorrhea or infrequent bleeding throughout the study. Amenorrhea increased over time (RP1 vs. RP4: CVR 10% vs. 21% and COC 2% vs. 30%). Compliance with the menstrually signaled regimen was poor. Ceasing hormones for 4 days stopped a bleeding episode within 5 days in the majority of episodes and many stopped spontaneously. Bleeding patterns with continuous use of the CVR and COC are similar and improve over 1 year of use. The unpredictability, but short duration, of bleeding episodes should be stressed during counseling. This information for clinicians and women about breakthrough bleeding patterns with use of a CVR or combined pill over 12 months using a menstrually signaled regimen will give women an indication of what to expect with continuous use. Copyright © 2015 Elsevier Inc. All rights reserved.

Factors associated with the contraindicated use of oral contraceptives in Brazil

PubMed Central

Corrêa, Daniele Aparecida Silva; Felisbino-Mendes, Mariana Santos; Mendes, Mayara Santos; Malta, Deborah Carvalho; Velasquez-Melendez, Gustavo

2016-01-01

ABSTRACT OBJECTIVE To estimate the prevalence of the contraindicated use of oral contraceptives and the associated factors in Brazilian women. METHODS 20,454 women who answered the VIGITEL survey in 2008 also participated in this study, of which 3,985 reported using oral contraceptives. We defined the following conditions for the contraindicated use of contraceptives: hypertension; cardiovascular diseases such as heart attack, stroke/cerebrovascular accident; diabetes mellitus; being smoker and 35 years old or older. We estimated the prevalence and 95% confidence intervals of contraindicated use in users of oral contraceptives and the factors associated with contraindication by prevalence ratio and 95% confidence intervals. RESULTS In the total population, 21% (95%CI 19.7–21.9) of women showed some contraindication to the use of oral contraceptives, of which 11.7% (95%CI 10.6–13.7) belonged to the group of users of oral contraceptives. The most frequent contraindication in users of oral contraceptives was hypertension (9.1%). The largest proportion of women with at least one contraindication was aged between 45 and 49 years (45.8%) and with education level between zero and eight years (23.8%). The prevalence of contraindication to oral contraceptives was higher in women less educated (zero to eight years of study) (PR = 2.46; 95%CI 1.57–3.86; p < 0.05) and with age between 35-44 years (PR = 4.00; 95%CI 2.34–6.83) and 45-49 years (PR = 5.59; 95%CI 2.90–10.75). CONCLUSIONS Age greater than or equal to 35 and low education level were demographic and iniquity factors, respectively, in the contraindicated use of oral contraceptives. PMID:28099550

Extended regimen combined oral contraception: A review of evolving concepts and acceptance by women and clinicians.

PubMed

Nappi, Rossella E; Kaunitz, Andrew M; Bitzer, Johannes

2016-01-01

The clinical utility of extended regimen combined oral contraceptives (COCs) is increasingly being recognised. Our objective was to understand the attitudes of women and clinicians about the use of these regimens. We present the rationale for extended regimen COCs from a historical perspective, and trace their evolution and growing popularity in light of their clinical benefits. We conclude by offering potential strategies for counselling women about extended regimen COC options. We conducted a MEDLINE search to identify and summarise studies of extended regimen COCs, focusing on attitudes of women and clinicians regarding efficacy, safety/tolerability and fewer scheduled bleeding episodes and other potential benefits. The body of contemporary literature on extended regimen COCs suggests that their contraceptive efficacy is comparable to that of conventional 28-day (i.e., 21/7) regimens. For women seeking contraception that allows infrequent scheduled bleeding episodes, particularly those who suffer from hormone withdrawal symptoms and cyclical symptoms (e.g., headache, mood changes, dysmenorrhoea, heavy menstrual bleeding), extended regimen COCs are an effective and safe option. Although satisfaction with extended regimen COCs in clinical trials is high, misperceptions about continuous hormone use may still limit the widespread acceptance of this approach. Despite the widespread acceptance among clinicians of extended regimen COCs as an effective and safe contraceptive option, these regimens are underused, likely due to a lack of awareness about their availability and utility among women. Improved patient education and counselling regarding the safety and benefits of extended regimen COCs may help women make more informed contraceptive choices.

Extended regimen combined oral contraception: A review of evolving concepts and acceptance by women and clinicians

PubMed Central

Nappi, Rossella E.; Kaunitz, Andrew M.; Bitzer, Johannes

2016-01-01

ABSTRACT Objectives: The clinical utility of extended regimen combined oral contraceptives (COCs) is increasingly being recognised. Our objective was to understand the attitudes of women and clinicians about the use of these regimens. We present the rationale for extended regimen COCs from a historical perspective, and trace their evolution and growing popularity in light of their clinical benefits. We conclude by offering potential strategies for counselling women about extended regimen COC options. Methods: We conducted a MEDLINE search to identify and summarise studies of extended regimen COCs, focusing on attitudes of women and clinicians regarding efficacy, safety/tolerability and fewer scheduled bleeding episodes and other potential benefits. Results: The body of contemporary literature on extended regimen COCs suggests that their contraceptive efficacy is comparable to that of conventional 28-day (i.e., 21/7) regimens. For women seeking contraception that allows infrequent scheduled bleeding episodes, particularly those who suffer from hormone withdrawal symptoms and cyclical symptoms (e.g., headache, mood changes, dysmenorrhoea, heavy menstrual bleeding), extended regimen COCs are an effective and safe option. Although satisfaction with extended regimen COCs in clinical trials is high, misperceptions about continuous hormone use may still limit the widespread acceptance of this approach. Conclusions: Despite the widespread acceptance among clinicians of extended regimen COCs as an effective and safe contraceptive option, these regimens are underused, likely due to a lack of awareness about their availability and utility among women. Improved patient education and counselling regarding the safety and benefits of extended regimen COCs may help women make more informed contraceptive choices. PMID:26572318

Risk of thromboembolism in women taking ethinylestradiol/drospirenone and other oral contraceptives.

PubMed

Seeger, John D; Loughlin, Jeanne; Eng, P Mona; Clifford, C Robin; Cutone, Jennifer; Walker, Alexander M

2007-09-01

The oral contraceptive ethinylestradiol 0.03 mg/drospirenone 3 mg contains a progestin component that differs from other oral contraceptives. Case reports and prescription event monitoring suggested that ethinylestradiol/drospirenone might be associated with an elevated risk of thromboembolism. We sought to estimate the association between ethinylestradiol/drospirenone and risk of thromboembolism relative to the association among other oral contraceptives. We identified ethinylestradiol/drospirenone initiators and a twofold larger group of other oral contraceptive initiators between June 2001 and June 2004 within a U.S. health insurer database. The comparison group was selected to have demographic and health care characteristics preceding oral contraceptive initiation that were similar to ethinylestradiol/drospirenone initiators. Thromboembolism during the follow-up of the cohorts was identified through claims for medical services, and only medical record-confirmed cases were included in analyses. The primary (as-matched) analysis used proportional hazards regression, whereas a secondary (as-treated) analysis accounted for changes in oral contraceptives during follow-up using Poisson regression. The 22,429 ethinylestradiol/drospirenone initiators and 44,858 other oral contraceptive initiators were followed for an average of 7.6 months, and there were 18 cases of thromboembolism in ethinylestradiol/drospirenone initiators and 39 in the comparators (rate ratio 0.9, 95% confidence interval 0.5-1.6). More than 9,000 women would need to be prescribed oral contraceptives to observe a difference of one case of thromboembolism. Results of the as-treated analysis were similar to those of the as-matched analysis. Ethinylestradiol/drospirenone initiators and initiators of other oral contraceptives are similarly likely to experience thromboembolism. II.

Speech Articulation of Low-Dose Oral Contraceptive Users.

PubMed

Meurer, Eliséa Maria; Fontoura, Giana Valeria Fagundez; Corleta, Helena von Eye; Capp, Edison

2015-11-01

In the female life cycle, hormonal fluctuations may result in impaired verbal efficiency and vocal worsening during the premenstrual phase. Oral contraceptives may interfere with vocal range. Voice, resonance, and articulation variations clarify speech content. To investigate the phonoarticulatory sounds produced by oral contraceptive users aged between 20 and 30 years. This is a cross-sectional study. Our study included four groups of women (n = 66): two groups used low-dose oral contraceptives and two groups did not use any oral contraceptives. Questionnaires and sound records were used. Acoustic analysis was performed using the Computerized Speech Laboratory program, Model 4341 (Kay Elemetrics Corp, Lincoln Park, New Jersey). The statistical analysis of the SPPS database, version 13.0, was performed by means of generalized estimating equation. In the groups that did not use oral contraceptives, sustained vowel tones were more acute in the two phases and cycles of women older than 25 years (w/oOC1, 175 ± 74 to 190 ± 55 Hz; w/oOC2, 194 ± 56 to 210 ± 32 Hz). At the midfollicular phase (Fph) and midluteal phase (Lph) of the two cycles, the speed of the speech was slower in this group (w/oOC1: Fph, 5.3 ± 1.6/s and Lph, 5.4 ± 1.4/s; w/oOC2: Fph, 4.5 ± 1.7/s and Lph, 4.8 ± 1.1/s). In both groups that used oral contraceptives, there was a higher modulation frequency in the sentences when compared with nonusers (OC1, 33 ± 10 Hz; w/oOC1, 28 ± 10 Hz; OC2, 34 ± 10 Hz; w/oOC2, 27 ± 10 Hz). Vocal intensity was closer between the OC1 (62 ± 4 dB), w/oOC1 (61 ± 3 dB), and OC2 (63 ± 4 dB) groups when compared with the w/oOC2 (67 ± 6 dB) group. We demonstrated hormonal influences on speech articulation of contraceptive users and nonusers. Copyright © 2015 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Attitudes to current oral contraceptive use and future developments: the women's perspective.

PubMed

Fuchs, N; Prinz, H; Koch, U

1996-09-01

The study was planned to determine current trends in contraceptive usage and to examine the attitudes, needs and preferences of women with respect to oral contraceptives. Semi-structured interviews were carried out with women (n = 1201, aged 16-45 years) in Germany, the UK and France. The study revealed that oral contraceptives were the most popular method of contraception employed, followed by condoms, and that the majority of respondents were aged 16-19 years when they first used an oral contraceptive. An important finding of the study was that an oral contraceptive was first used only after having sexual intercourse for the first time (within 1 year), emphasizing the importance of effective contraceptive information and education for adolescents. Regarding non-contraceptive health benefits, protection from ovarian and endometrial cancer was perceived by respondents to be of the greatest importance; however, few women were spontaneously aware of this benefit. When given a number of different oral contraceptive intake options to assess, the established 'once daily for 21 consecutive days' option remained the most popular, although a 'once weekly' alternative was cited by many women. When asked about the preferred frequency of menstrual bleeding, there was a polarization between women favoring the normal monthly bleed and those wanting a 'no-bleed' regimen. Women are poorly informed about oral contraceptive use, and are largely unaware of the important long-term non-contraceptive benefits. Many women would prefer alternative pill intake options and a significant number would favor a 'no-bleed' regimen.

Family Planning for women unable to tolerate oral contraceptives.

PubMed

Spellacy, W N

1974-04-08

Should women with a family history of diabetes or myocardial infarcation, or women with abnormal blood glucose or cholesterol levels receive oral contraceptives? There is clear evidence that oral contraceptives can alter both carbohydrate and lipid metabolism in certain women. The lipid alteration is mainly an elevation of the circulating triglyceride levels, and only rarely is cholesterol content altered. It is also clear from extensive research during the past ten years that women who already have subclinical abnormalities, either in their triglyceride levels (family hyperlipoproteinemia) or glucose tolerance, are at great risk for the development of clinical disease while using oral contraceptives. Accordingly, all pharmaceutical firms are required by the Food and Drug Administration to instruct physicians about these problems through the package inserts and other means. Specifically, the physician should be alerted by the patient's history, and then he should use the laboratory to confirm any suspicion of abnormalities of carbohydrate or lipid metabolism. If there is any abnormal blood glucose or triglyceride value, the oral contraceptives should not be prescribed. There are other forms of contraception available for child spacing. Mechanical contraceptives will not aggravate a metabolic disorder. A useful substitute then would be an intrauterine device plus vaginal foam. When the woman has completed her family, she should be all means be offered surgical sterilization as a permanent family planning technique.

Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data

PubMed Central

Hernandez, Rohini K

2011-01-01

Objective To compare the risk of non-fatal venous thromboembolism in women receiving oral contraceptives containing drospirenone with that in women receiving oral contraceptives containing levonorgestrel. Design Nested case-control and cohort study. Setting The study was based on information from PharMetrics, a United States based company that collects information on claims paid by managed care plans. Participants The study encompassed all women aged 15 to 44 years who received an oral contraceptive containing either drospirenone or levonorgestrel after 1 January 2002. Cases were women with current use of a study oral contraceptive and a diagnosis of venous thromboembolism in the absence of identifiable clinical risk factors (idiopathic venous thromboembolism). Up to four controls were matched to each case by age and calendar time. Main outcome measures Odds ratios comparing the risk of non-fatal venous thromboembolism in users of the two contraceptives; incidence rates and rate ratios of non-fatal venous thromboembolism for users of each of the study contraceptives. Results 186 newly diagnosed, idiopathic cases of venous thromboembolism were identified in the study population and matched with 681 controls. In the case-control analysis, the conditional odds ratio for venous thromboembolism comparing use of oral contraceptives containing drospirenone with use of those containing levonorgestrel was 2.3 (95% confidence interval 1.6 to 3.2). The incidence rates for venous thromboembolism in the study population were 30.8 (95% confidence interval 25.6 to 36.8) per 100 000 woman years among users of oral contraceptives containing drospirenone and 12.5 (9.61 to 15.9) per 100 000 woman years among users of oral contraceptives containing levonorgestrel. The age adjusted incidence rate ratio for venous thromboembolism for current use of oral contraceptives containing drospirenone compared with those containing levonorgestrel was 2.8 (2.1 to 3.8). Conclusions The risk of

Estrogen and Progestin (Oral Contraceptives)

MedlinePlus

... from entering. Oral contraceptives are a very effective method of birth control, but they do not prevent ... tell you whether you need to use another method of birth control during the first 7 to ...

Progestin-only pills for contraception.

PubMed

Grimes, David A; Lopez, Laureen M; O'Brien, Paul A; Raymond, Elizabeth G

2010-01-20

The introduction of a new progestin-only oral contraceptive in Europe has renewed interest in this class of oral contraceptives. Unlike the more widely used combined oral contraceptives containing an estrogen plus progestin, these pills contain only a progestin (progestogen) and are taken without interruption. How these pills compare to others in their class or to combined oral contraceptives is not clear. This review examined randomized controlled trials of progestin-only pills for differences in efficacy, acceptability, and continuation rates. We searched the computerized databases MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), POPLINE, LILACS, and EMBASE for studies of progestin-only pills. We also searched for current trials via ClinicalTrials.gov and ICTRP. We included all randomized controlled trials in any language that included progestin-only pills for contraception. We incorporated any comparison with a progestin-only pill; this could include different doses, other progestin-only pills, combined oral contraceptives, or other contraceptives. The first author abstracted the data and entered the information into RevMan 5. Another author performed a second, independent data abstraction to verify the initial data entry. Because of disparate exposures, we were not able to combine studies in meta-analysis. Six trials met the inclusion criteria. In the trial comparing the desogestrel versus levonorgestrel progestin-only pill, desogestrel was not associated with a significantly lower risk of accidental pregnancy; the rate ratio was 0.27 (95% CI 0.06 to 1.19). However, the desogestrel progestin-only pill caused more bleeding problems, although this difference was not statistically significant. The trial comparing low-dose mifepristone versus a levonorgestrel progestin-only pill found similar pregnancy rates. In the trial comparing ethynodiol diacetate versus a combined oral contraceptive, irregular cycles occurred in all women assigned to the

Oral contraceptive use and psychiatric disorders in a nationally representative sample of women.

PubMed

Cheslack-Postava, Keely; Keyes, Katherine M; Lowe, Sarah R; Koenen, Karestan C

2015-02-01

The purpose of this study is to examine the association between oral contraceptive use (any current use, duration, and type) and major depressive disorder (MDD), generalized anxiety disorder (GAD), and panic disorder (PD) in a nationally representative sample of women in the USA. Data were drawn from 1,105 women aged 20-39 in the National Health and Nutrition Examination Surveys from 1999 to 2004. The associations between self-reported use of oral contraceptives in the past year and DSM-IV diagnosed and subthreshold MDD, GAD, and PD in the past year were assessed comparing oral contraceptive users to all non-users, former users, and former long-term users. Women using oral contraceptives had a lower past-year prevalence of all disorders assessed, other than subthreshold MDD. When adjusted for confounders, women using oral contraceptives in the past year had significantly lower odds of subthreshold PD, compared to former users (odds ratio (OR) = 0.34, 95 % CI 0.14-0.84). Effects estimates were strongest for monophasic (versus multiphasic) oral contraceptive users. Hormonal contraceptive use was associated with reduced risk of subthreshold PD. A potential mental health benefit of hormonal contraceptives has substantial public health implications; prospective longitudinal studies are needed to confirm whether hormonal contraceptive use improves mental health.

Semaglutide, a Once-Weekly Human GLP-1 Analog, Does Not Reduce the Bioavailability of the Combined Oral Contraceptive, Ethinylestradiol/Levonorgestrel

PubMed Central

Kapitza, Christoph; Nosek, Leszek; Jensen, Lene; Hartvig, Helle; Jensen, Christine B; Flint, Anne

2015-01-01

The effect of semaglutide, a once-weekly human glucagon-like peptide-1 (GLP-1) analog in development for type 2 diabetes (T2D), on the bioavailability of a combined oral contraceptive was investigated. Postmenopausal women with T2D (n = 43) on diet/exercise ± metformin received ethinylestradiol (0.03 mg)/levonorgestrel (0.15 mg) once daily for 8 days before (semaglutide-free) and during (steady-state 1.0 mg) semaglutide treatment (subcutaneous once weekly; dose escalation: 0.25 mg 4 weeks; 0.5 mg 4 weeks; 1.0 mg 5 weeks). Bioequivalence of oral contraceptives was established if 90%CI for the ratio of pharmacokinetic parameters during semaglutide steady-state and semaglutide-free periods was within prespecified limits (0.80–1.25). The bioequivalence criterion was met for ethinylestradiol area under the curve (AUC0–24 h) for semaglutide steady-state/semaglutide-free; 1.11 (1.06–1.15). AUC0–24 h was 20% higher for levonorgestrel at semaglutide steady-state vs. semaglutide-free (1.20 [1.15–1.26]). Cmax was within bioequivalence criterion for both contraceptives. Reductions (mean ± SD) in HbA1c (–1.1 ± 0.6%) and weight (–4.3 ± 3.1 kg) were observed. Semaglutide pharmacokinetics were compatible with once-weekly dosing; the semaglutide dose and dose-escalation regimen were well tolerated. Adverse events, mainly gastrointestinal, were mild to moderate in severity. Asymptomatic increases in mean amylase and lipase were observed. Three subjects had elevated alanine aminotransferase levels ≥3x the upper limit of normal during semaglutide/oral contraceptive coadministration, which were reported as adverse events, but resolved during follow-up. Semaglutide did not reduce the bioavailability of ethinylestradiol and levonorgestrel. PMID:25475122

Pharmacists' counseling on oral contraceptives: A theory informed analysis.

PubMed

Amin, Mohamed E K; Chewning, Betty

2016-01-01

Providing correct and complete counseling on the use of oral contraceptives (OCs) is central to securing the autonomy of women in child-bearing age and is a powerful, proven tool of social change. Pharmacists in many developing countries such as Egypt are involved in dispensing and at times prescribing pharmaceuticals, including oral contraceptives that are readily available without a prescription. To predict Egyptian community pharmacists' counseling on oral contraceptives while utilizing a theoretical framework guided by the Theory of Planned Behavior (TPB). A cross-sectional, self-administered survey was completed by a random sample of community pharmacists in Alexandria, Egypt to determine their attitudes and behaviors regarding counseling on OCs. Multiple regression was used to predict self-reported counseling on oral contraceptives as a function of the TPB-related constructs and six other factors - "perceived importance of profit from dispensing OCs on pharmacy revenue," "number of hours worked," "age," "gender," "pharmacy practice degree" and "marital status" of the pharmacist. Of the 181 pharmacists invited to complete the survey, 168 (93%) participated. Pharmacists indicated they talked to a slightly higher proportion of women about the importance of taking OCs at the same time daily than about topics such as which day to start taking OCs, side effects and what to do when a dose of OCs was missed. Pharmacists' reported counseling on oral contraceptives was positively associated with their perception that women welcomed pharmacist initiated OC counseling (β = 0.315, P < 0.001), perceived adequacy of time available to counsel women on OCs (β = 0.290, P = 0.003) and the perceived number of women who asked for their help in selecting an OC without providing a prescription in the past week (β = 0.160, P = 0.018). Pharmacists reported that women's welcoming pharmacists initiating OC counseling was associated with the pharmacists' reported percent

Breast cancer and combined oral contraceptives: results from a multinational study. The WHO Collaborative Study of Neoplasia and Steroid Contraceptives.

PubMed Central

1990-01-01

A collaborative, hospital-based case-control study was conducted at 12 participating centres in 10 countries. Based on data from personal interviews of 2,116 women with newly diagnosed breast cancer and 12,077 controls, the relative risk of breast cancer in women who ever used oral contraceptives was estimated to be 1.15 (1.02, 1.29). Estimated values of this relative risk based on data from three developed and seven developing countries were 1.07 (0.91, 1.26) and 1.24 (1.05, 1.47) respectively; these estimates are not significantly different (P = 0.22). Estimates for women under and over age 35 were 1.26 (0.95, 1.66) and 1.12 (0.98, 1.27), respectively, and these estimates are also not significantly different (P = 0.38). Risk was highest in recent and current users and declined with time since last use regardless of use. Risk did not increase with duration of use after stratifying on time since last use. Risk did not increase significantly with increasing duration of use before age 25 or before a first live birth. However, a relative risk of 1.5 that was of borderline statistical significance was observed in women who used oral contraceptives for more than 2 years before age 25. No single source of bias or confounding was identified that could explain the small increases in risk that were observed. Chance alone is also an unlikely explanation. The results could be due to a combination of chance and potential sources of bias, or they could represent a weak causal relationship. PMID:2404507

Use of and access to oral and injectable contraceptives in Brazil.

PubMed

Farias, Mareni Rocha; Leite, Silvana Nair; Tavares, Noemia Urruth Leão; Oliveira, Maria Auxiliadora; Arrais, Paulo Sergio Dourado; Bertoldi, Andréa Dâmaso; Pizzol, Tatiane da Silva Dal; Luiza, Vera Lucia; Ramos, Luiz Roberto; Mengue, Sotero Serrate

2016-12-01

combined oral contraceptives were the most frequently reported (71.6%) and low-level levonorgestrel + ethinylestradiol combination accounted for 38.7% of them. The most frequently reported medicines are included in the Relação Nacional de Medicamentos Essenciais (RENAME - National List of Essential Medicines. Most women aged 15 to 49 who reported using contraceptives had access to the medicine and use monophasic combined oral contraceptives of appropriate efficiency and safety purchased by direct payment, mainly from retail pharmacies. Analisar a prevalência do uso atual de contraceptivos orais e injetáveis por mulheres brasileiras, segundo variáveis demográficas, socioeconômicas e aspectos relacionados ao acesso a esses medicamentos. Estudo transversal, analítico, baseado nos dados da Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM), de base populacional e amostra probabilística, realizada entre setembro/2013 e fevereiro/2014, em 20.404 domicílios urbanos brasileiros. A prevalência foi calculada a partir do relato das mulheres de 15 a 49 anos, não grávidas, sobre o uso de contraceptivos orais ou contraceptivos injetáveis. As variáveis independentes foram sexo, idade, escolaridade, nível socioeconômico, região geográfica e situação conjugal. Também foram analisados acesso, fontes de financiamento, fontes de obtenção e medicamentos citados. As análises estatísticas consideraram intervalos de confiança de 95% (IC95%) e teste Qui-quadrado de Pearson para avaliação da significância estatística das diferenças entre os grupos, considerando o nível de significância de 5%. A prevalência de uso de contraceptivos orais (CO) foi 28,2% e de contraceptivos injetáveis (CI), 4,5%. A prevalência de contraceptivos orais foi maior no Sul (37,5%) e menor no Norte (15,7%). Para contraceptivos injetáveis não houve diferença entre as regiões. O acesso foi maior para as usuárias de contraceptivos orais (90

Pharmacokinetic overview of ethinyl estradiol dose and bioavailability using two transdermal contraceptive systems and a standard combined oral contraceptive

PubMed Central

Hofmann, Birte; Reinecke, Isabel; Schuett, Barbara; Merz, Martin; Zurth, Christian

2014-01-01

Objective: To determine the relative bioavailability of ethinyl estradiol (EE) and gestodene (GSD) after application of a novel transdermal contraceptive patch vs. a standard combined oral contraceptive (COC) pill (study 1), and to evaluate the pharmacokinetics (PK) of EE after application of the EE/GSD patch compared with an EE/norelgestromin (NGMN) patch (study 2). Materials: Participants were healthy, non-obese women aged 18 – 45 years (study 1) or 18 – 35 years (study 2). Compositions of study treatments were as follows: 0.55 mg EE/2.1 mg GSD (EE/GSD patch); 0.02 mg EE/0.075 mg GSD (standard COC); 0.6 mg EE/6 mg NGMN (EE/NGMN patch). Methods: In study 1, which consisted of 3 treatment periods (each followed by 7 patch- or pill-free days), treatments were administered in one of two randomized orders: either P–M–E (EE/GSD patch (P) every 7 days for 28 days → COC (M) once-daily for 21 days → two 7-day patch-wearing periods followed by one 10-day patch-wearing phase (E)), or the same treatments administered in sequence M–P–E. For study 2, participants received either the EE/GSD patch or EE/NGMN patch for seven treatment cycles (one patch per week for 3 weeks followed by a 7-day patch-free interval). Results: In study 1, average daily exposure to EE was similar for treatments P and M; the mean daily area under the concentration-time curve (AUC) ratio of treatment P vs. treatment M for EE was 1.06 (90% confidence interval (CI): 0.964 – 1.16), indicating average daily delivery similar to oral administration of 0.019 – 0.023 mg EE. For unbound GSD, average daily exposure was lower for treatment P vs. treatment M. The mean AUC ratio of treatment P vs. treatment M for unbound GSD was 0.820 (90% CI: 0.760 – 0.885), indicating average daily delivery from the patch of 0.057 – 0.066 mg GSD. Prolonged patch wearing did not result in a distinct decline in GSD and EE serum concentrations. In study 2, AUC at steady state (AUC0–168,ss

Consumers of oral contraceptives in a social marketing program in Honduras.

PubMed

Bailey, P E; Janowitz, B; Solis, M; Machuca, M; Suazo, M

1989-01-01

This paper presents data on the characteristics of oral contraceptive users in Honduras, obtained from a point-of-purchase survey conducted in pharmacies in 1986. The oral contraceptive Perla, provided by the Social Marketing Program, accounted for 42 percent of sales. Forty-five percent of those using Perla were considered "new" users; either they were purchasing contraceptives for the first time or had used only Perla. Almost half of those who switched to Perla previously had obtained their orals in the noncommercial sector. Brand substitution occurred among users of commercial brands at about the same rate as among Perla users (51 percent versus 55 percent). Most women switching contraceptives did so within two months of their last purchase.

Side and site of deep vein thrombosis in women using oral contraceptives.

PubMed

Kierkegaard, A

1985-01-01

The anatomy of the thrombus in acute deep vein thrombosis (DVT) in women using oral contraceptives was studied in 277 reports on DVT received by the Swedish Adverse Drug Reaction Advisory Committee (SADRAC). The study revealed a similarity between the anatomy of DVT in women on oral contraceptives and that of DVT in pregnant women, suggesting a pharmacologic influence of the hormones in the pill on the pathogenesis of DVT in women on oral contraceptives. The anatomy of DVT in women on low-estrogen pills was identical with that of DVT in women on high-estrogen pills, suggesting an identical pharmacologic influence of the two types of pill on the pathogenesis of DVT in women on oral contraceptives.

Combined oral contraceptives in polycystic ovary syndrome - indications and cautions.

PubMed

Bozdag, Gurkan; Yildiz, Bulent Okan

2013-01-01

Combined oral contraceptive pills (OCPs) have been used in women with polycystic ovary syndrome (PCOS) for the treatment of menstrual disorders, acne and hirsutism. Despite years of their use and broad clinical experience, there are still ongoing doubts concerning their implications for the cardiovascular system and carbohydrate metabolism both in the general population and women with PCOS. In the general population, the risk of venous thromboembolism is reported to be increased. However, arterial thrombotic events seem to require concomitant risk factors to appear during administration of OCPs. In terms of carbohydrate metabolism, available data do not consistently suggest an increased risk of impaired glucose tolerance (IGT) or conversion of IGT to type 2 diabetes mellitus, in spite of some subtle fluctuations in glucose and insulin levels. In subgroup analyses of epidemiological studies in the general population, there is no finding indicating an increased risk of cardiovascular disease and related mortality in premenopausal women with PCOS. There is no significant alteration in carbohydrate and lipid metabolism after use of OCP in PCOS either. The absence of further cardiometabolic risk with OCP use in PCOS might suggest some unproven preventive alterations in this patient population. Copyright © 2013 S. Karger AG, Basel.

Experience with oral emergency contraception since the OTC switch in Germany.

PubMed

Kiechle, Marion; Neuenfeldt, Miriam

2017-03-01

In March 2015, the oral emergency contraceptives levonorgestrel (LNG) and ulipristal acetate (UPA) were released from prescription-only status in Germany. The main research question is to analyse whether the OTC status of oral emergency contraceptives has an influence on the patterns of use. All information is based on searches for public domain sources on emergency contraception. Searches were made for scientific publications, statistics, and surveys. Due to additional active ingredient properties, UPA is superior to LNG in terms of ovulation-inhibiting effect. Since the OTC switch, demand for oral emergency contraceptives has risen by almost 50%, especially at weekends when sexual encounters and thus contraceptive failures are most frequent. However, the age distribution of the users has not changed as a result of the OTC switch. Doctors still play an important role in advising on emergency contraception after the removal of the prescription-only requirement. Pregnancies despite emergency contraception are terminated in more than half of the cases. In federal states with higher rates of use of the morning-after pill, fewer terminations of pregnancy were performed. As a result of the OTC switch, more women and girls use the morning-after pill after unprotected intercourse and the time between unprotected intercourse and taking the oral emergency contraceptive decreases. This is of great advantage in terms of the mechanism of action. UPA is used more frequently than LNG. Only half of all people aged between 16 and 39 years in Germany are aware of the morning-after pill and 94% of women who had a pregnancy terminated in 2015 did not use any emergency contraception after the unprotected intercourse. In the population, there is still a great need for information and education on contraception and emergency contraception.

Safety, efficacy and patient satisfaction with continuous daily administration of levonorgestrel/ethinylestradiol oral contraceptives

PubMed Central

Benagiano, Giuseppe; Carrara, Sabina; Filippi, Valentina

2009-01-01

The progestational steroid norgestrel was synthesized and tested between 1960 and 1965 through an international cooperation between Wyeth, USA and Schering, Berlin. It is a mixture of two “enantiomers,” with only one form (designated as levonorgestrel) biologically active. When taken orally, it is rapidly absorbed, not subjected to a “first-pass” effect and is approximately 90% bioavailable, with a circulating half-life around 15 hours. Its contraceptive action is exerted at the central (hypothalamic) and peripheral (cervical mucus and endometrium) levels. Levonorgestrel (LNG), alone or in combination with ethinyl estradiol (EE), is the most widely employed contraceptive progestin: it is used in combined oral contraceptives, progestogen-only pills, long-acting contraceptive implants, intrauterine contraceptive systems and in emergency contraception. It is also the steroid of choice for new oral contraceptive regimens aimed at reducing the frequency of bleeding episodes. This novel approach, already tried more than 30 years ago, gained interest around the year 2000 when surveys of women’s attitudes toward monthly menstrual bleeding started to show a major change: more and more women declared that they would welcome a hormonal contraceptive method that reduced bleeding episodes to 4, 2 or even 1 per year. At this point, while the debate on the significance and “usefulness” of menstruation went on, attention focused on new regimens. The first new modality consisted of changing the 7-day medication-free interval, either shortening it to fewer than 7 days, or by the administration of low-dose estrogens during the interval between packages. Then, continuous administration regimens started to be investigated. This, however, did not happen suddenly, since, in specific situations, doctors had for years empirically utilized various continuous administration regimens. The first extended-cycle oral contraceptive regimen introduced in clinical practice is an 84

Effects of oral contraceptive agents and sex steroids on carbohydrate metabolism.

PubMed

Kalkhoff, R K

1972-01-01

The article offers a general interpretation of the influence of oral contraceptive agents on glucose tolerance, emphasizing comparisons of synthetic sex hormones. Although there are conflicting reports on steroid-induced diabetes in normal women, their glucose curves are often higher when under oral contraceptive treatment, suggesting that oral contraceptives may induce a form of subclinical diabetes melitus that is reversible. Evidence from diabetic women suggests definite deliterious effects from contraceptive administration. Estradiol, estriol, and estrone may improve glucose tolerance in nondiabetic women and reduce insulin requirements in diabetics. Progesterone has little effect on carbohydrate tolerance, as did synthetic progestin. Conjugated equine estrogens (equilenine or Premarin) may provoke mild to moderate deterioration of carbohydrate tolerance. Parenterally administered natural estrogens and orally administered synthetic derivatives appear to differ sharply in their effects. Sex hormones' effects on carbohydrate metabolism likely involve interactions with insulin and endogenous glucocorticoids.

Oral contraceptives combined with interferon β in multiple sclerosis

PubMed Central

De Giglio, Laura; Barletta, Valeria T.; Marinelli, Fabiana; Angelis, Floriana De; Gallo, Valentina; Pagano, Veronica A.; Marini, Stefano; Piattella, Maria C.; Tomassini, Valentina; Pantano, Patrizia

2015-01-01

Objective: To test the effect of oral contraceptives (OCs) in combination with interferon β (IFN-β) on disease activity in patients with relapsing-remitting multiple sclerosis (RRMS). Methods: One hundred fifty women with RRMS were randomized in a 1:1:1 ratio to receive IFN-β-1a subcutaneously (SC) only (group 1), IFN-β-1a SC plus ethinylstradiol 20 μg and desogestrel 150 μg (group 2), or IFN-β-1a SC plus ethinylestradiol 40 μg and desogestrel 125 μg (group 3). The primary endpoint was the cumulative number of combined unique active (CUA) lesions on brain MRI at week 96. Secondary endpoints included MRI and clinical and safety measures. Results: The estimated number of cumulative CUA lesions at week 96 was 0.98 (95% confidence interval [CI] 0.81–1.14) in group 1, 0.84 (95% CI 0.66–1.02) in group 2, and 0.72 (95% CI 0.53–0.91) in group 3, with a decrease of 14.1% (p = 0.24) and 26.5% (p = 0.04) when comparing group 1 with groups 2 and 3, respectively. The number of patients with no gadolinium-enhancing lesions was greater in group 3 than in group 1 (p = 0.03). No significant differences were detected in other secondary endpoints. IFN-β or OC discontinuations were equally distributed across groups. Conclusions: Our results translate the observations derived from experimental models to patients, supporting the anti-inflammatory effects of OCs with high-dose estrogens, and suggest possible directions for future research. Classification of evidence: This study provides Class II evidence that in women with RRMS, IFN-β plus ethinylstradiol and desogestrel decreases the cumulative number of active brain MRI lesions compared with IFN-β alone. PMID:26140279

Rational use of oral contraceptives in the perimenopausal woman.

PubMed

Connell, E B

1993-12-01

Oral contraceptives have undergone extensive revision in their labeling over the past 10 years to remove warnings about cardiovascular and other risks and to highlight their noncontraceptive benefits. While these changes are becoming better known, the potential bone-sparing effects of oral contraceptives in the premenopausal and perimenopausal woman remain under-appreciated. Osteoporosis is a major health care problem worldwide in terms of both its associated morbidity and mortality and its economic impact. Although the benefits of postmenopausal hormone replacement therapy for the prevention and treatment of osteoporosis are generally recognized, little attention has been paid to strategies that might be used to maintain bone mass up to the time of menopause, at which time bone loss accelerates. An additional noncontraceptive benefit of oral contraceptives may be to maintain and build bone mass up to the time of menopause.

Physiologic and psychologic symptoms associated with use of injectable contraception and 20 microg oral contraceptive pills.

PubMed

Berenson, Abbey B; Odom, Susan D; Breitkopf, Carmen Radecki; Rahman, Mahbubur

2008-10-01

The objective of the study was to compare menstrual, physiologic, and psychologic symptoms over 2 years among women initiating use of depot medroxyprogesterone acetate or an oral contraceptive pill with a reduced pill-free interval and those not using hormonal contraception. A total of 608 women reported their experience regarding 17 symptoms prior to initiating contraception and every 6 months thereafter for 24 months. Longitudinal relationships between symptoms and contraceptives were assessed after adjusting for age, visits, and baseline status of symptoms. Oral contraceptive pills were protective against mastalgia (odds ratio [OR], 0.7), cramping (OR, 0.5), hair loss (OR, 0.6), acne (OR, 0.4), nervousness (OR, 0.5), and mood swings (OR, 0.7). Depot medroxyprogesterone acetate (DMPA) was protective against bloating (OR, 0.5) and mood swings (OR, 0.7) but caused weight gain (OR, 2.3), bleeding episodes more than 20 days (OR, 13.4), and missed periods (OR, 96.9). Both methods caused intermenstrual bleeding. Evidence-based data regarding beneficial and adverse symptoms associated with these methods may help clinicians counsel patients appropriately prior to contraceptive initiation.

Oral contraception in the former Czech and Slovak Federal Republic: attitudes and use.

PubMed

Ketting, E; Visser, A P; Uzel, R; Lehert, P

1993-06-01

This paper presents and discusses data on oral contraception from a national representative survey (n = 1072) on knowledge, attitudes and practice with regard to contraceptive use in the Czech and Slovak Federal Republic (CSFR). Only 7% of the women at risk of unplanned pregnancy used the pill. The low rate of use seems to be due to the general negative image of oral contraception, reinforced by the experiences of past users and opinions expressed by relative, friends, doctors, and the media. In particular, perceived psychological disadvantages have an important bearing on the decision not to use the method, whereas perceived advantages have hardly any impact. It is likely that this negative image is closely linked with the types of oral contraceptives that have been available in the country and also with the limited choice. Second- and third-generation oral contraceptives have only very recently become available. It is recommended that balanced information on the advantages and disadvantages of oral contraception be made available to doctors and to the general public on a large scale and through a variety of channels.

Pituitary, ovarian and additional contraceptive effects of an estradiol-based combined oral contraceptive: results of a randomized, open-label study.

PubMed

Endrikat, Jan; Parke, Susanne; Trummer, Dietmar; Serrani, Marco; Duijkers, Ingrid; Klipping, Christine

2013-02-01

The estrogen step-down/progestogen step-up 28-day estradiol valerate/dienogest (E(2)V/DNG) oral contraceptive effectively inhibits ovulation; however, limited data are available regarding its effects on estradiol (E2), progesterone, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) or its additional extraovarian contraceptive effects. In this secondary analysis, 100 women received E(2)V 3 mg on days 1-2, E(2)V 2 mg/DNG 2 mg on days 3-7, E(2)V 2 mg/DNG 3 mg on days 8-24, E(2)V 1 mg on days 25-26 and placebo on days 27-28 for one treatment cycle. Measures included the presence/absence of cervical mucus; endometrial thickness; and serum E2, progesterone, and gonadotropin levels. E2, progesterone, LH and FSH levels did not exhibit the typical ovulatory increase and remained relatively stable during the cycle. E(2)V/DNG reduced mean maximal endometrial thickness and proportion of women with visible cervical mucus. All parameters returned to pretreatment levels during the posttreatment cycle. E(2)V/DNG provides extraovarian contraceptive effects (reducing endometrial thickness and cervical mucus production) in addition to inhibiting ovulation, assuring contraceptive efficacy. Copyright © 2013 Elsevier Inc. All rights reserved.

Efficacy and safety of an ascending-dose, extended-regimen levonorgestrel/ethinyl estradiol combined oral contraceptive.

PubMed

Portman, David J; Kaunitz, Andrew M; Howard, Brandon; Weiss, Herman; Hsieh, Jennifer; Ricciotti, Nancy

2014-04-01

To evaluate the efficacy and safety of an ascending-dose, extended-regimen (ADER) combined oral contraceptive consisting of levonorgestrel (LNG) 150 mcg/ethinyl estradiol (EE) 20 mcg for 42 days, LNG 150 mcg/EE 25 mcg for 21 days, LNG 150 mcg/EE 30 mcg for 21 days and EE 10 mcg for 7 days. This was a multicenter, open-label, phase 3, single-arm study. Sexually active women aged 18-40 years were enrolled and received ADER for up to 1 year (4 consecutive 91-day cycles). Participants kept diaries to record adherence, bleeding/spotting and other contraceptive use. Efficacy was measured using the Pearl Index and the life-table method; safety and tolerability were assessed through reported adverse events (AEs). A total of 3701 women were enrolled and 2144 completed the study. The Pearl Index was 3.19 [95% confidence interval (CI), 2.49-4.03], based on 70 pregnancies that occurred after ADER initiation and ≤ 7 days after the last LNG/EE or EE-only pill in women aged 18-35 years, excluding cycles in which another contraceptive method was used. Life-table pregnancy rate was 2.82% (95% CI, 2.23%-3.57%) for all users aged 18-35 years. Unscheduled bleeding/spotting decreased with increasing EE doses within each cycle and decreased after cycle 1. No unexpected AEs or changes in laboratory parameters were reported. This study demonstrated that ADER effectively prevented pregnancy with a favorable safety and tolerability profile. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

Amygdala reactivity to negative stimuli is influenced by oral contraceptive use.

PubMed

Petersen, Nicole; Cahill, Larry

2015-09-01

The amygdala is a highly interconnected region of the brain that is critically important to emotional processing and affective networks. Previous studies have shown that the response of the amygdala to emotionally arousing stimuli can be modulated by sex hormones. Because oral contraceptive pills dramatically lower circulating sex hormone levels with potent analogs of those hormones, we performed a functional magnetic resonance imaging experiment to measure amygdala reactivity in response to emotional stimuli in women using oral contraceptives, and compared their amygdala reactivity with that of naturally cycling women. Here, we show that women who use oral contraceptive pills have significantly decreased bilateral amygdala reactivity in response to negatively valenced, emotionally arousing stimuli compared with naturally cycling women. We suggest that by modulating amygdala reactivity, oral contraceptive pills may influence behaviors that have previously been shown to be amygdala dependent-in particular, emotional memory. © The Author (2015). Published by Oxford University Press. For Permissions, please email: journals.permissions@oup.com.

Semaglutide, a once-weekly human GLP-1 analog, does not reduce the bioavailability of the combined oral contraceptive, ethinylestradiol/levonorgestrel.

PubMed

Kapitza, Christoph; Nosek, Leszek; Jensen, Lene; Hartvig, Helle; Jensen, Christine B; Flint, Anne

2015-05-01

The effect of semaglutide, a once-weekly human glucagon-like peptide-1 (GLP-1) analog in development for type 2 diabetes (T2D), on the bioavailability of a combined oral contraceptive was investigated. Postmenopausal women with T2D (n = 43) on diet/exercise ± metformin received ethinylestradiol (0.03 mg)/levonorgestrel (0.15 mg) once daily for 8 days before (semaglutide-free) and during (steady-state 1.0 mg) semaglutide treatment (subcutaneous once weekly; dose escalation: 0.25 mg 4 weeks; 0.5 mg 4 weeks; 1.0 mg 5 weeks). Bioequivalence of oral contraceptives was established if 90%CI for the ratio of pharmacokinetic parameters during semaglutide steady-state and semaglutide-free periods was within prespecified limits (0.80-1.25). The bioequivalence criterion was met for ethinylestradiol area under the curve (AUC0-24 h ) for semaglutide steady-state/semaglutide-free; 1.11 (1.06-1.15). AUC0-24 h was 20% higher for levonorgestrel at semaglutide steady-state vs. semaglutide-free (1.20 [1.15-1.26]). Cmax was within bioequivalence criterion for both contraceptives. Reductions (mean ± SD) in HbA1c (-1.1 ± 0.6%) and weight (-4.3 ± 3.1 kg) were observed. Semaglutide pharmacokinetics were compatible with once-weekly dosing; the semaglutide dose and dose-escalation regimen were well tolerated. Adverse events, mainly gastrointestinal, were mild to moderate in severity. Asymptomatic increases in mean amylase and lipase were observed. Three subjects had elevated alanine aminotransferase levels ≥3x the upper limit of normal during semaglutide/oral contraceptive coadministration, which were reported as adverse events, but resolved during follow-up. Semaglutide did not reduce the bioavailability of ethinylestradiol and levonorgestrel. © 2015 The Authors. The Journal of Clinical Pharmacology Published by Wiley Periodicals, Inc. on behalf of American College of Clinical Pharmacology.

Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects

ClinicalTrials.gov

2012-02-17

Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction; Laymen Terminology Level of Oral Contraceptive in Blood, Oral Contraceptive, Rheumatoid Arthritis, Drug -Drug Interaction

Investigation on the association between breast cancer and consumption patterns of combined oral contraceptive pills in the women of Isfahan in 2011.

PubMed

Ehsanpour, Soheila; Nejad, Fahime Seyed Ahmadi; Rajabi, Fariborz Mokarian; Taleghani, Fariba

2013-05-01

Oral contraceptive pills are among the most popular contraceptive methods, but the fear of cancer and cardiovascular disease overshadows its continuous use among women. This study aimed to define the association between consumption patterns of combined oral contraceptives among women with breast cancer. This is an analytical case-control study conducted on 175 women with breast cancer, referring to Seyed al Shohada Medical Center and private clinics in Isfahan to be treated and followed up in 2011, as well as 350 healthy women who were identical with the subjects in the study group regarding age and residential location. The data were collected using a researcher-made questionnaire. Content validity and Cronbach's alpha were employed to confirm validity and scientific reliability of the questionnaire, respectively. The data were analyzed by descriptive and analytical statistical methods through SPSS. The findings showed that there was a significant association between history of contraceptive pills' consumption and incidence of breast cancer (P < 0.001). It was shown that the risk of developing breast cancer is increased by 2.27-fold among those with pills' consumption compared to those with no history of that. It was also shown that pills' consumption for 36-72 months increased the risk of breast cancer by 2.18-fold, the age of the first use being less than 20 years increased the risk by 3.28-fold, and time since the last use of less than 25 years increased the risk by 2.63-fold. There was no significant association between duration of use, age of the first and last use, and time since the first and last use in the study and control groups. The results showed that history of pills' consumption is associated with incidence of breast cancer regardless of the consumption pattern. Use of oral contraceptives pills at any age and for any duration can increase the risk of breast cancer.

Effects of the Menstrual Cycle and Oral Contraception on Singers' Pitch Control

ERIC Educational Resources Information Center

La, Filipa M. B.; Sundberg, Johan; Howard, David M.; Sa-Couto, Pedro; Freitas, Adelaide

2012-01-01

Purpose: Difficulties with intonation and vibrato control during the menstrual cycle have been reported by singers; however, this phenomenon has not yet been systematically investigated. Method: A double-blind randomized placebo-controlled trial assessing effects of the menstrual cycle and use of a combined oral contraceptive pill (OCP) on pitch…

[Hyperplastic changes and oral contraceptives in Anglo-Saxon countries].

PubMed

Markuszewski, C

1978-09-18

One of the major problems being researched and studied by the World Health Organization is the incidence of harmful side effects in users of steroid contraceptives. A literature search indicates that Anglo-Saxon countries report alarming hyperplastic changes, particularly in the liver, blood clots, hyperlipidemia leading to high blood pressure, porphyria, atypical leiomyomas and cervical hyperplasia. Currently attention is being focused on the relationship between steroid contraceptives and breast cancer. Fazala and Paffenbarger in their study of 1770 women found such benign changes as fibroadenoma, mastopathia fibrosa cystica and papilloma intraductale. In women who had used oral contraceptives for 2-4 yrs, malignancies were 1.9% to 2.5% more frequent than in non-users; in 6 yrs of use, 11 times greater than in non-users. Estrogens, particularly mestranol has been recognized as being harmful to the liver. Length of usage is a definite factor. Beginning with 1960, relatively frequent occurrences of hepotoma in young women on the pill were noted. Caught at an early stage, peliosis hepatis can be reversed if the patient discontinues the use of contraceptives. In some cases, even after a long interval of 6 months to 10 yrs, the disease continued to develop. Liver cell adenoma in the U. S. occurs 1/500,00 to 1/1,000,000. After 5 to 7 yrs of using oral contraceptives, the chance of developing liver cell adenoma is 5 times greater; after 10 yrs of use, 35 times greater. Hepatomas rupture in 43.4% of cases when the patient had been on a contraceptive, while in only 22.2% in cases of non-users. The literature which the author investigated did not establish a clear proof that the hyperplastic changes discussed were due exclusively to usage of oral contraceptives.

Oral contraceptives and mood in women with and without premenstrual dysphoria: a theoretical model.

PubMed

Kurshan, N; Neill Epperson, C

2006-01-01

Despite numerous studies on the topic, there is no consensus to date on the effects of oral contraceptives on mood or the mechanism(s) by which they exert these effects. This review article presents a theoretical model to explain the way in which oral contraceptives may affect mood. Specifically, it is argued that progestins exert differential effects on endogenous levels of neurosteroids, thereby altering mood. After providing an overview of the effects of estrogen, progesterone, and progesterone's metabolites on cortical excitability and the role of neurosteroids in depression and premenstrual dysphoria, this article reviews the research that has been conducted on the relationship between oral contraceptives and neurosteroids. Finally, suggestions for future research are made with the dual aim of improving existing studies on the relationship between oral contraceptives and mood and further investigating the possibility that fluctuations in neurosteroid levels are responsible for the effects of oral contraceptives on mood.

Noncontraceptive use of oral combined hormonal contraceptives in polycystic ovary syndrome-risks versus benefits.

PubMed

Dokras, Anuja

2016-12-01

The use of steroid sex hormones for noncontraceptive benefits has been endorsed by several medical societies. In women with polycystic ovary syndrome (PCOS), hormonal contraceptives are first-line therapy for concurrent treatment of menstrual irregularity, acne, and hirsutism. The association of PCOS with obesity, diabetes, and dyslipidemia frequently brings up the debate regarding risks versus benefits of hormonal contraceptives in this population. In women with PCOS, the lack of large-scale studies evaluating the risks with varying doses of ethinyl estradiol, types of progestins, and presence of confounding factors such as obesity, smoking, and other cardiometabolic comorbidities is a significant limitation in these deliberations. Although it is important to assess the absolute risk for major morbidities including cardiovascular events, currently, there are a paucity of long-term data for these outcomes in PCOS. Most of the current studies do not suggest an increase in risk of prediabetes/diabetes, clinically significant dyslipidemia, inflammatory changes, or depressive/anxiety symptoms with oral contraceptive pill use. Screening of women with PCOS for cardiometabolic and psychiatric comorbidities is routinely recommended. This information should be used by health care providers to individualize the choice of hormonal contraceptive treatment, adequately counsel patients regarding risks and benefits, and formulate an appropriate follow-up plan. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Progestin-only pills for contraception.

PubMed

Grimes, David A; Lopez, Laureen M; O'Brien, Paul A; Raymond, Elizabeth G

2013-11-13

The introduction of a new progestin-only oral contraceptive in Europe has renewed interest in this class of oral contraceptives. Unlike the more widely used combined oral contraceptives containing an estrogen plus progestin, these pills contain only a progestin (progestogen) and are taken without interruption. How these pills compare to others in their class or to combined oral contraceptives is not clear. This review examined randomized controlled trials of progestin-only pills for differences in efficacy, acceptability, and continuation rates. Through October 2013, we searched the computerized databases MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), POPLINE, and LILACS for studies of progestin-only pills. We also searched for current trials via ClinicalTrials.gov and ICTRP. Previous searches also included EMBASE. We included all randomized controlled trials in any language that included progestin-only pills for contraception.  We incorporated any comparison with a progestin-only pill; this could include different doses, other progestin-only pills, combined oral contraceptives, or other contraceptives. The first author abstracted the data and entered the information into RevMan 5. Another author performed a second, independent data abstraction to verify the initial data entry.We attempted to extract life-table rates (actuarial or continuous) and used the rate difference as the effect measure. Where life-table rates were not published, we used the incidence rate ratio (ratio of Pearl rates). Where only the crude number of events was published, we calculated the Peto odds ratio with 95% confidence interval (CI) using a fixed-effect model. For continuous variables, the mean difference (MD) was computed with 95% CI. Because of disparate exposures, we were not able to combine studies in meta-analysis. Six trials met the inclusion criteria. We have not found any new studies since the initial review. In the trial comparing the desogestrel versus

Use of Oral Contraceptives for Management of Acne Vulgaris: Practical Considerations in Real World Practice.

PubMed

Harper, Julie C

2016-04-01

Acne vulgaris may be effectively treated with combination oral contraceptive pills (COCs) in women. COCs may be useful in any woman with acne in the absence of known contraindications. When prescribing a COC to a woman who also desires contraception, the risks of the COC are compared with the risks associated with pregnancy. When prescribing a COC to a woman who does not desire contraception, the risks of the COC must be weighed against the risks associated with acne. COCs may take 3 cycles of use to show an effect in acne lesion count reductions. Copyright © 2016 Elsevier Inc. All rights reserved.

Contraindications to progestin-only oral contraceptive pills among reproductive aged women

PubMed Central

White, Kari; Potter, Joseph E.; Hopkins, Kristine; Fernández, Leticia; Amastae, Jon; Grossman, Daniel

2012-01-01

Background Progestin-only oral contraceptive pills (POPs) have fewer contraindications to use compared to combined pills. However, the overall prevalence of contraindications to POPs among reproductive aged women has not been assessed. Study Design We collected information on contraindications to POPs in two studies: 1) the Self-Screening Study, a sample of 1,267 reproductive aged women in the general population in El Paso, Texas, and 2) the Prospective Study of Oral Contraceptive (OC) Users, a sample of current OC users who obtained their pills in El Paso clinics (n=532) or over the counter (OTC) in Mexican pharmacies (n=514). In the Self-Screening Study, we also compared women’s self-assessment of contraindications using a checklist to a clinician’s evaluation. Results Only 1.6% of women in the Self-Screening Study were identified as having at least one contraindication to POPs. The sensitivity of the checklist for identifying women with at least one contraindication was 75.0% (95% CI: 50.6–90.4%), and the specificity was 99.4% (95% CI: 98.8–99.7%). In total, 0.6% of women in the Prospective Study of OC Users reported having any contraindication to POPs. There were no significant differences between clinic and OTC users. Conclusion The prevalence of contraindications to POPs was very low in these samples. POPs may be the best choice for the first OTC oral contraceptive in the US. PMID:22364816

Bleeding pattern and cycle control of a low-dose transdermal contraceptive patch compared with a combined oral contraceptive: a randomized study.

PubMed

Merz, M; Kroll, R; Lynen, R; Bangerter, K

2015-02-01

The aim of this study was to investigate the bleeding pattern and cycle control of a contraceptive patch containing 0.55 mg ethinyl estradiol (EE) and 2.1 mg gestodene (GSD) compared with a combined oral contraceptive (COC) containing 0.02 mg EE and 0.1 mg levonorgestrel (LNG). In this phase III, randomized, controlled, double-blind, double-dummy, multicenter trial, healthy women aged 18-45 years (smokers aged 18-35 years) received either the EE/GSD patch and a placebo tablet (n=171), or a placebo patch and the COC (n=175) for seven 28-day cycles. Bleeding control was assessed in two 90-day reference periods. Mean number of bleeding/spotting days was comparable across treatment groups in both reference periods (p>.05). Mean number of bleeding/spotting episodes was also comparable in reference period 1; however, there were fewer bleeding/spotting episodes for COC in reference period 2 (3.4 versus 3.1; p=.01). Mean length of bleeding/spotting episodes was comparable across treatment groups for both reference periods (p>.05). Withdrawal bleeding occurred consistently in both groups over the entire treatment period, but its absence was more common in the COC group in cycles 4 and 6 of reference period 2 (p<.01). Intracyclic bleeding was comparable between groups. Bleeding pattern and cycle control with the EE/GSD patch was comparable to an EE/LNG-containing COC. The findings suggest that bleeding patterns with the EE/GSD patch are similar to an EE/LNG-containing COC, except for absence of withdrawal bleeding, which was less common in patch users. The EE/GSD patch may constitute an additional contraceptive option for women. Copyright © 2015 Elsevier Inc. All rights reserved.

Peripheral arterial disease in a female using high-dose combined oral contraceptive pills.

PubMed

Pallavee, P; Samal, Sunita; Samal, Rupal

2013-01-01

The association between oral contraceptive (OC) pills and vascular diseases is well-known, although, the present generation of pills is considered to be relatively safer in this regard. Hormonal treatment for severe abnormal uterine bleeding is usually considered after ruling out malignancy, when such bleeding is resistant to all other forms of treatment. We report a case of severe peripheral arterial disease in a female, who had been on high-dose OC pills for an extended period of time for severe uterine bleeding.

Oral Contraceptive Use and Affective Changes Across the Menstral Cycle,

DTIC Science & Technology

1998-06-19

1986). The original study was done to describe the prevalence of perimenstrual symptoms in a population-based sample. The parent study used a cross ...4. TITLE AND SUBTITLE Oral Contraceptive Use and Affective Changes Across the Menstrual Cycle 5. FUNDING NUMBERS 6. AUTHOR(S) Jill J. O’Rear 7...University of Washington Abstract Oral Contraceptive Use and Affective Changes Across the Menstrual Cycle by Jill J. O’Rear Chairperson of the

Oral contraceptives in the immediate postpartum period.

PubMed

Hume, A L; Hijab, J C

1991-04-01

Although there is a critical need for effective contraception in the immediate postpartum period for women who are not breastfeeding, this need must be balanced against the inherent risks. The most effective form of contraceptive protection--oral contraceptives (OCs)--can present an increased risk of thromboembolism in the period after delivery. The thrombotic changes associated with pregnancy, and the statistics and vascular damage following a delivery, can combine to create greater potential for thromboembolism after delivery than during pregnancy. Reported here is the case of a 21-year-old woman who, 4 weeks postpartum, developed pain and swelling in the right lower calf and mottled discoloration extending from the proximal thigh to the toes. A diagnosis of deep venous thrombosis was made and heparin was administered. In the hospital, the patient experienced pleuritic chest pain and diaphoresis. A ventilation-perfusion scan indicated a pulmonary embolism. 1 week after delivery, the patient had initiated use of Triphasil. Although this woman had other risk factors (obesity, light cigarette smoking, and a sedentary life-style), OC use in the immediate postpartum period may have been the final factor precipitating the thromboembolic event. It is recommended that OC use should be delayed until at least 2 weeks postpartum in women without other risk factors for thromboembolism and until 4-6 weeks postpartum in those with such factors.

Adolescents and oral contraceptives.

PubMed

Sanfilippo, J S

1991-01-01

Oral contraceptive (OC) options for adolescents are provides. Clarification for those desiring a birth control method is necessary and the benefits of decreased acne and dysmenorrhea with low dose OCs should be stressed along with the importance of compliance. A community effort is suggested to communicate the sexual and contraceptive alternatives, including abstinence and outercourse (sexual stimulation to orgasm without intercourse). Attention is given to concerns associated with teenage sexual activity, prevention of adolescent pregnancy, contraceptive options for the adolescent patient, adolescent attitudes toward birth control OCs, management of the adolescent OC user, manipulation of steroid components of OCs to respond to adolescent concerns, and other hormonal contraceptive options such as minipills or abstinence. The text is supplemented with tables: the % of US women by single years of age for 1971, 1976, 1979, and 1982; comparative pregnancy and abortion rates for the US and 5 other countries; federal cost for teen childbearing; adolescent nonhormonal contraceptive methods (advantages, disadvantages, and retail cost); checklist to identify those at risk for noncompliance with OCs; hormonal side effects of OCs; risks from OCs to adolescents; and benefits of OCs. Concern about adolescent pregnancy dates back to Aristotle. A modern profile shows girls form single-parent families are sexually active at an earlier age, adolescent mothers produce offspring who repeat the cycle, victims of sexual abuse are more likely to be sexually active, and teenagers in foster care are 4 times more likely to be sexually active and 8 times more likely to become pregnant. Prevention involves a multifaceted approach. OCs are the most appropriate contraceptive choice for adolescents. Frequency of intercourse is closely associated with OC use after approximately 15 months of unprotected sexual activity. At risk for noncompliance variables are scales of personality development

Frequency of Candidiasis and Colonization of Candida albicans in Relation to Oral Contraceptive Pills.

PubMed

Aminzadeh, Atousa; Sabeti Sanat, Ali; Nik Akhtar, Saeed

2016-10-01

Candidiasis, the infection caused by Candida albicans , is one of the most common infections of the oral cavity in humans. Candidiasis causes irritation and is known for its carcinogenic effects. Thus, it is important to recognize the predisposing factors for this opportunistic infection. Several previous studies have demonstrated an increased frequency of vaginal candidiasis in relation to oral contraceptive consumption. Only a few studies on the relation between oral contraceptives and oral candidiasis have been previously conducted. This study aims to evaluate the possible relation between oral contraceptive pills and oral candidiasis. This analytic, case-control study included 40 non-pregnant women divided into two groups: 20 who used oral contraceptive pills and 20 who did not. The groups were matched according to age, oral health, and past and present medical history. Samples were collected from the tongue's dorsum using a cotton swab and inoculated on CHROMagar culture plates. The frequency of positive cultures and the number of Candida colonies were compared between the two groups using independent t-tests and Mann-Whitney statistical tests with SPSS18 software. The frequency of positive cultures of Candida albicans was higher (P value = 0.03) for the case group. Also, the number of C. albicans and C. krusei was significantly higher for the case group compared to the control group (P value = 0.04, P value = 0.03). The results of the present study demonstrate that oral contraceptives containing estradiol can lead to Candida colonization in the oral cavity. It is recommended that further studies comparing the influence of oral contraceptives on Candida's adherence to the epithelium is highly recommended.

[Oral contraception].

PubMed

Montloin, A

1990-11-01

This brief discussion of the different types of oral contraceptives (OCs) makes abundant use of flow charts, tables, and diagrams to present information and stress specific points. The work begins by defining the different hypothalamic, pituitary, and ovarian hormones and diagramming and describing the menstrual cycle. A discussion of combined OCs defines and diagrams monophasic, biphasic, and triphasic pills, distinguishes between different dose levels, and describes the mechanisms of action of OCs. Sequential pills and their mechanism of action are briefly discussed. The discussion of OCs containing progestins distinguishes between low does pills and high dose pills and describes the use of injectable progestins. A table then lists the dose-dependent side effects of estrogens and progestins. Simple instructions are provided for administering pills beginning on the 1st cycle day and for actions to take in the event a pill is forgotten. A flow chart taking into account age and presence or absence of vascular and gynecologic risk factors indicates which type of OC should be selected. Some advantages of OCs are identified, including maximum effectiveness and prevention of benign breast disease and perhaps of some type of rheumatoid arthritis. Another flow chart, on patient monitoring, identifies the contraindications that should be ruled out before OCs are prescribed and the routine follow-up examinations required for safe use. Other charts list absolute and relative contraindications and possible drug interferences.

Oral contraceptives for pain associated with endometriosis.

PubMed

Brown, Julie; Crawford, Tineke J; Datta, Shree; Prentice, Andrew

2018-05-22

Endometriosis is a common gynaecological condition which affects many women of reproductive age worldwide and is a major cause of pain and infertility. The combined oral contraceptive pill (COCP) is widely used to treat pain occurring as a result of endometriosis, although the evidence for its efficacy is limited. To determine the effectiveness, safety and cost-effectiveness of oral contraceptive preparations in the treatment of painful symptoms ascribed to the diagnosis of laparoscopically proven endometriosis. We searched the following from inception to 19 October 2017: the Cochrane Gynaecology and Fertility Group Specialised Register of Controlled Trials, the Cochrane CENTRAL Register of Studies Online (CRSO), MEDLINE, Embase, PsycINFO, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and the trial registers ClinicalTrials.gov and the World Health Organization Clinical Trials Registry Platform (WHO ICTRP). We also handsearched reference lists of relevant trials and systematic reviews retrieved by the search. We included randomised controlled trials (RCT) of the use of COCPs in the treatment of women of reproductive age with symptoms ascribed to the diagnosis of endometriosis that had been made visually at a surgical procedure. Two review authors independently assessed study quality and extracted data. One review author was an expert in the content matter. We contacted study authors for additional information. The primary outcome was self-reported pain (dysmenorrhoea) at the end of treatment. Five trials (612 women) met the inclusion criteria. Only three trials (404 women) provided data that were suitable for analysis.Combined oral contraceptive pill versus placeboTwo trials compared COCP with a placebo. These studies were at high risk of bias. For GRADE outcomes (self-reported pain (dysmenorrhoea) at the end of treatment), the quality of the evidence very low. Evidence was downgraded for imprecision as it was based on a single, small trial and

Mineralocorticoid receptor haplotype, oral contraceptives and emotional information processing.

PubMed

Hamstra, D A; de Kloet, E R; van Hemert, A M; de Rijk, R H; Van der Does, A J W

2015-02-12

Oral contraceptives (OCs) affect mood in some women and may have more subtle effects on emotional information processing in many more users. Female carriers of mineralocorticoid receptor (MR) haplotype 2 have been shown to be more optimistic and less vulnerable to depression. To investigate the effects of oral contraceptives on emotional information processing and a possible moderating effect of MR haplotype. Cross-sectional study in 85 healthy premenopausal women of West-European descent. We found significant main effects of oral contraceptives on facial expression recognition, emotional memory and decision-making. Furthermore, carriers of MR haplotype 1 or 3 were sensitive to the impact of OCs on the recognition of sad and fearful faces and on emotional memory, whereas MR haplotype 2 carriers were not. Different compounds of OCs were included. No hormonal measures were taken. Most naturally cycling participants were assessed in the luteal phase of their menstrual cycle. Carriers of MR haplotype 2 may be less sensitive to depressogenic side-effects of OCs. Copyright © 2015 IBRO. Published by Elsevier Ltd. All rights reserved.

Influence of Menstrual Cycle and Oral Contraceptive Phase on Spinal Excitability.

PubMed

Casey, Ellen; Reese, Maria; Okafor, Ezi; Chun, Danielle; Gagnon, Christine; Nigl, Franz; Dhaher, Yasin Y

2016-09-01

Rates of musculoskeletal injury differ substantially between the genders, with females more likely to experience conditions such as anterior cruciate ligament (ACL) injuries than males in the same sports. Emerging evidence suggests a significant hormonal contribution. Most research has focused solely on how hormonal fluctuations affect connective tissue, but a direct link between hormonal shifts, ligamentous laxity, and ACL injury has not been borne out. There is also evidence to suggest that sex hormones can modulate the central nervous system, but how this affects neuromuscular control is not well understood. To determine whether changes in sex hormone concentrations would alter spinal excitability, measured across the menstrual and oral contraceptive pill cycle. We hypothesized that spinal excitability would fluctuate across the menstrual cycle (with increased excitability during the periovulatory phase due to peak estradiol concentration), but that there would be no fluctuation in oral contraceptive users. This was a prospective cohort study. The study took place at a biomechanics laboratory at a rehabilitation hospital. A total of 30 healthy women aged 18-35 who were similar in age, body composition, and exercise-training status were included. Fifteen of the women were eumenorrheic and nonusers of oral contraceptives (nonusers), and 15 of the women were taking oral contraceptives (users). H-reflex (Hmax/Mmax ratio), serum estradiol, and progesterone concentrations were measured at 3 time points during the menstrual and contraceptive pill cycle. The H-reflex (Hmax/Mmax ratio) remained stable across the menstrual and contraceptive pill cycle. Spinal excitability was lower in the users compared with the nonusers across all testing sessions, but this was not statistically significant. Our results suggest that acute fluctuations of endogenous estradiol and progesterone do not modulate spinal excitability. However, long-term exposure to exogenous estrogen and

Expression profiles of antimicrobial peptides in the genital tract of women using progesterone intrauterine devices versus combined oral contraceptives.

PubMed

Introini, Andrea; Kaldensjö, Tove; Hirbod, Taha; Röhl, Maria; Tjernlund, Annelie; Andersson, Sonia; Broliden, Kristina

2014-11-01

Sex hormones can influence the immune defenses of the female genital tract (FGT) and its susceptibility to infections. Here we investigated the effect of different hormonal contraceptives on the production of antimicrobial peptides (AMPs) in different compartments of the female genital mucosa (FGM), secretions and tissue. Cervicovaginal secretions (CVS) and ectocervical tissue samples obtained from women using progesterone intrauterine devices (pIUD) (n = 23) and combined oral contraceptives (COC) (n = 23) were analyzed for the expression and in situ localization of HNP1-3, BD-2, LL-37, SLPI and trappin-2 by ELISA, real-time PCR and immunohistochemistry. Women using COC had significantly lower mRNA levels of BD-2 and trappin-2 in ectocervical tissue than pIUD users. The two groups showed no differences in CVS concentration, as well as similar in situ expression patterns in ectocervical tissue, of all five AMPs. The use of hormonal contraceptives influences AMP expression differently in genital secretions compared to ectocervical tissue. This suggests that the impact of sex hormones on local immune defenses varies in different compartments of the FGM, and likely in different locations across the FGT. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Do oral contraceptives increase epileptic seizures?

PubMed

Reddy, Doodipala Samba

2017-02-01

Hormonal contraceptives are used by over 100 million people worldwide. Recently, there has been an emerging interest in studying the potential impact of oral contraceptives (OCs) on certain neurological conditions. It has been suspected for some time that hormonal birth control increases seizure activity in women with epilepsy, but there is little supportive data. Areas covered: Literature from PubMed and online sources was analyzed with respect to hormonal contraception and epilepsy or seizures. New evidence indicates that OCs can cause an increase in seizures in women with epilepsy. The epilepsy birth control registry, which surveyed women with epilepsy, found that those using hormonal contraceptives self-reported 4.5 times more seizures than those that did not use such contraceptives. A preclinical study confirmed these outcomes wherein epileptic animals given ethinyl estradiol, the primary component of OCs, had more frequent seizures that are more likely to be resistant. Expert commentary: OC pills may increase seizures in women with epilepsy and such refractory seizures are more likely to cause neuronal damage in the brain. Thus, women of child bearing age with epilepsy should consider using non-hormonal forms of birth control to avoid risks from OC pills. Additional research into the mechanisms and prospective clinical investigation are needed.

Oral contraceptives and the prothrombin time.

PubMed

Pangrazzi, J; Roncaglioni, M C; Donati, M B

1980-02-02

Dr. De Teresa and others reported that mean prothrombin time ratio of 12 patients on long-term anticoagulation with warfarin was significantly higher when they were also taking oral contraceptives (OCs). A study of prothrombin complex activity was recently conducted in female rats treated with an estrogen-progestogen combination (lynestrenol 5 mg; mestranol 0.3 mg/kg body weight) which resulted in a 100% infertility in this species. After 1 treatment for only 1 estral cycle, OC-treated rats had a significantly longer Normotest clotting time (37.7+ or-0.5 sec) than control rats (31.0+or-0.4); the difference was even more notable after 10 cycles. Although this finding has not been reported in women on OCs, it may be that the estrogen-induced "lability" of the prothrombin complex occurs in humans only in special conditions, such as anticoagulation. Alternatively, liver dysfunction occurring among women on OCs may be responsible for reduced metabolism of warfarin, contributing to the effectiveness of the anticoagulation. Further pharmacology studies should be done to clarify the interaction between OCs and oral anticoagulants.

Effects on bone mineral density of a monophasic combined oral contraceptive containing nomegestrol acetate/17β-estradiol in comparison to levonorgestrel/ethinylestradiol.

PubMed

Sørdal, Terje; Grob, Paul; Verhoeven, Carole

2012-11-01

To compare the effects of a monophasic combined oral contraceptive containing nomegestrol acetate/17β-estradiol (NOMAC/E2) on bone mineral density with a combined oral contraceptive containing levonorgestrel/ethinylestradiol (LNG/EE). Prospective, randomized, open-label, comparative clinical study. Gynecology center in Norway. One hundred and ten women (20-35 years old) actively seeking contraception. Methods. For 26 consecutive 28-day cycles, women received one of the following two treatments: NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n= 56); or LNG/EE (150 μg/30 μg) in a 21/7-day regimen (n= 54). Main outcome measures. Bone mineral density of the lumbar spine, femoral neck, hip and trochanter (measured by dual energy X-ray absorptiometry); associated z-scores of the lumbar spine and femoral neck. In NOMAC/E2 users, mean (±SD) z-score change from baseline for lumbar spine and femoral neck were 0.019 ± 0.242 and -0.007 ± 0.228, respectively, vs. 0.121 ± 0.269 and 0.044 ± 0.253 in LNG/EE users, respectively. Differences between treatment groups were not significant (p= 0.19 and p= 0.57, respectively). There were no significant differences between changes in hip and trochanter z-scores between NOMAC/E2 and LNG/EE treatments. After two years, NOMAC/E2 had no clinically relevant effect on bone mineral density. No significant difference in the effect on bone mineral density between NOMAC/E2 and LNG/EE was observed. © 2012 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2012 Nordic Federation of Societies of Obstetrics and Gynecology.

Psychosexual well-being in women using oral contraceptives containing drospirenone.

PubMed

Nappi, Rossella E; Albani, Francesca; Tonani, Silvia; Santamaria, Valentina; Pisani, Carla; Terreno, Erica; Martini, Ellis; Polatti, Franco

2009-01-01

Considerable advances have been made in hormonal contraception in recent years, geared at maximizing compliance and minimizing discontinuation. In oral contraceptive (OC) formulations, the estrogenic component, generally ethinyl estradiol (EE), has been reduced significantly and newer progestins like dienogest and drospirenone (DRSP), compounds with different molecular structures, have been introduced; in addition, new regimens (extended, flexible, 24/4 formats instead of the standard 21/7 format) and innovative delivery systems (vaginal rings, transdermal patches, subcutaneous implants and intrauterine devices) are available. The multitude of choices allows hormonal contraception to be tailored to the individual woman in order to obtain non-contraceptive benefits, without significant side effects, and also a favorable risk/benefit profile for her general and reproductive health. Over the past few years, new OC formulations combining DRSP (3 mg), a unique progestin with both antimineralocorticoid and antiandrogenic activities, with estrogen (30 mcg or 20 mcg EE), in two regimens (24/4 and 21/7) of active pills in a 28-day cycle, have shown positive effects on water retention-related weight gain and physical, emotional and psychosexual well-being. It seems likely that the use of a low-dose, well-balanced OC and the shorter 4-day hormone-free interval may minimize the side effects that can impair quality of life and thus increase women's compliance with hormonal contraception therapy.

The effect on acne quality of life of topical azelaic acid 15% gel versus a combined oral contraceptive in adult female acne: A randomized trial.

PubMed

Rocha, Marco; Sanudo, Adriana; Bagatin, Edileia

2017-01-01

Acne vulgaris is a chronic inflammatory disease that affects the pilosebaceous unit. Recent studies have shown an increasing number of cases of acne in adult women. These cases are predominantly normoandrogenic and have show some clinical differences compared to adolescent acne. In addition to the physical aspects, acne has a strong psychosocial impact and can lead to the onset of signs and symptoms of depression, such as anger. Our objective was to evaluate the effect on acne-specific quality of life in adult women treated with topical azelaic acid versus a combined oral contraceptive. The study population consisted of 38 adult women with acne and without any features of hyperandrogenism recruited from the clinic of Dermatology Hospital Division of São Paulo, Federal University of São Paulo from January 2012 to September 2014. Patients were randomized into two different groups: one receiving containing 20 ug of ethinylestradiol and 3 mg drospirenone in a regimen of 24 days of medication, a combined oral contraceptive (COC), and the other group topical 15% azelaic acid (AA) gel, twice daily, both for six months. The quality of life was evaluated at baseline and end of treatment with an acne specific measure (Acne-QoL). Before treatment, our data revealed a significant impact of the presence of acne on quality of life. Both treatments resulted in improvement with significant statistical values in quality of life scores. Comparing the four domains of Acne-QoL, patients treated with an oral contraceptive showed greater improvement in two domains (self-perception and acne symptoms) than those treated with azelaic acid.

Spanish women's attitudes towards menstruation and use of a continuous, daily use hormonal combined contraceptive regimen.

PubMed

Sánchez-Borrego, Rafael; García-Calvo, Carmen

2008-02-01

The main objective of this survey was to explore the attitude of Spanish women towards menstruation, as well as their acceptability of a daily, continuous, combination oral contraceptive regimen. National survey carried out in Spain in 2006. A total of 588 women aged between 18 and 45 years old answered an anonymous questionnaire that included questions regarding menstruation and acceptability of new contraceptive regimens. Overall, 24.5% of women expressed interest in using the continuous oral contraceptive regimen. This percentage increased up to nearly 50% in women younger than 25 years old and those not using any contraceptive method but willing to use them in the future. The attitude of Spanish women towards menstruation observed in this survey seems to be more conservative than that obtained in other recent international surveys. An improvement in the education provided by practitioners would help women to make informed decisions.

Effect of saxagliptin on the pharmacokinetics of the active components of Ortho-Cyclen(®), a combined oral contraceptive containing ethinyl estradiol and norgestimate, in healthy women.

PubMed

Upreti, V V; Hsiang, C B; Li, L; Xu, X; LaCreta, F P; Boulton, D W

2012-12-01

Saxagliptin (Onglyza™) is a dipeptidyl peptidase-4 (DPP4) inhibitor for treating type 2 diabetes mellitus. This open-label, randomized, two-way crossover study in 20 healthy female subjects investigated the effect of saxagliptin on the pharmacokinetics (PK) of the active components of a combined oral contraceptive (COC). Subjects received either COC (Ortho-Cyclen(®)) once daily (QD) for 21 days, then 5 mg saxagliptin QD + COC QD for 21 days, or vice versa. Coadministration of saxagliptin and COC did not alter the steady-state PK of the primary active oestrogen (ethinyl estradiol) or progestin (norelgestromin) COC components. The area under the concentration-time curve (AUC) and peak plasma concentration (Cmax) of an active metabolite of norelgestromin (norgestrel) were increased by 13 and 17%, respectively, a magnitude that was not considered clinically meaningful. Coadministration of saxagliptin and COC in this study was generally well-tolerated. Saxagliptin can be co-prescribed with an oestrogen/progestin combination for women taking oral contraceptive. © 2012 Blackwell Publishing Ltd.

Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-9

PubMed Central

Nielsen, Lars Hougaard; Skovlund, Charlotte Wessel; Skjeldestad, Finn Egil; Løkkegaard, Ellen

2011-01-01

Objective To assess the risk of venous thromboembolism from use of combined oral contraceptives according to progestogen type and oestrogen dose. Design National historical registry based cohort study. Setting Four registries in Denmark. Participants Non-pregnant Danish women aged 15-49 with no history of thrombotic disease and followed from January 2001 to December 2009. Main outcome measures Relative and absolute risks of first time venous thromboembolism. Results Within 8 010 290 women years of observation, 4307 first ever venous thromboembolic events were recorded and 4246 included, among which 2847 (67%) events were confirmed as certain. Compared with non-users of hormonal contraception, the relative risk of confirmed venous thromboembolism in users of oral contraceptives containing 30-40 µg ethinylestradiol with levonorgestrel was 2.9 (95% confidence interval 2.2 to 3.8), with desogestrel was 6.6 (5.6 to 7.8), with gestodene was 6.2 (5.6 to 7.0), and with drospirenone was 6.4 (5.4 to 7.5). With users of oral contraceptives with levonorgestrel as reference and after adjusting for length of use, the rate ratio of confirmed venous thromboembolism for users of oral contraceptives with desogestrel was 2.2 (1.7 to 3.0), with gestodene was 2.1 (1.6 to 2.8), and with drospirenone was 2.1 (1.6 to 2.8). The risk of confirmed venous thromboembolism was not increased with use of progestogen only pills or hormone releasing intrauterine devices. If oral contraceptives with desogestrel, gestodene, or drospirenone are anticipated to increase the risk of venous thromboembolism sixfold and those with levonorgestrel threefold, and the absolute risk of venous thromboembolism in current users of the former group is on average 10 per 10 000 women years, then 2000 women would need to shift from using oral contraceptives with desogestrel, gestodene, or drospirenone to those with levonorgestrel to prevent one event of venous thromboembolism in one year. Conclusion After

Dangerous triplet: Polycystic ovary syndrome, oral contraceptives and Kounis syndrome.

PubMed

Erol, Nurdan; Karaagac, Aysu Turkmen; Kounis, Nicholas G

2014-12-26

Polycystic ovary syndrome is characterized by ovulatory dysfunction, androgen excess and polycystic ovaries and is associated with hypertension, diabetes, metabolic syndrome and cardiovascular events. Oral contraceptives constitute first-line treatment, particularly when symptomatic hyperandrogenism is present. However, these drugs are associated with cardiovascular events and hypersensitivity reactions that pose problem in differential diagnosis and therapy. We present a 14 year-old female with polycystic ovary syndrome taking oral contraceptive and suffering from recurrent coronary ischemic attacks with increased eosinophils, and troponin levels suggesting Kounis syndrome.

Practice Bulletin No. 152: Emergency Contraception.

PubMed

2015-09-01

Emergency contraception, also known as postcoital contraception, is therapy used to prevent pregnancy after an unprotected or inadequately protected act of sexual intercourse. Common indications for emergency contraception include contraceptive failure (eg, condom breakage or missed doses of oral contraceptives) and failure to use any form of contraception (). Although oral emergency contraception was first described in the medical literature in the 1960s, the U.S. Food and Drug Administration (FDA) approved the first dedicated product for emergency contraception in 1998. Since then, several new products have been introduced. Methods of emergency contraception include oral administration of combined estrogen-progestin, progestin only, or selective progesterone receptor modulators and insertion of a copper intrauterine device (IUD). Many women are unaware of the existence of emergency contraception, misunderstand its use and safety, or do not use it when a need arises (). The purpose of this Practice Bulletin is to review the evidence for the efficacy and safety of available methods of emergency contraception and to increase awareness of these methods among obstetrician-gynecologists and other gynecologic providers.

An epigenetic basis for autism spectrum disorder risk and oral contraceptive use.

PubMed

Strifert, Kim

2015-12-01

In the United States 1 in 68 children are diagnosed with autism spectrum disorder (ASD). Although the etiology is unknown, many scientists believe ASD is caused by a combination of genetic and environmental factors and/or epigenetic factors. The widespread use of oral contraceptives is one environmental risk factor that has been greatly overlooked in the biomedical literature. Oral contraceptives, synthetic hormones created to imitate natural human hormones and disrupt endogenous endocrine function to inhibit pregnancy, may be causing the harmful neurodevelopmental effects that result in the increased prevalence of ASD. It is conceivable that the synthetic hormones repeatedly assault the oocyte causing persistent changes in expression of the estrogen receptor beta gene. Ethinylestradiol, a known endocrine disruptor, may trigger DNA methylation of the estrogen receptor beta gene causing decreased mRNA resulting in impaired brain estrogen signaling in progeny. In addition, it is possible the deleterious effects are transgenerational as the estrogen receptor gene and many of its targets may be imprinted and the methylation marks protected from global demethylation and preserved through fertilization and beyond to progeny generations. This article will delineate the hypothesis that ethinylestradiol activates DNA methylation of the estrogen receptor beta gene causing decreased mRNA resulting in diminished brain estrogen signaling in offspring of mothers exposed to oral contraceptives. Considering the detrimental epigenetic and transgenerational effects proposed, it calls for further study. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

[The efficiency of oral contraception containing drospirenone in treating symptoms of premenstrual syndrome or premenstrual dysphoric disorder in gyneacology practice].

PubMed

Svojanovská, K

2010-10-01

The efficiency of oral contraception containing drospirenone in treating symptoms of premenstrual dysphoric disorder (PMDD) was demonstrated in a number of studies. The objective of this observation was to use the "Premenstrual Symptoms Screening Tool" (PSST) to identify women who suffer from severe premenstrual syndrome (PMS) or PMDD and evaluate the benefits of their treatment through using the oral contraceptive containing drospirenone in regime 24/4 in gyneacology practice. The retrospective study was conducted from September 2008 to August 2009. Fifty-one women met by the PSST (Premenstrual Symptoms Screening Tool, Steiner et. al., 2003) the criteria of severe PMS/PMDD. Twenty-eight women took no contraception at the start of the evaluation and twenty-three already took oral contraceptives before changing to the oral contraceptive with drospirenone. The women completed the PSST and in the case of severe PMS/PMDD started treatment with the oral contraceptive containing 20 microg ethinylestradiol /EE/ + 3 mg drospirenone /drsp/ in regime 24/4. The next evaluation was conducted by the same PSST after 3 or 4 months of treatment with this oral contraceptive. The study involved 51 women between the ages of 15 and 44 years (average 25.7 years), who completed the PSST before and after 3 or 4 months of treatment with the oral contraceptive containing drospirenone. The summary score of all subjects significantly decreased from 24.6 before they started using the oral contraceptive with drospirenone to 7,2 after 3 or 4 months of treatment with this oral contraceptive. Significant declines in summary scores have been shown in both groups (in the group without oral contraception from 24.9 at the start of the observation to 8.2 after 3 or 4 months of using this oral contraceptive with drospirenone; and from 24.3 to 6.0 in the group with the change from using various oral contraceptives to using the contraceptive containing drospirenone). The application of PSST for detection

Effect of combined metformin and oral contraceptive on metabolic factors and endothelial function in overweight and obese women with polycystic ovary syndrome

PubMed Central

Essah, Paulina A; Arrowood, James A; Cheang, Kai I; Adawadkar, Swati S; Stovall, Dale W.; Nestler, John E.

2011-01-01

In this randomized, double-blind, placebo controlled study, 19 overweight women with PCOS were randomized to a 3-month course of either metformin plus combined hormonal oral contraceptive (OC) (n=9) or OC and matched placebo (n=10). After 3 months, both treatments had similar effects on androgen levels, lipid profile, insulin sensitivity and serum inflammatory markers, but flow-mediated dilatation increased by 69.0% in the metformin-OC group (p=0.01) while it remained unchanged in the OC group. PMID:21733508

Laryngeal aerodynamics associated with oral contraceptive use: preliminary findings.

PubMed

Gorham-Rowan, Mary; Fowler, Linda

2009-01-01

The purpose of this study was to examine possible differences in laryngeal aerodynamic measures during connected speech associated with oral contraceptive (OC) use. Eight women taking an OC, and eight others not taking an OC, participated in the study. Three trials of syllable /p/repetitions were obtained using a circumferentially vented face mask and small translabial tube. All participants were recorded on or near days 7 and 14 of their menstrual cycle. Subglottal pressure (P(SG)) and average airflow rates were obtained to determine laryngeal airway resistance. Glottal airflow measures of peak flow, minimum flow, alternating flow, as well as relative sound level (RSL) were obtained. P(SG) was obtained from the pressure peak associated with/p/. All airflow parameters and RSL were obtained from the vowel portion. No significant differences were found related to day of recording or OC use, indicating that OC use does not significantly affect laryngeal airflow regulation. The reader will better understand the effects of hormones and oral contraceptives on the female voice, as well as the specific changes in vocal function that may occur in conjunction with the use of oral contraceptives.

Efficacy and safety of a combined oral contraceptive containing estradiol valerate/dienogest: results from a clinical study conducted in North America.

PubMed

Nelson, Anita; Parke, Susanne; Mellinger, Uwe; Zampaglione, Edio; Schmidt, Anja

2014-03-01

This study investigated the efficacy and safety of a combined oral contraceptive (COC) containing estradiol valerate/dienogest (E2V/DNG). This was a multicenter, noncomparative, 13-cycle (extended to 28 cycles) study conducted in the United States and Canada. Contraceptive efficacy was calculated as a Pearl Index for 13 cycles, based on all on-treatment pregnancies; bleeding patterns were calculated based on bleeding and spotting information recorded daily in diary cards. Safety events during a 16-month extension study were added to the 1-year data. In total, 499 women, aged 18-35 years, were enrolled, and 490 of them were included in the full analysis set for contraceptive efficacy. Five pregnancies occurred in the first year (unadjusted Pearl Index=1.64). In cycles 1-12, an average 23.5% of women had absent scheduled (withdrawal) bleeding. Among women with scheduled (withdrawal) bleeding, bleeding started after a median of 2 days after intake of the last DNG-containing pill. For safety, data included from 147 women followed over an additional 16 months were added to the original 13-cycle data set. Treatment-related adverse events (AEs) occurred in 51.8% of women; 14.9% discontinued because of AEs over the entire 28-month study period. A COC with E2V and DNG was shown to provide effective contraception in women aged 18-35 years in North America.

Examining the role of oral contraceptive users as an experimental and/or control group in athletic performance studies.

PubMed

Elliott-Sale, Kirsty Jayne; Smith, Stephanie; Bacon, James; Clayton, David; McPhilimey, Martin; Goutianos, Georgios; Hampson, Jennifer; Sale, Craig

2013-09-01

This study was conducted to examine the effect of oral contraceptives on endogenous reproductive hormone levels in order to assess the suitability of oral contraceptive users as experimental and/or control groups in human performance studies. Ninety-five females who were taking a variety of oral contraceptives (2 types and 11 brands) were recruited. A single blood sample was analysed for endogenous concentrations of oestradiol and progesterone. There were significant differences (p<.05) in circulating oestradiol and progesterone as a result of oral contraceptive type and brand. Overall, oral contraceptive use resulted in low levels of oestradiol and progesterone and large variation in hormone concentration when multiple brands were analysed together. This study indicates that future studies should employ a single pill type and brand when using oral contraceptive users as either a control or experimental group and that comparison between oral contraceptive users as a control group and the early follicular phase of the menstrual cycle as an experimental group should be reconsidered. Copyright © 2013 Elsevier Inc. All rights reserved.

Oral contraceptives and colorectal cancer risk: a meta-analysis

PubMed Central

Fernandez, E; Vecchia, C La; Balducci, A; Chatenoud, L; Franceschi, S; Negri, E

2001-01-01

Several studies have suggested an inverse association between use of combined oral contraceptives (OC) and the risk of colorectal cancer and here we present a meta-analysis of published studies. Articles considered were epidemiological studies published as full papers in English up to June 2000 that included quantitative information on OC use. The pooled relative risks (RR) of colorectal cancer for ever OC use from the 8 case-control studies was 0.81 (95% confidence interval (CI): 0.69–0.94), and the pooled estimate from the 4 cohort studies was 0.84 (95% CI: 0.72–0.97). The pooled estimate from all studies combined was 0.82 (95% CI: 0.74–0.92), without apparent heterogeneity. Duration of use was not associated with a decrease in risk, but there was some indication that the apparent protection was stronger for women who had used OCs more recently (RR = 0.46; 95% CI: 0.30–0.71). A better understanding of this potential relation may help informed choice of contraception. © 2001 Cancer Research Campaign http://www.bjcancer.com PMID:11237397

Bleeding pattern with drospirenone 3 mg+ethinyl estradiol 20 mcg 24/4 combined oral contraceptive compared with desogestrel 150 mcg+ethinyl estradiol 20 mcg 21/7 combined oral contraceptive.

PubMed

Anttila, Leena; Kunz, Michael; Marr, Joachim

2009-11-01

The study was conducted to compare cycle control, bleeding pattern and efficacy of two low-dose combined oral contraceptives. Four hundred fifty-three women were randomized to receive a 24/4 regimen of drospirenone 3 mg/ethinyl estradiol 20 mcg (drsp 3 mg/EE 20 mcg; n=230) or a 21/7 regimen of desogestrel 150 mcg/EE 20 mcg (DSG 150 mcg/EE 20 mcg; n=223), and recorded bleeding daily over 7 treatment cycles. The duration [mean 4.7 (SD 1.5)-5.2 (SD 2.2) days in the drsp 3 mg/EE 20 mcg 24/4 group and 5.1 (SD 1.5)-5.4 (SD 2.1) days in the DSG 150 mcg/ EE 20 mcg group] and maximum intensity ("normal bleeding" for >50% of all subjects) of scheduled bleeding in Cycles 1-6 was comparable between treatment groups. The incidence of unscheduled bleeding during Cycles 2-6 was also similar between the two groups (drsp 3 mg/EE 20 mcg, 8.8-17.3%; DSG 150 mcg/ EE 20 mcg, 9.4-16.3%). Drsp 3 mg/EE 20 mcg 24/4 achieved an acceptable bleeding profile with reliable cycle control, comparable with an established formulation.

The link between oral contraceptive use and prevalence in autism spectrum disorder.

PubMed

Strifert, Kim

2014-12-01

Autism spectrum disorder (ASD) is a group of developmental disabilities that include full syndrome autism, Asperger's syndrome, and other pervasive developmental disorders. The identified prevalence of ASD has increased in a short time period across multiple studies causing some to conclude that it has reached epidemic proportions in the U.S. Many possible explanations for the rise in numbers of individuals diagnosed with ASD have been offered and yet, causes and contributing factors for ASD are inadequately understood. Current evidence suggests that both genetics and environment play a part in causing ASD. One possible risk factor for the increase in prevalence has been profoundly overlooked in the existing biomedical and epidemiologic literature. As the prevalence of ASD has risen in the last sixty years, so has the prevalence of the usage of the oral contraceptives and other modern hormonal delivery methods. In 1960 about one million American women were using oral contraceptives, today close to 11 million women in the U.S. use oral contraceptives. Eighty-two percent of sexually active women in the U.S. have used oral contraceptives at some point during their reproductive years. Thus, the growth in use of progesterone/estrogen-based contraceptives in the United State has reached near-ubiquitous levels among women in the child-bearing age range. The suppression of ovulation produced by estrogen-progesterone is an indisputable abnormality. It is logical to consider the outcome of the ovum that would have been normally released from the ovary during ovulation. To date there is no comprehensive research into the potential neurodevelopmental effects of oral contraceptive use on progeny. The issue has been only sparsely considered in the biomedical literature. This article hypothesizes that the compounds, estrogen and progesterone, used in oral contraceptives modify the condition of the oocyte and give rise to a potent risk factor that helps explain the recent increase

Efficacy and bleeding profile of a combined oral contraceptive containing oestradiol valerate/dienogest: a pooled analysis of three studies conducted in North America and Europe.

PubMed

Nelson, Anita; Parke, Susanne; Makalova, Dagmar; Serrani, Marco; Palacios, Santiago; Mellinger, Uwe

2013-08-01

To summarise all clinical data on the contraceptive efficacy and bleeding profile associated with an oestradiol valerate (E2V) and dienogest (DNG) [E2V/DNG] combined oral contraceptive (COC) derived from Phase III trials. Pooled analysis of three large-scale multicentre trials conducted in healthy women who received oral E2V/DNG for 7 to 28 cycles (28-day cycles). A total of 2266 women were included in this analysis. Overall, 19 pregnancies occurred over 13 cycles during 880,950 days of relevant exposure (Pearl Index [PI] of 0.79; upper limit of the two-sided 95% confidence interval [CI]: 1.23). Ten pregnancies attributed to method failure came about during 871,091 days of relevant exposure (adjusted PI of 0.42; upper limit of the two-sided 95% CI: 0.77). In women aged 18 to 35 years (n = 1687), the corresponding PI and adjusted PI were 1.01 (upper limit of the two-sided 95% CI: 1.59) and 0.51 (upper limit of the two-sided 95% CI: 0.97), respectively. In the first 13 cycles of treatment, 76 to 81% of women experienced scheduled withdrawal bleeding, and 13 to 23% experienced intracyclic bleeding. E2V/DNG provides reliable contraceptive efficacy in women aged 18 to 50 years.

Emergency contraception.

PubMed

2012-12-01

Despite significant declines over the past 2 decades, the United States continues to have teen birth rates that are significantly higher than other industrialized nations. Use of emergency contraception can reduce the risk of pregnancy if used up to 120 hours after unprotected intercourse or contraceptive failure and is most effective if used in the first 24 hours. Indications for the use of emergency contraception include sexual assault, unprotected intercourse, condom breakage or slippage, and missed or late doses of hormonal contraceptives, including the oral contraceptive pill, contraceptive patch, contraceptive ring (ie, improper placement or loss/expulsion), and injectable contraception. Adolescents younger than 17 years must obtain a prescription from a physician to access emergency contraception in most states. In all states, both males and females 17 years or older can obtain emergency contraception without a prescription. Adolescents are more likely to use emergency contraception if it has been prescribed in advance of need. The aim of this updated policy statement is to (1) educate pediatricians and other physicians on available emergency contraceptive methods; (2) provide current data on safety, efficacy, and use of emergency contraception in teenagers; and (3) encourage routine counseling and advance emergency-contraception prescription as 1 part of a public health strategy to reduce teen pregnancy. This policy focuses on pharmacologic methods of emergency contraception used within 120 hours of unprotected or underprotected coitus for the prevention of unintended pregnancy. Emergency contraceptive medications include products labeled and dedicated for use as emergency contraception by the US Food and Drug Administration (levonorgestrel and ulipristal) and the "off-label" use of combination oral contraceptives.

Simultaneous total occlusion of two coronary arteries associated with use of drospirenone-ethinyl estradiol (oral contraceptive).

PubMed

Atmaca, Hüsnü; Köprülü, Diyar; Kiriş, Tuncay; Zeren, Gönül; Şahin, İrfan

2018-01-01

Although the use of oral contraceptives is associated with an increased risk of venous thromboembolic disease, the risk of myocardial infarction (MI) is unclear. A new, third-generation contraceptive agent, drospirenone-ethinyl estradiol, which contains less estrogen and a new progestogen, drospirenone, in a different combination, has been considered more reliable in terms of risk of MI. However, there have been some cases of MI associated with the use of drospirenone-ethinyl estradiol, despite the protective effects of this oral contraceptive. In this report, a 33-year-old woman who had used drospirenone-ethinyl estradiol for 6 months was admitted with MI and symptoms of cardiogenic shock. Coronary angiography revealed the total occlusion of 2 coronary arteries and so percutaneous coronary intervention was performed. To the best of our knowledge, this is the first case report of simultaneous total occlusion of 2 coronary arteries associated with the use of drospirenone-ethinyl estradiol in the English-language medical literature.

Comparison of combined hormonal vaginal ring with ultralow-dose combined oral contraceptive pills in the management of heavy menstrual bleeding: A pilot study.

PubMed

Agarwal, N; Gupta, M; Kriplani, A; Bhatla, N; Singh, N

2016-01-01

The aim of this study was to compare combined hormonal vaginal ring with ultralow-dose combined oral contraceptive (COC) pills in management of heavy menstrual bleeding (HMB). Fifty patients were randomised into Group I: vaginal ring (n = 25) and group II: COC pills (n = 25). Menstrual blood loss (MBL) was assessed at baseline, 1, 3 and 6 months (while on treatment) and at 9 months (3 months after stopping therapy). There was significant reduction in baseline pictorial blood loss assessment chart (PBAC) score from 440 ± 188 (Mean ± SD) to 178 ± 95, 139 ± 117, 112 ± 84 and 120 ± 108 in group I and from 452 ± 206 to 204 ± 152, 179 ± 125, 176 ± 164 and 202 ± 167 in group II at 1, 3, 6 and 9 months, respectively (p = 0.001). Reduction in MBL was 72% and 62% at 6 months and up to 71% and 55% at 9 months in group I and group II, respectively (p = 0.001). Reduction in MBL with ring was greater at higher baseline PBAC score but lesser in patients with fibroid > 2 cm. Combined vaginal hormonal treatment for HMB is as effective as oral hormonal therapy, with minor and transient side effects and persistence of response after cessation of therapy.

Practice Bulletin Summary No. 152: Emergency Contraception.

PubMed

2015-09-01

Emergency contraception, also known as postcoital contraception, is therapy used to prevent pregnancy after an unprotected or inadequately protected act of sexual intercourse. Common indications for emergency contraception include contraceptive failure (eg, condom breakage or missed doses of oral contraceptives) and failure to use any form of contraception (1-3). Although oral emergency contraception was first described in the medical literature in the 1960s, the U.S. Food and Drug Administration (FDA) approved the first dedicated product for emergency contraception in 1998. Since then, several new products have been introduced. Methods of emergency contraception include oral administration of combined estrogen-progestin, progestin only, or selective progesterone receptor modulators and insertion of a copper intrauterine device (IUD). Many women are unaware of the existence of emergency contraception, misunderstand its use and safety, or do not use it when a need arises (4-6). The purpose of this Practice Bulletin is to review the evidence for the efficacy and safety of available methods of emergency contraception and to increase awareness of these methods among obstetrician-gynecologists and other gynecologic providers.

Combined oral contraceptives and body weight: do oral contraceptives cause weight gain? A primate model.

PubMed

Edelman, A; Jensen, J T; Bulechowsky, M; Cameron, J

2011-02-01

The aim of this study was to determine if oral contraceptive (OC) use affects body weight, body composition and metabolism in primates. Reproductive-age female rhesus monkeys of normal and obese BMI were studied to document baseline weight stability, then treated continuously with an OC (dosed to achieve equivalent human serum levels for a 30 µg ethinyl estradiol/150 µg levonorgestrel preparation) for 237 days. Monkeys were monitored for changes in body weight, levels of physical activity (measured by a triaxial Actical accelerometer), food/caloric intake, percent body fat (dual energy X-ray absorptiometry, DEXA) and metabolism (24 h metabolic rate and serum metabolic substrate and hormone concentrations). All 10 monkeys completed the study protocol with no adverse events. While body weight (-0.73% change) and percent body fat (-1.78% change) of the normal BMI group did not significantly decrease from baseline, obese monkeys showed a significant decrease in body weight (-8.58% change, P < 0.01) and percent body fat (-12.13% change P = 0.02) with OC treatment. In both the obese (P = 0.03) and the normal BMI (P = 0.01) groups, there was a significant increase in basal metabolic rate with OC use. No changes were seen in food intake, activity level or % lean muscle mass with OC use for either BMI-based group. Overall, OC use appears to cause a slight increase in basal metabolic rate in female monkeys, leading to a decrease in body weight and percent body fat in obese individuals.

Efficacy and safety of a low-dose monophasic combination oral contraceptive containing 100 microg levonorgestrel and 20 microg ethinyl estradiol (Alesse). North american Levonorgestrel Study Group (NALSG).

PubMed

Archer, D F; Maheux, R; DelConte, A; O'Brien, F B

1999-11-01

The efficacy and safety of a low-dose 21-day combination oral contraceptive containing 100 microg levonorgestrel and 20 microg ethinyl estradiol were evaluated in an open-label, multicenter trial. A total of 1708 subjects with regular menstrual cycles (27,011 cycles) were evaluated. The oral contraceptive was administered once a day for 21 days, followed by 7 days of placebo for a complete cycle. During 26,554 cycles evaluated for efficacy, 18 pregnancies occurred (Pearl index of 0.88); 6 of these events were attributable to subject noncompliance. After 30 cycles of exposure the cumulative rate of withdrawal as a result of accidental pregnancy was 1.9%. Breakthrough bleeding (with or without spotting) occurred in 12.9% of the cycles and spotting alone occurred in 10.1% of the cycles. The 2 most common adverse events cited as reasons for discontinuation were headache (2% of subjects) and metrorrhagia (2%). One serious event led to withdrawal of a subject. Overall, the results of this study demonstrate that the monophasic regimen of 100 microg levonorgestrel and 20 microg ethinyl estradiol offers effective contraception, acceptable cycle control, and a good tolerability profile.

A survey of bonobo (Pan paniscus) oral contraceptive pill use in North American zoos.

PubMed

Agnew, Mary K; Asa, Cheryl S; Clyde, Victoria L; Keller, Dominique L; Meinelt, Audra

2016-09-01

Contraception is an essential tool in reproductive management of captive species. The Association of Zoos and Aquariums (AZA) Reproductive Management Center (RMC) gathers data on contraception use and provides recommendations. Although apes have been given oral contraceptive pills (OCPs) for at least 30 years, there have been no published reports with basic information on why the pill is administered, formulations and brands used, and effects on physiology and behavior. Here, we report survey results characterizing OCP use in bonobos (Pan paniscus) housed in North American zoos, as well as information accumulated in the RMC's Contraception Database. Of 26 females treated, there have been no failures and nine reversals. The most commonly administered OCP formulation in bonobos contained ethinyl estradiol (EE) 35 μg/norethindrone 1 mg. Few females on combined oral contraceptives (COCs) were given a continuous active pill regimen; a hormone-free interval of at least 5 days was allowed in most. Crushing the pill and mixing with juice or food was common. Females on COCs seldom experienced breakthrough estrus or bleeding, while these conditions were sometimes observed for females on continuous COCs. All females on COCs exhibited some degree of perineal swelling, with a mean score of 3 or 3+ most commonly reported. Behavioral changes included less sexual behavior, dominant females becoming subordinate, and a negative effect on mood. No appreciable change in weight was noted. Taken together, these results indicate that OCPs are an effective and reversible contraceptive option for bonobos that can be used by zoos and sanctuaries to limit reproduction. Zoo Biol. 35:444-453, 2016. © Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Metabolic and cardiovascular impact of oral contraceptives in polycystic ovary syndrome.

PubMed

Soares, G M; Vieira, C S; de Paula Martins, W; Dos Reis, R M; de Sá, M F S; Ferriani, R A

2009-01-01

Chronic anovulation, polycystic ovarian morphology and hyperandrogenism are the diagnostic criteria for polycystic ovary syndrome (PCOS). Metabolic disturbances are more common in PCOS women who are prone to develop metabolic syndrome and to present higher levels of some cardiovascular disease risk marker. Oral contraceptives are widely used in PCOS, but conflicting data have been reported regarding their impact on carbohydrate and lipid metabolism on PCOS women. This paper presents a critical evaluation of combined oral contraceptives (COCs) metabolic effect - carbohydrate metabolism and insulin sensitivity, lipid metabolism, haemostasis, body weight, arterial pressure and cardiovascular impact - on PCOS women. Because of the paucity of data on the impact of COCs on cardiovascular and metabolic parameters in PCOS patients, most of there commendations are based on studies involving ovulatory women. The use of low-dose COCs is preferable in PCOS, especially among patients with glucose intolerance, insulin resistance and uncomplicated diabetes mellitus. Although reported as a side effect of COCs, marked weight gain has not been confirmed among users. However, when arterial hypertension or elevated risk for thromboembolism is present, progestogen-only hormonal contraceptives should be used instead of COCs. Regarding dyslipidaemia, COCs reduce low-density lipoprotein and total cholesterol and elevate high-density lipoprotein and triglycerides, and therefore are not recommended for women with high triglycerides levels. The choice of a COC, which alleviates the PCOS-induced hyperandrogenism without significant negative impact on cardiovascular risk, is one of the greatest challenges faced by gynaecologists nowadays.

How does intimate partner violence affect condom and oral contraceptive Use in the United States?: A systematic review of the literature.

PubMed

Bergmann, Julie N; Stockman, Jamila K

2015-06-01

Intimate partner violence (IPV) is estimated to affect 25% of adult women in the United States alone. IPV directly impacts women's ability to use contraception, resulting in many of unintended pregnancies and STIs. This review examines the relationship between IPV and condom and oral contraceptive use within the United States at two levels: the female victim's perspective on barriers to condom and oral contraceptive use, in conjunction with experiencing IPV (Aim 1) and the male perpetrator's perspective regarding condom and oral contraceptive use (Aim 2). We systematically reviewed and synthesized all publications meeting the study criteria published since 1997. We aimed to categorize the results by emerging themes related to each study aim. We identified 42 studies that met our inclusion criteria. We found 37 studies that addressed Aim 1. Within this we identified three themes: violence resulting in reduced condom or oral contraceptive use (n=15); condom or oral contraceptive use negotiation (n=15); which we further categorized as IPV due to condom or oral contraceptive request, perceived violence (or fear) of IPV resulting in decreased condom or oral contraceptive use, and sexual relationship power imbalances decreasing the ability to use condoms or oral contraceptives; and reproductive coercion (n=7). We found 5 studies that addressed Aim 2. Most studies were cross-sectional, limiting the ability to determine causality between IPV and condom or oral contraceptive use; however, most studies did find a positive relationship between IPV and decreased condom or oral contraceptive use. Quantitative, qualitative, and mixed methods research has demonstrated the linkages between female IPV victimization/male IPV perpetration and condom or oral contraceptive use. However, additional qualitative and longitudinal research is needed to improve the understanding of dynamics in relationships with IPV and determine causality between IPV, intermediate variables (e

Effect of eslicarbazepine acetate on the pharmacokinetics of a combined ethinylestradiol/levonorgestrel oral contraceptive in healthy women.

PubMed

Falcão, Amilcar; Vaz-da-Silva, Manuel; Gama, Helena; Nunes, Teresa; Almeida, Luís; Soares-da-Silva, Patrício

2013-08-01

To investigate the effect of once-daily (QD) eslicarbazepine acetate (ESL) 800 mg and 1,200 mg administration on pharmacokinetics of a combined ethinylestradiol/levonorgestrel oral contraceptive (OC) in women of childbearing potential. Two two-way, crossover, two-period, randomized, open-label studies were performed in 20 healthy female subjects, each. In one period (ESL+OC period), subjects received ESL 800 mg QD in one study and ESL 1200 mg QD in the other study, for 15 days; concomitantly with the Day 14 ESL dose, an oral single dose of 30 μg ethinylestradiol and 150 μg levonorgestrel was administered. In the other period (OC alone), a single dose of 30 μg ethinylestradiol and 150 μg levonorgestrel was administered. Three weeks or more separated the periods. An analysis of variance (ANOVA) was used to test for differences between pharmacokinetic parameters of 30 μg ethinylestradiol and 150 μg levonorgestrel following ESL+OC and OC alone, and 90% confidence intervals (90%CI) for the ESL+OC/OC alone geometric mean ratio (GMR) were calculated. ESL significantly decreased the systemic exposure to both ethinylestradiol and levonorgestrel. GMR (90%CI) for AUC0-24 of ethinylestradiol were 68% (64%; 71%) following 1,200 mg ESL and 75% (71%; 79%) following 800 mg ESL. GMR (90%CI) for AUC0-24 of levonorgestrel were 76% (68%; 86%) following 1,200 mg ESL and 89% (82%; 97%) following 800 mg ESL. A clinically relevant dose-dependent effect of ESL administration on the pharmacokinetics of ethinylestradiol and levonorgestrel was observed. Therefore, to avoid inadvertent pregnancy, women of childbearing potential should use other adequate methods of contraception during treatment with ESL, and, in case ESL treatment is discontinued, until CYP3A4 activity returns to normal. Copyright © 2013 Elsevier B.V. All rights reserved.

Comparing the effects of the second-and third-generation oral contraceptives on sexual functioning

PubMed Central

Shahnazi, Mahnaz; Bayatipayan, Somaye; Khalili, Azizeh Farshbaf; Kochaksaraei, Fatemeh Ranjbar; Jafarabadi, Mohammad Asghari; Banoi, Kamala Gaza; Nahaee, Jila

2015-01-01

Background: The aim of this study was to compare the effects of the second- and third-generation oral contraceptives on women's reproductive sexual function. Materials and Methods: This randomized, double-blind, placebo-controlled clinical trial was conducted on 82 married women of reproductive age in Tehran. Samples were randomized into the groups receiving second- and third-generation oral contraceptive pills. Female Sexual Function Index (FSFI) tool was used before the intervention and 2 and 4 months after the intervention. Data analysis was carried out using analysis of variance (ANOVA) within repeated measures and P < 0.05 were considered significant. Results: There was a statistically significant difference in the positive and negative moods between the experimental and control groups before the intervention in the second and fourth months. The second-generation pills caused a decrease in sexual function in the second month and an increase in sexual function in the fourth month, but the third-generation pills led to an increase in sexual function in the second and fourth months. The increase in sexual function that resulted from using the third-generation pills was significantly higher than that resulted on using the second-generation pills. Conclusions: According to the results of this study, sexual functioning decreased in the second month of using the second-generation pills and sexual performance was significantly more on using the third-generation pills compared to second-generation pills. The most common type of oral contraceptive used in Iran is the second-generation oral contraceptive LD™ (low-dose estrogen), which is freely distributed in health centers. Therefore, it is necessary for women who wish to use these contraceptive methods to be educated and consulted before they start using them. The third-generation contraceptive pills can be recommended to women who wish to use oral contraceptives. PMID:25709690

Comparing the effects of the second-and third-generation oral contraceptives on sexual functioning.

PubMed

Shahnazi, Mahnaz; Bayatipayan, Somaye; Khalili, Azizeh Farshbaf; Kochaksaraei, Fatemeh Ranjbar; Jafarabadi, Mohammad Asghari; Banoi, Kamala Gaza; Nahaee, Jila

2015-01-01

The aim of this study was to compare the effects of the second- and third-generation oral contraceptives on women's reproductive sexual function. This randomized, double-blind, placebo-controlled clinical trial was conducted on 82 married women of reproductive age in Tehran. Samples were randomized into the groups receiving second- and third-generation oral contraceptive pills. Female Sexual Function Index (FSFI) tool was used before the intervention and 2 and 4 months after the intervention. Data analysis was carried out using analysis of variance (ANOVA) within repeated measures and P < 0.05 were considered significant. There was a statistically significant difference in the positive and negative moods between the experimental and control groups before the intervention in the second and fourth months. The second-generation pills caused a decrease in sexual function in the second month and an increase in sexual function in the fourth month, but the third-generation pills led to an increase in sexual function in the second and fourth months. The increase in sexual function that resulted from using the third-generation pills was significantly higher than that resulted on using the second-generation pills. According to the results of this study, sexual functioning decreased in the second month of using the second-generation pills and sexual performance was significantly more on using the third-generation pills compared to second-generation pills. The most common type of oral contraceptive used in Iran is the second-generation oral contraceptive LD™ (low-dose estrogen), which is freely distributed in health centers. Therefore, it is necessary for women who wish to use these contraceptive methods to be educated and consulted before they start using them. The third-generation contraceptive pills can be recommended to women who wish to use oral contraceptives.

Success with oral contraceptives: a pilot study.

PubMed

Gilliam, Melissa; Knight, Sara; McCarthy, Martin

2004-05-01

The objective of this pilot study was to examine the effectiveness of a postpartum educational intervention aimed at increasing compliance with oral contraception (OCs) and decreasing repeat pregnancies in young, African American women in the year following an unplanned pregnancy. In this longitudinal study, 43 young, pregnant women attending Prentice Ambulatory Care, Northwestern Hospital, were enrolled and 33 were randomized to receive an antepartum, multicomponent intervention consisting of counseling, a videotape about OCs and written material or resident-physician counseling (usual care). Questionnaire data were collected at enrollment, immediately following the intervention, at 6 weeks, 6 months and 12 months. At 1 year, 25 women remained in the study. More women in the intervention group were not pregnant and still using contraception, and were able to successfully switch contraceptive methods compared to women in the control group. There was no decrease in repeat pregnancy in the intervention group at 1 year compared to the control group. Our intervention resulted in a sustained increase in knowledge of OCs throughout the study period. However, more is needed to promote postpartum contraceptive compliance and decrease repeat pregnancies in young, low-income African Americans with unintended pregnancies.

Intrauterine devices and other forms of contraception: thinking outside the pack.

PubMed

Allen, Caitlin; Kolehmainen, Christine

2015-05-01

A variety of contraception options are available in addition to traditional combined oral contraceptive pills. Newer long-acting reversible contraceptive (LARC) methods such as intrauterine devices and subcutaneous implants are preferred because they do not depend on patient compliance. They are highly effective and appropriate for most women. Female and male sterilization are other effective but they are irreversible and require counseling to minimize regret. The contraceptive injection, patch, and ring do not require daily administration, but their typical efficacy rates are lower than LARC methods and similar to those for combined oral contraceptive pills. Copyright © 2015 Elsevier Inc. All rights reserved.

The effect of combined oral contraceptives and age on dysmenorrhoea: an epidemiological study.

PubMed

Lindh, Ingela; Ellström, Agneta Andersson; Milsom, Ian

2012-03-01

Combined oral contraceptives (COCs) are widely advocated as treatment for primary dysmenorrhoea, but their efficacy has been questioned in a Cochrane review. The aim of this study was to evaluate COCs and the influence of age on the severity of dysmenorrhoea. Postal questionnaires regarding weight/height, contraception, pregnancy history and other reproductive health factors were sent to random samples of 19-year-old women born in 1962 (n = 656), 1972 (n = 780) and 1982 (n = 666) resident in the city of Gothenburg in 1981, 1991 and 2001. The responders were assessed again 5 years later at the age of 24 years. Current severity of dysmenorrhoea was measured on each occasion by a verbal multidimensional scoring system (VMS) and by a visual analogue scale (VAS). The severity of dysmenorrhoea was lower (P< 0.0001) in COC users compared with non-users. In a longitudinal analysis of the severity of dysmenorrhoea, COC use and increasing age, independently of each other, were associated with the severity of dysmenorrhoea (COC use, VMS score: a reduction of 0.3 units/VAS: a reduction of 9 mm, both P< 0.0001; increasing age, VMS score: a reduction of 0.1 units per 5 years, P< 0.0001/VAS: a reduction of 5 mm per 5 years, P< 0.0001). Childbirth also reduced the severity of dysmenorrhoea (VAS, P< 0.01 with a reduction of 7 mm). Women from the 82-cohort reported a greater severity of dysmenorrhoea compared with the 62 and 72 cohorts at both 19 and 24 years of age. In this longitudinal case-control study, COC use and increasing age, independent of each other, reduced the severity of dysmenorrhoea. COC use reduced the severity of dysmenorrhoea more than increasing age and childbirth. There was a trend over time regarding the severity of dysmenorrhoea where women from the 82-cohort reported a greater severity of dysmenorrhoea compared with the 62 and 72 cohorts.

Decreased maximal aerobic capacity with use of a triphasic oral contraceptive in highly active women: a randomised controlled trial

PubMed Central

Lebrun, C; Petit, M; McKenzie, D; Taunton, J; Prior, J

2003-01-01

Background: Oral contraceptives are commonly used by women athletes. However, their effect on athletic performance is unclear. Objectives: To examine the effects of a moderate dose, triphasic oral contraceptive on measures of athletic performance in highly trained women athletes. Methods: This is a double blind, placebo controlled trial in 14 women with ovulatory menstrual cycles and maximal aerobic capacity (VO2MAX) ≥50 ml/kg/min. Four measures of athletic performance were tested: VO2MAX, anaerobic capacity (anaerobic speed test), aerobic endurance (time to fatigue at 90% of VO2MAX), and isokinetic strength (Cybex II dynamometer). Height, weight, and six skinfold measurements were also recorded. All these observational tests were completed during both the follicular and mid-luteal phases of an ovulatory menstrual cycle. Cycle phases were confirmed by assaying plasma oestradiol and progesterone. Participants were subsequently randomly assigned to either a tricyclic oral contraceptive or placebo and retested in identical fashion (oral contraceptive phase). Results: Absolute and relative changes in VO2MAX from follicular to oral contraceptive phase decreased in the oral contraceptive group by 4.7%, whereas the placebo group showed a slight increase (+1.5%) over the same time period. Two of the women taking oral contraceptive had decreases of 4 and 9 ml/kg/min. In contrast, most women in the placebo group improved or maintained VO2MAX. There was also a significant increase in the sum of skinfolds in women taking oral contraceptive compared with those taking placebo (p<0.01). There were no significant changes in other physiological variables (maximum ventilation, heart rate, respiratory exchange ratio, packed cell volume) or measures of performance (anaerobic speed test, aerobic endurance, isokinetic strength) as a function of oral contraceptive treatment. Conclusions: The decrease in VO2MAX that occurs when oral contraceptive is taken may influence elite sporting

The CORALIE study: improving patient education to help new users better understand their oral contraceptive.

PubMed

de Reilhac, Pia; Plu-Bureau, Geneviève; Serfaty, David; Letombe, Brigitte; Gondry, Jean; Christin-Maitre, Sophie

2016-10-01

Combined oral contraceptives (COCs) are the most widely used contraceptive method in Europe. Paradoxically, rates of unintended pregnancy and abortion are still remarkably high. A lack of knowledge about COCs is often reported to lead to poor adherence, suggesting an unmet need for adequate contraceptive counselling. Our objective was to investigate the impact on the knowledge level of users of a structured approach to deliver contraceptive information for a first COC prescription. The Oral Contraception Project to Optimise Patient Information (CORALIE) is a multicentre, prospective, randomised study conducted in France between March 2009 and January 2013. The intervention involved providing either an 'essential information' checklist or unstructured counselling to new COC users. The outcome measure was a questionnaire that assessed whether the information provided to the new user by the gynaecologist had been correctly understood. One hundred gynaecologists and an expert committee used the Delphi method to develop an 'essential information' checklist, after which 161 gynaecologists were randomised to two groups. Group I (n = 81) used the checklist with 324 new COC users and group II (n = 80) delivered unstructured information to 307 new COC users. The average score for understanding the information delivered during the visit was significantly higher in women in group I than in the women in group II, even after adjustment for age and previous history of pregnancy: 16.48/20 vs 14.27/20 (p < 0.0001). Delivering structured information for a first COC prescription is beneficial for understanding contraception. Our tool could ultimately contribute to increased adherence and should be investigated in a prospective study of long-term outcomes.

Women's perceptions of contraceptive efficacy and safety.

PubMed

Kakaiya, Roshni; Lopez, Lia L; Nelson, Anita L

2017-01-01

Adoption of contraceptive implants and intrauterine devices has been less than might be expected given their superior efficacy and convenience. The purpose of this study was to assess knowledge and beliefs held by women, which may influence their contraceptive choices and theirongoing utilization of contraceptive methods. English speaking, nonpregnant, reproductive-age women, who were not surgically sterilized, were individually interviewed to obtain limited demographic characteristics and to assess their knowledge about the efficacy of various contraceptive methods in typical use and about the relative safety of oral contraceptives. A convenience sample of 500 women aged 18-45 years, with education levels that ranged from middle school to postdoctoral level was interviewed. The efficacy in typical use of both combined oral contraceptives and male condoms was correctly estimated by 2.2%; over two-thirds of women significantly over estimated the efficacy of each of those methods in typical use. Oral contraceptives were thought to be at least as hazardous to a woman's health as pregnancy by 56% of women. The majority of reproductive aged women surveyed substantially overestimated the efficacy of the two most popular contraceptive methods, often saying that they were 99% effective. Women with higher education levels were most likely to overestimate efficacy of oral contraceptives. Women of all ages and education levels significantly overestimated the health hazards of oral contraceptives compared to pregnancy. Overestimation of effectiveness of these methods of contraception, may contribute to lower adoption of implants and intrauterine devices. When individualizing patient counselling, misperceptions must be identified and addressed with women of all educational backgrounds. Not applicable.

Oral Contraceptives Attenuate Cardiac Autonomic Responses to Musical Auditory Stimulation: Pilot Study.

PubMed

Milan, Réveni Carmem; Plassa, Bruna Oliveira; Guida, Heraldo Lorena; de Abreu, Luiz Carlos; Gomes, Rayana L; Garner, David M; Valenti, Vitor E

2015-01-01

The literature presents contradictory results regarding the effects of contraceptives on cardiac autonomic regulation. The research team aimed to evaluate the effects of musical auditory stimulation on cardiac autonomic regulation in women who use oral contraceptives. The research team designed a transversal observational pilot study. The setting was the Centro de Estudos do Sistema Nervoso Autônomo (CESNA) in the Departamento de Fonoaudiologia at the Universidade Estadual Paulista (UNESP) in Marília, SP, Brazil. Participants were 22 healthy nonathletic and nonsedentary females, all nonsmokers and aged between 18 and 27 y. Participants were divided into 2 groups: (1) 12 women who were not taking oral contraceptives, the control group; and (2) 10 women who were taking oral contraceptives, the oral contraceptive group. In the first stage, a rest control, the women sat with their earphones turned off for 20 min. After that period, the participants were exposed to 20 min of classical baroque music (ie, "Canon in D Major," Johann Pachelbel), at 63-84 dB. Measurements of the equivalent sound levels were conducted in a soundproof room, and the intervals between consecutive heartbeats (R-R intervals) were recorded, with a sampling rate of 1000 Hz. For calculation of the linear indices, the research team used software to perform an analysis of heart rate variability (HRV). Linear indices of HRV were analyzed in the time domain: (1) the standard deviation of normal-to-normal R-R intervals (SDNN), (2) the root-mean square of differences between adjacent normal R-R intervals in a time interval (RMSSD), and (3) the percentage of adjacent R-R intervals with a difference of duration greater than 50 ms (pNN50). The study also analyzed the frequency domain-low frequency (LF), high frequency (HF), and LF/HF ratio. For the control group, the musical auditory stimulation reduced (1) the SDNN from 52.2 ± 10 ms to 48.4 ± 16 ms (P = .0034); (2) the RMSSD from 45.8 ± 22 ms to 41.2 �

Effects of two forms of combined oral contraceptives on carbohydrate metabolism in adolescents with polycystic ovary syndrome.

PubMed

Mastorakos, George; Koliopoulos, Carolina; Deligeoroglou, Efthymios; Diamanti-Kandarakis, Evanthia; Creatsas, George

2006-02-01

To compare the effects of combined oral contraceptives (OCs) containing cyproterone acetate or desogestrel on insulin sensitivity in adolescents with polycystic ovary syndrome (PCOS). A prospective randomized clinical trial. Outpatient gynecological clinic of Aretaieion University Hospital. Thirty-six adolescent girls with hyperandrogenism and six or less menses in the preceding 12 months. Patients were separated in two groups: group A (n = 18) received 0.15 mg of desogestrel plus 0.030 mg of ethinyl E2 daily; and group B (n = 18) received 2 mg of cyproterone acetate plus 0.035 mg of ethinyl E2 daily, for 21 days followed by a 7-day rest, for 12 months. Hirsutism score, lipid, androgen, and sex hormone-binding globulin (SHBG) levels were evaluated at baseline. An oral glucose tolerance test (OGTT) was performed and metabolism indices, based on previously studied mathematical formulas, were assessed at baseline and at 12 months. After 12 months of treatment, the homeostasis model assessment index of insulin resistance increased significantly in both groups. The fasting glucose-to-insulin ratio and predicted insulin sensitivity index decreased in group B. The delta of the area under the OGTT curve for insulin and predicted first and second phase insulin secretion indices increased significantly only in group B. We conclude that treatment of adolescent girls with PCOS with the two combined OCs administered, results in unfavorable changes of insulin sensitivity. In addition, cyproterone acetate is associated with an increase of insulin secretion and hyperinsulinemia.

Sexually transmitted diseases, human immunodeficiency virus, and pregnancy prevention. Combined contraceptive practices among urban African-American early adolescents.

PubMed

Stanton, B F; Li, X; Galbraith, J; Feigelman, S; Kaljee, L

1996-01-01

To evaluate the success of efforts to educate youth not only to use prescription contraceptives to avoid pregnancy, but also to use condoms to avoid sexually transmitted diseases, including infection with the human immunodeficiency virus. Longitudinal study of 383 African-American youth aged 9 to 15 years enrolled in a randomized, controlled trial of an acquired immunodeficiency syndrome (AIDS) risk reduction intervention. Data about contraceptive practices were obtained at baseline and 6, 12, and 18 months later using a culturally and developmentally appropriate risk assessment tool administered with "talking" computers (Macintosh, Apple Computer Inc, Cupertino, Calif). Approximately three fourths of sexually active youth used some form of contraception in each 6-month round, with almost half of the youth using combinations of contraceptives. Among all youth at baseline and among control youth throughout the study, more than half used condoms and more than two thirds who used oral contraceptives also used condoms. Receipt of an AIDS education intervention was associated with use of more effective contraceptive practices (eg, condoms and another prescription or nonprescription method of birth control). After receiving the intervention, more than 80% of the youth who used oral contraceptives also used condoms. Contraceptive practices showed considerable stability. Knowledge about AIDS was positively associated with use of more effective contraceptive methods. Many youth are using condoms and prescription birth control simultaneously, and these use rates can be increased through AIDS education interventions.

Potential public sector cost-savings from over-the-counter access to oral contraceptives.

PubMed

Foster, Diana G; Biggs, M Antonia; Phillips, Kathryn A; Grindlay, Kate; Grossman, Daniel

2015-05-01

This study estimates how making oral contraceptive pills (OCPs) available without a prescription may affect contraceptive use, unintended pregnancies and associated contraceptive and pregnancy costs among low-income women. Based on published figures, we estimate two scenarios [low over-the-counter (OTC) use and high OTC use] of the proportion of low-income women likely to switch to an OTC pill and predict adoption of OCPs according to the out-of-pocket costs per pill pack. We then estimate cost-savings of each scenario by comparing the total public sector cost of providing OCPs OTC and medical care for unintended pregnancy. Twenty-one percent of low-income women at risk for unintended pregnancy are very likely to use OCPs if they were available without a prescription. Women's use of OTC OCPs varies widely by the out-of-pocket pill pack cost. In a scenario assuming no out-of-pocket costs for the over-the counter pill, an additional 11-21% of low-income women will use the pill, resulting in a 20-36% decrease in the number of women using no method or a method less effective than the pill, and a 7-25% decrease in the number of unintended pregnancies, depending on the level of use and any effect on contraceptive failure rates. If out-of-pocket costs for such pills are low, OTC access could have a significant effect on use of effective contraceptives and unintended pregnancy. Public health plans may reduce expenditures on pregnancy and contraceptive healthcare services by covering oral contraceptives as an OTC product. Interest in OTC access to oral contraceptives is high. Removing the prescription barrier, particularly if pill packs are available at low or zero out-of-pocket cost, could increase the use of effective methods of contraception and reduce unintended pregnancy and healthcare costs for contraceptive and pregnancy care. Copyright © 2015 Elsevier Inc. All rights reserved.

Adverse mood effects of combined oral contraceptives in relation to personality traits.

PubMed

Borgström, Anna; Odlind, Viveca; Ekselius, Lisa; Sundström-Poromaa, Inger

2008-12-01

Mood symptoms, such as depressed mood, anxiety and increased irritability, remain one of the major reasons for discontinuation of combined oral contraceptive (COC) pills. The aim of this study was to compare personality traits in women with ongoing or previous use of COCs and different experiences from these compounds with respect to adverse mood symptoms. Thirty women currently on COCs with no reports of adverse mood symptoms, 28 women currently on COCs and experiencing mood-related side effects, 27 women who had discontinued COC use for reasons other than adverse mood symptoms and 33 women who had discontinued COC use due to adverse mood effects were included. All participants were asked to fill out the Swedish universities Scales of Personality (SSP) to assess different personality traits. The women who were experiencing mood-related side effects on their current COC use exhibited higher scores on the somatic anxiety and stress susceptibility traits as compared to the women who did not experience any mood-related side effects from their current COCs. Women who had discontinued COC treatment because of adverse mood effects had higher scores of detachment and mistrust compared to women who had discontinued COC for reasons unrelated to mood effects. Higher scores on specific personality traits such as somatic anxiety and stress susceptibility are found in women with ongoing experience of adverse mood symptoms from COC. Higher scores of mistrust and detachment are more common among women who have discontinued COC treatment due to adverse mood effects.

[Combined hormonal contraception in cycles artificially extended].

PubMed

Bustillos-Alamilla, Edgardo; Zepeda-Zaragoza, J; Hernández-Ruiz, M A; Briones-Landa, Carlos Humberto

2010-01-01

To compare the bleeding patterns, satisfaction and tolerability of 3 different contraceptive in an extended regimens in the service of Family Planning of the North Central Hospital of PEMEX. Healthy, adult women with desire of contraception for one year (N 120) were randomly assigned to receive oral contraceptive drospirenone/ethinyl E2 (group1), the norelgestromin/ethinyl E2 transdermal patch (group 2) and vaginal ring etonogestrel/ ethinyl E2 (group 3) in an extended regimen (42 consecutive days, 1 hormone-free week). Study assessments were conducted at scheduled visits at the time of initial screening, at baseline after 1, 3, 6, and 12 months. Subjects recorded menstrual associated symptoms bleeding data and completed satisfaction questionnaires. Subjects and investigators provided overall assessments of the regimens. Extended use of 3 different contraceptive resulted in fewer bleeding days in every group (66.6%, 55% and 58.3% P 0.0024), and less mastalgia and menstrual pain. Subjects were highly satisfied with three regimens (93.3%, 96.6% and 91.6% P 0.00421). Although not mayor adverse events were reported with this regimen, there was an increase in spotting days; it decreased with each successive cycle of therapy. Efficacy and safety were similar to those reported for traditional cycle. Extended-contraceptive regimen delays menses and reduces bleeding, a profile that may be preferred by women who seek flexibility with their contraceptive method.

Evaluating the practice of Iranian community pharmacists regarding oral contraceptive pills using simulated patients.

PubMed

Foroutan, Nazanin; Dabaghzadeh, Fatemeh

2016-01-01

As oral contraceptive pills are available over the counter in pharmacies, pharmacists are professionally responsible for checking and informing patients about every aspect of taking these drugs. Simulated patient method is a new and robust way to evaluate professional performance of pharmacists. The aim of the present study was to evaluate the pharmacy practice of Iranian pharmacists regarding over-the-counter use of oral contraceptive pills using simulated patient method. Simulated patients visited pharmacy with a prescription containing ciprofloxacin and asked for oral contraceptive pills. The pharmacist was expected to ask important questions for using these drugs and to inform the patient about them properly. Moreover, the Pharmacists should advise patients in regard to the possible interaction. Ninety four pharmacists participated in this study. In 24 (25.3%) visits, the liable pharmacist was not present at the time of purchase. Furthermore, In 13 (18.57 %) visits by the simulated patients, the liable pharmacists did not pay any attention to the simulated patients even when they asked for consultation. Twenty nine (41.43%) pharmacists did not ask any question during dispensing. Nausea was the most frequent described side effect by pharmacists (27 (38.57%)). Yet important adverse effects of oral contraceptive pills were not mentioned by the pharmacists except for few ones. Only twelve (17.14%) pharmacists mentioned the possible interaction. There was a significant relation between the pharmacists' gender and detection of possible interaction (p value= 0.048). The quality of the pharmacists' consultations regarding the over the counter use of oral contraceptive pills was not satisfactory and required improvement.

Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial.

PubMed

Maloney, J Michael; Dietze, Peter; Watson, David; Niknian, Minoo; Lee-Rugh, Sooji; Sampson-Landers, Carole; Korner, Paul

2008-10-01

To assess the efficacy of the combined oral contraceptive containing 3-mg drospirenone/20-microgram ethinyl estradiol (3-mg drospirenone/20-microgram ethinyl estradiol) administered as 24 consecutive days of active treatment after a 4-day hormone-free interval (24/4 regimen) compared with placebo for the treatment of moderate acne vulgaris. Healthy females aged 14-45 years with moderate acne were randomized in this double-blind study to 3-mg drospirenone/20-microgram ethinyl estradiol (n=270) or placebo (n=268) for six cycles of 28 days. The primary outcome measures of acne lesion counts and Investigator Static Global Assessment scale ratings were assessed at baseline and during cycles 1, 3, and 6. The percentage reduction from baseline to endpoint for total lesions is 46.3% for 3-mg drospirenone/20-microgram ethinyl estradiol 24/4 combination oral contraceptive group and 30.6% for placebo group (P<.001). The likelihood of participants in the 3-mg drospirenone/20-microgram ethinyl estradiol 24/4 regimen group having "clear" or "almost clear" skin as rated by the investigators at endpoint was about threefold (odds ratio 3.13, 95% confidence interval 1.69-5.81; P=.001) greater than in the placebo group. The 3-mg drospirenone/20-microgram ethinyl estradiol 24/4 regimen was well tolerated. The low-dose combined oral contraceptive containing 3-mg drospirenone/20-microgram ethinyl estradiol administered in a 24/4 regimen significantly reduced acne lesion counts more effectively than placebo and demonstrated greater improvement in the Investigator Static Global Assessment rating of acne. The safety profile was consistent with low-dose combined oral contraceptive use.

Early Impact Of The Affordable Care Act On Oral Contraceptive Cost Sharing, Discontinuation, And Nonadherence.

PubMed

Pace, Lydia E; Dusetzina, Stacie B; Keating, Nancy L

2016-09-01

The oral contraceptive pill is the contraceptive method most commonly used by US women, but inconsistent use of the pill is a contributor to high rates of unintended pregnancy. The relationship between consumer cost sharing and consistent use of the pill is not well understood, and the impact of the elimination of cost sharing for oral contraceptive pills in a mandate in the Affordable Care Act (ACA) is not yet known. We analyzed insurance claims for 635,075 women with employer-sponsored insurance who were initiating use of the pill, to examine rates of discontinuation and nonadherence, their relationship with cost sharing, and trends before and during the first year after implementation of the ACA mandate. We found that cost sharing for oral contraceptives decreased markedly following implementation, more significantly for generic than for brand-name versions. Higher copays were associated with greater discontinuation of and nonadherence to generic pills than was the case with zero copayments. Discontinuation of the use of generic or brand-name pills decreased slightly but significantly following ACA implementation, as did nonadherence to brand-name pills. Our findings suggest a modest early impact of the ACA on improving consistent use of oral contraceptives among women initiating their use. Project HOPE—The People-to-People Health Foundation, Inc.

[Place of persistence trouble during oral contraception and subsequent use of emergency contraception].

PubMed

Jamin, C; Lachowsky, M

2015-10-01

In order to improve the understanding of hormonal contraceptive failures, this study evaluates the persistence of oral contraception and the use of emergency contraception (EC) during persistence incidents. We made the hypothesis of the existence of a strong link between the risk of unplanned pregnancies and these two parameters. In this study, we also evaluated women's perception of EC in order to elucidate the reasons of EC insufficient use. One survey was carried out on Internet on a representative sample of women, aged 16-45. In this survey, 3775 French women were interviewed (source-population). We defined a target population of 2415 fertile women who had heterosexual intercourse during the last 12 months, and a population of 760 women at risk of unintended pregnancy who had unprotected sexual intercourse during the last 12 months(risk-population). A little more than 30% of the target population, meaning 20% of the source-population (n=745) stopped their contraceptive method temporarily for an average time of two months. Almost 60% of women had a risk of unwanted pregnancy during this period without contraception, which is 59% of the risk-population. Only 20% of women among the population at risk used EC. The main reasons given for EC insufficient use were the misperception of the risk of pregnancy, the lack of knowledge about EC and its way of use. For the first time, this survey shows that 13% of women (of the source population) decide to stop temporarily their contraceptive method for an average time of two months per year. Fifty-nine percent of unplanned pregnancy situations are due to this poor contraception persistence. Although there is a need to reduce the risk of women being at risk, it seems also highly desirable to overcome the consequences of this poor persistence. Giving information about EC and a systematic prescription during contraception consultations would lead to an increased use of EC. Copyright © 2014 Elsevier Masson SAS. All rights

Combined hormonal versus nonhormonal versus progestin-only contraception in lactation.

PubMed

Lopez, Laureen M; Grey, Thomas W; Stuebe, Alison M; Chen, Mario; Truitt, Sarah T; Gallo, Maria F

2015-03-20

Postpartum contraception improves the health of mothers and children by lengthening birth intervals. For lactating women, contraception choices are limited by concerns about hormonal effects on milk quality and quantity and passage of hormones to the infant. Ideally, the contraceptive chosen should not interfere with lactation or infant growth. Timing of contraception initiation is also important. Immediately postpartum, most women have contact with a health professional, but many do not return for follow-up contraceptive counseling. However, immediate initiation of hormonal methods may disrupt the onset of milk production. To determine the effects of hormonal contraceptives on lactation and infant growth We searched for eligible trials until 2 March 2015. Sources included the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, POPLINE, Web of Science, LILACS, ClinicalTrials.gov, and ICTRP. We also examined review articles and contacted investigators. We sought randomized controlled trials in any language that compared hormonal contraception versus another form of hormonal contraception, nonhormonal contraception, or placebo during lactation. Hormonal contraception includes combined or progestin-only oral contraceptives, injectable contraceptives, implants, and intrauterine devices.Trials had to have one of our primary outcomes: breast milk quantity or biochemical composition; lactation initiation, maintenance, or duration; infant growth; or timing of contraception initiation and effect on lactation. Secondary outcomes included contraceptive efficacy while breastfeeding and birth interval. For continuous variables, we calculated the mean difference (MD) with 95% confidence interval (CI). For dichotomous outcomes, we computed the Mantel-Haenszel odds ratio (OR) with 95% CI. Due to differing interventions and outcome measures, we did not aggregate the data in a meta-analysis. In 2014, we added seven trials for a new total of 11. Five reports were

Effects of menstrual cycle phase and oral contraceptives on alertness, cognitive performance, and circadian rhythms during sleep deprivation

NASA Technical Reports Server (NTRS)

Wright, K. P. Jr; Badia, P.; Czeisler, C. A. (Principal Investigator)

1999-01-01

The influence of menstrual cycle phase and oral contraceptive use on neurobehavioral function and circadian rhythms were studied in healthy young women (n = 25) using a modified constant routine procedure during 24 h of sleep deprivation. Alertness and performance worsened across sleep deprivation and also varied with circadian phase. Entrained circadian rhythms of melatonin and body temperature were evident in women regardless of menstrual phase or oral contraceptive use. No significant difference in melatonin levels, duration, or phase was observed between women in the luteal and follicular phases, whereas oral contraceptives appeared to increase melatonin levels. Temperature levels were higher in the luteal phase and in oral contraceptive users compared to women in the follicular phase. Alertness on the maintenance of wakefulness test and some tests of cognitive performance were poorest for women in the follicular phase especially near the circadian trough of body temperature. These observations suggest that hormonal changes associated with the menstrual cycle and the use of oral contraceptives contribute to changes in nighttime waking neurobehavioral function and temperature level whereas these factors do not appear to affect circadian phase.

Effect of combined metformin and oral contraceptive therapy on metabolic factors and endothelial function in overweight and obese women with polycystic ovary syndrome.

PubMed

Essah, Paulina A; Arrowood, James A; Cheang, Kai I; Adawadkar, Swati S; Stovall, Dale W; Nestler, John E

2011-08-01

In this randomized, double-blind, placebo-controlled study, 19 overweight women with polycystic ovary syndrome were randomized to a 3-month course of either metformin plus combined hormonal oral contraceptive (OC) (n = 9) or OC plus matched placebo (n = 10). After 3 months, both treatments had similar effects on androgen levels, lipid profile, insulin sensitivity, and serum inflammatory markers, but flow-mediated dilatation increased by 69.0% in the metformin plus OC group while it remained unchanged in the OC group. CLINICAL TRIAL REGISTRATION NO: NCT00682890. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Differences in Reporting Pearl Indices in the United States and Europe: Focus on a 91-Day Extended-Regimen Combined Oral Contraceptive with Low-Dose Ethinyl Estradiol Supplementation

PubMed Central

Abascal, Paloma Lobo; Luzar-Stiffler, Vesna; Giljanovic, Silvana; Howard, Brandon; Weiss, Herman; Trussell, James

2017-01-01

Background Regulatory agencies in the United States (US) and Europe differ in requirements for defining pregnancies after the last dose of oral contraceptive, sometimes resulting in discrepant Pearl Indices (PIs) for the same product despite identical clinical data. This brief report highlights one such example, a 91-day extended-regimen combined oral contraceptive (COC). Methods The US- and European-based PI methodologies were compared for a 91-day extended-regimen COC consisting of 84 days of active levonorgestrel/EE 150 μg/30 μg tablets, followed by 7 days of EE 10 μg tablets in place of placebo. Conclusions At the times of approval of the 91-day extended-regimen COC in the US and Europe, the requirements for defining ‘on-treatment’ pregnancies differed (14-day vs. 2-day rule, respectively). This difference resulted in a higher PI in the US- vs. European-based calculation (1.34 and 0.76, respectively). The differences in the PI should not be interpreted as the extended-regimen COC being less effective in preventing pregnancy in the US compared with Europe. PMID:26115381

Differences in reporting Pearl Indices in the United States and Europe: Focus on a 91-day extended-regimen combined oral contraceptive with low-dose ethinyl estradiol supplementation.

PubMed

Lobo Abascal, Paloma; Luzar-Stiffler, Vesna; Giljanovic, Silvana; Howard, Brandon; Weiss, Herman; Trussell, James

2016-01-01

Regulatory agencies in the United States (US) and Europe differ in requirements for defining pregnancies after the last dose of oral contraceptive, sometimes resulting in discrepant Pearl Indices (PIs) for the same product despite identical clinical data. This brief report highlights one such example, a 91-day extended-regimen combined oral contraceptive (COC). The US- and European-based PI methodologies were compared for a 91-day extended-regimen COC consisting of 84 days of active levonorgestrel/EE 150 μg/30 μg tablets, followed by seven days of EE 10 μg tablets in place of placebo. At the times of approval of the 91-day extended-regimen COC in the US and Europe, the requirements for defining 'on-treatment' pregnancies differed (14-day vs. 2-day rule, respectively). This difference resulted in a higher PI in the US- vs. European-based calculation (1.34 and 0.76, respectively). The differences in the PI should not be interpreted as the extended-regimen COC being less effective in preventing pregnancy in the US compared with Europe.

Comparison of efficacy of metformin and oral contraceptive combination of ethinyl estradiol and drospirenone in polycystic ovary syndrome.

PubMed

Suvarna, Yashasvi; Maity, Nivedita; Kalra, Pramila; Shivamurthy, M C

2016-01-01

The 2013 Endocrine Society guidelines state that hormonal contraceptives should be used for treating both menstrual irregularity and hirsutism in patients with polycystic ovary syndrome (PCOS). Metformin should be reserved for the treatment of women presenting with only menstrual irregularity because it has limited benefits in treating hyperandrogenism associated with PCOS. A high prevalence of insulin resistance is noted among the South Asians, and these guidelines may not hold good for this population. Thus, this study was conducted to investigate and compare the effects of metformin and an oral contraceptive containing drospirenone on menstrual pattern, body mass index, serum testosterone levels, and dehydroepiandrosterone sulfate (DHEAS) levels at baseline to 6 months of therapy in the treatment groups. This was a prospective observational study that was conducted over a year in patients visiting the Endocrinology outpatient department at a tertiary care center in a south Indian city. Forty-six subjects diagnosed with PCOS as per the Rotterdam criteria were included. They received either metformin twice daily or an oral contraceptive containing drospirenone once daily as a monthly regimen for 6 months. Metformin regularized menstrual cycles in 72% of patients who were followed up at 6 months. No significant difference was observed between the two treatment groups with respect to decreasing the body mass index, serum testosterone levels, and DHEAS levels (p=0.40, p=0.65, and p=0.22, respectively). Metformin is effective in regularizing menstrual cycles, decreasing body mass index, and treating hyperandrogenism in Indian women diagnosed with PCOS.

CONTRACEPTION TECHNOLOGY: PAST, PRESENT AND FUTURE

PubMed Central

Sitruk-Ware, Regine; Nath, Anita; Mishell, Daniel R.

2012-01-01

Steady progress in contraception research has been achieved over the past 50 years. Hormonal and non-hormonal modern contraceptives have improved women’s lives by reducing different health conditions that contributed to considerable morbidity. However the contraceptives available today are not suitable to all users and the need to expand contraceptive choices still exists. Novel products such as new implants, contraceptive vaginal rings, transdermal patches and newer combinations of oral contraceptives have recently been introduced in family planning programs and hormonal contraception is widely used for spacing and limiting births. Concerns over the adverse effects of hormonal contraceptives have led to research and development of new combinations with improved metabolic profile. Recent developments include use of natural compounds such as estradiol (E2) and estradiol valerate (E2V) with the hope to decrease thrombotic risk, in combination with newer progestins derived from the progesterone structure or from spirolactone, in order to avoid the androgenic effects. Progesterone antagonists and progesterone receptor modulators are highly effective in blocking ovulation and preventing follicular rupture and are undergoing investigations in the form of oral pills and in semi long-acting delivery systems. Future developments also include the combination of a contraceptive with an antiretroviral agent for dual contraception and protection against sexually transmitted diseases, to be used before intercourse or on demand, as well as for continuous use in dual-protection rings. Alhough clinical trials of male contraception have reflected promising results, limited involvement of industry in that area of research has decreased the likelihood of having a male method available in the current decade. Development of non-hormonal methods are still at an early stage of research, with the identification of specific targets within the reproductive system in ovaries and testes, as

Contraception technology: past, present and future.

PubMed

Sitruk-Ware, Regine; Nath, Anita; Mishell, Daniel R

2013-03-01

Steady progress in contraception research has been achieved over the past 50 years. Hormonal and nonhormonal modern contraceptives have improved women's lives by reducing different health conditions that contributed to considerable morbidity. However, the contraceptives available today are not suitable to all users, and the need to expand contraceptive choices still exists. Novel products such as new implants, contraceptive vaginal rings, transdermal patches and newer combinations of oral contraceptives have recently been introduced in family planning programs, and hormonal contraception is widely used for spacing and limiting births. Concerns over the adverse effects of hormonal contraceptives have led to research and development of new combinations with improved metabolic profile. Recent developments include use of natural compounds such as estradiol and estradiol valerate with the hope to decrease thrombotic risk, in combination with newer progestins derived from the progesterone structure or from spirolactone, in order to avoid the androgenic effects. Progesterone antagonists and progesterone receptor modulators are highly effective in blocking ovulation and preventing follicular rupture and are undergoing investigations in the form of oral pills and in semi-long-acting delivery systems. Future developments also include the combination of a contraceptive with an antiretroviral agent for dual contraception and protection against sexually transmitted diseases, to be used before intercourse or on demand, as well as for continuous use in dual-protection rings. Although clinical trials of male contraception have reflected promising results, limited involvement of industry in that area of research has decreased the likelihood of having a male method available in the current decade. Development of nonhormonal methods is still at an early stage of research, with the identification of specific targets within the reproductive system in ovaries and testes, as well as

Rationale for eliminating the hormone-free interval in modern oral contraceptives.

PubMed

London, Andrew; Jensen, Jeffrey T

2016-07-01

Although most low-dose combined oral contraceptives (COCs) include 7-day hormone-free intervals (HFIs), these COCs could incompletely suppress ovarian activity. To review the impact of HFIs on ovarian suppression and tolerability, and evaluate the utility of COCs without traditional 7-day HFIs. PubMed was searched for clinical studies published in English between January 1980 and April 2015 on the impact of HFIs and HFI modifications in COCs. Articles assessing contraceptive efficacy or tolerability as the primary focus were included. Abstracts of 319 articles were screened. Analysis of the 161 articles selected revealed that suppression of ovarian activity with low-dose COCs with 7-day HFIs is suboptimal. Loss of ovarian suppression during 7-day HFIs is commonly associated with follicular development, and most dominant follicles appear during this period. By contrast, increased ovarian suppression was noted in regimens that shortened or eliminated the HFI, or that substituted low-dose ethinyl estradiol for the HFI. Extended regimens with modified HFIs may provide greater ovarian suppression with the potential for increased contraceptive effectiveness. Additional research is needed to evaluate whether COC regimens that include 10μg ethinyl estradiol instead of an HFI may improve tolerability. Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen

PubMed Central

Mansour, Diana; Verhoeven, Carole; Sommer, Werner; Weisberg, Edith; Taneepanichskul, Surasak; Melis, Gian Benedetto; Sundström-Poromaa, Inger; Korver, Tjeerd

2011-01-01

Objectives The primary objective was to assess the efficacy, cycle control and tolerability of a monophasic combined oral contraceptive (COC) containing nomegestrol acetate (NOMAC) and 17β-oestradiol (E2). Effects on acne were evaluated as a secondary objective. Results were compared to those of a COC containing drospirenone (DRSP) and ethinylestradiol (EE). Methods Women (aged 18-50 years) were randomised to receive NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n = 1591) or DRSP/EE (3 mg/30 μg) in a 21/7-day regimen (n = 535) for 13 cycles. Results Estimated Pearl Indices for NOMAC/E2 and DRSP/EE were 0.38 and 0.81 in women aged ≤ 35 years and 0.31 and 0.66 for all women (18–50 years), respectively. Scheduled withdrawal bleedings were shorter and lighter among users of NOMAC/E2 and were sometimes absent altogether. Intracyclic bleeding/spotting was infrequent in both groups, and decreased over time. Type and frequency of adverse events were similar to those typically reported for COCs. Conclusions These data show that NOMAC/E2 provides high contraceptive efficacy with acceptable cycle control as well as an overall adverse event profile similar to that of DRSP/EE. PMID:21995590

Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen.

PubMed

Mansour, Diana; Verhoeven, Carole; Sommer, Werner; Weisberg, Edith; Taneepanichskul, Surasak; Melis, Gian Benedetto; Sundström-Poromaa, Inger; Korver, Tjeerd

2011-12-01

The primary objective was to assess the efficacy, cycle control and tolerability of a monophasic combined oral contraceptive (COC) containing nomegestrol acetate (NOMAC) and 17β-oestradiol (E2). Effects on acne were evaluated as a secondary objective. Results were compared to those of a COC containing drospirenone (DRSP) and ethinylestradiol (EE). Women (aged 18-50 years) were randomised to receive NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n=1591) or DRSP/EE (3 mg/30 μg) in a 21/7-day regimen (n=535) for 13 cycles. Estimated Pearl Indices for NOMAC/E2 and DRSP/EE were 0.38 and 0.81 in women aged≤35 years and 0.31 and 0.66 for all women (18-50 years), respectively. Scheduled withdrawal bleedings were shorter and lighter among users of NOMAC/E2 and were sometimes absent altogether. Intracyclic bleeding/spotting was infrequent in both groups, and decreased over time. Type and frequency of adverse events were similar to those typically reported for COCs. These data show that NOMAC/E2 provides high contraceptive efficacy with acceptable cycle control as well as an overall adverse event profile similar to that of DRSP/EE.

Effect of oral contraceptive agents on ascorbic acid metabolism in the rhesus monkey.

PubMed

Weininger, J; King, J C

1982-06-01

Ascorbic acid (AA) metabolism was studied in six sexually mature female rhesus monkeys with normal menstrual cycles before and during oral contraceptive administration. The animals were fed a commercial monkey stock diet (15% protein) containing no AA and given a 100 mg AA tablet daily throughout the study. After an initial adaptation period and a control period (total 8 months), combined-type oral contraceptive agents (OCAs) (50 micrograms mestranol and 1 mg norethindrone for 21 days each month) were administered to each monkey for 4 months. Serum copper and ceruloplasmin were significantly elevated during OCA treatment. There were no significant changes in plasma or leukocyte AA values during OCA use; however, urinary AA excretion decreased significantly. During the last month of the control period and the 3rd month of OCA treatment, 50 muCi of 1-14C-L-ascorbic acid were injected intravenously into each monkey. Urinary excretion of radioactivity, measured for 1 month, indicated a significantly faster AA turnover rate during the period of OCA use. These results suggest that women using OCAs may have an increased dietary requirement for AA.

Effect of low zinc intake and oral contraceptive agents on nitrogen utilization and clinical findings in young women.

PubMed

Hess, F M; King, J C; Margen, S

1977-12-01

In a previous paper we reported that serum, urine and fecal zinc levels fell markedly in women taking a combination oral contraceptive agent (+OCA) and in women with normal menstrual cycles (-OCA) when they consumed a low-zinc diet (less than 0.2 mg/day) for 35 days. We evaluated other biochemical and clinical data in order to determine if depletion of accessible body zinc and/or physiologic adjustment to conserve body zinc stores had occurred. Neither low zinc intake nor oral contraceptive use appeared to influence nitrogen balance or body weight. Use of contraceptive drugs appeared to influence the response of blood parameters to zinc depletion. Serum transferrin and cholesterol declined significantly in the -OCA group, whereas alkaline phosphatase and gamma-globulin changed significantly in both groups. Clinical problems developed in all the subjects with serum zinc levels below 50 microgram/dl during the study; three of the six with serum zinc levels above 50 microgram/dl also complained of clinical symptoms. The results suggest that zinc deficiency through depletion of accessible body zinc stores developed during the 35-day study.

Body composition is improved during 12 months' treatment with metformin alone or combined with oral contraceptives compared with treatment with oral contraceptives in polycystic ovary syndrome.

PubMed

Glintborg, Dorte; Altinok, Magda Lambaa; Mumm, Hanne; Hermann, Anne Pernille; Ravn, Pernille; Andersen, Marianne

2014-07-01

Central obesity in polycystic ovary syndrome (PCOS) is associated with increased inflammatory markers and increased risk for type 2 diabetes. The objective of the study was to evaluate whether treatment with metformin (M) or M combined with oral contraceptive pills (OCPs) resulted in a more advantageous body composition than treatment with OCP alone. The study was conducted at an outpatient clinic. This was a randomized, controlled clinical trial. Ninety patients with PCOS were randomized to 12 months' treatment with M (2 g/d), M + OCP (150 mg desogestrel+30 μg ethinylestradiol), or OCP. Whole-body dual-energy x-ray absorptiometry scans and clinical and hormonal evaluations were performed before and after the intervention period. A total of 65 of 90 patients completed the study. Changes in weight at 6 and 12 months and changes in regional fat mass estimates at 12 months were measured. Dropout rates between intervention groups were not significantly different. Treatment with M and M+OCP were superior to OCP regarding weight and regional fat mass. The median (quartiles) weight changes during 12 months of M, M+OCP, and OCP treatment were -3.0 (-10.3; 0.6), -1.9 (-4.9; 0.1), and 1.2 (-0.8; 3.0) kg, respectively, P < .05. Upper to lower fat mass ratio was unchanged. Changes in body composition were predicted by the type of medical intervention (M, M+OCP, or OCP) and not by body mass index at study inclusion. OCP and M+OCP were superior to M regarding reduction in free T levels. M treatment alone or in combination with OCP was associated with weight loss and improved body composition compared with OCP, whereas free T levels decreased during M+OCP or OCP. Combined treatment with M+OCP should be considered as an alternative to treatment with OCP alone to avoid weight gain in PCOS.

[Oral contraceptives: a new suspicion].

PubMed

Cohen, J

1979-05-05

It is possible that oral contraception (OC) may cause hepatic side effects, such as liver tumors, jaundice, and biliar lithiasis. Carcinogenic side effects of OC depend widely on age, education, marital status, and, apparently, even religion of users. Cervical cancer, endometrial cancer, and breast cancer are problems continuously investigated with different results. Contradictory studies have been conducted on the possibility of infections of the urinary tract in OC users, and on the possibility of congenital abnormalities in children of OC users. Statistics concerning OC must be carefully studied, and the balance between advantages and risks carefully weighted. Patients on OC must be regularly surveilled throughout the period of treatment.

A multicentre, open-label, randomised phase III study comparing a new levonorgestrel intrauterine contraceptive system (LNG-IUS 8) with combined oral contraception in young women of reproductive age.

PubMed

Borgatta, Lynn; Buhling, Kai J; Rybowski, Sarah; Roth, Katrin; Rosen, Kimberly

2016-10-01

To compare user satisfaction and adverse events (AEs) with a levonorgestrel intrauterine system (LNG-IUS 8; average levonorgestrel release rate approximately 8 μg/24 h over the first year [total content 13.5 mg]) and a 30 μg ethinyl estradiol/3 mg drospirenone (EE/DRSP) combined oral contraceptive (COC) in a population of young women. Nulliparous and parous women (aged 18-29 years) with regular menstrual cycles (21-35 days) were randomised to LNG-IUS 8 or EE/DRSP for 18 months. The primary endpoint was the overall user satisfaction rate at month 18/end of study visit. Overall, 279 women were randomised to LNG-IUS 8 with attempted placement and 281 women were randomised to EE/DRSP and took ≥1 pill; the mean age was 23.7 and 23.9 years, and 77.4% and 73.3% were nulliparous, respectively. At month 18/end of study, 82.1% and 81.9% of women, respectively, reported being 'very satisfied' or 'satisfied' with their treatment; however, significantly more LNG-IUS 8 users reported a preference to continue their treatment post-study (66.2% vs 48.8%; p = 0.0001). There were two pregnancies (one ectopic pregnancy, one spontaneous abortion) reported in the LNG-IUS 8 group and six (three live births, two spontaneous abortions, one induced abortion) in the EE/DRSP group. LNG-IUS 8 and EE/DRSP were associated with similarly high user satisfaction rates. However, LNG-IUS 8 users were significantly more likely to prefer to continue their contraceptive method post-study, indicating that a levonorgestrel intrauterine system is an appealing contraceptive option for young women.

Treatment of unscheduled bleeding in continuous oral contraceptive users with doxycycline: a randomized controlled trial.

PubMed

Kaneshiro, Bliss; Edelman, Alison; Carlson, Nichole; Morgan, Kristin; Nichols, Mark; Jensen, Jeffrey

2010-06-01

To estimate whether doxycycline, a matrix metalloproteinase inhibitor, would decrease unscheduled bleeding associated with initiation of a continuous oral contraceptive pill. Participants initiating a continuous oral contraceptive pill (20 micrograms of ethinyl estradiol/90 micrograms of levonorgestrel) were randomly assigned to receive either doxycycline (100 mg orally twice daily) or placebo taken for 5 days at the onset of each bleeding or spotting episode during the first 84 days of the study period. For the final 28 days of the study, participants were observed on the oral contraceptive pill alone. The primary outcome was the number of bleeding and spotting days. A sample size of 66 (33 in each arm) was calculated to detect a 50% reduction in bleeding (beta=0.80, alpha=0.05) and accounted for a 30% dropout rate. Sixty-six women were randomly assinged (33 in each study group). There were no significant differences during the 84-day treatment in bleeding or spotting days (doxycycline [mean {standard error}, placebo, P=.32) or the length of the longest bleeding or spotting episode (doxycycline, placebo, P=.70) between study groups. Similarly, no significant differences in bleeding patterns existed between groups during the final 28 days. Doxycycline, administered once bleeding has started, does not decrease unscheduled bleeding or shorten episodes of unscheduled bleeding in continuous oral contraceptive pill users. I.

Oral Contraceptives and Bone Health in Female Runners

DTIC Science & Technology

2006-10-01

activity. Previous cross-sectional research has shown that women with exercise - induced menstrual irregularities have a significantly higher...6. Cumming D.C. Exercise -associated amenorrhea , low BMD, and estrogen replacement therapy. Arch Intern Med. 156:2193-2195, 1996. 34 7. De...Science in Sports & Exercise . (i) Abstract from manuscript, “Randomized trial of the effect of oral contraceptives on bone mass and stress

Deep vein thrombosis and the oestrogen content in oral contraceptives. An epidemiological analysis.

PubMed

Kierkegaard, A

1985-01-01

Epidemiological studies have pointed to a correlation between the oestrogen content of oral contraceptives and the risk of deep vein thrombosis (DVT). The correlation has been strongest in studies which partially consisted of adverse drug reaction reports to the Swedish Adverse Drug Reaction Advisory Committee (SADRAC). The present study analyzes the epidemiological basis of the adverse drug reaction reports on DVT in women on oral contraceptives to SADRAC. It verifies the reported correlation between the oestrogen content of the pills and the risk of DVT but it also demonstrates that this correlation probably was secondary to differences in the diagnostic standard of DVT, to differences in reporting policies to SADRAC and to an age difference between women on low-oestrogen-pills and those on high-oestrogen pills and is thus due to bias. It is concluded that adverse drug reaction reporting on oral contraceptives has been very unreliable, for which reason it cannot support any epidemiological conclusion concerning the relative thrombogenicity of high-oestrogen pills compared with that of low-oestrogen pills.

Reproductive health preventive screening among clinic vs. over-the-counter oral contraceptive users

PubMed Central

Hopkins, Kristine; Grossman, Daniel; White, Kari; Amastae, Jon; Potter, Joseph E.

2015-01-01

Background Interest is growing in moving oral contraceptives over-the-counter (OTC), although concerns exist about whether women would continue to get preventive health screening. Study Design We recruited cohorts of US-resident women who obtained oral contraceptives from US family planning clinics (n=532) and OTC from pharmacies in Mexico (n=514) and interviewed them four times over 9 months. Based on self-reports of having a Pap smear within 3 years or ever having had a pelvic exam, clinical breast exam and testing for sexually transmitted infections (STIs), we assessed the prevalence of preventive screening using Poisson regression models. Results The prevalence of screening was high for both groups (>88% for Pap smear, pelvic exam and clinical breast exam and >71% for STI screening), while the prevalence ratios for screening were higher for clinic users, even after multivariable adjustment. Conclusions Results suggest that most women would obtain reproductive health preventive screening if oral contraceptives were available OTC, and also highlight the need to improve access to preventive screening for all low-income women. PMID:22520645

A multicenter phase IIb study of a novel combination of intramuscular androgen (testosterone decanoate) and oral progestogen (etonogestrel) for male hormonal contraception.

PubMed

Hay, Cathy J; Brady, Brian M; Zitzmann, Michael; Osmanagaoglu, Kaan; Pollanen, Pasi; Apter, Dan; Wu, Frederick C W; Anderson, Richard A; Nieschlag, Eberhard; Devroey, Paul; Huhtaniemi, Ilpo; Kersemaekers, Wendy M

2005-04-01

The effect of a novel combination of oral etonogestrel (ENG) and im testosterone decanoate (TD) on suppression of gonadotropins and spermatogenesis as a potential lead for male contraception was investigated. Healthy male volunteers were randomized into two groups receiving 300 microg ENG daily and 400 mg TD every 4 (n = 55) or 6 (n = 57) wk for 48 wk. At wk 48, all men except one in the 6-wk group suppressed sperm concentration to less than 1 million/ml. Faster suppression occurred in the 4-wk group. Gonadotropins were suppressed in both groups and most consistently in the 4-wk group. During treatment, trough testosterone levels increased into the normal range in the 4-wk group but remained just below normal in the 6-wk group. All peak levels were within the normal range. After treatment cessation, recovery of sperm counts and gonadotropins to normal levels occurred in both groups. Minor effects on weight and cholesterol were noted. Fourteen subjects withdrew because of an adverse event with those possibly related to the study medication reported more frequently in the 6-wk group (nine vs. one). In conclusion, the combination of 300 microg ENG with 400 mg TD every 4 wk was superior in terms of efficacy, hormone profiles, and safety. This represents a promising approach to male hormonal contraception.

Improvement in Quality of Life Questionnaire Measures (PCOSQ) in Obese Adolescent Females with PCOS treated with Lifestyle Changes and Oral Contraceptives, with or without Metformin

PubMed Central

Harris-Glocker, Miranda; Davidson, Kristin; Kochman, Lynda; Guzick, David; Hoeger, Kathleen

2013-01-01

We studied the effect of metformin or placebo in a lifestyle modification program (LSM) combined with oral contraceptives (OC) on quality of life parameters measured by the PCOS questionnaire (PCOSQ) in obese adolescent women with validated PCOS. The quality of life indicators were measured at baseline and conclusion for 5 domains on the PCOSQ, with equal improvement in scores in both placebo and Metformin groups, suggesting metformin addition does not add improvement to quality of life measures above those observed with lifestyle modification and oral contraceptive treatment. PMID:19781696

Laryngeal Aerodynamics Associated with Oral Contraceptive Use: Preliminary Findings

ERIC Educational Resources Information Center

Gorham-Rowan, Mary; Fowler, Linda

2009-01-01

The purpose of this study was to examine possible differences in laryngeal aerodynamic measures during connected speech associated with oral contraceptive (OC) use. Eight women taking an OC, and eight others not taking an OC, participated in the study. Three trials of syllable /p[subscript alpha] /repetitions were obtained using a…

An effective hormonal male contraceptive using testosterone undecanoate with oral or injectable norethisterone preparations.

PubMed

Kamischke, Axel; Heuermann, Tanja; Krüger, Kathrin; von Eckardstein, Sigrid; Schellschmidt, Ilka; Rübig, Alexander; Nieschlag, Eberhard

2002-02-01

Suppression of spermatogenesis to azoospermia is the goal of hormonal male contraception based on T combined with gestagens. The combination of the long-acting T, ester testosterone undecanoate (TU), with norethisterone (NET) enanthate (E) showed high efficacy. In the present study, we tested the validity of this approach by varying the NET dose and mode of application. The aim of the study was to achieve high rates of suppression of spermatogenesis as reflected by sperm counts, monitor gonadotropins as well as other hormones, and evaluate any possible side effects. In a phase II clinical trial, groups of normal volunteers received: 1000 mg TU im at wk 2, 6, 12, and 18 combined with 200 mg NETE im at wk 0, 6, 12, and 18 (group I); 1000 mg TU im and 400 mg NETE im at wk 0, 6, 12, and 18 (group II); and 1000 mg TU im at wk 0, 6, 12, and 18 with daily oral NET acetate (NETA) from wk 0 to 24 (group III). In all groups marked suppression of gonadotropins resulted in a significant decrease of spermatogenesis and azoospermia in 13/14, 11/12, and 12/14 men in groups I to III, respectively. The remaining men all had less than 1 million sperm/ml. Reversible side effects included increase in body weight, erythrocytes, hemoglobin, and hematocrit and decrease in high-density lipoprotein cholesterol and alkaline phosphatase in all groups and increase in liver enzymes in the oral NETA group. This study documents the high efficacy of TU in combination with NET and confirms that this dose and mode of application (1000 mg TU im every 6 wk plus 400 mg NETE im every 6 wk or plus 10 mg daily oral NETA) is as effective as the previously reported regimen containing 1000 mg TU + 200 mg NETE im every 6 wk. The contraceptive efficacy of this combination of TU and NETE should be evaluated in further clinical trials.

Obesity and hormonal contraceptive efficacy.

PubMed

Robinson, Jennifer A; Burke, Anne E

2013-09-01

Obesity is a major public health concern affecting an increasing proportion of reproductive-aged women. Avoiding unintended pregnancy is of major importance, given the increased risks associated with pregnancy, but obesity may affect the efficacy of hormonal contraceptives by altering how these drugs are absorbed, distributed, metabolized or eliminated. Limited data suggest that long-acting, reversible contraceptives maintain excellent efficacy in obese women. Some studies demonstrating altered pharmacokinetic parameters and increased failure rates with combined oral contraceptives, the contraceptive patch and emergency contraceptive pills suggest decreased efficacy of these methods. It is unclear whether bariatric surgery affects hormonal contraceptive efficacy. Obese women should be offered the full range of contraceptive options, with counseling that balances the risks and benefits of each method, including the risk of unintended pregnancy.

ESTIMATING SYSTEMIC EXPOSURE TO ETHINYL ESTRADIOL FROM AN ORAL CONTRACEPTIVE

PubMed Central

WESTHOFF, Carolyn L.; PIKE, Malcolm C.; TANG, Rosalind; DINAPOLI, Marianne N.; SULL, Monica; CREMERS, Serge

2015-01-01

Objectives This study was conducted to compare single-dose pharmacokinetics of ethinyl estradiol in an oral contraceptive to steady-state values, and to assess whether any simpler measures could provide an adequate proxy of the ‘gold standard’ 24-hour steady-state area-under-the-curve. Identifying a simple, less expensive, measure of systemic ethinyl estradiol exposure would be useful for larger studies designed to assess the relationship between an individual’s ethinyl estradiol exposure and her side effects. Study Design We conducted a 13 samples over 24 hours pharmacokinetic analysis on day 1 and day 21 of the first cycle of a monophasic oral contraceptive containing 30 mcg ethinyl estradiol and 150 mcg levonorgestrel in 17 non-obese healthy white women. We also conducted an abbreviated single dose 9-sample pharmacokinetic analysis after a month washout. Ethinyl estradiol was measured by liquid chromatography-tandem mass spectrometry. We compared results of full 13-sample steady-state pharmacokinetic analysis with results calculated using fewer samples (9 or 5) and following the single doses. We calculated Pearson correlation coefficients to evaluate the relationships between these estimates of systemic ethinyl estradiol exposure. Results The area-under-the-curve, maximum (Cmax), and 24-hour (C24) values were similar following the two single oral contraceptive doses (area-under-the-curve, r = 0.92). The steady-state 13-sample 24-hour area-under-the-curve was highly correlated with the average 9-sample area-under-the-curve after the two single doses (r = 0.81, p = 0.0002). This correlation remained the same if the number of samples was reduced to 4, taken at time 1, 2.5, 4 and 24 hours. The C24 at steady-state was highly correlated with the 24-hour steady-state area-under-the-curve (r = 0.92, p < 0.0001). The average of the C24 values following the two single doses was also quite highly correlated with the steady-state area-under-the-curve (r = 0.72, p = 0

Estimating systemic exposure to ethinyl estradiol from an oral contraceptive.

PubMed

Westhoff, Carolyn L; Pike, Malcolm C; Tang, Rosalind; DiNapoli, Marianne N; Sull, Monica; Cremers, Serge

2015-05-01

This study was conducted to compare single-dose pharmacokinetics of ethinyl estradiol in an oral contraceptive with steady-state values and to assess whether any simpler measures could provide an adequate proxy of the "gold standard" 24-hour steady-state area under the curve (AUC) value. Identification of a simple, less expensive measure of systemic ethinyl estradiol exposure would be useful for larger studies that are designed to assess the relationship between an individual's ethinyl estradiol exposure and side-effects. We collected 13 samples over 24 hours for pharmacokinetic analysis on days 1 and 21 of the first cycle of a monophasic oral contraceptive that contained 30 μg ethinyl estradiol and 150 μg levonorgestrel in 17 nonobese healthy white women. We also conducted an abbreviated single-dose 9-sample pharmacokinetic analysis after a month washout. Ethinyl estradiol was measured by liquid chromatography-tandem mass spectrometry. We compared results of a full 13-sample steady-state pharmacokinetic analysis with results that had been calculated with the use of fewer samples (9 or 5) and after the single doses. We calculated Pearson correlation coefficients to evaluate the relationships between these estimates of systemic ethinyl estradiol exposure. The AUC, maximum, and 24-hour values were similar after the 2 single oral contraceptive doses (AUC; r=0.92). The steady-state 13-sample 24-hour AUC value was correlated highly with the average 9-sample AUC value after the 2 single doses (r=0.81; P=.0002). This correlation remained the same if the number of single-dose samples was reduced to 4, taken at time 1, 2.5, 4, and 24 hours. The 24-hour value at steady-state was correlated highly with the 24-hour steady-state AUC value (r=0.92; P<.0001). The average of the 24-hour values after the 2 single doses was also correlated quite highly with the steady-state AUC value (r=0.72; P=.0026). Limited blood sampling, including results from 2 single doses, gave highly

Evaluation of smartphone oral contraceptive reminder applications.

PubMed

Gal, Noga; Zite, Nikki B; Wallace, Lorraine S

2015-01-01

Oral contraceptives (OCs) are the most widely used contraceptive method among women of reproductive age in the United States (US). Routine download and use of health-related smartphone applications (apps) continues to increase. The purpose of this study was to evaluate the utility of English-language, smartphone-platform OC reminder apps currently available for download in the US. During June-July 2013, official Internet-based, mobile app platforms for the two major smartphone operating systems in the US-Android (Google Play Store) and iPhone (iTunes)-were searched. "Birth control," "the pill," and "contraception" were entered into the search-bar of each Smartphone store. Apps were assessed for the following: cost, health care professionals' involvement in app development, reminder mechanisms, and functionality. Of the 39 unique OC reminder apps meeting inclusion criteria, 7 (18%) did not operate as intended when downloaded. Most apps functioned without an Internet connection (97%) and included pop-up notifications (84%). Certain app features overcome common causes of missing an alarm, and hypothetically, may minimize likelihood of an OC user missing a daily pill. Health care providers should inform users of potential pitfalls and advise them that an OC reminder app should be not be used as a sole reminder method. Copyright © 2015 Elsevier Inc. All rights reserved.

Injectable and oral contraceptive use and cancers of the breast, cervix, ovary, and endometrium in black South African women: case-control study.

PubMed

Urban, Margaret; Banks, Emily; Egger, Sam; Canfell, Karen; O'Connell, Dianne; Beral, Valerie; Sitas, Freddy

2012-01-01

Oral contraceptives are known to influence the risk of cancers of the female reproductive system. Evidence regarding the relationship between injectable contraceptives and these cancers is limited, especially in black South Africans, among whom injectable contraceptives are used more commonly than oral contraceptives. We analysed data from a South African hospital-based case-control study of black females aged 18-79 y, comparing self-reported contraceptive use in patients with breast (n = 1,664), cervical (n = 2,182), ovarian (n = 182), and endometrial (n = 182) cancer, with self-reported contraceptive use in 1,492 control patients diagnosed with cancers with no known relationship to hormonal contraceptive use. We adjusted for potential confounding factors, including age, calendar year of diagnosis, education, smoking, alcohol, parity/age at first birth, and number of sexual partners. Among controls, 26% had used injectable and 20% had used oral contraceptives. For current and more recent users versus never users of oral or injectable contraceptives, the odds ratios (ORs) for breast cancer were significantly increased in users of oral and/or injectable contraceptives (OR 1.66, 95% CI 1.28-2.16, p<0.001) and separately among those exclusively using oral (1.57, 1.03-2.40, p = 0.04) and exclusively using injectable (OR 1.83, 1.31-2.55, p<0.001) contraceptives; corresponding ORs for cervical cancer were 1.38 (1.08-1.77, p = 0.01), 1.01 (0.66-1.56, p = 0.96), and 1.58 (1.16-2.15, p = 0.004). There was no significant increase in breast or cervical cancer risk among women ceasing hormonal contraceptive use ≥10 y previously (p = 0.3 and p = 0.9, respectively). For durations of use ≥5 y versus never use, the ORs of ovarian cancer were 0.60 (0.36-0.99, p = 0.04) for oral and/or injectable contraceptive use and 0.07 (0.01-0.49, p = 0.008) for injectable use exclusively; corresponding ORs for endometrial cancer were 0.44 (0

Parental Gender Equality and Use of Oral Contraceptives Among Young Women: A Longitudinal, Population-based Study in Sweden.

PubMed

Rashid, Mamunur; Kader, Manzur

2014-07-01

Little is known about how parental gender equality early in their children lives can influence daughters' decision to use contraceptive pills. The study aimed at exploring whether maternal working time and paternity leave in Sweden during the first two years of their daughters' lives is associated with the use of oral contraceptives when they are adolescents or young adults. The study population was selected from a cohort of all Swedish fathers and mothers who had their first child together between 1988 and 1989 (n = 57,520 family units). Multivariate logistic regression was used to estimate the association. Mothers' longer working time was mildly associated with daughters' oral contraceptive pill use, though no clear trend was observed. Longer paternity leave periods (>30 days) were not associated with use of oral contraceptives among their daughters, but 1-30 day periods showed a mild positive association. For maternal working time, there seems to be an association, but trends by working hours are not clear. There is no clear association between paternity leave during the first two years of their daughters' life and the use of oral contraceptives when they are adolescents and young adults.

Cardiovascular disease incidence among females in South Carolina by type of oral contraceptives, 2000-2013: a retrospective cohort study.

PubMed

Samson, Marsha E; Adams, Swann A; Merchant, Anwar T; Maxwell, Whitney D; Zhang, Jiajia; Bennett, Charles L; Hebert, James R

2016-11-01

Certain types of oral contraceptives can produce favorable effects on lipid metabolism and vascular tone, while others have potentially detrimental effects. Endogenous and exogenous hormones exert different effects on high-density lipoprotein (HDL) and low-density lipoprotein (LDL) depending on the type, combination, and dose of the hormone. The estrogenic and progestogenic effects of exogenous hormones on HDL and LDL are inconsistent. Studying surrogate end points (LDL, HDL levels) may provide a misleading picture of OCs. Medicaid data from 2000 to 2013 were used to assess the relationship between the type of OCs and CVD incidence. Multivariable logistic regression was used to model relationships between cardiovascular disease and OC use adjusting for potential confounders. Compared to combined oral contraceptives (COC), progestin-only oral contraceptives (POC) were associated with decreased heart disease and stroke incidence after adjusting for important covariates (OR 0.74; 95 % CI 0.57, 0.97 and OR 0.39; 95 % CI 0.16, 0.95, respectively). However, there was a positive association between POC + COC and both heart disease and stroke incidence (OR 2.28; 95 % CI 1.92, 2.70 and OR 2.12; 95 % CI 1.34, 3.35, respectively). In light of an association between POC use and decreased heart disease and stroke, women's CVD risk factors should be carefully considered when choosing which OC to use. Baseline CVD risk should be a part of the discussion between women and their primary care providers when making choices regarding OCs.

Adverse mood symptoms with oral contraceptives.

PubMed

Poromaa, Inger Sundström; Segebladh, Birgitta

2012-04-01

In spite of combined oral contraceptives (COCs) having been available for more than 50 years, surprisingly little is known about the prevalence of truly COC-related adverse mood symptoms and about the underlying biological mechanisms of proposed changes in mood and affect. Precise estimates of COC-related adverse mood symptoms are not available due to the lack of placebo-controlled trials. In prospective trials the frequency of women who report deteriorated mood or deteriorated emotional well-being varies between 4 and 10%, but it can be assumed that the causal relation in these prevalence rates is overestimated. Adverse mood symptoms and somatic symptoms are most pronounced during the pill-free interval of the treatment cycles, but whether extended COC regimens would be more favorable in this respect is not known. COCs with anti-androgenic progestagens, such as drospirenone and desogestrel, appear more favorable in terms of mood symptoms than progestagens with a more androgenic profile. Available data suggest that lower doses of ethinylestradiol could be beneficial. © 2012 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2012 Nordic Federation of Societies of Obstetrics and Gynecology.

The Emotional Responses of Married Women Receiving Oral Contraceptives

PubMed Central

Ringrose, C. A. Douglas

1965-01-01

One hundred women taking oral contraceptives were questioned concerning their opinions about personal and sociological effects of this method of conception control. Fifty-three per cent reported improved coital satisfaction while 4% noted the opposite effect. Libido was increased in 22% and decreased in 13%. One woman in five believed that an increase in premarital and extramarital sexual activity would take place in the general population as a result of tablet-induced infertility. The problem of population control is discussed. It is paradoxical that the incidence of unplanned pregnancies continues to increase despite the availability of completely reliable conception control. This reflects present inability to communicate contraceptive knowledge to the appropriate people. PMID:14292887

An update on emergency contraception.

PubMed

Bosworth, Michele C; Olusola, Patti L; Low, Sarah B

2014-04-01

Emergency contraception decreases the risk of unintended pregnancy after unprotected sexual intercourse or after suspected failure of routine contraception (e.g., a condom breaking). Oral methods include combined contraceptive pills (i.e., Yuzpe method), single- or split-dose levonorgestrel, and ulipristal. The Yuzpe method and levonorgestrel are U.S. Food and Drug Administration-approved for use 72 hours postcoitus, whereas the newest method, ulipristal, is approved for up to 120 hours postcoitus. The copper intrauterine device may be used as emergency contraception up to seven days after unprotected intercourse. It is nonhormonal and has the added benefit of long-term contraception. Advanced provision of emergency contraception may be useful for all patients, and for persons using ulipristal because it is available only by prescription. Physicians should counsel patients on the use and effectiveness of emergency contraception, the methods available, and the benefits of routine and consistent contraception use.

A combined oral contraceptive containing 30 mcg ethinyl estradiol and 3.0 mg drospirenone does not impair endothelium-dependent vasodilation.

PubMed

Meendering, Jessica R; Torgrimson, Britta N; Miller, Nicole P; Kaplan, Paul F; Minson, Christopher T

2010-10-01

Ethinyl estradiol (EE) increases endothelium-dependent vasodilation in young women, but certain progestins paired with EE in combination oral contraceptive pills (OCPs) have been shown to antagonize the vasodilatory effects of EE. Therefore, the purpose of this study was to investigate how endothelial function, serum biomarkers and resting blood pressures change across an OCP cycle in women using a monophasic OCP formulation containing the progestin drospirenone. Twelve women were studied during two hormone phases of their OCP cycle: once at the end of 3 weeks of active pills (30 mcg EE and 3.0 mg drospirenone) and once at the end of a week of placebo pills (no exogenous hormones) Endothelium-dependent vasodilation was greater during the active phase compared to the placebo phase (p<.001). In contrast, there was no difference in endothelium-independent dilation between hormone phases. These data suggest that the combination of 30 mcg EE and 3.0 mg drospirenone used in the active phase of this OCP increases endothelium-dependent vasodilation compared to a placebo phase. Copyright © 2010 Elsevier Inc. All rights reserved.

[Contraception and adolescence].

PubMed

Amate, P; Luton, D; Davitian, C

2013-06-01

The mean age of first sexual intercourse is still around 17 in France, but a lot of teenagers are concerned by contraception before, with approximately 25% of sexually active 15-year-old girls. The contraceptive method must take into consideration some typical features of this population, as sporadic and non-planned sexual activity, with several sexual partners in a short period of time. In 2004, the "Haute Autorité de santé" has recommended, as first-line method, combined oral contraceptive (COC) pills, in association with male condoms. Copper-containing intrauterine contraceptive devices (IUCD) and etonogestrel-containing subcutaneous implant have been suggested but not recommended. However, oral contraceptive pill, as a user-based method, carries an important typical-use failure rate, because remembering taking a daily pill, and dealing with stop periods, may be challenging. Some easier-to-use method should be kept in mind, as 28-day COC packs, transdermal contraceptive patches, and vaginal contraceptive rings. Moreover, American studies have shown that long-acting reversible contraceptives (LARC), i.e. IUCD and implant, have many advantages for teenagers: very effective, safe, invisible. They seem well-fitted for this population, with high satisfaction and continuation rates, as long as side effects are well explained. Thus, LARC methods should be proposed more widely to teenagers. Anyway, before prescribing a contraceptive method, it is important to determine the specific situation of every teenager, to let them choose the method that they consider as appropriate in their own case, and to think about the availability of the chosen method. It is necessary to explain how to handle mistakes or misses with user-based contraceptive methods, and emergency contraception can be anticipated and prescribed in advanced provision. The use of male condoms should be encouraged for adolescents, with another effective contraceptive method, in order to reduce the high risk

Injectable and Oral Contraceptive Use and Cancers of the Breast, Cervix, Ovary, and Endometrium in Black South African Women: Case–Control Study

PubMed Central

Urban, Margaret; Banks, Emily; Egger, Sam; Canfell, Karen; O'Connell, Dianne; Beral, Valerie; Sitas, Freddy

2012-01-01

Background Oral contraceptives are known to influence the risk of cancers of the female reproductive system. Evidence regarding the relationship between injectable contraceptives and these cancers is limited, especially in black South Africans, among whom injectable contraceptives are used more commonly than oral contraceptives. Methods and Findings We analysed data from a South African hospital-based case–control study of black females aged 18–79 y, comparing self-reported contraceptive use in patients with breast (n = 1,664), cervical (n = 2,182), ovarian (n = 182), and endometrial (n = 182) cancer, with self-reported contraceptive use in 1,492 control patients diagnosed with cancers with no known relationship to hormonal contraceptive use. We adjusted for potential confounding factors, including age, calendar year of diagnosis, education, smoking, alcohol, parity/age at first birth, and number of sexual partners. Among controls, 26% had used injectable and 20% had used oral contraceptives. For current and more recent users versus never users of oral or injectable contraceptives, the odds ratios (ORs) for breast cancer were significantly increased in users of oral and/or injectable contraceptives (OR 1.66, 95% CI 1.28–2.16, p<0.001) and separately among those exclusively using oral (1.57, 1.03–2.40, p = 0.04) and exclusively using injectable (OR 1.83, 1.31–2.55, p<0.001) contraceptives; corresponding ORs for cervical cancer were 1.38 (1.08–1.77, p = 0.01), 1.01 (0.66–1.56, p = 0.96), and 1.58 (1.16–2.15, p = 0.004). There was no significant increase in breast or cervical cancer risk among women ceasing hormonal contraceptive use ≥10 y previously (p = 0.3 and p = 0.9, respectively). For durations of use ≥5 y versus never use, the ORs of ovarian cancer were 0.60 (0.36–0.99, p = 0.04) for oral and/or injectable contraceptive use and 0.07 (0.01–0.49, p = 0.008) for injectable use exclusively

Impact of a women's counselling programme on combined hormonal contraception in Portugal--the IMAGINE Study.

PubMed

Costa, Ana Rosa R; Palma, Fátima; Sá, José Luís; Vicente, Lisa; Bombas, Teresa; Nogueira, Ana Maria; Rocha, Pedro

2011-12-01

The aim of this health education project was to measure the impact of counselling about combined hormonal contraceptive (CHC) methods on the subsequent choice of method by Portuguese women. This was a multi-centre study with a representative population, at the national and regional levels, of 2951 Portuguese women≥16 years of age visiting the gynaecologist. Counselling on available CHC methods was provided using a single leaflet, and their CHC choice was assessed before and after counselling. A combined oral contraceptive (COC) was the method preferred by the majority of the women prior to counselling. After counselling, 35% of women who initially had chosen the pill, switched to either the vaginal ring or the transdermal patch, and the difference was statistically significant. Ease of use was the major reason for choosing the COC, while a lower probability of omission was the reason for choosing the vaginal ring and the patch. The implementation of a counselling programme significantly affected contraceptive choices leading in a number of cases to the selection of alternatives better suited to women's lifestyle. Age and educational level are socio-demographic factors which play an important role.

[Post-abortion contraception: effects of contraception services and reproductive intention].

PubMed

Borges, Ana Luiza Vilela

2016-02-01

Contraceptive counseling and the supply of contraceptive methods are part of post-abortion care and positively influence the subsequent use of contraceptive methods. Studies showing such evidence have been conducted predominantly in countries with no legal restrictions on abortion and with adequate care for women that terminate a pregnancy. However, little is known about contraceptive practices in contexts where abortion is illegal, as in Brazil, in which post-abortion contraceptive care is inadequate. The objective of this study was to analyze the effect of contraceptive care on male condom use and oral and injectable contraceptives in the six months post-abortion, considering reproductive intention. The results showed that contraceptive care only has a positive effect on the use of oral contraceptives in the first six months post-abortion, as long as the woman had a medical consultation in the same month in which she received information on contraception. One or the other intervention alone had no significant impact.

Effect of a continuous regimen of contraceptive combination of ethinylestradiol and drospirenone on lipid, carbohydrate and coagulation profiles.

PubMed

Machado, Rogério Bonassi; de Melo, Nilson Roberto; Maia, Hugo; Cruz, Achilles Machado

2010-02-01

The objective of this study was to evaluate the effects of a contraceptive pill containing ethinylestradiol (30 mcg) and drospirenone (3 mg) in a continuous regimen on lipid, carbohydrate and coagulation parameters. This open, prospective, randomized study included 78 participants (mean age 27.8 years) who were randomized into two groups to use the pill continuously for 168 days or for six 28-day cycles with a 7-day hormone-free interval between cycles. Markers of lipid, carbohydrate and coagulation profiles were measured prior to initiation and after the 6 months of pill use. No statistically significant differences were found between the two contraceptive regimens with respect to carbohydrate or lipid profiles or in the parameters related to coagulation. The contraceptive combination of ethinylestradiol and drospirenone used in a continuous regimen was associated with metabolic alterations similar to those found during the traditional cyclic regimen of oral contraceptive use.

Parental Gender Equality and Use of Oral Contraceptives Among Young Women: A Longitudinal, Population-based Study in Sweden

PubMed Central

Rashid, Mamunur; Kader, Manzur

2014-01-01

Background: Little is known about how parental gender equality early in their children lives can influence daughters’ decision to use contraceptive pills. Aim: The study aimed at exploring whether maternal working time and paternity leave in Sweden during the first two years of their daughters’ lives is associated with the use of oral contraceptives when they are adolescents or young adults. Materials and Methods: The study population was selected from a cohort of all Swedish fathers and mothers who had their first child together between 1988 and 1989 (n = 57,520 family units). Multivariate logistic regression was used to estimate the association. Results: Mothers’ longer working time was mildly associated with daughters’ oral contraceptive pill use, though no clear trend was observed. Longer paternity leave periods (>30 days) were not associated with use of oral contraceptives among their daughters, but 1-30 day periods showed a mild positive association. Conclusion: For maternal working time, there seems to be an association, but trends by working hours are not clear. There is no clear association between paternity leave during the first two years of their daughters’ life and the use of oral contraceptives when they are adolescents and young adults. PMID:25077078

Comparative performance of a combined injectable contraceptive (50 mg norethisterone enanthate plus 5mg estradiol valerate) and a combined oral contraceptive (0.15 mg levonorgestrel plus 0.03 mg ethinyl estradiol) in adolescents.

PubMed

Molina, Ramiro C; Sandoval, Jorge Z; Montero, Adela V; Oyarzún, Pamela G; Molina, Temístocles G; González, Electra A

2009-02-01

To compare in a regular non-clinical trial experience the efficacy, acceptability, and continuation rates of an injectable contraceptive containing 50 mg norethisterone enanthate plus 5mg estradiol valerate (IC) and an oral contraceptive containing 0.15 mg levonorgestrel plus 0.03 mg ethinyl estradiol (OC), among adolescent users. A total of 251 adolescents ages 14-19 were followed during 12 months. The IC group (124 subjects) was studied for 1044 cycles and the OC group (127 subjects) was studied for 1368 cycles. The users were not assigned in a random selection. Information was collected from clinical records. Groups were compared using Pearson chi-square, odds ratio (95% confidence interval), t-test, and proportion difference test. The IC group had significant differences in baseline social risk, confidence, psychiatric problems, consumption of alcohol, and number of sexual partners. At 12 months, the IC group showed significant decrease in weight and increase in hypermenorrhea. In the OC group, dysmenorrhea decreased, and hypomenorrhea and regular cycles were significantly more frequent. One pregnancy occurred in the OC group (Pearl Index: 0.88). Final continuation rates at 12 months were 41.9% and 37.8% for IC and OC, respectively. The monthly injectable is a recommended contraceptive option for adolescents, especially for those facing psychosocial risk factors.

Efficacy and safety of an oral contraceptive containing ethinylestradiol 20 µg/drospirenone 3 mg (24/4 regimen) in three indications in the People’s Republic of China: a comparison with international studies

PubMed Central

Marr, Joachim; Huang, Zirong; Wang, Baoxi; Zhang, Hongyan; Roth, Katrin

2015-01-01

While combined oral contraceptives are a popular choice in developed Western countries, they are used by only 1% of women who are married or in a relationship in the People’s Republic of China. The purpose of this review is to describe the efficacy and safety of the combined oral contraceptive containing ethinylestradiol (EE) 20 µg/drospirenone 3 mg taken in a 24/4 regimen (YAZ®; Bayer HealthCare Pharmaceuticals, Berlin, Germany) by Chinese women and to compare these results with those in women assessed in the international studies. Studies of EE 20 µg/drospirenone 3 mg in three different indications (contraception, acne, and premenstrual dysphoric disorder [PMDD]) have been conducted in Chinese women. The results of these three studies indicate that the EE 20 µg/drospirenone 3 mg combined oral contraceptive is a good long-term contraceptive option in Chinese women, providing 99% contraceptive protection over the observed 1-year treatment period, and additionally had a favorable effect on moderate acne vulgaris and relieved the symptoms of PMDD. The contraceptive efficacy, improvement in acne, and relief from PMDD symptoms observed in these studies did not differ from the effects observed in other international studies of EE 20 µg/drospirenone 3 mg, indicating that EE 20 µg/drospirenone 3 mg is as effective in Chinese women as in other ethnicities. Further, EE 20 µg/drospirenone 3 mg demonstrated a similar safety and tolerability profile in women enrolled in the Chinese and international trials, with no unexpected adverse events reported in any of the three Chinese trials. Overall, the efficacy, tolerability, and degree of non-contraceptive benefits with EE 20 µg/drospirenone 3 mg appear similar in Chinese women when compared with those reported in larger studies done at other international centers. PMID:29386927

The Combined Influence of Oral Contraceptives and Human Papillomavirus Virus on Cutaneous Squamous Cell Carcinoma

PubMed Central

Efird, Jimmy T.; Toland, Amanda E.; Lea, C. Suzanne; Phillips, Christopher J.

2011-01-01

The vast majority of cutaneous squamous cell carcinoma (CSCC) will occur in those with fair complexion, tendency to burn, and high ultraviolet radiation (UVR) exposure. Organ transplant recipients also are an important population at great risk for CSCC. An association has been reported between oral contraceptive (OC) use, human papillomavirus virus (HPV) and cervical cancer, and there could be a similar association for CSCC. The cutaneous HPV β-E6 protein, a close cousin of the transformative E6 protein underlying anogenital cancers, has been shown to inhibit apoptosis in response to UVR damage and stimulate morphologic transformation in rodent fibroblast cell lines. Furthermore, OC use has been shown to enhance HPV transcription and may contribute to CSCC risk through this pathway. PMID:21499554

21 CFR 310.501 - Patient package inserts for oral contraceptives.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Patient package inserts for oral contraceptives. 310.501 Section 310.501 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... the requirements of this section is misbranded under section 502 of the Federal Food, Drug, and...

21 CFR 310.501 - Patient package inserts for oral contraceptives.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Patient package inserts for oral contraceptives. 310.501 Section 310.501 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... the requirements of this section is misbranded under section 502 of the Federal Food, Drug, and...

Oral contraceptives and venous thromboembolism: pill scares and public health.

PubMed

Reid, Robert L

2011-11-01

Post-marketing surveillance of combined oral contraceptives (COCs) for rare complications such as venous thromboembolism (VTE) presents unique challenges. Prospective studies, which are costly and time consuming, have to date been undertaken by only a few contraceptive manufacturers willing to commit to full evaluation of product safety. Often such studies are conducted with the approval of regulatory authorities as a precondition for marketing. Alternatively, independent investigators with access to large databases have conducted retrospective studies to compare the incidence of VTE between new and older products. Such studies, however, run the risk of erroneous conclusions if they cannot ensure comparable risk profiles for users of these different products. Often database studies are unable to access information on important confounders, and medical records may not be available to validate the actual diagnosis of VTE. "Pill scares" generated following publication and media dissemination of worrisome findings, when the conclusions are in doubt and not corroborated by stronger prospective study designs, are frequently damaging to public health. From a review of recent publications on the VTE risk with drospirenone-containing COCs, it can be concluded that the best quality evidence does not support a difference in risk between users of COCs containing drospirenone and those of COCs containing levonorgestrel.

Access to data and the information explosion: oral contraceptives and risk of cancer.

PubMed

Weiner, J M; Shirley, S; Gilman, N J; Stowe, S M; Wolf, R M

1981-09-01

This report describes a technically feasible method to deal with the enormous volume of literature published regarding oral contraceptives. This subject was discussed in 3735 publications during the period from November 1977 through October 1980. Our findings showed that those papers reporting original, numeric relationships involving risk of cancer and use of oral contraceptives were one percent of the total 3735 publications. However, only seven of the 27 articles involved were authored by individuals from departments of obstetrics and gynecology. Further, only four of the 27 were published in journals devoted to obstetrics and gynecology. The analyses suggest a form of censorship taking place, in that the obstetrics/gynecology specialists do not have ready access to the primary data.

Utilization of and Adherence to Oral Contraceptive Pills and Associated Disparities in the United States: A Baseline Assessment for the Impact of the Affordable Care Act of 2010.

PubMed

Lin, Hsien-Chang; Lee, Hsiao-Yun

2015-01-01

This study investigated sociological factors that may influence women's utilization of and adherence to oral contraceptive pills. This was a retrospective cross-sectional study using the 2010-2012 Medical Expenditure Panel Survey. Female adults aged 18-50 years were included. Logistic regression was performed to discern women's decisions to use oral contraceptive pills or not. Ordinary least squares and Poisson regressions were conducted to examine the number of oral contraceptive pills received, refill frequency, and annual out-of-pocket expenditure on oral contraceptive pills. Covariates were based on the Andersen model of health care utilization. Among the study sample (weighted n = 207,007,531), 14.8% were oral contraceptive pill users. Factors positively related to oral contraceptive pill use included non-Hispanic white ethnicity, younger age, not currently married, having private insurance, residing in the Midwest, higher education level, and higher annual family income. Being non-Hispanic white and having a higher education level were positively related to oral contraceptive pill adherence. Our findings therefore demonstrate disparities in oral contraceptive pill utilization and adherence, especially according to women's race/ethnicity and educational level. This study serves as a baseline assessment for the impact of the Affordable Care Act on oral contraceptive pill utilization and adherence for future studies. © The Author(s) 2015.

Effects on cycle control and bodyweight of the combined contraceptive ring, NuvaRing, versus an oral contraceptive containing 30 microg ethinyl estradiol and 3 mg drospirenone.

PubMed

Milsom, I; Lete, I; Bjertnaes, A; Rokstad, K; Lindh, I; Gruber, C J; Birkhäuser, M H; Aubeny, E; Knudsen, T; Bastianelli, C

2006-09-01

The objective of this study was to compare cycle control, cycle-related characteristics and bodyweight effects of NuvaRing with those of a combined oral contraceptive (COC) containing 30 microg of ethinyl estradiol and 3 mg of drospirenone. A randomized, multicentre, open-label trial in which 983 women were treated (intent-to-treat population) with NuvaRing or the COC for 13 cycles. Breakthrough bleeding or spotting during cycles 2-13 was in general less frequent with NuvaRing than that with the COC (4.7-10.4%) and showed a statistically significant odds ratio of 0.61 (95% confidence interval: 0.46, 0.80) with longitudinal analysis. Intended bleeding was significantly better for all cycles with NuvaRing (55.2-68.5%) than that with the COC (35.6-56.6%) (P < 0.01). Changes from baseline in mean bodyweight and body composition parameters were relatively small for both groups with no notable between-group differences. NuvaRing was associated with better cycle control than the COC, and there was no clinically relevant difference between the two groups in bodyweight.

Compliance and use behaviour, an issue in injectable as well as oral contraceptive use? A study of injectable and oral contraceptive use in Johannesburg.

PubMed

Beksinska, M E; Rees, V H; Nkonyane, T; McIntyre, J A

1998-04-01

This study examines the compliance, use behaviour and knowledge of method of women using injectable and oral contraceptives in two clinic sites in the Johannesburg area, South Africa. An interviewer administered questionnaire was used to collect information in the clients' home language. A total of 400 women were interviewed in the clinics. The mean age of clients was 26.2 years (range 13 to 43 years). Of the clients not wanting to get pregnant, 30.4 per cent of injectable users and 18.4 per cent of oral contraceptive (OC) users had stopped using their method temporarily before returning to the same method (called the nonuse segment) and had not used any other form of contraception during this time. Almost one third of injectable users (31.2 per cent) had been late for their next injection at least once. Although nearly all women using injectables had experienced some menstrual disturbances, over one third (38.5 per cent) had not been informed by the providers about the possibility of these changes. Many women gave the disruption of their menstrual cycle as the reason for the nonuse segment. The majority of OC users lacked information on how to use their method correctly. Nearly all women expressed an interest in obtaining more information on their current method and other available methods. This study shows that compliance is an issue in injectable as well as OC users.

Study of low-density lipoprotein receptor regulation by oral (steroid) contraceptives: desogestrel, levonorgestrel and ethinyl estradiol in JEG-3 cell line and placental tissue.

PubMed

Ramakrishnan, Gopalakrishnan; Rana, Anita; Das, Chandana; Chandra, Nimai Chand

2007-10-01

The aim of this study was to compare in vitro the role of two oral contraceptives, desogestrel (a less androgenic derivative of levonorgestrel) and levonorgestrel--alone and in combination with ethinyl estradiol--on low-density lipoprotein (LDL) receptor regulation by assessing receptor protein expression and functional effectiveness. Placental tissue and cultured placental cells (JEG-3) were used to study the expression and endocytotic activity of LDL receptor protein. The expression of the receptor was assessed by immunocytochemistry and immunoblot assays with and without contraceptive challenge. Functioning activity of LDL receptor was studied by measuring the rate of uptake of LDL by placental cells. Quantification of LDL was based on the total cholesterol content of the lipoprotein. A combination of desogestrel (20 ng/mL of incubation medium) and ethinyl estradiol (10 ng/mL of incubation medium) maintained the LDL receptor at high level of expression and functioning mode. In contrast, the double-blind preparation of levonorgestrel (20 ng/mL) and ethinyl estradiol (10 ng/mL) had shown much lower expression as well as receptor-mediated LDL uptake. The concentration of contraceptives used in this study was similar to the prevailing concentration of oral contraceptives in clinical use. Higher expression of LDL receptor and enhanced rate of LDL uptake by the receptor protein projects the possibility that there might be less atherosclerosis-related disorders from the combination of desogestrol and ethinyl estradiol.

Influence of hormonal contraceptives and the occurrence of stroke: integrative review.

PubMed

Lima, Adman Câmara Soares; Martins, Larissa Castelo Guedes; Lopes, Marcos Venícios de Oliveira; Araújo, Thelma Leite de; Lima, Francisca Elisângela Teixeira; Aquino, Priscila de Souza; Moura, Escolástica Rejane Ferreira

2017-01-01

To identify scientific evidence regarding the influence of hormonal contraceptive use and the occurrence of stroke. Integrative review of the literature, through database search using the descriptors "contraceptive agents", "contraceptive devices", "contraceptives, Oral" and "Stroke". Original studies in Portuguese, Spanish and English, published in full and available online were included. Studies that did not answer our guiding questions and duplicated studies were excluded. Women using combined oral contraceptives have higher risk of stroke, even with a lower hormonal dosage and different types of progestogen, regardless of the duration of use. The use of contraceptives associated with smoking, hypertension, migraine, hypercholesterolemia, obesity and sedentary lifestyle increases the chance of stroke. Contraceptive patch and vaginal ring are associated to increased risk. Use of combined hormonal contraceptives, except for the injectable and the transdermal ones, increases the chance of occurrence of the event. Progestogen-only contraceptives were considered safe. Identificar evidências científicas acerca da influência do uso de anticoncepcionais hormonais na ocorrência do acidente vascular cerebral (AVC). Revisão integrativa da literatura, com pesquisa em bases de dados, utilizando os descritores "contraceptive agents", "contraceptive devices", "contraceptives, Oral" e "stroke". Foram incluídos artigos originais nos idiomas português, espanhol e inglês, publicados na íntegra e disponíveis eletronicamente. Foram excluídos artigos que não respondiam às questões norteadoras e repetidos. Usuárias de anticoncepcional oral combinado apresentam risco maior de AVC, mesmo com dosagem hormonal menor e diferentes tipos de progestágeno, independente do tempo de uso. A presença associada de tabagismo, hipertensão arterial, enxaqueca, hipercolesterolemia, obesidade e sedentarismo aumenta a chance desse desfecho. Adesivo anticoncepcional e anel vaginal s

Contraceptive efficacy, compliance and beyond: factors related to satisfaction with once-weekly transdermal compared with oral contraception.

PubMed

Urdl, Wolfgang; Apter, Dan; Alperstein, Alan; Koll, Peter; Schönian, Siegfried; Bringer, Jacques; Fisher, Alan C; Preik, Michael

2005-08-01

To investigate contraceptive efficacy, compliance and user's satisfaction with transdermal versus oral contraception (OC). Randomized, open-label, parallel-group trial conducted at 65 centers in Europe and South Africa. One thousand four hundred and eighty-nine women received a contraceptive patch (n = 846) or an OC (n = 643) for 6 or 13 cycles. Overall/method-failure Pearl Indices were 0.88/0.66 with the patch and 0.56/0.28 with the OC (p = n.s.). Compliance was higher at all age groups with the patch compared to the OC. Significantly more users were very satisfied with the contraceptive patch than with the OC. The percentage of patch users being very satisfied increased with age whereas it did not in the OC group. Likewise, improvements of premenstrual symptoms as well as emotional and physical well-being increased with age in the patch-group in contrast to the OC group. Ratings of satisfaction with the study medication correlated weakly with emotional (r = 0.33) and physical well-being (r = 0.39) as well as premenstrual symptoms (r = 0.30; p < 0.001). Contraceptive efficacy of the patch is comparable to OC, but compliance is consistently better at all age groups. Higher satisfaction with the patch at increasing age may be attributed to improvements in emotional and physical well-being as well as reduction of premenstrual symptoms.

Comparison of rates of and charges from pregnancy complications in users of extended and cyclic combined oral contraceptive (COC) regimens: a brief report.

PubMed

Howard, Brandon; Trussell, James; Grubb, ElizaBeth; Lage, Maureen J

2014-05-01

To evaluate pregnancy complication rates and related charges in users of 84/7, 21/7 and 24/4 combined oral contraceptives (COCs). Data were obtained from the i3 InVision Data Mart™ retrospective claims database. Subjects were aged 15-40 years, first prescribed a COC between 1/1/2006 and 4/1/2011 and continuously insured for ≥1 year. 84/7 users were matched 1:1 to 21/7 and 24/4 users. Pregnancy-related complication rates and associated charges were significantly lower with 84/7 vs. 21/7 and 24/4 regimens. Preliminary data suggest 84/7 regimens may be associated with fewer pregnancy complications and lower related charges. Copyright © 2014 Elsevier Inc. All rights reserved.

Myths about oral contraceptives. Does OC availability result in increased sexual activity among teens?

PubMed

Chaney

1993-11-01

Parents, educators, public health officials, health-care providers, religious organizations, and advocacy groups are very concerned about the rise in teenage pregnancy and the increase in sexually transmitted diseases among the young. Some say the increased availability and acceptance of oral contraceptives is directly related to an increase in sexual activity among teens. Less than 50% of women use a contraceptive method at first intercourse. Use is much lower in Hispanic and African-American women than among White women; women with low socioeconomic status, living in one-parent households, or having sex at an early age are the least likely to use a contraceptive method at first intercourse. According to the National Survey of Family Growth, teens engaging in sexual intercourse for the first time, who use a contraceptive method, typically choose the condom. Oral contraceptive use is very low and use at first intercourse has not increased over time. It is only after the establishment of routine sexual intercourse that the pill becomes the preferred method. The use of a condom has more than doubled for the period from 1982 to 1988. Adolescents under age 16 are at greatest risk for unintended pregnancies because this group is the least likely to use any method of contraception. The increase in teen sexual activity over the years does not coincide with an increase in pill use. Education must begin in elementary schools, stressing abstinence, but also include facts about sex, contraception, and disease prevention, because 40% of teens are sexually active by 9th grade. Skills can focus on changing behavior, such as learning to delay intercourse, building self-esteem as well as proper use of contraceptives. Easy, nonthreatening access to medical care can prevent many unintended pregnancies and the spread of sexually transmitted diseases.

Regional lipiodolized chemotherapy for cholangiocarcinoma associated with oral contraceptives.

PubMed Central

McAleer, J. J.; Dickey, W.; Clarke, R.; Johnston, G. W.; Callender, M. E.

1987-01-01

We describe a case of cholangiocarcinoma in a young woman, who presented with cholestatic jaundice following oral contraceptive ingestion. Following diagnostic laparotomy she received intra-arterial 'lipiodolized' chemotherapy. Intravenous mitozantrone was given for 2 years and she is asymptomatic, with computed tomographic evidence of tumour response, 27 months after diagnosis. We suggest that this form of treatment is of value for cholangiocarcinoma. PMID:2821526

Preference for and efficacy of oral levonorgestrel for emergency contraception with concomitant placement of a levonorgestrel IUD: a prospective cohort study.

PubMed

Turok, David K; Sanders, Jessica N; Thompson, Ivana S; Royer, Pamela A; Eggebroten, Jennifer; Gawron, Lori M

2016-06-01

We assessed intrauterine device (IUD) preference among women presenting for emergency contraception (EC) and the probability of pregnancy among concurrent oral levonorgestrel (LNG) plus LNG 52 mg IUD EC users. We offered women presenting for EC at a single family planning clinic the CuT380A IUD (copper IUD) or oral LNG 1.5 mg plus the LNG 52 mg IUD. Two weeks after IUD insertion, participants reported the results of a self-administered home urine pregnancy test. The primary outcome, EC failure, was defined as pregnancies resulting from intercourse occurring within five days prior to IUD insertion. One hundred eighty-eight women enrolled and provided information regarding their current menstrual cycle and recent unprotected intercourse. Sixty-seven (36%) chose the copper IUD and 121 (64%) chose oral LNG plus the LNG IUD. The probability of pregnancy two weeks after oral LNG plus LNG IUD EC use was 0.9% (95% CI 0.0-5.1%). The only positive pregnancy test after treatment occurred in a woman who received oral LNG plus the LNG IUD and who had reported multiple episodes of unprotected intercourse including an episode more than 5 days prior to treatment. Study participants seeking EC who desired an IUD preferentially chose oral LNG 1.5 mg with the LNG 52 mg IUD over the copper IUD. Neither group had EC treatment failures. Including the option of oral LNG 1.5 mg with concomitant insertion of the LNG 52 mg IUD in EC counseling may increase the number of EC users who opt to initiate highly effective reversible contraception. Consideration should be given to LNG IUD insertion with concomitant use of oral LNG 1.5 mg for EC. Use of this combination may increase the number of women initiating highly effective contraception at the time of their EC visit. Copyright © 2016 Elsevier Inc. All rights reserved.

Oral contraceptive use may not preclude condom use: a study of non‐pregnant African‐American adolescent females

PubMed Central

Crosby, Richard A; DiClemente, Ralph J; Wingood, Gina M; Salazar, Laura F; Rose, Eve; Sales, Jessica M; Caliendo, Angela M

2007-01-01

Objective To determine the association between oral contraceptive and condom use, and laboratory‐confirmed sexually transmitted infection (STI) among African‐American adolescent females at a high risk of STI acquisition. Methods A cross‐sectional study of 715 African‐American adolescent females (15–21 years old) was conducted. Data collection included (a) an audio‐computer‐assisted self‐interview and a self‐collected vaginal swab for nucleic acid amplification testing of Trichomonas vaginalis, Chlamydia trachomatis and Neisseria gonorrhoeae. Results The age‐adjusted odds ratio (AOR) indicated a modest protective effect of oral contraceptive use against unprotected vaginal sex (UVS) using a 60‐day recall period (AOR = 0.66; 95% CI 0.43 to 0.99). The age‐adjusted difference in mean frequency of UVS in the past 60 days was non‐significant (p = 0.23) as was condom use at last sex (p = 0.34). The age‐AOR relative to STI prevalence also showed a protective effect (AOR = 0.60; 95% CI 0.36 to 0.98) for those using oral contraceptives. Conclusion The findings suggest that the use of oral contraceptives may not preclude safer sex practices for the prevention of STIs among high‐risk African‐American adolescent females. PMID:17569720

Current oral contraceptive use instructions: an analysis of patient package inserts.

PubMed

Williams-Deane, M; Potter, L S

1992-01-01

Oral contraceptive use instructions contained in manufacturers' patient package inserts (PPIs) are often inconsistent or conflicting, both among manufacturers and among different brands and regimens from the same manufacturer. Instructions on what to do about missed pills are often incomplete or inadequate, as are instructions on backup contraceptive use when pills are missed. The format of many PPIs is confusing and makes instructions difficult to find and read. Comprehending the PPIs requires the user to read at a 10th-12th-grade level, far higher than the generally accepted 5th-6th grade level considered standard for health education materials.

Cluster headache in women: relation with menstruation, use of oral contraceptives, pregnancy, and menopause

PubMed Central

van Vliet, J A; Favier, I; Helmerhorst, F M; Haan, J; Ferrari, M D

2006-01-01

In contrast with migraine, little is known about the relation between cluster headache and menstrual cycle, oral contraceptives, pregnancy, and menopause. A population based questionnaire study was performed among 224 female cluster headache patients, and the possible effect of hormonal influences on cluster headache attacks studied. For control data, a similar but adjusted questionnaire was sent to healthy volunteers and migraine patients. It was found that menstruation, use of oral contraceptives, pregnancy, and menopause had a much smaller influence on cluster headache attacks than in migraine. Cluster headache can, however, have a large impact on individual women, for example to refrain from having children. PMID:16407458

Reproductive Health Outcomes of Insured Women Who Access Oral Levonorgestrel Emergency Contraception

PubMed Central

Raine-Bennett, Tina; Merchant, Maqdooda; Sinclair, Fiona; Lee, Justine W.; Goler, Nancy

2015-01-01

Objectives To assess the level of risk for women who seek emergency contraception through various clinical routes and the opportunities for improved care provision. Methods This study looked at a retrospective cohort to assess contraception and other reproductive health outcomes among women aged 15-44 who accessed oral levonorgestrel emergency contraception through an office visit or the call center at Kaiser Permanente Northern California from 2010 to 2011. Results Of 21,421 prescriptions, 14,531(67.8%) were accessed through the call center. In the subsequent 12 months, 12,127(56.6%) women had short-acting contraception (pills, patches, rings, depot medroxyprogesterone) dispensed and 2,264(10.6%) initiated very effective contraception (intrauterine contraception, implants, sterilization). Initiation of very effective contraception was similar for women who accessed it through the call center -1,569(10.8%) and office visits – 695(10.1%) (adjusted OR 1.02 95% confidence interval (CI) 0.93-1.13). In the subsequent 6 months, 2,056(9.6%) women became pregnant. Women who accessed emergency contraception through the call center were less likely to become pregnant within 3 months of accessing emergency contraception than woman who accessed it through office visits (adjusted OR 0.82 95% CI 0.72-0.94); however they were more likely to become pregnant within 4-6 months (adjusted OR 1.37 95%CI 1.16-1.60). Among women who were tested for chlamydia and gonorrhea, 689(7.8%) and 928(7.9%) were positive in the 12 months before and after accessing emergency contraception, respectively. Conclusions Protocols to routinely address unmet need for contraception at every call for emergency contraception and all office visits including visits with primary care providers should be investigated. PMID:25751211

Crying, oral contraceptive use and the menstrual cycle.

PubMed

Romans, Sarah E; Clarkson, Rose F; Einstein, Gillian; Kreindler, David; Laredo, Sheila; Petrovic, Michele J; Stanley, James

2017-01-15

Crying, a complex neurobiological behavior with psychosocial and communication features, has been little studied in relationship to the menstrual cycle. In the Mood and Daily Life study (MiDL), a community sample of Canadian women aged 18-43 years, n=76, recorded crying proneness and crying frequency daily for six months along with menstrual cycle phase information. Crying proneness was most likely during the premenstruum, a little less likely during menses and least likely during the mid-cycle phase, with statistically significant differences although the magnitude of these differences were small. By contrast, actual crying did not differ between the three menstrual cycle phases. Oral contraceptive use did not alter the relationship between menstrual cycle phase and either crying variable. A wide range of menstrual cycle phase - crying proneness patterns were seen with visual inspection of the individual women's line graphs. timing of ovulation was not ascertained. Using a three phase menstrual cycle division precluded separate late follicular and early luteal data analysis. The sample size was inadequate for a robust statistical test of actual crying. reproductive aged women as a group report feeling more like crying premenstrually but may not actually cry more during this menstrual cycle phase. Individual patterns vary substantially. Oral contraceptive use did not affect these relationships. Suggestions for future research are included. Copyright © 2016 Elsevier B.V. All rights reserved.

Effect of mavoglurant (AFQ056), a selective mGluR5 antagonist, on the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and levonorgestrel in healthy women.

PubMed

Sivasubramanian, Rama; Chakraborty, Abhijit; Rouzade-Dominguez, Marie-Laure; Neelakantham, Srikanth; Jakab, Annamaria; Mensinga, Tjeert; Legangneux, Eric; Woessner, Ralph; Ufer, Mike

2015-07-01

To compare the pharmacokinetics (PKs) of a combination oral contraceptive (OC) when given alone or concomitantly with the selective metabotropic glutamate receptor 5 antagonist mavoglurant (AFQ056). This open-label, fixed-sequence, two-period study included 30 healthy female subjects aged 18-40 years. In period 1, a single oral dose of an OC containing 30 μg ethinyl estradiol (EE)/150 μg levonorgestrel (LNG) was administered alone. In period 2, the OC was administered with a clinically relevant multiple dose of mavoglurant 100 mg b.i.d. under steady-state conditions. Plasma concentrations of EE and LNG were measured up to 72 hours post administration, and the PK parameters Cmax and AUClast were estimated using noncompartmental methods. The geometric mean ratios of EE Cmax and AUClast obtained with and without mavoglurant were 0.97 (90% confidence interval (CI): 0.90-1.06) and 0.94 (90% CI: 0.86-1.03), respectively. The corresponding Cmax and AUClast for LNG were 0.81 (90% CI: 0.75-0.87) and 0.68 (90% CI: 0.63-0.73), respectively. In conclusion, EE PK was unchanged, whereas Cmax and AUClast of LNG were 19% and 32% lower, respectively, when given with mavoglurant Further investigation regarding the impact on contraceptive efficacy is warranted.

Oral contraception following abortion

PubMed Central

Che, Yan; Liu, Xiaoting; Zhang, Bin; Cheng, Linan

2016-01-01

Abstract Oral contraceptives (OCs) following induced abortion offer a reliable method to avoid repeated abortion. However, limited data exist supporting the effective use of OCs postabortion. We conducted this systematic review and meta-analysis in the present study reported immediate administration of OCs or combined OCs postabortion may reduce vaginal bleeding time and amount, shorten the menstruation recovery period, increase endometrial thickness 2 to 3 weeks after abortion, and reduce the risk of complications and unintended pregnancies. A total of 8 major authorized Chinese and English databases were screened from January 1960 to November 2014. Randomized controlled trials in which patients had undergone medical or surgical abortions were included. Chinese studies that met the inclusion criteria were divided into 3 groups: administration of OC postmedical abortion (group I; n = 1712), administration of OC postsurgical abortion (group II; n = 8788), and administration of OC in combination with traditional Chinese medicine postsurgical abortion (group III; n = 19,707). In total, 119 of 6160 publications were included in this analysis. Significant difference was observed in group I for vaginal bleeding time (P = 0.0001), the amount of vaginal bleeding (P = 0.03), and menstruation recovery period (P < 0.00001) compared with the control groups. Group II demonstrated a significant difference in vaginal bleeding time (P < 0.00001), the amount of vaginal bleeding (P = 0.0002), menstruation recovery period (P < 0.00001), and endometrial thickness at 2 (P = 0.003) and 3 (P < 0.00001) weeks postabortion compared with the control group. Similarly, a significant difference was observed in group III for reducing vaginal bleeding time (P < 0.00001) and the amount of vaginal bleeding (P < 0.00001), shortening the menstruation recovery period (P < 0.00001), and increasing endometrial thickness 2 and 3 weeks after surgical abortion (P < 0

Efficacy, acceptability and tolerability of the combined contraceptive ring, NuvaRing, compared with an oral contraceptive containing 30 microg of ethinyl estradiol and 3 mg of drospirenone.

PubMed

Ahrendt, Hans-Joachim; Nisand, Israel; Bastianelli, Carlo; Gómez, Maria Angeles; Gemzell-Danielsson, Kristina; Urdl, Wolfgang; Karskov, Birgit; Oeyen, Luc; Bitzer, Johannes; Page, Geert; Milsom, Ian

2006-12-01

This randomized multicenter, open-label, trial compared efficacy, acceptability, tolerability and compliance of NuvaRing with a combined oral contraceptive (COC), containing 30 microg of ethinyl estradiol (EE) and 3 mg of drospirenone. In this 13-cycle study, 983 women were randomized and treated (intent-to-treat population) with NuvaRing or COC. One in-treatment pregnancy occurred with NuvaRing (Pearl Index=0.25) (95% confidence interval [CI]: 0.006, 1.363) and four with the COC (Pearl Index=0.99) (95% CI: 0.269, 2.530). For both groups, compliance (89.2% NuvaRing, 85.5% COC) and satisfaction (84% NuvaRing; 87% COC) were high; the vast majority of women found NuvaRing easy to insert (96%) and remove (97%). Tolerability was similar; the most frequent adverse events with NuvaRing were related to ring use, whereas estrogen-related events were more common with the COC. NuvaRing has comparable efficacy and tolerability to a COC containing 30 microg of EE and 3 mg drospirenone. User acceptability of both methods was high.

Oral progestogen combined with testosterone as a potential male contraceptive: additive effects between desogestrel and testosterone enanthate in suppression of spermatogenesis, pituitary-testicular axis, and lipid metabolism.

PubMed

Wu, F C; Balasubramanian, R; Mulders, T M; Coelingh-Bennink, H J

1999-01-01

The effects of a synthetic oral progestogen, desogestrel (DSG), administered with low dose testosterone (T) were investigated to determine the optimal combination for suppression of gonadotropins and spermatogenesis to targets compatible with effective male contraception. Twenty-four healthy male volunteers (33.2 +/- 0.9 yr) were randomly assigned to 3 groups (n = 8) to receive: 1) 300 microg DSG orally daily and 100 mg T enanthate, i.m., weekly; 2) 300 microg DSG and 50 mg T enanthate; or 3) 150 microg DSG and 100 mg T enanthate for 24 weeks. To investigate the individual contribution to the combined action, DSG was administered alone for the first 3 weeks, and T enanthate was added on day 22. After 24-week treatment, sperm density in 78% (18 of 23) of the subjects became azoospermic, whereas 91.7% (22 of 24) and 95.8% (23 of 24) suppressed to less than 1 million/mL and less than 3 million/mL, respectively. The 300 microg DSG with 50 mg T enanthate combination induced azoospermia in 8 of 8 subjects, and the suppression of sperm density was significantly greater than that in the 300 microg DSG/100 mg T enanthate group, but was not different from that in the 150 microg DSG/100 mg T enanthate group. DSG (300 or 150 microg daily) alone in the first 3 weeks suppressed LH, FSH, and T to 60.6%, 48.0%, and 35.4%, respectively, of the baseline. Addition of T enanthate (50 and 100 mg weekly) raised plasma T to the physiological range and induced a further fall in LH and FSH to the limits of assay detection. There was no consistent difference in mean LH and FSH levels among the three groups during treatment or recovery, except that FSH remained detectable in a higher proportion of samples from the group receiving 300 microg DSG with 50 mg T enanthate. Total cholesterol, high density lipoprotein cholesterol, and low density lipoprotein cholesterol decreased by 9.3 +/- 1.7%, 10.3 +/- 2.6%, and 7.7 +/- 2.8%, respectively, during treatment with DSG alone with no difference

Comparing the effects of low-dose contraceptive pills to control dysfunctional uterine bleeding by oral and vaginal methods.

PubMed

Mehrabian, Ferdous; Abbassi, Fariba

2013-09-01

Background and Objective : Contraceptive pills are generally taken orally and can cause side effects such as nausea, vomiting and hypertension. The vaginal use of these pills can reduce such complications. Our objective was to compare the efficacy and side effects of low dose contraceptive pills by oral and vaginal route in the management of dysfunctional uterine bleeding-(DUB) Methods: This comparative observational study was conducted at Beheshti and Alzahra (SA) teaching hospitals, affiliated to Isfahan University of Medical Sciences in 2010-2011. One hundred women who presented with DUB were randomly assigned into two groups of equal number, receiving the low dose oral contraceptive pills by oral or vaginal route for three month. The amount and duration of bleeding were compared at the beginning and at the end of the study and side effects by these two methods compared. The results of this study showed that both oral and vaginal routes effectively reduced the duration and amount of bleeding due to DUB after three courses of treatment. This effect was better in the vaginal method compared with oral administration (P = 0.03). Regarding the side effects, nausea and vomiting were significantly higher in the oral group than in the vaginal group (P = 0.03). Vulvovaginitis infection was more frequent in the vaginal group than in the oral group (P = 0.03). Low dose contraceptive pills are effective in reducing the amount, time, and duration of bleeding in patients with DUB. In addition, reduction of gastrointestinal side effects by vaginal route helps to use these pills by the patient with proper training of physicians, midwives and patients.

A 1-year randomized study to evaluate the effects of a dose reduction in oral contraceptives on lipids and carbohydrate metabolism: 20 microg ethinyl estradiol combined with 100 microg levonorgestrel.

PubMed

Skouby, Sven O; Endrikat, Jan; Düsterberg, Bernd; Schmidt, Werner; Gerlinger, Christoph; Wessel, Jens; Goldstein, Henri; Jespersen, Joergen

2005-02-01

To evaluate the impact on lipid and carbohydrate variables of a combined one-third ethinyl estradiol (EE)/levonorgestrel (LNG) dose reduction in oral contraceptives. In an open-label, randomized study, a dose-reduced oral contraceptive containing 20 microg EE and 100 microg LNG (20 EE/100 LNG) was compared with a reference preparation containing 30 microg EE and 150 microg LNG (30 EE/150 LNG). One-year data from 48 volunteers were obtained. We found a decrease of HDL2 cholesterol and increases of low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol and total triglycerides in both treatment groups from baseline to the 13th treatment cycle. Although for four of six variables, the changes in the 20 EE group were lower compared with the 30 EE group, none of the differences between the two treatments were statistically significant. The median values for the fasting levels of insulin, C-peptide and free fatty acids slightly increased or remained unchanged while the fasting glucose levels slightly decreased after 13 treatment cycles. While the glucose area under the curve (AUC) (0-3 h) was similar in both groups during the OGTT, the insulin AUC(0-3 h) was less increased in the 20 EE/100 LNG group compared with the 30 EE/150 LNG group. None of the differences between the treatment groups for any of the carbohydrate metabolism variables were statistically significant at any time point. Both study treatments were safe and well tolerated by the volunteers. Similar effects on the lipid and carbohydrate profiles were found for both preparations. The balanced one-third EE dose reduction in this new oral contraceptive caused slightly lower, but insignificant, changes in the lipid and carbohydrate variables compared with the reference treatment.

Opinion and experience of Brazilian women regarding menstrual bleeding and use of combined oral contraceptives.

PubMed

Makuch, Maria Y; Duarte-Osis, Maria J; de Pádua, Karla S; Petta, Carlos; Bahamondes, Luis

2012-04-01

To describe the opinion and experience of Brazilian women regarding menstruation and the use of combined oral contraceptives (COCs) to control monthly bleeding and induce amenorrhea. Women attending regional public healthcare clinics for non-gynecologic conditions, and female members of staff from university schools unrelated to the field of medicine completed a questionnaire. Of the 1111 women interviewed, 64.3% reported disliking menstruation. The desired frequency of bleeding was never (65.3%), less than monthly (18.2%), and every month or more often (16.5%). More than 60% of the women reported that they would use COCs to control menstrual bleeding, 82.0% would use COCs to reduce the amount of bleeding experienced, and 86.1% would use COCs to induce amenorrhea. When compared with women who disliked menstruation, those who reported that they liked to experience monthly bleeding had fewer years of schooling (OR1.98; 95% CI, 1.30-2.97), low socioeconomic status (OR 1.66; 95% CI, 1.12-2.46), fewer days of menstruation each month (OR 1.62; 95% CI, 1.11-2.36), and 1 or more child (OR 1.13; 95% CI, 1.01-1.26). Many of the women surveyed disliked monthly menstruation and were interested in the use of COCs to control menstrual bleeding and induce amenorrhea. Copyright © 2012 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Effect of betel chewing on the frequency of sister chromatid exchanges in pregnant women and women using oral contraceptives.

PubMed

Ghosh, P K; Ghosh, R

1988-06-01

The incidence of sister chromatid exchange (SCE) was investigated in the lymphocyte chromosomes of betel chewing and non-chewing normal women, pregnant women, and women using oral contraceptives. The frequency of SCE was found to be 7.82 +/- 0.24 and 8.27 +/- 0.27 in non-chewing pregnant women and women using oral contraceptives respectively, which were significantly higher than the mean value of 5.21 +/- 0.18 observed in non-chewing normal women. Betel chewing induced higher SCE in pregnant women and women using oral contraceptives, the frequencies being 11.79 +/- 0.38 and 12.51 +/- 0.44, respectively, which were significantly higher than the SCE frequency of 6.28 +/- 0.21 found in normal betel chewing females.

Controversies in contraception for women with epilepsy

PubMed Central

Thomas, Sanjeev V.

2015-01-01

Contraception is an important choice that offers autonomy to women with regard to prevention of unintended pregnancies. There is wide variation in the contraceptive practices between continents, countries, and societies. The medical eligibility for contraception for sexually active women with epilepsy (WWE) is determined by the type of anti-epileptic drugs (AEDs) that they use. Enzyme inducing AEDs such as phenobarbitone, phenytoin, carbamazepine, and oxcarbazepine increase the metabolism of orally administered estrogen (and progesterone to a lesser extent). Estrogen can increase the metabolism of certain AEDs, such as lamotrigine, leading to cyclical variation in its blood level with resultant adverse effect profile or seizure dyscontrol. AEDs and sex hormones can increase the risk of osteoporosis and fracture in WWE. The potential interactions between AEDs and hormonal contraception need to be discussed with all women in reproductive age-group. The alternate options of oral contraception such as intrauterine copper device, intrauterine levonorgestrel release system, and supplementary protection with barriers need to be presented to them. World Health Organization has recommended to avoid combination contraceptive pills containing estrogen and progesteron in women who desire contraception and in breastfeeding mothers. Care providers need to consider the option of non-enzyme-inducing AEDs while initiating long-term treatment in adolescent and young WWE. PMID:26425002

An assessment of the quality of advice provided by patent medicine vendors to users of oral contraceptive pills in urban Nigeria.

PubMed

Ujuju, Chinazo; Adebayo, Samson B; Anyanti, Jennifer; Oluigbo, Obi; Muhammad, Fatima; Ankomah, Augustine

2014-01-01

In Nigeria about 50% of oral contraceptive pill users obtain their products from proprietary patent medicine vendors (PPMVs). This group of service providers are poorly trained and have very limited knowledge about contraception. This paper investigated the nature of the advice offered to simulated current and potential users of oral contraceptive pills. The main objective was to assess the nature and quality of advice provided by PPMVs to pill users. This study is based on findings from a 'mystery client' approach in which three scenarios related to contraceptive pill use were simulated. Each of the 12 mystery clients simulated one of the following three scenarios: new pill users (new to family planning or switching from condom to pills); user seeking a resupply of pills; and dissatisfied pill users intending to discontinue use. Simple random sampling was used to select 410 PPMVs from a total of 1,826 in four states in Nigeria. Qualitative study using in-depth interviews was also conducted. A majority of the PPMVs had pills in stock on the day of the survey and resupplied pills to the clients. PPMVs also understood the reason and importance of referring clients who were new adopters of oral contraceptive methods to a health facility; 30% of the PPMVs referred new adopters to a health facility. However, demand from clients who do not want to go to health care facilities (for various reasons) necessitated the provision of oral contraceptive pills to 41% of the first time users. Some PPMVs prescribed treatment to mystery clients who presented with perceived complications arising from the use of pills, while 49% were referred to a health facility. The advice given by PPMVs often falls short of safety guidelines related to the use of oral contraceptive pills. There is a need to continuously update knowledge among the PPMVs to ensure that they provide quality oral contraceptive services as PPMVs bridge the gap between medical experts and users in rural communities.

An assessment of the quality of advice provided by patent medicine vendors to users of oral contraceptive pills in urban Nigeria

PubMed Central

Ujuju, Chinazo; Adebayo, Samson B; Anyanti, Jennifer; Oluigbo, Obi; Muhammad, Fatima; Ankomah, Augustine

2014-01-01

Introduction In Nigeria about 50% of oral contraceptive pill users obtain their products from proprietary patent medicine vendors (PPMVs). This group of service providers are poorly trained and have very limited knowledge about contraception. This paper investigated the nature of the advice offered to simulated current and potential users of oral contraceptive pills. The main objective was to assess the nature and quality of advice provided by PPMVs to pill users. Method This study is based on findings from a ‘mystery client’ approach in which three scenarios related to contraceptive pill use were simulated. Each of the 12 mystery clients simulated one of the following three scenarios: new pill users (new to family planning or switching from condom to pills); user seeking a resupply of pills; and dissatisfied pill users intending to discontinue use. Simple random sampling was used to select 410 PPMVs from a total of 1,826 in four states in Nigeria. Qualitative study using in-depth interviews was also conducted. Results A majority of the PPMVs had pills in stock on the day of the survey and resupplied pills to the clients. PPMVs also understood the reason and importance of referring clients who were new adopters of oral contraceptive methods to a health facility; 30% of the PPMVs referred new adopters to a health facility. However, demand from clients who do not want to go to health care facilities (for various reasons) necessitated the provision of oral contraceptive pills to 41% of the first time users. Some PPMVs prescribed treatment to mystery clients who presented with perceived complications arising from the use of pills, while 49% were referred to a health facility. Conclusion The advice given by PPMVs often falls short of safety guidelines related to the use of oral contraceptive pills. There is a need to continuously update knowledge among the PPMVs to ensure that they provide quality oral contraceptive services as PPMVs bridge the gap between medical

Comparison of scales for evaluating premenstrual symptoms in women using oral contraceptives.

PubMed

Coffee, Andrea L; Kuehl, Thomas J; Sulak, Patricia J

2008-05-01

To compare two scales used in research to evaluate daily premenstrual mood symptoms during use of a monophasic oral contraceptive. Subanalysis of data from a prospective study. University-affiliated medical center. SUBJECTS; One hundred two reproductive-aged (18-48 yrs) women taking a monophasic oral contraceptive containing ethinyl estradiol and drospirenone in the standard 21-7 fashion (21 days of hormones followed by 7 days of placebo), and who had self-identified premenstrual symptoms of headache, mood changes, or pelvic pain. Subjects completed a single-item questionnaire, the Scott & White Daily Diary of Symptoms, and a multiple-item questionnaire, the Penn State Daily Symptom Report (DSR), to assess their premenstrual symptoms. The Scott & White diary used a visual analog scale of 0-10 to assess pelvic pain, headache, and mood (a composite of anxiety, depression, and irritability). The Penn State DSR contained 17 items: 10 behavioral and seven physical components, each rated on a scale of 0-4, with one item that specifically rated mood swings. Scores from the two scales were compared by using Spearman correlation coefficients, the Kendall W for concordance, and linear regression of ranked sums for study cycles. The Scott & White mood score significantly correlated with the total of the 17 items on the Penn State DSR, as well as the 10 behavioral items, the seven physical items, and the single mood-swing item (p<0.0001); specific coefficients of concordance were 0.44, 0.23, 0.10, and 0.28, respectively, and R2 values were 0.39, 0.39, 0.30, and 0.34, respectively. The daily Scott & White mood score was positively correlated with all 17 elements of the Penn State DSR (0.25-0.57). The greatest correlation was seen with the mood-swing element. Both instruments demonstrated the same patterns during the 21-7 oral contraceptive cycle, with symptoms increasing immediately before and peaking during the 7-day hormone-free interval. A single-item daily mood score using

Injectable contraception. New and existing options.

PubMed

Kaunitz, A M

2000-12-01

DMPA and MPA/E2C contraception offer women safe, effective, convenient, and reversible birth control choices. The use of DMPA, a 3-month injectable, is characteristically associated with amenorrhea. Lactating women and women in whom contraceptive doses of estrogen are contraindicated can use this progestin-only birth control method. Return of fertility can be delayed in women discontinuing DMPA to become pregnant. In some cases, the use of DMPA also confers important noncontraceptive and therapeutic benefits. A monthly estrogen/progestin injectable contraceptive, MPA/E2C should appeal to women who are concerned about daily pill taking, who prefer regular cycles to amenorrhea, and who find monthly injections acceptable and accessible. As is true for oral contraceptives, MPA/E2C represents an appropriate choice for women who prefer a rapidly reversible contraceptive. Currently, the proposed contraindications for MPA/E2C parallel those for combined oral contraceptives. As MPA/E2C contraception becomes available for American women, clinicians will learn how to best include this new method among the array of contraceptive choices. By individualizing contraceptive selection, counseling, and management approaches based on the relevant behavioral and medical considerations reviewed herein, clinicians can maximize their patients' success with injectable contraceptives. The more innovative that clinicians, family planning agencies, and insurers are in facilitating access to care (including reinjections), the more women will be able to avail themselves of safe, effective, and reversible methods of contraception. In addition to the physician's office or health clinic, other sites at which women might receive contraceptive injections include employee health clinics, college health clinics, or perhaps the pharmacy where the prescription is filled. Self-administration may become an appropriate option for some users of injectable contraception.

Contraceptive Development.

ERIC Educational Resources Information Center

Troen, Philip; And Others

This report provides an overview of research activities and needs in the area of contraceptive development. In a review of the present state, discussions are offered on the effectiveness and drawbacks of oral contraceptives, intrauterine devices, barrier methods, natural family planning, and sterilization. Methods of contraception that are in the…

Pituitary and ovarian hormone activity during the 7-day hormone-free interval of various combined oral contraceptive regimens.

PubMed

Cho, Michael; Atrio, Jessica; Lim, Aaron H; Azen, Colleen; Stanczyk, Frank Z

2014-07-01

The objective was to investigate changes in luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol (E2) and progesterone (P) during the hormone-free interval (HFI) of 6 combined oral contraceptives (COCs). Blood samples were obtained from 62 women. When COCs were grouped by ethinyl estradiol (EE) dose, there was a significant positive mean slope for LH and FSH during the HFI for the 30- and 35 mcg-EE doses, whereas 20 showed a gradual nonsignificant slope. All E2 slopes were significant. P remained suppressed with all doses. A more rapid rebound of gonadotropin levels is found with higher doses of EE during the HFI. This study showed a more rapid rebound of pituitary hormone levels among women using higher-EE-dosage formulations, which was demonstrated by the statistically significant slope for mean LH and FSH from day 1 to day 7 of the HFI. The degree of suppression did not vary across progestin generations. It remains to be established whether women who experience side effects during their HFI may benefit from using a COC with a lower EE dose to minimize changes in endogenous pituitary hormone levels. Copyright © 2014 Elsevier Inc. All rights reserved.

Contraceptive choices for women with endocrine complications.

PubMed

Loriaux, D L; Wild, R A

1993-06-01

Previous confusion regarding the interference by oral contraceptives in measurements of endocrine function have been largely eliminated by the advent of improved, more sensitive assays. There are few if any contraindications to oral contraceptive use in patients with thyroid disease. Patients with prolactinoma can be treated with bromocriptine to restore fertility and prevent mineral loss. However, as a less expensive alternative, oral contraceptives can be prescribed to correct mineral loss, because there is no convincing evidence of an adverse effect on prolactinomas by the steroidal content of the pill. Oral contraceptives comprise a near ideal treatment modality for women with polycystic ovary disease because, among other effects, oral contraceptives reduce synthesis of androgen by inhibiting pituitary gonadotropin secretion.

Women's ability to self-screen for contraindications to combined oral contraceptive pills in Tanzanian drug shops.

PubMed

Chin-Quee, Dawn; Ngadaya, Esther; Kahwa, Amos; Mwinyiheri, Thomas; Otterness, Conrad; Mfinanga, Sayoki; Nanda, Kavita

2013-10-01

To estimate the accuracy of self-screening for contraindications to combined oral contraceptive pills (COCs) and to estimate the proportion of women with contraindications to hormonal methods among those using drug shops in Tanzania. Trained nurses interviewed 1651 women aged 18-39 years who self-screened for contraindications to COCs with the help of a poster at drug shops in Tanzania. Nurse assessment of the women served as the gold standard for comparison with self-assessment. Blood pressure was also measured onsite. Nurses reported that 437 (26.5%) women were not eligible to use COCs, compared with 485 (29.4%) according to self-report. Overall, 133 (8.1%) women who said that they were eligible were deemed ineligible by nurses. The rate of ineligibility was artificially high owing to participant and nurse assessments that were incorrectly based on adverse effects of pill use and cultural reasons, and because of the sampling procedure, which intercepted women regardless of their reasons for visiting the drug shop. Adjusted rates of ineligibility were 8.6% and 12.7%, respectively, according to nurse and participant assessment. Both nurses and women underestimated the prevalence of hypertension in the present group. Self-screening among women in rural and peri-urban Tanzania with regard to contraindications to COC use was comparable to assessment by trained nurses. © 2013.

Efficacy and safety of the contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive in Chinese women: a 1-year randomised trial.

PubMed

Fan, Guang Sheng; Ren, Mulan; Di, Wen; Su, Ping; Chang, Qin; Wu, Shuying; Qin, Yun; Korver, Tjeerd; Marintcheva-Petrova, Maya; Yacik, Carol; McCrary Sisk, Christine; Wang, Guoqin

2016-08-01

The aim of the study was to assess the efficacy and tolerability of the monthly vaginal ring (NuvaRing; 15 μg ethinylestradiol [EE] and 120 μg etonogestrel per day) compared with a monophasic (21/7) combined oral contraceptive (COC) containing 30 μg EE and 3 mg drospirenone in healthy Chinese women aged 18-40 years. This was a phase III, open-label, randomised multicentre trial conducted in China. Participants received NuvaRing or COC for 13 cycles (3 weeks of ring/pill treatment followed by a 1-week ring-free/pill-free period). Contraceptive efficacy was assessed by in-treatment pregnancies and expressed by the Pearl Index (PI; number of pregnancies/100 woman-years of use). Cycle control was assessed by unscheduled (breakthrough) and absence of scheduled (withdrawal) bleeding events. Safety and tolerability were assessed throughout the study. Participants were randomised either to the NuvaRing (n = 732) or to the COC (n = 214); 588 (82.4%) and 182 (78.4%) participants, respectively, completed the study. There were 10 in-treatment pregnancies in the NuvaRing group (PI 1.92; 95% confidence interval [CI] 0.92, 3.53) and five in the COC group (PI 3.12; 95% CI 1.01, 7.29). Breakthrough bleeding/spotting ranged from 18.6% (Cycle 1) to 4.2% (Cycle 11) for NuvaRing and from 21.6% (Cycle 1) to 7.9% (Cycle 11) for COC. Absence of withdrawal bleeding ranged from 8.6% (Cycle 1) to 3.0% (Cycle 11) for NuvaRing and from 14.6% (Cycle 1) to 6.4% (Cycle 5) for COC. For NuvaRing and COC, respectively, 26.6% and 25.0% of participants had treatment-related adverse events, and 7.0% and 9.1% discontinued the study as a result. Once-monthly NuvaRing is efficacious and safe for use in Chinese women.

The not-so-bitter pill: Effects of combined oral contraceptives on peripheral physiological indicators of emotional reactivity.

PubMed

Armbruster, Diana; Kirschbaum, Clemens; Strobel, Alexander

2017-08-01

Combined oral contraceptives (COC) are used by millions of women worldwide. Although findings are not entirely consistent, COC have been found to impact on brain function and, thus, to modulate affective processes. Here, we investigated electro-physiological responses to emotional stimuli in free cycling women in both the early follicular and late luteal phase as well as in COC users. Skin conductance response (SCR), startle reflex, corrugator and zygomaticus activity were assessed. COC users showed reduced overall startle magnitude and SCR amplitude, but heightened overall zygomaticus activity, although effect sizes were small. Thus, COC users displayed reduced physiological reactions indicating negative affect and enhanced physiological responses signifying positive affect. In free cycling women, endogenous 17β-estradiol levels were associated with fear potentiated startle in both cycle phases as well as with SCR and zygomaticus activity during the follicular phase. Testosterone was associated with corrugator and zygomaticus activity during the luteal phase, while progesterone levels correlated with corrugator activity in the follicular phase. To the contrary, in COC users, endogenous hormones were not associated with electro-physiological measures. The results further underscore the importance of considering COC use in psychophysiological studies on emotional processing. Copyright © 2017 Elsevier Inc. All rights reserved.

Emerging Options for Emergency Contraception

PubMed Central

Koyama, Atsuko; Hagopian, Laura; Linden, Judith

2013-01-01

Emergency post-coital contraception (EC) is an effective method of preventing pregnancy when used appropriately. EC has been available since the 1970s, and its availability and use have become widespread. Options for EC are broad and include the copper intrauterine device (IUD) and emergency contraceptive pills such as levonorgestrel, ulipristal acetate, combined oral contraceptive pills (Yuzpe method), and less commonly, mifepristone. Some options are available over-the-counter, while others require provider prescription or placement. There are no absolute contraindications to the use of emergency contraceptive pills, with the exception of ulipristal acetate and mifepristone. This article reviews the mechanisms of action, efficacy, safety, side effects, clinical considerations, and patient preferences with respect to EC usage. The decision of which regimen to use is influenced by local availability, cost, and patient preference. PMID:24453516

Quantification of the adverse effect of ethinylestradiol containing oral contraceptive pills when used in conjunction with growth hormone replacement in routine practice.

PubMed

Phelan, Niamh; Conway, Sophy H; Llahana, Sofia; Conway, Gerard S

2012-05-01

Oestrogen antagonizes the action of growth hormone (GH). For women with combined GH and oestrogen deficiency, transdermal oestradiol is more favourable in this regard compared to oral oestradiol. Oral contraceptive pills containing ethinylestradiol (EE) are commonly used in young women with GHD and there is little information on the impact of this form of oestrogen. A case note review of women with growth hormone deficiency (GHD) attending a tertiary endocrine clinic comparing the dose of GH and serum insulin-like growth factor 1 concentrations and the type of exogenous oestrogen. All women with GHD between the ages of 18 and 47 attending University College London Hospitals (UCLH) were included and grouped according to type of oestrogen replacement. Weight, GH dose and serum IGF-I concentrations were recorded at 121 visits in 88 women. The daily dose of GH was significantly higher and the GH responsivity was significantly lower in the EE group compared to those taking no oestrogen and transdermal oestrogen. The additional cost of GH for women using EE compared to transdermal oestradiol was £6016 per patient per year. Effectiveness of GH improved in all women changing from EE to another form of oestrogen. Use of oral contraceptive pills containing EE should be avoided in women receiving treatment with GH. Alternative options include oral or transdermal hormone replacement therapy (HRT) preparations for those that require oestrogen replacement or a progesterone-based regimen for contraceptive purposes. © 2012 Blackwell Publishing Ltd.

User satisfaction with the combined oral contraceptive drospirenone 3 mg/ethinylestradiol 20 microg (Yasminelle) in clinical practice: a multi-country, questionnaire-based study.

PubMed

Short, Mary

2009-01-01

To assess women's perception of a combined oral contraceptive (COC) containing drospirenone 3 mg/ethinylestradiol (EE) 20 microg administered in the conventional 21/7 regimen (drospirenone 3 mg/EE 20 microg 21/7 regimen [Yasminelle]) in clinical practice. This questionnaire-based study was performed in 12 European countries and included women who had been taking the drospirenone 3 mg/EE 20 microg 21/7 regimen COC for > or =3 months. Of 16 461 completed questionnaires, 12 277 were from women who had been using the drospirenone 3 mg/EE 20 microg 21/7 regimen COC for > or =3 months - 34% of women were new users of COCs and 65% had switched from alternative contraceptive brands. The mean age of these respondents was approximately 27 years. Seventy percent of women who indicated that they had skin problems before taking the drospirenone 3 mg/EE 20 microg 21/7 regimen COC responded that their skin had improved with treatment (3030/4305). Sixty-nine percent of women who had switched to the drospirenone 3 mg/EE 20 microg 21/7 regimen COC because of weight problems with their previous method of contraception responded that they had experienced weight loss (1205/1745). Approximately 95% of respondents said they were satisfied with the drospirenone 3 mg/EE 20 microg 21/7 regimen COC. Moreover, 83% of respondents said they would recommend this COC to a friend. There were high levels of perceived satisfaction with the drospirenone 3 mg/EE 20 microg 21/7 regimen COC. The reported effects on weight loss (due to decreased water retention) and skin problems are consistent with the antimineralocorticoid and antiandrogenic benefits of drospirenone-containing COCs.

Combined hormonal contraceptive trials: variable data collection and bleeding assessment methodologies influence study outcomes and physician perception.

PubMed

Mishell, Daniel R; Guillebaud, John; Westhoff, Carolyn; Nelson, Anita L; Kaunitz, Andrew M; Trussell, James; Davis, Ann Jeanette

2007-01-01

Initially approved for use in the United States nearly 50 years ago, oral hormonal contraceptives containing both estrogen and progestin have undergone steady improvements in safety and convenience. Concurrent with improvements in safety associated with decreasing doses of both steroids, there has been an increased incidence of unscheduled bleeding and spotting. There exist no standards regarding data collection techniques and methods, and reporting and analysis of bleeding and spotting events during combined hormonal contraceptive (CHC) trials. For the regulatory review of hormonal contraceptives, data regarding the incidence of bleeding and spotting events are not included in either of the traditional categories of efficacy and safety. Standardization of methods for collecting and analyzing data about cycle control in all clinical trials of CHCs is long overdue. Until such standards are developed and implemented, clinicians need to familiarize themselves with the techniques used in each study in order to provide correct information to their patients about the frequency of bleeding and spotting associated with different formulations and delivery systems.

Impact of a passive social marketing intervention in community pharmacies on oral contraceptive and condom sales: a quasi-experimental study.

PubMed

Farris, Karen B; Aquilino, Mary L; Batra, Peter; Marshall, Vince; Losch, Mary E

2015-02-13

Almost 50% of pregnancies in the United States are unwanted or mistimed. Notably, just over one-half of unintended pregnancies occurred when birth control was being used, suggesting inappropriate or poor use or contraceptive failure. About two-thirds of all women who are of reproductive age use contraceptives, and oral hormonal contraceptives remain the most common contraceptive method. Often, contraceptive products are obtained in community pharmacies. The purpose of this study was to determine whether a pharmacy-based intervention would impact sales of contraceptive products in pharmacies. This study was conducted in Iowa and used a quasi-experimental design including 55 community pharmacies (independent and grocery) in 12 counties as the intervention and 32 grocery pharmacies in 10 counties as a comparison group. The passive intervention was focused towards 18-30 year old women who visited community pharmacies and prompted those of childbearing age to "plan your pregnancy" and "consider using birth control". The intervention was delivered via educational tri-fold brochures, posters and 'shelf talkers.' Data sources for evaluation were contraceptive sales from intervention and comparison pharmacies, and a mixed negative binomial regression was used with study group*time interactions to examine the impact of the intervention on oral contraceptive and condom sales. Data from 2009 were considered baseline sales. From 2009 to 2011, condom sales decreased over time and oral contraceptives sales showed no change. Overall, the units sold were significantly higher in grocery pharmacies than in independent pharmacies for both contraceptive types. In the negative binomial regression for condoms, there was an overall significant interaction between the study group and time variables (p = 0.003), indicating an effect of the intervention, and there was a significant slowing in the drop of sales at time 3 in comparison with time 1 (p < 0.001). There was a statistically

Non-contraceptive benefits of hormonal and intrauterine reversible contraceptive methods.

PubMed

Bahamondes, Luis; Valeria Bahamondes, M; Shulman, Lee P

2015-01-01

Most contraceptive methods present benefits beyond contraception; however, despite a large body of evidence, many healthcare professionals (HCPs), users and potential users are unaware of those benefits. This review evaluates the evidence for non-contraceptive benefits of hormonal and non-hormonal contraceptive methods. We searched the medical publications in PubMed, POPLINE, CENTRAL, EMBASE and LILACS for relevant articles, on non-contraceptive benefits of the use of hormonal and intrauterine reversible contraceptive methods, which were published in English between 1980 and July 2014. Articles were identified using the following search terms: 'contraceptive methods', 'benefits', 'cancer', 'anaemia', 'heavy menstrual bleeding (HMB)', 'endometrial hyperplasia', 'endometriosis' and 'leiomyoma'. We identified, through the literature search, evidence that some combined oral contraceptives have benefits in controlling HMB and anaemia, reducing the rate of endometrial, ovarian and colorectal cancer and ectopic pregnancy as well as alleviating symptoms of premenstrual dysphoric disorder. Furthermore, the use of the levonorgestrel-releasing intrauterine system also controls HMB and anaemia and endometrial hyperplasia and cancer, reduces rates of endometrial polyps in users of tamoxifen and alleviates pain associated with endometriosis and adenomyosis. Depot medroxyprogesterone acetate controls crises of pain associated with sickle cell disease and endometriosis. Users of the etonogestrel-releasing contraceptive implant have the benefits of a reduction of pain associated with endometriosis, and users of the copper intrauterine device have reduced rates of endometrial and cervical cancer. Despite the high contraceptive effectiveness of many hormonal and intrauterine reversible contraceptive methods, many HCPs, users and potential users are concerned mainly about side effects and safety of both hormonal and non-hormonal contraceptive methods, and there is scarce information

The new extended-cycle levonorgestrel-ethinyl estradiol oral contraceptives.

PubMed

Bonnema, Rachel A; Spencer, Abby L

2011-09-19

Effective contraceptive counseling requires an understanding of a woman's preferences and medical history as well as the risks, benefits, side effects, and contraindications of each contraceptive method. Hormonal contraceptives using a variety of delivery methods are highly effective and this review highlights the new extended-cycle levonorgestrel-ethinyl estradiol contraceptives. Extended-cycle OCPs are unique in offering fewer or no withdrawal bleeds over the course of one year but providers need to carefully counsel women regarding the initial increased breakthrough bleeding. Extended-cycle OCPs may be of particular benefit in women with medical comorbidities who would benefit from less withdrawal bleeds, those desiring to avoid monthly menses due to increased hormonal withdrawal symptoms, or simply women who don't desire a monthly period. The risks associated with all extended-cycle OCPs have been found to be similar to those of traditional OCPs therefore counseling on the risks and side effects is comparable to that of any combined hormonal contraceptives. Newer extended-cycle regimens shorten or eliminate the hormone-free interval, decrease frequency of menses to four times per year or eliminate menses altogether. This can reduce the risk of common menstrual symptoms, endometriosis, or severe dysmenorrhea by offering potentially greater ovarian suppression and preventing endogenous estradiol production while still providing highly effective, rapidly reversible, and safe contraception.

Evaluation of the Effect of Tofacitinib on the Pharmacokinetics of Oral Contraceptive Steroids in Healthy Female Volunteers

PubMed Central

Menon, Sujatha; Riese, Richard; Wang, Ronnie; Alvey, Christine W.; Shi, Haihong; Petit, Wendy

2016-01-01

Abstract Tofacitinib is an oral Janus kinase inhibitor. Tofacitinib metabolism is primarily mediated by cytochrome P450 3A4. This phase 1 randomized, open‐label, 2‐way crossover study (NCT01137708) evaluated the effect of tofacitinib 30 mg twice daily on the single‐dose pharmacokinetics of combination oral contraceptives ethinylestradiol (EE) and levonorgestrel (LN). EE and LN were administered as a single Microgynon 30® tablet (30 μg EE and 150 μg LN) to 19 healthy women. In the presence of tofacitinib, the area under the curve from time zero to infinity (AUC∞) increased by 6.6% and 0.9% for EE and LN, respectively. Maximal plasma concentrations decreased by 10.4% for EE and increased by 12.2% for LN when coadministered with tofacitinib. The 90% confidence intervals for the adjusted geometric mean ratios for AUC∞ fell within the 80%–125% region for both EE and LN. Mean half‐life was similar in the presence and absence of tofacitinib: 13.8 and 13.3 hours, respectively, for EE; 25.9 and 25.4 hours, respectively, for LN. Tofacitinib had no clinically relevant net inhibitory or inductive effect on the pharmacokinetics of EE and LN. Therefore, there is no evidence to suggest dose adjustments of oral contraceptive drugs containing EE or LN when coadministered with tofacitinib. PMID:27138968

Evaluation of the Effect of Tofacitinib on the Pharmacokinetics of Oral Contraceptive Steroids in Healthy Female Volunteers.

PubMed

Menon, Sujatha; Riese, Richard; Wang, Ronnie; Alvey, Christine W; Shi, Haihong; Petit, Wendy; Krishnaswami, Sriram

2016-09-01

Tofacitinib is an oral Janus kinase inhibitor. Tofacitinib metabolism is primarily mediated by cytochrome P450 3A4. This phase 1 randomized, open-label, 2-way crossover study (NCT01137708) evaluated the effect of tofacitinib 30 mg twice daily on the single-dose pharmacokinetics of combination oral contraceptives ethinylestradiol (EE) and levonorgestrel (LN). EE and LN were administered as a single Microgynon 30® tablet (30 μg EE and 150 μg LN) to 19 healthy women. In the presence of tofacitinib, the area under the curve from time zero to infinity (AUC∞ ) increased by 6.6% and 0.9% for EE and LN, respectively. Maximal plasma concentrations decreased by 10.4% for EE and increased by 12.2% for LN when coadministered with tofacitinib. The 90% confidence intervals for the adjusted geometric mean ratios for AUC∞ fell within the 80%-125% region for both EE and LN. Mean half-life was similar in the presence and absence of tofacitinib: 13.8 and 13.3 hours, respectively, for EE; 25.9 and 25.4 hours, respectively, for LN. Tofacitinib had no clinically relevant net inhibitory or inductive effect on the pharmacokinetics of EE and LN. Therefore, there is no evidence to suggest dose adjustments of oral contraceptive drugs containing EE or LN when coadministered with tofacitinib. © 2016, The American College of Clinical Pharmacology.

Across many behaviors, long-term oral contraceptive use lowers risk for ovarian, endometrial cancer

Cancer.gov

DCEG researchers investigated whether the relationship between oral contraceptive use and risks for ovarian, endometrial, breast, and colorectal cancers change when looking at groups of women who have different health behaviors.

Cost-effectiveness of emergency contraception options over 1 year.

PubMed

Bellows, Brandon K; Tak, Casey R; Sanders, Jessica N; Turok, David K; Schwarz, Eleanor B

2018-05-01

The copper intrauterine device is the most effective form of emergency contraception and can also provide long-term contraception. The levonorgestrel intrauterine device has also been studied in combination with oral levonorgestrel for women seeking emergency contraception. However, intrauterine devices have higher up-front costs than oral methods, such as ulipristal acetate and levonorgestrel. Health care payers and decision makers (eg, health care insurers, government programs) with financial constraints must determine if the increased effectiveness of intrauterine device emergency contraception methods are worth the additional costs. We sought to compare the cost-effectiveness of 4 emergency contraception strategies-ulipristal acetate, oral levonorgestrel, copper intrauterine device, and oral levonorgestrel plus same-day levonorgestrel intrauterine device-over 1 year from a US payer perspective. Costs (2017 US dollars) and pregnancies were estimated over 1 year using a Markov model of 1000 women seeking emergency contraception. Every 28-day cycle, the model estimated the predicted number of pregnancy outcomes (ie, live birth, ectopic pregnancy, spontaneous abortion, or induced abortion) resulting from emergency contraception failure and subsequent contraception use. Model inputs were derived from published literature and national sources. An emergency contraception strategy was considered cost-effective if the incremental cost-effectiveness ratio (ie, the cost to prevent 1 additional pregnancy) was less than the weighted average cost of pregnancy outcomes in the United States ($5167). The incremental cost-effectiveness ratios and probability of being the most cost-effective emergency contraception strategy were calculated from 1000 probabilistic model iterations. One-way sensitivity analyses were used to examine uncertainty in the cost of emergency contraception, subsequent contraception, and pregnancy outcomes as well as the model probabilities. In 1000 women

Risk factors for recurrence of venous thromboembolism associated with the use of oral contraceptives.

PubMed

Vaillant-Roussel, Hélène; Ouchchane, Lemlih; Dauphin, Claire; Philippe, Pierre; Ruivard, Marc

2011-11-01

Combined oral contraceptives (COC) increase the risk of venous thromboembolism (VTE), but the risk of recurrent VTE is not precisely determined. In this retrospective cohort study, we sought the risk factors for recurrence after a first VTE that occurred in women taking COC. Time-to-event analysis was done with Kaplan-Meier estimates. In total, 172 patients were included (43% with pulmonary embolism): 82% had no other clinical risk factor for VTE. Among the 160 patients who stopped anticoagulation, the cumulative incidence of recurrent VTE was 5.1% after 1 year and 14.2% after 5 years. Significant factors associated with recurrence were renewed use of COC [hazard ratio (HR)=8.2 (2.1-32.2)], antiphospholipid syndrome [HR=4.1 (1.3-12.5)] and protein C deficiency or factor II G20210A [HR=2.7 (1.1-7)]. Pure-progestin contraception [HR=1.3 (0.5-3.0)] or factor V Leiden [HR=1.3 (0.5-3.4)] did not increase recurrence. Postsurgical VTE had a lower risk of recurrence [HR=0.1 (0.0-0.9)]. Further studies are warranted to determine whether testing for antiphospholipid syndrome, protein C deficiency or the factor II G20210A could modify the duration of anticoagulation. This study confirms the safety of pure-progestin contraception. Copyright © 2011 Elsevier Inc. All rights reserved.

Efficacy and safety of the combined oral contraceptive ethinylestradiol/drospirenone (Yasmin) in healthy Chinese women: a randomized, open-label, controlled, multicentre trial.

PubMed

Guang-Sheng, Fan; Mei-Lu, Bian; Li-Nan, Cheng; Xiao-Ming, Cao; Zi-Rong, Huang; Zi-Yan, Han; Xiao-Ping, Jing; Jian, Li; Shu-Ying, Wu; Cheng-Liang, Xiong; Zheng-Ai, Xiong; Tian-Fu, Yue

2010-01-01

To evaluate and compare the contraceptive efficacy, bleeding pattern, side effects and other positive effects of a combined oral contraceptive (COC) containing drospirenone (DRSP) [Yasmin] with those of a COC containing desogestrel (DSG) in healthy Chinese women. This was a randomized, open-label, controlled, multicentre study of 768 healthy Chinese women requiring contraception. The subjects were randomized to ethinylestradiol (EE) 30 microg/DRSP 3 mg (n = 573) or EE 30 microg/ DSG 150 microg (n = 195), at a ratio of 3 : 1. Each individual was treated for 13 cycles. Further visits were required at cycle 4, cycle 7, cycle 10 and cycle 13 of treatment. Weight, height and body mass index were evaluated at each visit. The Menstrual Distress Questionnaire (MDQ) was administered at baseline, visit 3 (cycle 7) and visit 5 (after cycle 13). Baseline characteristics were similar between the two groups (p > 0.05). The Pearl Index (method failure) for EE/DRSP was 0.208 per 100 women-years, which was lower than that for EE/DSG (0.601 per 100 women-years). There were no significant differences between the treatment groups with regard to bleeding patterns. According to the MDQ subscale, improvements in water retention and increases in appetite during the intermenstrual period and in water retention and general well-being during the menstrual period in the EE/DRSP group (-0.297, -0.057, 0.033 and 0.150, respectively) were significantly improved compared with the EE/DSG group (-0.108, 0.023, 0.231 and -0.023, respectively) [all p < 0.05]. Other values that improved in both groups, particularly improvement in breast pain and tenderness and skin condition, were more evident in the EE/DRSP group (18.0%, 89/494; 12.6%, 62/494) than in the EE/DSG group (11.3%, 19/168; 5.4%, 9/168). Mean weight increased in the EE/DSG group (0.57 kg) while there was a significant decrease in mean weight (-0.28 kg) in the EE/DRSP group (p < 0.01). Both EE/DRSP and EE/DSG have good contraceptive efficacy

Oral Contraceptive Use and Reproductive Characteristics Affect Survival in Patients With Epithelial Ovarian Cancer

PubMed Central

Kolomeyevskaya, Nonna V.; Szender, J. Brian; Zirpoli, Gary; Minlikeeva, Albina; Friel, Grace; Cannioto, Rikki A.; Brightwell, Rachel M.; Grzankowski, Kassondra S.; Moysich, Kirsten B.

2015-01-01

Objectives Prognostic risk factors influencing survival in patients with epithelial ovarian cancer (EOC) include tumor stage, grade, histologic subtype, debulking, and platinum status. Little is known about the impact of hormonal milieu and reproductive factors before cancer diagnosis on clinical outcome. We sought to evaluate whether oral contraceptive (OC) use carries any prognostic significance on overall survival (OS) in patients with EOC. Methods Newly diagnosed patients with EOC, fallopian tube, and primary peritoneal cancers between 1982 and 1998 were prospectively evaluated with a comprehensive epidemiologic questionnaire. A retrospective chart review was performed to abstract clinicopathologic data, including OS. A Kaplan-Meier analysis was performed to compare survival across various exposures. A Cox regression model was used to compute adjusted hazards ratios (aHRs) and 95% confidence intervals (CIs). Results We identified 387 newly diagnosed cancers with evaluable information in this cohort. Decreased risk of death was observed in women who reported prior use of OC (aHR, 0.79; 95% CI, 0.58–1.09), previous pregnancy (aHR, 0.77; 95% CI, 0.57–1.04), or a live birth (aHR, 0.81; 95% CI, 0.60–1.08) after adjusting for age at diagnosis, stage, and histologic subtype. Oral contraceptive use was associated with a crude reduced risk of death (HR, 0.55; 95% CI, 0.42–0.72), with reported median OS of 81 months in OC users versus 46 months in nonusers. Patients who reported a single live birth experienced the largest potential survival advantage (aHR, 0.61; 95% CI, 0.39–0.94). Oral contraceptive use and prior pregnancy were associated with improved survival across all strata. Conclusions Oral contraceptive use may have lasting effects on epithelial ovarian tumor characteristics conferring favorable prognosis. Putative mechanisms that affect tumor biology include complex interactions between ovarian cells, host immune cells, and hormonal microenvironment

Oral contraception and adolescent women with insulin-dependent diabetes mellitus: risks, benefits, and implications for practice.

PubMed

Betschart, J

1996-01-01

Healthcare providers who work with adolescents with diabetes are in an ideal position to provide education and support regarding contraceptive issues. Diabetes educators and other health professionals who counsel teens focus on other aspects of diabetes care and management but frequently do not address sexual issues or assess contraceptive practices. The purpose of this paper is to review oral contraceptive issues for teens with diabetes and to provide practice implications for health professionals who are in a favorable position to influence the quality of diabetes and general health care for these adolescents.

[ORAL CONTRACEPTIVES AND MOOD/SEXUAL DISORDERS IN WOMEN].

PubMed

Sirakov, M; Tomova, E

2015-01-01

Oral contraceptives are used since more than 50 years and are very popular due to offering more than 99% confidence in preventing pregnancy. Over 100 million women worldwide use oral contraceptives. In the UK 27% of women between 16 and 49 y. use pills. In the United States they are about 30%, in Germany - 40%, and in The Netherlands - 60%. According to a study by B. Pehlivanov, 2008, in Bulgaria only 4% of women use OC. (1) Despite the convenience and security, in the U.S.A. 29% of women taking OC interrupt prematurely their use (2), while the percentage of adolescents appears to be higher (3) Earlier studies of the reasons for refusal of OC focus on their influence on the menstrual cycle, as well as on some physical side effects such as the appearance of hair growth, weight gain, bloating etc. They paid very little attention to their impact on mood and sexual behavior of women (4). Newer studies suggest that the side effects associated with mood and sexual behavior proved more powerful factor leading to early termination of the use of OC (5). This paper is a review of the literature and evaluation of the facts presented in studies from different countries. They found a high incidence of symptoms such as anxiety, susceptibility to stress, mood changes, incl. depression, anxiety, increased irritability and affection of sexual desire of women. (6) There are many indications that OC-users are at increased risk of suicide and mental illnesses. (9).

Contraception and the obese woman

PubMed Central

Reifsnider, Elizabeth; Mendias, Nonie; Davila, Yolanda; Babendure, Jennie Bever

2016-01-01

Purpose Obesity has reached epidemic rates among U.S. women of reproductive age, many of whom want to use contraception. However, some forms of contraception can have adverse effects on an obese woman's health. This article explores risks of contraception available in the United States and provides clinical recommendations for use by obese women. Data sources Information was compiled by reviewing the scientific literature on contraception and female obesity using CINAHL, MEDLINE, PubMed search engines. Conclusions The evidence is largely supportive of combined oral contraceptive (COC) use in carefully screened obese women without known risks factors for cardiovascular disease. The efficacy of COCs may be slightly reduced in obese women because of increased body mass. Other types of hormonal contraceptives have varying safety and efficacy reports when used by obese women. Intrauterine devices do not have reduced efficacy nor increased risks for obese women but insertion may be more difficult. Obesity has no effect on efficacy of barrier methods of contraception. Implications Clinicians should conduct a careful history and physical exam with selected supporting laboratory tests when considering prescription of hormonal contraceptives for obese women. Obese women require health counseling to carefully follow directions for contraceptive use to avoid unintended pregnancy. PMID:24170564

Resting state alpha frequency is associated with menstrual cycle phase, estradiol and use of oral contraceptives.

PubMed

Brötzner, Christina P; Klimesch, Wolfgang; Doppelmayr, Michael; Zauner, Andrea; Kerschbaum, Hubert H

2014-08-19

Ongoing intrinsic brain activity in resting, but awake humans is dominated by alpha oscillations. In human, individual alpha frequency (IAF) is associated with cognitive performance. Noticeable, performance in cognitive and emotional tasks in women is associated with menstrual cycle phase and sex hormone levels, respectively. In the present study, we correlated frequency of alpha oscillation in resting women with menstrual cycle phase, sex hormone level, or use of oral contraceptives. Electroencephalogram (EEG) was recorded from 57 women (aged 24.07 ± 3.67 years) having a natural menstrual cycle as well as from 57 women (aged 22.37 ± 2.20 years) using oral contraceptives while they sat in an armchair with eyes closed. Alpha frequency was related to the menstrual cycle phase. Luteal women showed highest and late follicular women showed lowest IAF or center frequency. Furthermore, IAF as well as center frequency correlated negatively with endogenous estradiol level, but did not reveal an association with endogenous progesterone. Women using oral contraceptives showed an alpha frequency similar to women in the early follicular phase. We suggest that endogenous estradiol modulate resting alpha frequency. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

Effects of a combined oral contraceptive containing 20 mcg of ethinylestradiol and 3 mg of drospirenone on the blood pressure, renin-angiotensin-aldosterone system, insulin resistance, and androgenic profile of healthy young women.

PubMed

Giribela, Cassiana Rosa Galvão; Consolim-Colombo, Fernanda Marciano; Nisenbaum, Marcelo Gil; Moraes, Tercio Lemos de; Giribela, Aricia Helena Galvão; Baracat, Edmund Chada; Melo, Nilson Roberto de

2015-01-01

Combined oral contraceptives (COCs) may increase the risk for cardiovascular disease depending on the ethynyl estradiol (EE) dose and the androgenicity of the progestogens. Our objective was to evaluate the impact of a COC containing 20 mcg EE + 3 mg drospirenone on blood pressure (BP), renin-angiotensin-aldosterone system, insulin resistance, and androgenic profile of healthy young women. Eighty-one healthy young women aged 30 ± 1 years (case group, n = 49, received COC; control group, n = 32, used no COC) were assessed twice, before and after the 6-month study. Statistical analysis employed the paired t-tests and expressed the data in mean and standard deviation. Results were as follows: no changes in BP or in BMI; a significant increase in aldosterone, plasma renin activity, triglycerides, and total cholesterol levels, but a non-significant increase in HDL and no significant changes in LDL levels (these parameters remained within normal ranges); a significant increase in the HOMA-IR index and a significant decrease in dehydroepiandrosterone sulfate (SDHEA), androstenedione, total testosterone, and free testosterone levels; no significant variations in the control group parameters. An oral contraceptive combination of a low EE dose and an anti-androgenic progestogen does not negatively influence the risk factors for a cardiovascular disease.

Acute effects of bright light and caffeine on nighttime melatonin and temperature levels in women taking and not taking oral contraceptives

NASA Technical Reports Server (NTRS)

Wright, K. P. Jr; Myers, B. L.; Plenzler, S. C.; Drake, C. L.; Badia, P.; Czeisler, C. A. (Principal Investigator)

2000-01-01

Caffeine and bright light effects on nighttime melatonin and temperature levels in women were tested during the luteal phase of the menstrual cycle (n=30) or the pseudo luteal phase for oral contraceptive users (n=32). Participants were randomly assigned to receive either bright (5000 lux) or dim room light (<88 lux) between 20:00 and 08:00 h under a modified constant routine protocol. Half the subjects in each lighting condition were administered either caffeine (100 mg) or placebo in a double-blind manner at 20:00, 23:00, 02:00 and 05:00 h. Results showed that the combination of bright light and caffeine enhanced nighttime temperature levels to a greater extent than did either caffeine or bright light alone. Both of the latter groups had higher temperature levels relative to the dim light placebo condition and the two groups did not differ. Temperature levels in the bright light caffeine condition were maintained at near peak circadian levels the entire night in the luteal and pseudo luteal phase. Melatonin levels were reduced throughout the duration of bright light exposure for all women. Caffeine reduced the onset of melatonin levels for women in the luteal phase, but it had little effect on melatonin levels for oral contraceptive users. The results for women in the luteal phase of the menstrual cycle are consistent with our previous findings in men. The results also suggest that oral contraceptives may alter the effects of caffeine on nighttime melatonin levels.

Quantitative bias analysis of a reported association between perfluoroalkyl substances (PFAS) and endometriosis: The influence of oral contraceptive use.

PubMed

Ngueta, Gerard; Longnecker, Matthew P; Yoon, Miyoung; Ruark, Christopher D; Clewell, Harvey J; Andersen, Melvin E; Verner, Marc-André

2017-07-01

An association between serum levels of perfluoroalkyl substances (PFAS) and endometriosis has recently been reported in an epidemiologic study. Oral contraceptive use to treat dysmenorrhea (pelvic pain associated with endometriosis) could potentially influence this association by reducing menstrual fluid loss, a route of excretion for PFAS. In this study, we aimed to evaluate the influence of differential oral contraceptive use on the association between PFAS and endometriosis. We used a published life-stage physiologically based pharmacokinetic (PBPK) model to simulate plasma levels of perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) from birth to age at study participation (range 18-44years). In the simulated population, PFAS level distributions matched those for controls in the epidemiologic study. Prevalence and geometric mean duration (standard deviation [SD]) of oral contraceptive use in the simulated women were based on data from the National Health and Nutrition Examination Survey; among the women with endometriosis the values were, respectively, 29% and 6.8 (3.1) years; among those without endometriosis these values were 18% and 5.3 (2.8) years. In simulations, menstrual fluid loss (ml/cycle) in women taking oral contraceptives was assumed to be 56% of loss in non-users. We evaluated the association between simulated plasma PFAS concentration and endometriosis in the simulated population using logistic regression. Based on the simulations, the association between PFAS levels and endometriosis attributable to differential contraceptive use had an odds ratio (95% CI) of 1.05 (1.02, 1.07) for a log e unit increase in PFOA and 1.03 (1.02, 1.05) for PFOS. In comparison, the epidemiologic study reported odds ratios of 1.62 (0.99, 2.66) for PFOA and 1.25 (0.87, 1.80) for PFOS. Our results suggest that the influence of oral contraceptive use on the association between PFAS levels and endometriosis is relatively small. Copyright © 2017 Elsevier

Continuous versus cyclic oral contraceptives for the treatment of endometriosis: a systematic review.

PubMed

Zorbas, Konstantinos A; Economopoulos, Konstantinos P; Vlahos, Nikos F

2015-07-01

Recurrence of endometriosis after conservative surgery has been observed in 40-50 % of patients within the first 5 years. A variety of regimens such as combined oral contraceptives, GnRH agonists, danazol, and progestins have been used postoperatively to reduce recurrence rates. Oral contraceptives (oCP) have been used either in a cyclic or in a continuous (no pill-free interval) fashion. The purpose of this article was to summarize the existing evidence on the efficacy and patient compliance for the use of oCP in a continuous versus cyclic fashion following conservative surgery for endometriosis. A systematic search of Medline identified four eligible studies. Studies were considered eligible, if they have evaluated oCP therapy, either in a cyclic or continuous regimen, after conservative surgery for endometriosis. Specifically, studies (1) reporting on women with endometriosis who were treated postoperatively with both continuous oCP and cyclic oCP, (2) written in English, (3) with minimum 6 months duration of medical treatment, and (4) with minimum 12 months duration of follow-up were considered eligible for our systematic review. Outcome measures of these eligible studies were tabulated and then analyzed cumulatively. A purely descriptive approach was adopted concerning all variables. Postoperative use of continuous oCP was associated with a reduction in the recurrence rate of dysmenorrhea, delay in the presentation of dysmenorrhea, reduction in nonspecific pelvic pain, and reduction in the recurrence rate for endometrioma. Use of oCP in a continuous fashion following conservative surgery for endometriosis is more beneficial to cyclic use.

Over-the-Counter Access to Oral Contraceptives.

PubMed

Grossman, Daniel

2015-12-01

Making oral contraceptives (OCs) available over the counter (OTC) could help to reduce the high rate of unintended pregnancy in the United States. Surveys show widespread support for OTC access to OCs among US women. Studies indicate that women can accurately use checklists to identify contraindications to OCs. Continuation is as good or better among OTC users compared with women using OCs obtained by prescription. Women and clinicians have expressed concerns related to making OCs available OTC. These concerns can be addressed by existing data or through research required by the Food and Drug Administration as part of the application to make OCs available OTC. Copyright © 2015 Elsevier Inc. All rights reserved.

Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17 beta-oestradiol on ovarian function in comparison to a monophasic combined oral contraceptive containing drospirenone and ethinylestradiol.

PubMed

Duijkers, Ingrid J M; Klipping, Christine; Grob, Paul; Korver, Tjeerd

2010-10-01

To compare the effects on ovarian activity of two oral contraceptives containing nomegestrol acetate (NOMAC)/17 beta-oestradiol (E2) or drospirenone (DRSP)/ethinylestradiol (EE). In this open-label, randomised, six-cycle study, 32 subjects using NOMAC/E2 (2.5-1.5 mg; 24/4-day regimen) were compared to 16 subjects using DRSP/EE (3 mg-30 microg; 21/7-day regimen). Measurements included serum oestradiol, progesterone, follicle stimulating hormone (FSH) and luteinising hormone (LH), and ultrasonography of follicular diameter. No ovulations occurred during treatment. Progesterone was fully suppressed, with mean maximum values <2 nmol/l in both groups over all cycles. For NOMAC/E2, mean maximum follicular diameter decreased from 19.3 mm before treatment to between 6.9 and 8.2 mm during treatment, with no subject having a follicular diameter ≥15 mm. For DRSP/EE, a decrease from 19.6 to between 7.4 and 10.8 mm was observed, with two subjects (12.5%) having a maximum follicle diameter ≥15 mm. These findings were consistent with observed FSH reductions; full suppression of LH surges was observed in both groups. Post-treatment return of ovulation in both groups occurred on average 21 days after the last active tablet intake. NOMAC/E2 achieves consistent ovulation inhibition, with suppressive effects on the ovaries at least similar to those of DRSP/EE.

Oral contraceptives in polycystic ovary syndrome: risk-benefit assessment.

PubMed

Yildiz, Bulent O

2008-01-01

Combined oral contraceptive pills (OCPs) have been a key component of the chronic treatment of polycystic ovary syndrome (PCOS) by improving androgen excess and regulating menstrual cycles. Earlier epidemiologic studies with second- and third-generation OCPs in the general population have raised important questions regarding long-term cardiometabolic effects of these agents. In PCOS, there are only a few short-term studies with contradictory results evaluating potential adverse effects of OCPs on cardiovascular risk factors and glucose homeostasis. These studies included a small number of participants and did not take into account several confounding factors that might influence the outcome. Nevertheless, limited available data support the benefits of long-term OCP use in PCOS. By contrast, solid evidence for cardiometabolic adverse outcome with the use of these agents, especially with newer OCPs containing antiandrogenic progestins, is lacking. More studies are needed to resolve controversies regarding the safety of long-term OCP use in PCOS. Meanwhile, assessment of each PCOS patient's personal cardiometabolic risk profile should be an essential component of the evaluation before prescribing OCPs and also during follow-up.

Treatment with liraglutide--a once-daily GLP-1 analog--does not reduce the bioavailability of ethinyl estradiol/levonorgestrel taken as an oral combination contraceptive drug.

PubMed

Jacobsen, Lisbeth V; Vouis, Jan; Hindsberger, Charlotte; Zdravkovic, Milan

2011-12-01

Liraglutide is a once-daily human GLP-1 analog for treatment of type 2 diabetes. Like other GLP-1 analogs, liraglutide delays gastric emptying, which could potentially affect absorption of concomitantly administered oral drugs. This study investigated the effect of liraglutide on the pharmacokinetics of the components of an oral contraceptive (ethinyl estradiol/levonorgestrel). Postmeno-pausal healthy women (n = 21) were included. A single dose of this contraceptive was administered. Blood samples for ethinyl estradiol/levonorgestrel measurements were drawn until 74 hours post dosing of the contraceptive during liraglutide and placebo treatments. The 90% confidence interval (CI) of the ratio of the area under the curve (AUC) (1.06; 90% CI, 0.99-1.13) for ethinyl estradiol (during liraglutide and placebo) was within defined limits, demonstrating equivalence. The 90% CI for the ratio of AUC for levonorgestrel was not fully contained within the limits (1.18; 90% CI, 1.04-1.34) (levonorgestrel AUC was 18% greater with liraglutide vs placebo). However, equivalence was demonstrated for levonorgestrel AUC(0-t) (1.15; 90% CI, 1.06-1.24). Equivalence was not demonstrated for maximum concentration (C(max)); values for ethinyl estradiol and levonorgestrel C(max) were 12% and 13% lower with liraglutide versus placebo, respectively. Both reached C(max) ~1.5 hours later with liraglutide. No clinically relevant reduction in bioavailability of ethinyl estradiol/levonorgestrel occurred.

Use of Simulated Patients to Evaluate Combined Oral Contraceptive Dispensing Practices of Community Pharmacists

PubMed Central

Obreli-Neto, Paulo Roque; Pereira, Leonardo Régis Leira; Guidoni, Camilo Molino; Baldoni, André de Oliveira; Marusic, Srecko; de Lyra-Júnior, Divaldo Pereira; de Almeida, Kelsen Luis; Pazete, Ana Claudia Montolezi; do Nascimento, Janaina Dutra; Kos, Mitja; Girotto, Edmarlon; Cuman, Roberto Kenji Nakamura

2013-01-01

Background Combined oral contraceptive (COC) use is the most commonly used reversible method of birth control. The incorrect use of COCs is frequent and one of the most common causes of unintended pregnancies. Community pharmacists (CPs) are in a strategic position to improve COC use because they are the last health professional to interact with patients before drug use. Objective To evaluate the COC dispensing practices of CPs in a developing country. Method A cross-sectional study was conducted in community pharmacies of Assis and Ourinhos microregions, Brazil, between June 1, 2012, and October 30, 2012. Four simulated patients (SPs) (with counseled audio recording) visited community pharmacies with a prescription for Ciclo 21® (a COC containing ethinyl estradiol 30 mcg + levonorgestrel 15 mcg). The audio recording of every SP visit was listened to independently by 3 researchers to evaluate the COC dispensing practice. The percentage of CPs who performed a screening for safe use of COCs (i.e., taking of patients’ medical and family history, and measuring of blood pressure) and provided counseling, as well as the quality of the screening and counseling, were evaluated. Results Of the 185 CPs contacted, 41 (22.2%) agreed to participate in the study and finished the study protocol. Only 3 CPs asked the SP a question (1 question asked by each professional), and all of the questions were closed-ended, viz., “do you smoke?” (n = 2) and “what is your age?” (n = 1). None of the CPs measured the patient’s blood pressure. Six CPs provided counseling when dispensing COCs (drug dosing, 5 CPs; possible adverse effects, 2 CPs), and one CP provided counseling regarding both aspects. Conclusion The CPs evaluated did not dispense COC appropriately and could influence in the occurrence of negatives therapeutic outcomes such as adverse effects and treatment failure. PMID:24324584

Use of simulated patients to evaluate combined oral contraceptive dispensing practices of community pharmacists.

PubMed

Obreli-Neto, Paulo Roque; Pereira, Leonardo Régis Leira; Guidoni, Camilo Molino; de Oliveira Baldoni, André; Marusic, Srecko; de Lyra-Júnior, Divaldo Pereira; de Almeida, Kelsen Luis; Pazete, Ana Claudia Montolezi; do Nascimento, Janaina Dutra; Kos, Mitja; Girotto, Edmarlon; Cuman, Roberto Kenji Nakamura

2013-01-01

Combined oral contraceptive (COC) use is the most commonly used reversible method of birth control. The incorrect use of COCs is frequent and one of the most common causes of unintended pregnancies. Community pharmacists (CPs) are in a strategic position to improve COC use because they are the last health professional to interact with patients before drug use. To evaluate the COC dispensing practices of CPs in a developing country. A cross-sectional study was conducted in community pharmacies of Assis and Ourinhos microregions, Brazil, between June 1, 2012, and October 30, 2012. Four simulated patients (SPs) (with counseled audio recording) visited community pharmacies with a prescription for Ciclo 21(®) (a COC containing ethinyl estradiol 30 mcg + levonorgestrel 15 mcg). The audio recording of every SP visit was listened to independently by 3 researchers to evaluate the COC dispensing practice. The percentage of CPs who performed a screening for safe use of COCs (i.e., taking of patients' medical and family history, and measuring of blood pressure) and provided counseling, as well as the quality of the screening and counseling, were evaluated. Of the 185 CPs contacted, 41 (22.2%) agreed to participate in the study and finished the study protocol. Only 3 CPs asked the SP a question (1 question asked by each professional), and all of the questions were closed-ended, viz., "do you smoke?" (n = 2) and "what is your age?" (n = 1). None of the CPs measured the patient's blood pressure. Six CPs provided counseling when dispensing COCs (drug dosing, 5 CPs; possible adverse effects, 2 CPs), and one CP provided counseling regarding both aspects. The CPs evaluated did not dispense COC appropriately and could influence in the occurrence of negatives therapeutic outcomes such as adverse effects and treatment failure.

Intention to use a combined contraceptive method and decision after counselling in Switzerland--Swiss data from the European CHOICE study.

PubMed

Merki-Feld, Gabriele S; Gruber, Isabel M L

2012-04-01

Considering the advantages of parenteral routes of administration of combined hormonal contraceptives (CHCs), their low prevalence of use in Europe is surprising. The Contraceptive health research of informed choice experience (CHOICE) study involved 11 European countries. It aimed at evaluating the influence of counselling on users' choice between three modalities of CHC administration (the pill, the transdermal patch, and the vaginal ring). We report here the results for Switzerland. Women (N = 2629) with a need for contraception received extended counselling. Questionnaires were used to collect data about the women's preferred method before and after counselling, and the reasons for their ultimate decision. After counselling, 40% of the women chose a contraceptive method that was different from the one initially intended. The number of vaginal ring users (28% vs. 11% intended) and patch users (7% vs. 4% intended) increased (p < 0.0001). Of the initially undecided women, 93% chose a contraceptive method after counselling. However, although information was provided on the risks, side effects and benefits associated with the different contraceptive methods, surprisingly few women retained this knowledge. The provision of balanced information on all CHCs influenced women's decisions to a great extent. Unlike the pill, non-oral methods were significantly more often chosen.

Forgettable contraception.

PubMed

Grimes, David A

2009-12-01

The term "forgettable contraception" has received less attention in family planning than has "long-acting reversible contraception." Defined here as a method requiring attention no more often than every 3 years, forgettable contraception includes sterilization (female or male), intrauterine devices, and implants. Five principal factors determine contraceptive effectiveness: efficacy, compliance, continuation, fecundity, and the timing of coitus. Of these, compliance and continuation dominate; the key determinants of contraceptive effectiveness are human, not pharmacological. Human nature undermines methods with high theoretical efficacy, such as oral contraceptives and injectable contraceptives. By obviating the need to think about contraception for long intervals, forgettable contraception can help overcome our human fallibility. As a result, all forgettable contraception methods provide first-tier effectiveness (contraceptives today with exclusively first-tier effectiveness is the one that can be started -- and then forgotten for years.

Maternal hormonal contraceptive use and offspring overweight or obesity.

PubMed

Jensen, E T; Daniels, J L; Stürmer, T; Robinson, W R; Williams, C J; Moster, D; Juliusson, P B; Vejrup, K; Magnus, P; Longnecker, M P

2014-10-01

Experiments in animal models have shown a positive association between in utero exposure to pharmacologic sex hormones and offspring obesity. The developmental effects of such hormones on human obesity are unknown. Using data from a large, prospective pregnancy cohort study (n=19 652), with linkage to a national prescription registry, we evaluated the association between use of hormonal contraceptives before and after conception (defined from dispensed prescription data and characterized by last date of use relative to conception, 12 to >4 months before (n=3392), 4 to >1 months before (n=2541), 1 to >0 months before (n=2997) and 0-12 weeks after (n=567)) in relation to offspring overweight or obesity at age 3 years. We observed a weak, inverse association between early pregnancy use of a combination oral contraceptive and offspring overweight or obesity at age 3 (adjusted odds ratio (OR): 0.75, 95% confidence interval (CI): 0.53, 1.08) and a positive, but imprecise, association with use of a progestin-only oral contraceptive in early pregnancy (adjusted OR: 1.26, 95% CI: 0.79, 2.02). In general, no association was observed between the use of a hormonal contraceptive before conception and offspring overweight or obesity. A sensitivity analysis comparing combination oral contraceptive users in early pregnancy to other unplanned pregnancies without hormonal contraceptive use further strengthened the inverse association (adjusted OR: 0.70, 95% CI: 0.48, 1.02). Other sensitivity analyses were conducted to evaluate the robustness of the associations observed given varying assumptions. Pharmacologic sex hormones in early pregnancy may be inversely or positively associated with offspring overweight or obesity at age 3, depending on the specific formulation used. The present study provides support for the potential for environmental sources of hormonally active agents to exert developmental effects.

[Contraception in immigrant women: influence of sociocultural aspects on the choice of contraceptive method].

PubMed

Paraíso Torras, B; Maldonado Del Valle, M D; López Muñoz, A; Cañete Palomo, M L

2013-01-01

There are currently 6 million immigrants living in Spain. Half of them are women, the majority of whom are of childbearing age. These women, who suffer high rates of induced abortion, form a special group who require a special approach to their reproductive health. In order to study the use of contraceptive methods in this population, a review was made of 1100 clinical histories from our Sexual Health and Reproduction Clinic. Latin American women were the most prevalent group who came to seek information about contraception, followed by Eastern Europeans and Moroccans. Fewer Asian and Sub-Saharan women sought these services. The contraceptives most frequently used were the intrauterine device (used mostly by Latin American and Eastern European women), and combined oral contraception, most used by Moroccan women. It is important to advise the immigrant women about contraceptive methods, taking into account their preferences, in order to improve adherence to the method. Copyright © 2012 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España. All rights reserved.

An open-label, two-period comparative study on pharmacokinetics and safety of a combined ethinylestradiol/gestodene transdermal contraceptive patch.

PubMed

Zhang, Chao; Li, Haiyan; Xiong, Xin; Zhai, Suodi; Wei, Yudong; Zhang, Shuang; Zhang, Yuanyuan; Xu, Lin; Liu, Li

2017-01-01

We investigated the pharmacokinetics and safety profiles of a newly developed combined ethinylestradiol (EE)/gestodene (GSD) transdermal contraceptive patch after a single-dose administration and compared with the market available tablet formulation in healthy adult subjects. An open-label, two-period comparative study was conducted in 12 healthy women volunteers. A single dose of the study combined EE/GE transdermal contraceptive patch and oral tablet (Milunet ® ) were administered. Blood samples at different time points after dose were collected, and concentrations were analyzed. A reliable, highly sensitive and accurate high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC/MS/MS) assay method was developed in this study to determine the plasma concentrations of EE and GSD. Compared to the tablet, the study patch had a significantly decreased maximum plasma concentration ( C max ), extended time to reach the C max and half-life, as well as increased clearance and apparent volume of distribution. The half-lives of EE and GSD of the patch were 3.3 and 2.2 times, respectively, than the half-life of the tablet. The areas under the plasma concentration-time curve (AUCs) of EE and GSD of the patch were 8.0 and 16.2 times, respectively, than the AUC of the tablet. No severe adverse event was observed during the whole study, and the general safety was acceptable. In conclusion, compared to the oral tablet Milunet, the study contraceptive patch was well tolerated and showed potent drug exposure, significant extended half-life and stable drug concentrations.

[Oral contraception and the vascular risk].

PubMed

Garnier, L F; Gruel, Y

1989-01-01

Vascular risk, mainly thromboembolitic risk, attributed to oral contraceptives (OCs) since 1962, has been primarily linked to ethinyl estradiol (EE). OCs which combine estrogen and have been associated with cerebral vascular accidents. A 1977 study showed a 40% increase of mortality due to cardiovascular complications in women taking OCs. There were of both an arterial and a venous character. The risk of myocardial infarction was 3 times more frequent among OC users. Deep venous thrombosis and pulmonary embolism were more numerous. Some other risk factors include smoking, hypertension, diabetes, and age 35. The risk of heart attack vanishes a few years after stopping OC use. The reduction of EE (and similarly progesterone) dosage from 100-50 mcg also lower the risk of hypertension, cerebral vascular accidents, and venous thrombosis. Prolonged use of OCs causes disorders of hemostasis affecting the walls of blood vessels, modifying the viscosity of blood flow (increase of hematocrits, reduction of venous tonus), modifying plasmatic coagulation (increase of platelets, increase of factors VII and X and plasma fibrinogen, and decrease of antithrombin III activity), and increased fibrinolysis. These anomalies are exclusively associated with high doses of estrogens. 5% of women using OCs develop moderate hypertension of 5-10 mm Hg of systolic pressure 5 years later, but after cessation it is reversed. OCs stimulate the renin-angiotensin-aldosterone system causing accelerated production of angiotensin II with the resultant forceful vasotension. 3 months after quitting OC use, high blood pressure returns to normal. EE can provoke diabetes; it increases very low density lipoprotein (VLDL) and high density lipoprotein (HDL) production, but total cholesterol is hardly affected. The androgenic property of progestogens reduces HDL. Combined OCs are contraindicated for women with hypertension, hyperlipidemia, diabetes, and a family history of vascular accidents.

Oral contraceptives cause evolutionarily novel increases in hormone exposure

PubMed Central

Lovett, Jennie L; Chima, Margo A; Wexler, Juliana K; Arslanian, Kendall J; Friedman, Andrea B; Yousif, Chantal B; Strassmann, Beverly I

2017-01-01

Abstract Background and objectives In the evolutionary past, women spent most of their reproductive lives either pregnant or in lactational amenorrhea, and rarely menstruated. The current pattern of frequent menses, and the associated increase in endogenous hormonal exposure, has been implicated in the current breast cancer epidemic. It is not known, however, whether oral contraceptives further increase, or actually decrease, hormonal exposure over one menstrual cycle. Here, we examined variation in hormonal exposure across seven oral contraceptive (OC) formulations, and produced the first quantitative comparison of exogenous versus endogenous hormone exposure. Methodology Data from 12 studies of serum estradiol (E2) and progesterone (P4) were aggregated to create a composite graph of endogenous hormone levels over one menstrual cycle in European or American women (age 19–40 years). Pharmacokinetic package insert data, also from Western women, were used to calculate exposures for hormones in seven different OC formulations. Endogenous and exogenous hormone levels were compared after adjusting for the relative binding affinity (RBA) of progestin to the progesterone receptor and ethinyl estradiol (EE) to the estrogen receptor. Results After adjusting for RBA, median ethinyl estradiol exposure across 28 days in the OCs was 11.4 nmol/l, similar to median E2 exposure. One formulation, however, was 40% higher in ethinyl estradiol exposure relative to median endogenous estradiol. Median exposure from progestins in OCs (1496 nmol/l) was 4-fold higher than the median endogenous exposure from P4 (364 nmol/l). Exposure from OC progestins ranged from one sixtieth to 8-fold median endogenous P4 over 28 days. Conclusions and implications Given that breast cancer risk increases with hormonal exposure, our finding that four widely prescribed formulations more than quadruple progestin exposure relative to endogenous progesterone exposure is cause for concern. As not all

[Oral contraception and carbohydrate metabolism--the physiopathological explanation].

PubMed

Hilal, M

1985-12-01

On the basis of observation of the effects on glucose metabolism of estrogens and progestins administered alone or in combination, it is believed that deterioration of glucose tolerance in the 1st trimester of oral contraceptive (OC) use is due to the synthetic estrogen, while hyperinsulinism after the 6th month of use is due to the progestin component. Either the estrogen-induced deterioration of glucose tolerance or the progestin-induced insulin resistence may lead to poor glucose tolerance or diabetes in predisposed individuals. The early deterioration of glucose tolerance with synthetic estrogens is probably due to a direct action of estrogens on the pancreas, where specific estrogen receptors have been identified, but the regression of this effect has not been explained. The reduction of fasting glucose levels by synthetic estrogens is due to a reduction of glucogenolysis and of gluconeogenesis with an increase of hepatic gluconeogenesis. These 3 effects may be explained by the action of estrogens on insulin and glucagon: estrogens inhibit the secretion of glucagon induced by arginine, an effect not obtained by progestins. A daily injection of estradiol for 6 weeks in overiectomized rats results in a lowered level of insulin and glucagon with an elevated insulin/glucagon ratio in the portal vein; this results in a decline in gluconeogenesis with a particular decline in phospho-enol-pyruvate-carboxy-kinase activity. Progestins on the other hand augment insulin and glucagon secretion without modifying their ratio in the portal vein. Hyperinsulinism in the basal state and after stimulation is observed in women using combined OCs or progestins only, whether or not there is a deterioration of glucose tolerance. The effect appears after 3 months of use and continues as long as OCs are used. This hyperinsulinism is due to a hypersecretion and not to a diminution in degradation of insulin. The insulin/glucose ratio is elevated; the hypersecretion of insulin

The 1998 Canadian Contraception Study.

ERIC Educational Resources Information Center

Fisher, William A.; Boroditsky, Richard; Bridges, Martha L.

1999-01-01

Describes the 1998 Canadian Contraception Study, a mailed survey which asked women about contraceptive practices past, present, and future (including use of oral contraceptives, condoms, and sterilization); familiarity with and opinion about different contraception methods; and general sexual and reproductive health. The paper also examines…

A comparison of the pharmacokinetic profile of an ascending-dose, extended-regimen combined oral contraceptive to those of other extended regimens.

PubMed

Darwish, Mona; Bond, Mary; Ricciotti, Nancy; Hsieh, Jennifer; Fiedler-Kelly, Jill; Grasela, Thaddeus

2014-11-01

Quartette (levonorgestrel [LNG]/ethinyl estradiol [EE] and EE) is an ascending-dose, extended-regimen combined oral contraceptive (COC) that consists of a constant dose of LNG 150 µg on days 1 to 84 with EE 20 µg on days 1 to 42, 25 µg on days 43 to 63, 30 µg on days 64 to 84, and 10 µg of EE monotherapy on days 85 to 91. A population pharmacokinetic (PK) model for EE was developed using nonlinear mixed-effects modeling to characterize the PK profile of EE administered in Quartette and other extended-regimen LNG/EE COCs. Model-predicted plasma concentration-time profiles demonstrated a stepwise increase in systemic exposure to EE during the first 84 days of the cycle following each EE dose change. Lower concentrations of EE were noted during the final 7-day period of EE 10 µg. Gradual increases in EE seen with Quartette may decrease the incidence of unscheduled bleeding frequently observed during early cycles of extended-regimen COCs. © The Author(s) 2014.

Oral contraceptive pills induced hemichorea in an adolescent female with polycystic ovarian disease.

PubMed

Sharmila, Vijayan; Babu, Thirunavukkarasu Arun

2015-01-01

Chorea is a neurological adverse effect of oral contraceptive pills (OCPs). The onset of chorea following OCPs usage varies widely from few weeks to several years. We report a rare case of chorea which developed within a week of starting OCPs in an adolescent girl with polycystic ovarian disease.

Ongoing contraception after use of emergency contraception from a specialist contraceptive service.

PubMed

Cameron, Sharon T; Glasier, Anna; Johnstone, Anne; Rae, Leanne

2011-10-01

A consultation for emergency contraception (EC) gives way to an opportunity to provide women with an ongoing effective method of contraception. A review of the case notes of women seeking EC from a large family planning clinic in Edinburgh, Scotland, was conducted to determine what percentage of women were provided with an effective method of ongoing contraception. Case notes of 460 women presenting for EC over a 2-year period were reviewed. Women were of mean age 26 years (range 15-49 years) and presented because they had used no contraception (47%), experienced condom failure (42%) or missed oral contraceptive pills (9%). Only 2% (n=11) were given an intrauterine device for EC. All women who had missed contraceptive pills prior to taking EC opted to continue this method. Only 23% (n=89) of women using no method or condoms at EC received supplies of an effective contraceptive method (pills, patch, injectable). Two thirds (n=263) of the women chose condoms for ongoing contraception. Research is required to develop strategies to improve the uptake of effective contraception after EC. Copyright © 2011 Elsevier Inc. All rights reserved.

Use of a monophasic, low-dose oral contraceptive in relation to mental functioning.

PubMed

Deijen, J B; Duyn, K J; Jansen, W A; Klitsie, J W

1992-10-01

The objective of the study was to evaluate the effect of Minulet, a new low-dose oral contraceptive on mood in two groups and to compare the effect with a control group of women not taking oral contraceptives (OC). The women participating were between 16 and 45 years of age. They completed the Amsterdam Mood Questionnaire (AMQ) and the Sickness Impact Profile (SIP) three times. They were filled in before treatment started, after taking Minulet for one month and then again after three months. The questionnaires were filled in by a group of 200 women who had not taken OC before (starters), and by a second group of 370 women who were already taking OC (switchers). A group of 140 women who did not use any OC during the study served as a control group. These women also filled in the same questionnaires, both at the start, and after one and three months. As far as the AMQ was concerned, the switchers appeared in the initial measurement to have significantly higher scores (that is to say, a worse mood) for "tiredness", "depression", "moodiness", "anxiety" and "anger", than those of the starters and the control group. Moreover, the switchers had reduced scores (that is to say, an improved mood) on the AMQ-scales during their use of Minulet compared to their initial use of oral contraceptives. The scores of the starters and the control group on the AMQ-scales remained unchanged on all three measurements. It can be concluded from this that these groups felt as well as they did before.(ABSTRACT TRUNCATED AT 250 WORDS)

Vitamins and oral contraceptive use.

PubMed

Wynn, V

1975-03-08

Reports concerning the interaction between steroidal contraceptives (the combined pill) and vitamins indicate that in users the mean serum-vitamin-A level is raised and the mean serum-vitamin-B2 (riboflavine), vitamin-B6 (pyridoxine), vitamine-C, folic-acid, and vitamin-B12 levels are reduced. Other vitamins have been insufficiently studied for comment. Biochemical evidence of co-enzyme deficiency has been reported for vitamin B2, vitamin B6, and folic acid. Clinical effects due to vitamin deficiency have been described for vitamin B6--namely, depression and impaired glucose tolerance. Folic-acid deficiency with megaloblastic anaemia has been reported in only 21 cases.

Contraception counselling of female soldiers in primary healthcare facilities.

PubMed

Crabb, Sarah L

2015-06-01

Effectiveness of barrier and oral contraceptive pills is dependent on daily adherence and consistency that cannot always be guaranteed by military lifestyle. Long-acting reversible contraceptive (LARC) methods could provide a good alternative to guarantee effective contraception in unpredictable scenarios, and recent studies have suggested they could provide wider non-contraceptive benefits. LARC has been proven to be more cost effective than the combined oral contraceptive pill. The National Institute of Health and Care Excellence (NICE) has released guidelines on contraception provision to ensure all women receive the contraception method that is most appropriate to the individual. A retrospective audit of 105 sets of primary healthcare notes of serving female soldiers was assessed to establish contraceptive choices and whether appropriate information had been provided within the last year of their last consultation. 100% had seen a healthcare provider capable of providing contraceptive advice in the last year. 69% documented as using some form of non-surgical contraception versus 58% quoted as national usage. 21% were using some form of LARC versus 8% national usage. 66% of eligible women had not had LARC discussed with them, and of these 50% did not have any contraceptive usage documented. Among other consultations, 41% had had a medical within the year period, of which over half had no documented contraceptive status. As military healthcare providers, we have more exposure to our patients than NHS equivalents and this small study suggests there is an increased demand for contraception. Contraceptive choice counselling should be a mandatory part of routine initial medicals. If the situation demands a medical for any other reason, a documented contraception status should form an important part of the risk assessment process. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A comparative analysis of the modification of sexual desire of users of oral hormonal contraceptives and intrauterine contraceptive devices.

PubMed

Martin-Loeches, M; Ortí, R M; Monfort, M; Ortega, E; Rius, J

2003-09-01

To compare the influence of oral hormonal contraceptives (OCs) and the use of intrauterine contraceptive devices (IUDs) on the modification of sexual desire. A prospective observational study of 1073 women using OCs or an IUD at the Family Planning Center 'Marina Alta' in Alicante, Spain. In order to evaluate the relative risk regarding the decrease in libido attributed to each contraceptive method, a logistic regression analysis was undertaken which considered the factors of age adjustment, level of studies, family planning information, relationship with partner, age when sexual relationships were initiated, parity, contraceptive method previously used and the duration of use of the contraceptive method. No differences in the decrease of sexual desire were observed between the use of the OC and IUD (odds ratio (OR) 1.32; 95% confidence interval (CI) 0.70-2.49), yet differences were noted, however, in relation to age (OR 1.05; 95% CI 1.01-1.10). Although these differences were not statistically significant, a high level of awareness regarding family planning was shown to increase sexual desire when compared to a lower level of information on this subject (OR 0.64; 95% CI 0.41-1.01). Sexual desire was seen to decrease if the quality of the relationship with the partner was average (OR 2.24; 95% CI 1.36-3.69) or poor (OR 4.69; 95% CI 1.93-11.4). Nulliparous women showed a greater decrease in sexual desire in relation to women who had already given birth (OR 1.57; 95% CI 1.00-2.47). Sexual desire was greater if the contraceptive method had already been in use for 6-12 months (OR 0.41; 95% CI 0.17-0.98). Sexual desire does not vary in relation to the use of OCs or IUDs, yet it does decrease with age, in nulliparous women and in those with an average or poor relationship with their partner. Furthermore, sexual desire shows an increase between the first 6 and 12 months of contraceptive treatment.

Pretreatment with oral contraceptives in infertile anovulatory patients with polycystic ovary syndrome who receive gonadotropins for controlled ovarian stimulation.

PubMed

Palomba, Stefano; Falbo, Angela; Orio, Francesco; Russo, Tiziana; Tolino, Achille; Zullo, Fulvio

2008-06-01

This study was intended to assess the effects of oral contraceptives given before treatment in infertile anovulatory patients with polycystic ovary syndrome who receive gonadotropins for controlled ovarian stimulation. Pretreatment with oral contraceptives increased the mono-ovulatory cycles, the duration of stimulation for noncanceled cycles, and the number of vials of gonadotropins used. It also reduced the number of dominant follicles and the peak E(2) levels for dominant follicles. No effect was observed in rates of cycle cancellation, pregnancy, abortion, live birth, multiple pregnancies, and ovarian hyperstimulation syndrome.

Bioavailability of the Yuzpe and levonorgestrel regimens of emergency contraception: vaginal vs. oral administration.

PubMed

Kives, Sari; Hahn, Philip M; White, Emily; Stanczyk, Frank Z; Reid, Robert L

2005-03-01

Separate crossover studies compared the bioavailability of oral vs. vaginal routes of administration for the Yuzpe (n=5) and levonorgestrel regimens (n=4) of emergency contraception. Twice the standard dose of the Yuzpe regimen (200 microg of ethinyl estradiol, 1000 microg of levonorgestrel) or the levonorgestrel regimen (1500 microg of levonorgestrel) was self-administered vaginally. One week later, each subject received orally the standard dose of the assigned medication. Serial blood samples were collected over 24 h and assayed for levonorgestrel and ethinyl estradiol (for the Yuzpe regimen only). Paired t tests were used to compare oral vs. vaginal administration for maximum concentration (Cmax), time to maximum concentration (Tmax) and area under the curve over 24 h (AUC0-24). Relative bioavailability (vaginal/oral) was derived from AUC0-24. Vaginal administration of double the standard dose of the Yuzpe regimen resulted in a lower Cmax (vaginal=5.4 vs. oral=14.6 ng/mL, p=.038) and a later Tmax (5.9 vs. 2.0 h, p=.066) for levonorgestrel, compared to oral administration. Corresponding ethinyl estradiol concentrations were higher (786 vs. 391 pg/mL, p=.039) and peaked later (4.0 vs. 1.9 hr, p=.154) with vaginal administration. Relative bioavailabilities for levonorgestrel and ethinyl estradiol were 58% and 175%, respectively. Similarly, vaginal administration of the levonorgestrel regimen resulted in a lower Cmax (vaginal=5.4 vs. oral=15.2 ng/mL, p=.006) and a later Tmax (7.4 vs. 1.3 h, p=.037) for levonorgestel, compared to oral administration. The relative bioavailability was 62%. Our preliminary data suggest that vaginal administration of these emergency contraception regimens appears to require at least three times the standard oral dose to achieve equivalent systemic levonorgestrel concentrations.

Efficacy of Acupuncture versus Combined Oral Contraceptive Pill in Treatment of Moderate-to-Severe Dysmenorrhea: A Randomized Controlled Trial

PubMed Central

Sriprasert, Intira; Suerungruang, Suparerk; Athilarp, Porntip; Matanasarawoot, Anuchart

2015-01-01

This open-label randomized controlled trial was designed to compare the efficacy of acupuncture and combined oral contraceptive (COC) pill in treating moderate-to-severe primary dysmenorrhea. Fifty-two participants were randomly assigned to receive either acupuncture (n = 27) or COC (n = 25) for three menstrual cycles. Mefenamic acid was prescribed as a recue analgesic drug with both groups. The statistical approach used for efficacy and safety assessments was intention-to-treat analysis. By the end of the study, both treatments had resulted in significant improvement over baselines in all outcomes, that is, maximal dysmenorrhea pain scores, days suffering from dysmenorrhea, amount of rescue analgesic used, and quality of life assessed by SF-36 questionnaire. Over the three treatment cycles, COC caused greater reduction in maximal pain scores than acupuncture, while improvements in the remaining outcomes were comparable. Responders were defined as participants whose maximal dysmenorrhea pain scores decreased at least 33% below their baseline. Response rates following both interventions at the end of the study were not statistically different. Acupuncture commonly caused minimal local side effects but did not cause any hormone-related side effects as did COC. In conclusion, acupuncture is an alternative option for relieving dysmenorrhea, especially when COC is not a favorable choice. PMID:26346199

Reproductive health outcomes of insured adolescent and adult women who access oral levonorgestrel emergency contraception.

PubMed

Raine-Bennett, Tina; Merchant, Maqdooda; Sinclair, Fiona; Lee, Justine W; Goler, Nancy

2015-04-01

To assess the level of risk for adolescents and women who seek emergency contraception through various clinical routes and the opportunities for improved care provision. This study looked at a retrospective cohort to assess contraception and other reproductive health outcomes among adolescents and women aged 15-44 years who accessed oral levonorgestrel emergency contraception through an office visit or the call center at Kaiser Permanente Northern California from 2010 to 2011. Of 21,421 prescriptions, 14,531 (67.8%) were accessed through the call center. In the subsequent 12 months, 12,127 (56.6%) adolescents and women had short-acting contraception (pills, patches, rings, depot medroxyprogesterone) dispensed and 2,264 (10.6%) initiated very effective contraception (intrauterine contraception, implants, sterilization). Initiation of very effective contraception was similar for adolescents and women who accessed it through the call center-1,569 (10.8%) and office visits-695 (10.1%) (adjusted odds ratio [OR] 1.02, 95% confidence interval [CI] 0.93-1.13). In the subsequent 6 months, 2,056 (9.6%) adolescents and women became pregnant. Adolescents and women who accessed emergency contraception through the call center were less likely to become pregnant within 3 months of accessing emergency contraception than woman who accessed it through office visits (adjusted OR 0.82, 95% CI 0.72-0.94); however, they were more likely to become pregnant within 4-6 months (adjusted OR 1.37, 95% CI 1.16-1.60). Among adolescents and women who were tested for chlamydia and gonorrhea, 689 (7.8%) and 928 (7.9%) were positive in the 12 months before and after accessing emergency contraception, respectively. Protocols to routinely address unmet needs for contraception at every call for emergency contraception and all office visits, including visits with primary care providers, should be investigated.

Efficacy of a combined contraceptive regimen consisting of condoms and emergency contraception pills.

PubMed

Zhao, Rui; Wu, Jun-Qing; Li, Yu-Yan; Zhou, Ying; Ji, Hong-Lei; Li, Yi-Ran

2014-04-14

To evaluate and compare the effectiveness of the combined regimen (consisting of condoms and emergency contraception pills (ECP)) and using condoms only for the purpose of preventing pregnancy. One-thousand-five-hundred-and-sixty-two (1,562) couples as volunteers enrolled at nine centers in Shanghai. Eight-hundred-and-twelve (812) were randomized to use male condoms and ECP (i.e., Levonorgestrel) as a back-up to condoms (the intervention group) and 750 to use male condoms only(the control group), according to their working unit. Participants were visited at admission and at the end of 1, 3, 6, 9, and 12 months. The cumulative life table rates were calculated for pregnancy and other reasons for discontinuation. The gross cumulative life table rates showed that the cumulative discontinuation rates for all reasons during the year of follow-up in the condoms plus emergency contraception group and the condoms only group were 7.76 ± 0.94 and 6.61 ± 0.91, respectively, per 100 women (χ2 = 0.41, p = 0.5227). The cumulative gross pregnancy rate of the condoms plus emergency contraception group and the condoms only group were 2.17 ± 0.52 and 1.25 ± 0.41, respectively, per 100 women (χ2 = 1.93, p = 0.1645). The Pearl Index in the condoms plus emergency contraception group and the condoms only group were 2.21% and 1.26%, respectively. Male condoms remain a highly effective contraceptive method for a period of one year while consistently and correctly used. In addition, the lowest pregnancy rate followed from perfect use condom.

The emotional impact of genetic testing and aspects of counseling prior to prescription of oral contraceptives.

PubMed

Gartner, Verena; Weber, Michael; Eichinger, Sabine

2008-11-01

Oral contraceptives increase the thrombotic risk in women with factor V Leiden. Emotional aspects of genetic testing prior to the prescription of oral contraceptives (OC), aspects of counseling and referral patterns are widely unknown. Two hundred forty-seven women with and 132 women without factor V Leiden were interviewed by questionnaire. One hundred sixty-one women (65%) with factor V Leiden and 63 (48%) with wild-type factor V responded. One hundred seventy-one women (76%) reported being emotionally disturbed by genetic testing. Eighty percent of women with factor V Leiden and 16% of women with wild-type factor V were discouraged from OC use. Three percent of women with factor V Leiden were encouraged to take OC. Forty-one percent of women with factor V Leiden used at least one hormone contraceptive method after diagnosis. Only 46 women (29%) with factor V Leiden were counseled about the relevance of the mutation in case of pregnancy. Testing for factor V Leiden has considerable emotional impact. Recommendations after testing are not consistently driven by the test result.

Perceived competence and contraceptive use during adolescence.

PubMed

Hillman, Jennifer B; Negriff, Sonya; Dorn, Lorah D

2010-03-01

Little is known about psychosocial correlates of different contraceptive methods in adolescence. Cross-sectional analyses of 209 postmenarcheal girls [mean age (years)+/-SD=15.68+/-1.74], primarily Caucasian (62.8%) or African American (32.8%). Competence (activities and social) and rule-breaking behavior were assessed by the Youth Self Report (YSR; adolescent) and the Child Behavior Checklist (CBCL; parent). Three contraceptive-use groups were created: no hormonal contraceptive (n=142), combined oral contraceptives or the transdermal patch (COCs/patch, n=41), and depot medroxyprogesterone acetate (DMPA, n=20). There was a significant effect of contraceptive-use group on competence (p=.003). The DMPA group had lower competence (CBCL activities and social; YSR social) than the no-hormonal-contraceptive and COCs/patch groups. The COCs/patch group scored lower than the no-hormonal-contraceptive group on YSR activities competence, but was not different from the DMPA group. Lastly, there was an effect of contraceptive-use group on CBCL (but not YSR) rule-breaking behavior (p=.029) with the DMPA group having higher rule-breaking behavior than the other groups. Type of contraceptive method was associated with parent and adolescent's perceived competence. For rule-breaking behavior, parental perception may be more relevant to contraceptive use. Copyright (c) 2010 Elsevier Inc. All rights reserved.

Supplementation with vitamin B6 reduces side effects in Cambodian women using oral contraception.

PubMed

Var, Chivorn; Keller, Sheryl; Tung, Rathavy; Freeland, Dylan; Bazzano, Alessandra N

2014-08-26

Hormonal contraceptives may produce side effects that deter women from their use as a method of family planning. In nutritionally vulnerable populations these effects may be more pronounced due to micronutrient deficiencies and health status. Previous studies have been unable to resolve whether micronutrient supplementation may reduce such side effects. In a longitudinal study, 1011 women obtaining oral contraception through the public health system in rural Cambodia were allocated to either intervention or control groups, receiving either daily Vitamin B6 supplement or care as usual (without placebo). The intervention participants (n = 577) reported fewer side effects in three categories: nausea/no appetite, headache, and depression compared with control group participants (n = 434). Women taking Vitamin B6 supplement were less likely to report side effects in a nutritionally vulnerable population. Underlying nutrition status should be considered by clinicians and reproductive health policy makers in the context of providing contraceptive services. Further investigation into micronutrient supplementation, particularly with B6, in reproductive-aged women using hormonal contraception should be conducted in other settings to determine the potential for widespread adoption.

Conditioning Military Women for Optimal Performance: Effects of Contraceptive Use

DTIC Science & Technology

1997-10-01

female soldier with three months of uncomplicated birth control . This contraceptive technique is worthy of study because it is used by an ever...of birth control (EU-OV) B. time: pre-training/heat acclimation post-training/heat acclimation 10 Null Hypotheses A. Null Hypotheses Associated with...IgG = immunoglobulin G birth control = eight subjects using either oral contraceptive (n = 7) or Depo Provera (n = 1) combined no birth control = eumenorrheic

The effect of combination oral contraceptives on smoking-related symptomatology during short-term smoking abstinence.

PubMed

Hinderaker, Katie; Allen, Alicia M; Tosun, Nicole; al'Absi, Mustafa; Hatsukami, Dorothy; Allen, Sharon S

2015-02-01

Although an estimated 25% of premenopausal smokers report using oral contraceptives (OC), little is known about how OC use may influence smoking cessation. The purpose of this study was to examine the difference in smoking-related symptomatology during acute smoking abstinence between women on a standardized combination OC (Tri-Sprintec(™)) compared to women not on OCs (no-OC). Participants were women aged 18-40 who smoked ≥5 cigarettes/day and reported regular menstrual cycles. Using a controlled cross-over design, participants completed two six-day testing weeks: Low Progesterone Week (LPW; Follicular (F) phase in no-OC or 1st week of pills in OC) and High Progesterone Week (HPW; Luteal (L) phase in no-OC or 3rd week of pills in OC). Each testing week included daily assessment of symptomatology and biochemical confirmation of smoking status. During smoking abstinence, the OC group (n=14) reported significantly lower levels of positive affect (21.56±7.12 vs. 24.57±6.46; β=3.63, p=0.0323) than the no-OC group (n=28). Further significant interactions between group and testing week were observed as follows: Smoking satisfaction was higher during LPW in the OC group (LPW: 4.29±1.30 vs. HPW: 4.10±1.37) but higher during HPW in the no-OC group (LPW: 3.91±1.30 vs. HPW: 4.23±1.30; β=-0.5499, p<0.0001). Similar interactions were noted in negative affect and psychological reward of smoking. These results suggest that women on OCs may have different patterns of smoking-related symptomatology during short-term smoking abstinence as compared to women not on OCs. Additional work is needed to examine how this may affect smoking cessation efforts. Copyright © 2014 Elsevier Ltd. All rights reserved.

Combined hormonal contraceptives: prescribing patterns, compliance, and benefits versus risks.

PubMed

Brynhildsen, Jan

2014-10-01

Combined hormonal contraceptives [combined oral contraceptives (COCs)] have been available for over 50 years and the impact of this invention may not be overestimated. Today over 100 million women are current users and in Western Europe and the United States approximately 80% of women of fertile ages can be considered as ever-users. Over the years several drawbacks have been identified and media alarms on risks are frequently presented, resulting in suboptimal compliance and low compliance and continuation rates. Poor compliance and discontinuation is a big problem and is not generally identified by prescribers. During ideal use COCs offer very good protection against unwanted pregnancies, however there is a big problem with compliance and continuation and thus the 'real-life' efficacy is much lower. Reasons for poor compliance include side effects and fear of side effects and it is crucial that the prescriber gives the individual woman thorough and balanced information on the benefits and risks. Most well known is the increased risk of venous thromboembolism, but also an elevated risk of arterial thrombosis and several types of cancer has been reported. The risk estimates are low but according to the large number of users a substantial number of extra cases will occur. However, use of COCs also offers several additional health benefits with significant impact on morbidity and quality of life. COC use is associated with a substantial decrease in the risk of ovarian cancer, endometrial cancer and colorectal cancer. Moreover, COCs are a major option of treatment for women suffering from heavy menstrual bleeding and dysmenorrhea as well as hirsutism and acne vulgaris. The net effect of the additional health effects of COC- use may very well be positive, i.e. a slight increase in life expectancy.

Contraceptive use at the time of unintended pregnancy: Findings from the Contraceptive Use, Pregnancy Intention and Decisions study.

PubMed

Coombe, Jacqueline; Harris, Melissa L; Wigginton, Britta; Lucke, Jayne; Loxton, Deborah

2016-11-01

Unintended pregnancy disproportionately affects young Australian women. However, contraceptive behaviours associated with unintended pregnancy are unclear. The objective of this article was to examine contraceptive use before unintended conception. Data from 3795 women (aged 18-23 years) who completed the baseline Contraceptive Use, Pregnancy Intention and Decisions (CUPID) study were analysed. The study found that 21.1% of participants reported ever being pregnant, of whom 84.6% indicated 'accidental' pregnancy. Most (73.4%) of these participants reported using contraception at the first unintended pregnancy, with the combined oral contraceptive pill being the most frequently used form (39.1%). Participants who reported unintended pregnancy were older (21.2 years of age ± 1.7) than those who had never been pregnant (20.5 years of age ± 1.7). They were also more likely to be in cohabitating relationships (34.7% versus 26.0%) or engaged/married (20.1% versus 8.4%). Most participants in this study considered their pregnancy to be accidental. The high rate of contraceptive use before becoming pregnant indicates the need to examine better ways to enhance the efficacy of contraceptive use among young Australian women.

Pharmacodynamics of combined estrogen-progestin oral contraceptives: 2. effects on hemostasis.

PubMed

Farris, Manuela; Bastianelli, Carlo; Rosato, Elena; Brosens, Ivo; Benagiano, Giuseppe

2017-10-01

The pharmacodynamic effects of various combined oral estrogen-progestin combinations (COC) are examined for their components alone or in the various combined formulations. Special emphasis is given to products containing natural estrogens. Areas covered: Recent information on the effect of androgens, estrogens, progestins, as well as various COC combinations on the coagulation cascade will be reviewed aiming at providing an updated picture. The present article reviews hemostatic changes occurring during use of classic and modern combinations of estrogens (ethinyl estradiol, estradiol, estradiol valerate and estetrol) and new progestins (desogestrel, gestodene, dienogest, drospirenone, nomegestrol acetate), compared to classic compounds, such as levonorgestrel. Both pro- and anti-coagulatory effects of COC in healthy women are detailed and possible links with incidence of thromboembolic events are discussed. Expert commentary: Overall, the picture is reassuring: the use of natural estrogens and of new generation progestins has reduced pro-coagulatory changes in healthy subjects, although the observed differences in the risk of venous thromboembolism between second and third generation progestins is still incompletely understood. At the same time, there still is a need for large comparative and surveillance studies before firm conclusions can be drawn. At any rate, available evidence indicates that hemostatic effects of the newer COC, especially those utilizing natural estrogens, are minimal and often remain with the normal range.

A new oral contraceptive regimen for endometriosis management: preliminary experience with 24/4-day drospirenone/ethinylestradiol 3 mg/20 mcg.

PubMed

Mabrouk, Mohamed; Solfrini, Serena; Frascà, Clarissa; Del Forno, Simona; Montanari, Giulia; Ferrini, Giulia; Paradisi, Roberto; Seracchioli, Renato

2012-06-01

We report our preliminary experience with the use of a low-dose oral contraceptive containing Drospirenone/Ethinylestradiol 3 mg/20 mcg, both in cyclic and continuous regimen for endometriosis management. A total of 93 women were retrospectively included: 52 were treated by medical therapy (exclusive combined oral contraceptives (COC)-users), while 41 were submitted to surgery followed by postoperative therapy (postoperative COC-users). A clinical examination was performed at baseline and at 6-months follow-up. Presence and intensity of endometriosis-related symptoms were assessed by a visual analogue scale. Presence and dimension of endometriotic lesions were evaluated by transvaginal ultrasonography. Adverse effects and tolerability were analysed. In exclusive COC-users, significant reductions in dysmenorrhoea and dyspareunia scores and in endometrioma mean diameter were observed at follow-up. In postoperative COC-users, anatomical and symptom recurrence rates at follow-up were 4.9% and 17%, respectively. The most frequent adverse effects were spotting and headache. No difference between cyclic and continuous regimen in terms of symptom relief, lesion progression and tolerability was observed. From our preliminary experience, Drospirenone/Ethinylestradiol 3 mg/20 mcg seems to be promising in endometriosis management.

Effects of menstrual cycle, oral contraception, and training on exercise-induced changes in circulating DHEA-sulphate and testosterone in young women.

PubMed

Enea, C; Boisseau, N; Ottavy, M; Mulliez, J; Millet, C; Ingrand, I; Diaz, V; Dugué, B

2009-06-01

The objective of this study was to ascertain the effects of menstrual cycle, oral contraception, and training status on the exercise-induced changes in circulating DHEA-sulphate and testosterone in young women. Twenty-eight healthy women were assigned to an untrained group (n = 16) or a trained group (n = 12) depending on their training background. The untrained group was composed of nine oral contraceptive users (OC+) and seven eumenorrheic women (OC-). The trained group was composed of OC+ subjects only. All the OC+ subjects were taking the same low-dose oral contraception. Three laboratory sessions were organised in a randomised order: a prolonged exercise test until exhaustion, a short-term exhaustive exercise test, and a control session. Blood specimens were collected before, during and after the exercise tests and at the same time of the day during the control session. Basal circulating testosterone was significantly lower in trained as compared to untrained subjects. In all subjects, the prolonged exhaustive exercise induced a significant increase in circulating DHEA-s and testosterone. The short-term exercise induced a significant increase in circulating DHEA-s in untrained eumenorrheic and in trained OC users only. Menstrual phases in OC- did not influence the responses. It was found that exhaustive physical exercise induced an increase in circulating DHEA-s and testosterone in young women. Oral contraception may limit short-term exercise-induced changes.

Divergent Effects of a Combined Hormonal Oral Contraceptive on Insulin Sensitivity in Lean versus Obese Women

PubMed Central

Cheang, Kai I.; Essah, Paulina A.; Sharma, Susmeeta; Wickham, Edmond P.; Nestler, John E.

2011-01-01

Objective To evaluate the effects of a commonly used combined hormonal oral contraceptive (OC) on carbohydrate metabolism in obese as compared with obese women. Design 6-month prospective study. Setting Clinical Research Center at an academic medical center. Patients Premenopausal non-diabetic women with BMI < 25 kg/m2 (n=15) or > 30 kg/m2 (n=14). Intervention Ethinyl estradiol 35mcg and norgestimate 0.18/0.215/0.25 mg for 6 cycles. Main Outcome Measures Insulin sensitivity (Si) by frequent sampling intravenous glucose tolerance test; other indices of insulin sensitivity (ISI HOMA, Matsuda index); fasting lipid panel. Results Si changed from 6.62±3.69 min−1/mu/L (baseline) to 8.23±3.30 min−1/mu/L (6 months) in lean women, and from 4.36±2.32 to 3.82±2.32 min−1/mu/L in obese women (p for interaction=0.0494). Divergent effects on insulin sensitivity were also observed with ISI HOMA (p=0.0128) and Matsuda index (p=0.0227). LDL increased by approximately 20 mg/dL in both groups (p<0.005 [lean]; p<0.01 [obese]). Conclusions Lean and obese women exhibit differential changes in insulin sensitivity when given 6 months of a commonly used OC. The mechanisms of these differences, and whether these divergent effects persist long-term, require further investigations. Capsule Lean and obese non-diabetic women exhibit differential changes in insulin sensitivity when given 6 months of a commonly used OC (ethinyl estradiol 35mcg and norgestimate 0.18/0.215/0.25 mg) PMID:21676394

Metformin plus oral contraceptive may decrease plasma sCD40 ligand in women with PCOS patients.

PubMed

Kebapcilar, Levent; Kebapcilar, Ayse Gul; Bilgir, Oktay; Taner, Cuneyt Eftal; Bozkaya, Giray; Yildiz, Yasar; Sari, Ismail

2011-02-01

To evaluate sCD40L levels in women with polycystic ovary syndrome (PCOS) who use combination therapy with metformin and oral contraceptives. Total of 60 patients with PCOS was studied to evaluate and compare with a non-PCOS group consisting of 30 subjects. A low-dose oral contraceptive containing ethinyl oestradiol-cyproterone acetate (EE/CA) and metformin (M; 850 mg metformin twice a day) were given for three cycles. Plasma sCD40L was measured before and after the treatment of 3 months. At baseline, the sCD40L levels of the patients with PCOS was significantly higher than those of control subjects (3.1 ± 2.0 vs. 2.05 ± 1.0, respectively; p=0.002). An average of 3 months of EE/CA-M therapy induced a significant decrease of sCD40L levels in the PCOS group (3.1 ± 2.0 vs. 2.5 ± 1.0; p=0.026). After having treated patients with PCOS, the sCD40L level was not completely normalised when compared to the healthy controls (2.5 ± 1.0 vs. 2.05 ± 1.0; p=0.039). PCOS is associated with elevated levels of sCD40L. Adding metformin therapy to EE/CA may decrease sCD40L levels in women PCOS. However, after the treatment for PCOS subjects, the sCD40L was not completely normalised when compared patients to healthy controls.

Contraception: traditional and religious attitudes.

PubMed

Schenker, J G; Rabenou, V

1993-04-01

Humans have tried to control fertility for centuries. Primitive, preliterate societies practiced infanticide and abortion. When primitive women understood the advantages of conception control, they tried, when possible, to use contraception. In the 4th century B.C., Plato and Aristotle advocated a one-child family. Greek medical literature reported a hollow tube inserted through the cervix into the uterus and a potion as contraceptives. Islamic physicians had much knowledge about conception control. The attitudes toward contraception. In the 5th century B.C., Saint Augustine condemned contraception, even among married couples. The condom emerged in the early modern period. Yet, they were usually worn to protect against disease, e.g., bilharzia in Egypt and syphilis in Europe. The cervical cap and the diaphragm are examples of occlusive pessaries. By 1880, contraceptives and spermicides were advertised. In 1928, the IUD joined the existing contraceptives. Today we have combined oral contraceptives. Judaic law requires husbands to fulfill their wives sexual needs, separate from their duty to procreate. It also calls men, not women, to procreate and forbids men from masturbating, thus Judaic law does not forbid women from practicing contraception. The Roman Catholic church forbids contraceptive use because it is a sin against nature. Some Protestant denominations have allowed contraceptive use. Islamic law states that children are gifts from Allah. Some Moslems believe that they must have many children, but Allah and the Prophet state that children have rights to education and future security. These rights allow couples to prevent pregnancy. Neither Hinduism nor Buddhism prohibit contraceptive use. Differences in husband-wife communication, sex roles, access to contraceptives, and traditional family values will have more of an effect on contraceptive use and fertility than theological barriers or the social class of religious groups.

The effect of oral contraceptives on current wheezing in young women.

PubMed

Erkoçoğlu, M; Kaya, A; Azkur, D; Özyer, Ş; Özcan, C; Beşli, M; Civelek, E; Kocabaş, C N

2013-01-01

Emerging evidence suggests that sex steroid hormones may influence respiratory symptoms. The existing literature about the role of oral contraceptive pill (OCP) on respiratory disease is scarce and conflicting especially during the adolescent period. In this study, we aimed to investigate the effect of OCPs on current wheezing among adolescents and young adults. A questionnaire was administered face-to-face to adolescents and young women by a physician. The questionnaire included ISAAC survey-comprised questions on ever wheezing, current wheezing, allergic diseases, smoking history (active or passive), and family history of allergic diseases and questions on OCP usage status. The effect of OCPs on wheezing was evaluated by logistic regression analysis. A total of 487 subjects aged between 11.3 and 25.6years participated in the study and 196 (40.2%) reported that they had used OCPs. 7.4% of the participants had physician-diagnosed asthma and 10.3% of them were active smokers. It was detected that OCPs were associated with increased risk for current wheezing (odds ratio, 2.36; 95% CI, 1.25-4.47 adjusted for asthma and current smoker) and this risk was related with the usage during the past year. Young women taking oral contraceptives had a higher rate of current wheezing, suggesting that sex steroids may be of importance for respiratory health. Copyright © 2011 SEICAP. Published by Elsevier Espana. All rights reserved.

Pharmacokinetics of Oral Combination Contraceptive Drugs Containing Ethinyl Estradiol and Levonorgestrel in Healthy Female Chinese Volunteers.

PubMed

Xin, X; Wu, Y; Liu, X; Sun, C; Geng, T; Ding, L

2016-02-01

A new combination contraceptive tablet containing 0.02 mg ethinyl estradiol (EE) and 0.10 mg levonorgestrel (LNG) with potential advantages has been developed in China. This study was aimed to describe the pharmacokinetic characteristics of this new combination contraceptive tablet in female Chinese volunteers. This study was designed as phase I, open-label, and one-sequence clinical trial. 12 healthy nonpregnant female Chinese volunteers received a single dose (1 tablet) and multiple dose (1 tablet per day) administration for 21 consecutive days under fasting condition. Blood samples were analyzed with 2 validated LC-MS/MS methods for EE and LNG, respectively. After the single dose administration, the C max of EE and LNG were 44.76±18.64 pg/mL and 2.256±1.008 ng/mL, respectively. The steady-state condition of EE was achieved on the 6(th) day after the beginning of the multiple dose administration, while the steady-state condition of LNG was achieved on the 21(st) day. For EE, the mean MRT 0-72 and t 1/2 increased by 40.2 and 30.6%, meanwhile the mean Cl/F and Vd/F decreased by 18.5 and 29.1%, respectively from Day 1 to Day 24. For LNG, the mean MRT 0-72 increased by 27.1%, while the mean Cl/F and Vd/F decreased by 62.4 and 86.3%, respectively from Day 1 to Day 24. The t 1/2 remained unchanged for LNG. The exposure of LNG significantly increased with repeated dosing, but that of EE just slightly increased. © Georg Thieme Verlag KG Stuttgart · New York.

[The influence of low-dose oral contraceptive pill on clinical and metabolic parameters in young women with polycystic ovary syndrome].

PubMed

Banaszewska, Beata; Spaczyński, Robert Z; Ozegowska, Katarzyna; Pawelczyk, Leszek

2011-06-01

Polycystic ovary syndrome (PCOS) is characterized by hyperandrogenism, oligo/anovulation and is associated with risk factors for cardiovascular diseases, such as insulin resistance and central adiposity. The aim of the study was to evaluation of influence of the oral contraceptive pill on the endocrinologic and metabolic parameters in women with PCOS. Forty nine PCOS women (aged 23,9 +/- 3,5 [mean +/- SD]) without any other diseases were included into the study. Oral contraceptives (0,02 mg ethynylestradiol + 0,15 mg desogestrel) were administered for 6 months. Hormonal and biochemical analyses were performed with specific assays at the beginning and after 6 month-therapy BMI, insulin sensitivity index (ISI) and QUICKI were calculated. Statistical analysis was performed using Wilcoxon test. All patients completed 6-month therapy and no severe side effects were reported during the study. A significant reduction in testosterone (T) concentrations was observed (p<0.005). We recorded a significant increase in lipid concentrations. The administration of oral contraceptives in our study group caused decrease in the testosterone level but negative effect on total cholesterol and triglycerides level was observed.

Use of contraceptive methods and contraceptive recommendations among health care providers actively involved in contraceptive counseling -- results of an international survey in 10 countries.

PubMed

Gemzell-Danielsson, Kristina; Cho, SiHyun; Inki, Pirjo; Mansour, Diana; Reid, Robert; Bahamondes, Luis

2012-12-01

This study was conducted to determine the personal choices of contraceptive methods among an international sample of contraception health care professionals (HCPs) and to determine if these choices are concordant with their recommendations to women. In an anonymous online survey, 1001 HCPs actively involved in contraceptive counseling [obstetrician/gynecologists (OB/GYNs), general practitioners (GPs) and midwives (only in Sweden)] from 10 countries (Australia, Brazil, Canada, France, Germany, Korea, Mexico, Spain, Sweden and the United Kingdom) were asked about their personal use of contraceptive methods and their recommendations to women in two different clinical scenarios: for spacing between children (Group A) and after completion of the family (Group B). The largest HCP group was OB/GYNs (67.1%), followed by GPs (31.4%) and midwives (1.5%). A total of 42.7% of respondents were male, and 57.3% were female. The majority of respondents were aged 36-45 years (38.9%) or 46-55 years (42.8%), 79.7% had children, and 53.9% were currently using contraception (by themselves or by their partners). Among 540 contraceptive users, the three most common methods were the levonorgestrel-releasing intrauterine system (LNG-IUS; 29.3%), combined oral contraceptives (COCs; 20.0%) and condoms (17.0%). OB/GYNs were more likely to be using the LNG-IUS than GPs (p=.014). Gender did not seem to influence contraceptive preference. Reasons for these choices were largely influenced by family situation and high contraceptive efficacy (for the LNG-IUS) or side effects caused by other methods (for condoms). The top contraceptive recommendation was COCs for Group A and the LNG-IUS for Group B. HCPs currently using COCs and the LNG-IUS were more likely to recommend these methods than other contraceptive methods for Group A and Group B, respectively. The most popular contraceptive method in this sample of HCPs was the LNG-IUS. Choice of contraceptive method was driven by family situation, age

Influence of an oral contraceptive containing drospirenone on insulin sensitivity of healthy women.

PubMed

Cagnacci, Angelo; Piacenti, Ilaria; Zanin, Renata; Xholli, Anjeza; Tirelli, Alessandra

2014-07-01

Oral contraceptives (OCs) containing androgenic second and third generation progestins decrease insulin sensitivity (SI). In this study we investigated whether an oral contraceptive containing the anti-androgenic progestin drospirenone (DRSP) still alters SI. Lipid modifications were investigated as well. Eleven young healthy women were allocated to receive for 6 months ethinyl-estradiol (EE) 30μg plus DRSP (3mg). SI and glucose utilization independent of insulin (Sg) was investigated by the minimal model method. Lipid modifications were also analyzed. SI did not vary during EE/DRSP (from 3.72±2.62 to 3.29±2.93; p=0.73). Similarly, values of Sg did not vary (from 0.03±0.02 to 0.032±0.014; p=0.87). An increase was observed in HDL cholesterol (9.4±9.8mg/dl; p=0.05) and triglycerides (46.9±75.1mg/dl; p=0.046), with no modification in LDL cholesterol (-4.64±1.704mg/dl; p=0.6). EE/DRSP does not deteriorate SI. These results are reassuring for the long-term use of this association. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC Study).

PubMed

Dinger, Juergen C; Bardenheuer, Kristina; Assmann, Anita

2009-11-18

A 24-day regimen of contraceptive doses of drospirenone and ethinylestradiol (DRSP/EE 24d) was recently launched. This regimen has properties which may be beneficial for certain user populations (e.g., women suffering from premenstrual dysphoric disorder or acne). However, it is unknown whether this extended regimen has an impact on the cardiovascular risk associated with the use of oral contraceptives (OCs). The INternational Active Surveillance study of women taking Oral Contraceptives (INAS-OC) is designed to investigate the short- and long-term safety of the new regimen in a population which is representative for the typical user of oral contraceptives. A large, prospective, controlled, non-interventional, long-term cohort study with active surveillance of the study participants has been chosen to ensure reliable and valid results. More than 2,000 gynecologists in the US and 5 European countries (Austria, Germany, Italy, Poland, and Sweden) will recruit more than 80,000 OC users. The two to five year follow-up of these women will result in at least 220,000 documented women-years. The main clinical outcomes of interest for the follow-up are deep venous thrombosis, pulmonary embolism, acute myocardial infarction and cerebrovascular accidents. Secondary objectives are general safety, effectiveness and drug utilization pattern of DRSP/EE 24d, return to fertility after stop of OC use, as well as the baseline risk for users of individual OC formulations. Because of the non-interference character of this study, potential participants (first-time users or switchers) are informed about the study only after the decision regarding prescription of a new OC. There are no specific medical inclusion or exclusion criteria. Study participation is voluntary and a written informed consent is required. After the baseline questionnaire, follow-up questionnaires will be mailed to the participants every 6 months for up to 5 years after baseline. Self-reported serious adverse events

Oral contraceptive use is associated with prostate cancer: an ecological study

PubMed Central

Fleshner, Neil E

2011-01-01

Background Several recent studies have suggested that oestrogen exposure may increase the risk of prostate cancer (PCa). Objectives To examine associations between PCa incidence and mortality and population-based use of oral contraceptives (OCs). It was hypothesised that OC by-products may cause environmental contamination, leading to an increased low level oestrogen exposure and therefore higher PCa incidence and mortality. Methods The hypothesis was tested in an ecological study. Data from the International Agency for Research on Cancer were used to retrieve age-standardised rates of prostate cancer in 2007, and data from the United Nations World Contraceptive Use 2007 report were used to retrieve data on contraceptive use. A Pearson correlation and multivariable linear regression were used to associate the percentage of women using OCs, intrauterine devices, condoms or vaginal barriers to the age standardised prostate cancer incidence and mortality. These analyses were performed by individual nations and by continents worldwide. Results OC use was significantly associated with prostate cancer incidence and mortality in the individual nations worldwide (r=0.61 and r=0.53, respectively; p<0.05 for all). PCa incidence was also associated with OC use in Europe (r=0.545, p<0.05) and by continent (r=0.522, p<0.05). All other forms of contraceptives (ie, intra-uterine devices, condoms or vaginal barriers) were not correlated with prostate cancer incidence or mortality. On multivariable analysis the correlation with OC was independent of a nation's wealth. Conclusion A significant association between OCs and PCa has been shown. It is hypothesised that the OC effect may be mediated through environmental oestrogen levels; this novel concept is worth further investigation. PMID:22102643

Oral contraceptive use is associated with prostate cancer: an ecological study.

PubMed

Margel, David; Fleshner, Neil E

2011-01-01

Background Several recent studies have suggested that oestrogen exposure may increase the risk of prostate cancer (PCa). Objectives To examine associations between PCa incidence and mortality and population-based use of oral contraceptives (OCs). It was hypothesised that OC by-products may cause environmental contamination, leading to an increased low level oestrogen exposure and therefore higher PCa incidence and mortality. Methods The hypothesis was tested in an ecological study. Data from the International Agency for Research on Cancer were used to retrieve age-standardised rates of prostate cancer in 2007, and data from the United Nations World Contraceptive Use 2007 report were used to retrieve data on contraceptive use. A Pearson correlation and multivariable linear regression were used to associate the percentage of women using OCs, intrauterine devices, condoms or vaginal barriers to the age standardised prostate cancer incidence and mortality. These analyses were performed by individual nations and by continents worldwide. Results OC use was significantly associated with prostate cancer incidence and mortality in the individual nations worldwide (r=0.61 and r=0.53, respectively; p<0.05 for all). PCa incidence was also associated with OC use in Europe (r=0.545, p<0.05) and by continent (r=0.522, p<0.05). All other forms of contraceptives (ie, intra-uterine devices, condoms or vaginal barriers) were not correlated with prostate cancer incidence or mortality. On multivariable analysis the correlation with OC was independent of a nation's wealth. Conclusion A significant association between OCs and PCa has been shown. It is hypothesised that the OC effect may be mediated through environmental oestrogen levels; this novel concept is worth further investigation.

Effect of combined oral contraceptive use on serum 25-hydroxy vitamin D levels and ultrasound parameters in patients with polycystic ovary syndrome.

PubMed

Namli Kalem, Müberra; Hizli, Deniz; Kamalak, Zeynep; Kösüs, Aydin; Kösüs, Nermin; Turhan, Nilgün; Kafali, Hasan

2016-01-01

To investigate if there is an effect of combined oral contraceptive (COC) use on serum 25-hydroxy vitamin D [25(OH)D] levels in patients with polycystic ovary syndrome (PCOS). PCOS was defined by the 2003 Rotterdam criteria. All patients with PCOS were treated with a COC containing 0.035 mg ethinylestradiol and 2 mg cyproterone acetate for 6 months. Serum 25(OH)D levels, HOMA-IR, ovarian volume and antral follicule count were measured before and after the treatment. The median 25(OH)D levels were 9.40 (range 4.40-24.50) μg/l and 7.00 (5.00-13.50) μg/l before and after COC use, respectively. Serum 25(OH)D levels decreased after the treatment; however, the difference was not statistically significant (p = 0.055). This study seems to be the first prospective trial revealing the effect of COC use on serum 25(OH)D levels in women with PCOS. Although the decrease in serum 25(OH)D levels in patients with PCOS with the use of COC alone, did not reach to statistically significance level after 6 months treatment with COC.

Pharmacokinetics of a combined oral contraceptive in obese and normal weight women

PubMed Central

Westhoff, Carolyn L.; Torgal, Anupama H.; Mayeda, Elizabeth R.; Pike, Malcolm C.; Stanczyk, Frank Z.

2010-01-01

Background This study was conducted to compare oral contraceptive (OC) pharmacokinetics (PK) in normal weight (BMI 19.0-24.9) and obese (BMI 30.0-39.9) women. Study Design During the third week of the third cycle of OC use, we admitted 15 normal weight and 15 obese women for collection of 12 venous specimens over 24 h. Using RIA techniques, we measured levels of ethinyl estradiol (EE) and levonorgestrel (LNG). During the same cycle, women underwent twice-weekly sonography to assess ovarian follicular development and blood draws to measure endogenous estradiol (E2) and progesterone levels. Results Obese women had a lower area under the curve (AUC; 1077.2 pg*h/mL vs 1413.7 pg*h/mL) and lower maximum values (85.7 pg/mL vs 129.5 pg/mL) for EE than normal weight women (p = 0.04 and 0.01, respectively); EE trough levels were similar between BMI groups. The similar, but smaller, differences in their LNG levels for AUC and maximum values (Cmax) were not statistically significant. While peak values differed somewhat, the LNG trough levels were similar for obese and normal weight women (2.6 ng/mL and 2.5 ng/mL, respectively). Women with greater EE AUC had smaller follicular diameters (p = 0.05) and lower E2 levels (p = 0.04). While follicular diameters tended to be larger among obese women, these differences were not statistically significant. Conclusion OC hormone peak levels are lower among obese women compared to normal weight women, but their trough levels are similar. In this small study, the observed PK differences did not translate into more ovarian follicular activity among obese OC users. PMID:20472113

Drug interactions between non-rifamycin antibiotics and hormonal contraception: a systematic review.

PubMed

Simmons, Katharine B; Haddad, Lisa B; Nanda, Kavita; Curtis, Kathryn M

2018-01-01

The purpose of this study was to determine whether interactions between non-rifamycin antibiotics and hormonal contraceptives result in decreased effectiveness or increased toxicity of either therapy. We searched MEDLINE, Embase, clinicaltrials.gov, and Cochrane libraries from database inception through June 2016. We included trials, cohort, case-control, and pharmacokinetic studies in any language that addressed pregnancy rates, pharmacodynamics, or pharmacokinetic outcomes when any hormonal contraceptive and non-rifamycin antibiotic were administered together vs apart. Of 7291 original records that were identified, 29 met criteria for inclusion. Two authors independently assessed study quality and risk of bias using the United States Preventive Services Task Force evidence grading system. Findings were tabulated by drug class. Study quality ranged from good to poor and addressed only oral contraceptive pills, emergency contraception pills, and the combined vaginal ring. Two studies demonstrated no difference in pregnancy rates in women who used oral contraceptives with and without non-rifamycin antibiotics. No differences in ovulation suppression or breakthrough bleeding were observed in any study that combined hormonal contraceptives with any antibiotic. No significant decreases in any progestin pharmacokinetic parameter occurred during co-administration with any antibiotic. Ethinyl estradiol area under the curve decreased when administered with dirithromycin, but no other drug. Evidence from clinical and pharmacokinetic outcomes studies does not support the existence of drug interactions between hormonal contraception and non-rifamycin antibiotics. Data are limited by low quantity and quality for some drug classes. Most women can expect no reduction in hormonal contraceptive effect with the concurrent use of non-rifamycin antibiotics. Copyright © 2017 Elsevier Inc. All rights reserved.

Venous Thromboembolism Due to Oral Contraceptive Intake and Spending Nights in a Vehicle -A Case from the 2016 Kumamoto Earthquakes.

PubMed

Sueta, Daisuke; Akahoshi, Rika; Okamura, Yoshinori; Kojima, Sunao; Ikemoto, Tomokazu; Yamamoto, Eiichiro; Izumiya, Yasuhiro; Tsujita, Kenichi; Kaikita, Koichi; Katabuchi, Hidetaka; Hokimoto, Seiji

2017-01-01

A 40-year-old woman experiencing sudden dyspnea went to her personal doctor for advice. She was previously diagnosed with endometriosis and prescribed oral contraceptives for treatment. During earthquakes, she spent 7 nights sleeping in a vehicle. The patient had swelling and pain in her left leg and high D-dimer concentration levels. A contrast-enhanced computed tomography scan revealed a contrast deficit in the bilateral pulmonary artery and in the left lower extremity. She was diagnosed with pulmonary thromboembolism (PTE), and anticoagulation therapy was initiated. This present case is the first report of PTE attributed to the use of oral contraceptives after earthquakes.

Ischemic stroke occurring during intercourse in young women on oral contraceptives.

PubMed

Miller, P Elliott; Brown, Lorrel; Khandheria, Paras; Resar, Jon R

2014-08-01

Ischemic stroke occurring during intercourse in young patients is exceedingly rare. We present 2 cases of young women taking oral contraceptives, each presenting with an ischemic stroke. Transthoracic echocardiography revealed a patent foramen ovale in one patient and an atrial septal defect in the other. The most likely cause of stroke in both patients is embolic. Despite conflicting evidence, young patients presenting with ischemic stroke and found to have a patent foramen ovale or atrial septal defect should be considered for possible device-based closure. Copyright © 2014 Elsevier Inc. All rights reserved.

Three-step method for menstrual and oral contraceptive cycle verification.

PubMed

Schaumberg, Mia A; Jenkins, David G; Janse de Jonge, Xanne A K; Emmerton, Lynne M; Skinner, Tina L

2017-11-01

Fluctuating endogenous and exogenous ovarian hormones may influence exercise parameters; yet control and verification of ovarian hormone status is rarely reported and limits current exercise science and sports medicine research. The purpose of this study was to determine the effectiveness of an individualised three-step method in identifying the mid-luteal or high hormone phase in endogenous and exogenous hormone cycles in recreationally-active women and determine hormone and demographic characteristics associated with unsuccessful classification. Cross-sectional study design. Fifty-four recreationally-active women who were either long-term oral contraceptive users (n=28) or experiencing regular natural menstrual cycles (n=26) completed step-wise menstrual mapping, urinary ovulation prediction testing and venous blood sampling for serum/plasma hormone analysis on two days, 6-12days after positive ovulation prediction to verify ovarian hormone concentrations. Mid-luteal phase was successfully verified in 100% of oral contraceptive users, and 70% of naturally-menstruating women. Thirty percent of participants were classified as luteal phase deficient; when excluded, the success of the method was 89%. Lower age, body fat and longer menstrual cycles were significantly associated with luteal phase deficiency. A step-wise method including menstrual cycle mapping, urinary ovulation prediction and serum/plasma hormone measurement was effective at verifying ovarian hormone status. Additional consideration of age, body fat and cycle length enhanced identification of luteal phase deficiency in physically-active women. These findings enable the development of stricter exclusion criteria for female participants in research studies and minimise the influence of ovarian hormone variations within sports and exercise science and medicine research. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Advances in Male Contraception

PubMed Central

Page, Stephanie T.; Amory, John K.; Bremner, William J.

2008-01-01

Despite significant advances in contraceptive options for women over the last 50 yr, world population continues to grow rapidly. Scientists and activists alike point to the devastating environmental impacts that population pressures have caused, including global warming from the developed world and hunger and disease in less developed areas. Moreover, almost half of all pregnancies are still unwanted or unplanned. Clearly, there is a need for expanded, reversible, contraceptive options. Multicultural surveys demonstrate the willingness of men to participate in contraception and their female partners to trust them to do so. Notwithstanding their paucity of options, male methods including vasectomy and condoms account for almost one third of contraceptive use in the United States and other countries. Recent international clinical research efforts have demonstrated high efficacy rates (90–95%) for hormonally based male contraceptives. Current barriers to expanded use include limited delivery methods and perceived regulatory obstacles, which stymie introduction to the marketplace. However, advances in oral and injectable androgen delivery are cause for optimism that these hurdles may be overcome. Nonhormonal methods, such as compounds that target sperm motility, are attractive in their theoretical promise of specificity for the reproductive tract. Gene and protein array technologies continue to identify potential targets for this approach. Such nonhormonal agents will likely reach clinical trials in the near future. Great strides have been made in understanding male reproductive physiology; the combined efforts of scientists, clinicians, industry and governmental funding agencies could make an effective, reversible, male contraceptive an option for family planning over the next decade. PMID:18436704

Pregnancy and contraceptive use among women participating in the FEM-PrEP trial.

PubMed

Callahan, Rebecca; Nanda, Kavita; Kapiga, Saidi; Malahleha, Mookho; Mandala, Justin; Ogada, Teresa; Van Damme, Lut; Taylor, Douglas

2015-02-01

Pregnancy among study participants remains a challenge for trials of new HIV prevention agents despite promotion and provision of contraception. We evaluated contraceptive use, pregnancy incidence, and study drug adherence by contraceptive method among women enrolled in the FEM-PrEP trial of once-daily oral tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) for HIV prevention. We required women to be using effective non-barrier contraception at enrollment. At each monthly follow-up visit, women were counseled on contraceptive use and tested for pregnancy. TDF-FTC adherence was determined by measuring plasma drug concentrations at 4-week intervals. We used Cox proportional hazards models to assess factors associated with incident pregnancy and multivariate logistic regression to examine the relationship between contraceptive method used at enrollment and TDF-FTC adherence. More than half of women were not using effective contraception before enrollment. Ninety-eight percent of these women adopted either injectable (55%) or oral (43%) contraceptives. The overall pregnancy rate was 9.6 per 100 woman-years. Among injectable users and new users of combined oral contraceptives (COCs), the rates were 1.6 and 35.1, respectively. New users of injectables had significantly greater odds of adhering to TDF-FTC than new COC users [odds ratio (95% confidence interval): 4.4 (1.7 to 11.6), P = 0.002], existing COC users [3.1 (1.3 to 7.3), P = 0.01], and existing injectable users [2.4 (1.1 to 5.6), P = 0.04]. Women using COCs during FEM-PrEP, particularly new adopters, were more likely to become pregnant and less likely to adhere to study product than injectable users. HIV prevention trials should consider requiring long-acting methods, including injectables, for study participation.

Effects of a contraceptive containing drospirenone and ethinylestradiol on blood pressure, metabolic profile and neurohumoral axis in hypertensive women at reproductive age.

PubMed

de Morais, Tercio Lemos; Giribela, Cassiana; Nisenbaum, Marcelo Gil; Guerra, Grazia; Mello, Nilson; Baracat, Edmundo; Consolim-Colombo, Fernanda M

2014-11-01

The use of combined oral contraceptives is widespread among hypertensive women despite being associated with increased cardiovascular risk. Contraceptives containing drospirenone, which has antimineralocorticoid properties, may have a positive or neutral effect on neurohumoral activation and metabolic homeostasis of hypertensive women at reproductive age. To evaluate the effect of combined oral contraceptive containing drospirenone+ethinylestradiol on the systemic blood pressure, metabolic variables and neurohumoral axis in hypertensive women in reproductive age. Prospective controlled trial with 56 hypertensive women allocated in two groups: 30 volunteers under oral combined contraceptive use and 26 volunteers using non-hormonal contraceptive methods. Subjects were tested before the introduction of the contraceptive method and 6 months after its use. For data acquisition, we used continuous non-invasive beat-to-beat blood pressure curve recordings and, for the biochemical and hormonal analyses two blood samples were obtained. Student's t test was used to determine differences between groups and moments and p<0.05 was considered statistically significant. Comparing antropometric and blood pressure measurements, cardiac sympatho-vagal modulation, baroreceptor sensitivity, metabolic and neurohumoral axis variables between baseline and after 6 months, no significant difference was detected in each group or between groups. Except serum triglyceride levels which increased in the group of women using EE+DRSP after 6 months of use. A contraceptive containing 20 mcg of ethinyl estradiol and 3 mg of drospirenone causes no significant changes in clinical and autonomic parameters, metabolic variables and neurohumoral axis of hypertensive women. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Approach to the patient: contraception in women with polycystic ovary syndrome.

PubMed

Yildiz, Bulent O

2015-03-01

Polycystic ovary syndrome (PCOS) is a common reproductive and metabolic disorder. Patients with PCOS present with clinical signs of androgen excess (ie, hirsutism and acne), menstrual irregularities, and infertility. Combined oral contraceptive (OC) pills are the first-line medical therapy for the long-term management of PCOS. Containing a combination of estrogen and progestin, OCs restore regular menses, improve androgen excess, and provide effective contraception and protection from endometrial cancer. The benefits of hormonal contraception outweigh the risks in the vast majority of women with PCOS. However, concerns have been raised about potential adverse cardiovascular and metabolic effects of OCs. Currently available evidence indicates an increased relative risk of venous thrombosis associated with OCs varying among different formulations. Arterial thrombosis risk attributable to OCs does not appear to be significantly increased in young nonsmoking women. OC use might be associated with increased risk of diabetes in morbidly obese women with PCOS with severe insulin resistance. A tailored clinical approach to oral contraception in women with PCOS requires individualized risk stratification and management by determination of each PCOS patient's personal cardiometabolic risk profile at baseline and during follow-up. Before prescribing an OC, clinicians should document individual risk factors including age, smoking, obesity, any degree of glucose intolerance including prediabetes and diabetes, hypertension, dyslipidemia, thrombophilia, and personal or family history of a venous thromboembolic event.

Effect of the ethinylestradiol/levonorgestrel combined oral contraceptive on the activity of cytochrome P4503A in obese women

PubMed Central

Edelman, Alison; Munar, Myrna; Elman, Miriam R; Koop, Dennis; Cherala, Ganesh

2012-01-01

AIM(S) While it is known that CYP3A4/5 activity is decreased with combined oral contraceptive (COC) use and obesity suppresses CYP expression, the combined effects of obesity and COC use on CYP3A4/5 activity are unclear. Therefore, our aim was to examine the effect of COC usage on CYP3A4/5 activity in obese women. METHODS Thirty-four, obese (body mass index, BMI > 30 kg m−2) women of reproductive age (18–35 years old) were placed on a COC pill containing 20 µg ethinylestradiol/100 µg levonorgestrel for 21 days starting at the onset of menses. A midazolam pharmacokinetic study was conducted prior to initiation and after 21 days of COC treatment. Serial blood samples were collected and plasma concentrations of midazolam were measured using liquid chromatography tandem mass spectrometry. Pharmacokinetic parameters were estimated using a non-compartmental method. RESULTS Midazolam clearance, a surrogate measure of CYP3A4/5 activity, was significantly decreased upon COC use (63.3 l h−1vs. 53.9 l h−1, P < 0.05). A median decrease of 5.6 l h−1 (95% CI −4.1, 13.3 l h−1) was observed. However, the magnitude of change was similar to that reported in women with normal BMI. CONCLUSIONS Although we hypothesized that obesity might amplify the impact on CYP3A4/5 activity in COC users, we found that this was not the case. This finding is reassuring regarding potential additional drug−drug interactions in obese COC users as CYP3A4/5 is a major enzyme in the metabolism of many marketed drugs. PMID:22299599

International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC Study)

PubMed Central

2009-01-01

Background A 24-day regimen of contraceptive doses of drospirenone and ethinylestradiol (DRSP/EE 24d) was recently launched. This regimen has properties which may be beneficial for certain user populations (e.g., women suffering from premenstrual dysphoric disorder or acne). However, it is unknown whether this extended regimen has an impact on the cardiovascular risk associated with the use of oral contraceptives (OCs). The INternational Active Surveillance study of women taking Oral Contraceptives (INAS-OC) is designed to investigate the short- and long-term safety of the new regimen in a population which is representative for the typical user of oral contraceptives. Methods/Design A large, prospective, controlled, non-interventional, long-term cohort study with active surveillance of the study participants has been chosen to ensure reliable and valid results. More than 2,000 gynecologists in the US and 5 European countries (Austria, Germany, Italy, Poland, and Sweden) will recruit more than 80,000 OC users. The two to five year follow-up of these women will result in at least 220,000 documented women-years. The main clinical outcomes of interest for the follow-up are deep venous thrombosis, pulmonary embolism, acute myocardial infarction and cerebrovascular accidents. Secondary objectives are general safety, effectiveness and drug utilization pattern of DRSP/EE 24d, return to fertility after stop of OC use, as well as the baseline risk for users of individual OC formulations. Because of the non-interference character of this study, potential participants (first-time users or switchers) are informed about the study only after the decision regarding prescription of a new OC. There are no specific medical inclusion or exclusion criteria. Study participation is voluntary and a written informed consent is required. After the baseline questionnaire, follow-up questionnaires will be mailed to the participants every 6 months for up to 5 years after baseline. Self

Oral contraceptive use and female genital arousal: methodological considerations.

PubMed

Seal, Brooke N; Brotto, Lori A; Gorzalka, Boris B

2005-08-01

This study explored effects of oral contraceptive pill (OCP) use on physiological sexual arousal as measured by a vaginal photoplethysmograph. Sixteen women aged 18-29 viewed audiovisual neutral and erotic stimuli before and an average of 6 weeks following the onset of OCP use. Although subjective measures of sexual arousal, including perceptions of genital arousal, significantly increased in response to erotic stimuli both before and after OCP onset, physiological sexual arousal only increased before OCP use. A comparison of individual responses before and after OCP onset reveals a much higher degree of intrasubject variability after OCP onset. We discuss these findings as they relate to OCP use as a confounding methodological variable to consider in future investigations employing vaginal photoplethysmography.

Effects of oral contraception with ethinylestradiol and drospirenone on oxidative stress in women 18-35 years old.

PubMed

De Groote, Donat; Perrier d'Hauterive, Sophie; Pintiaux, Axelle; Balteau, Bénédicte; Gerday, Colette; Claesen, Jürgen; Foidart, Jean-Michel

2009-08-01

Oral contraceptives (OCs) with estrogens and progestins may affect oxidative stress (OS) status. A group of 32 women using oral contraceptives (OCU) containing 0.03 mg ethinylestradiol and 3 mg drospirenone have been compared to a matched control group of 30 noncontraception users (NCU). Blood levels of antioxidants, trace elements and markers of lipid peroxidation were assessed by biochemical methods. A microarray analysis of whole blood mRNA levels of 200 genes involved in OS-dependant pathway was also performed. Levels of zinc, vitamin E and antibodies to oxidized low-density lipoproteins (LDLs) were not significantly different between the two groups. On the other hand, significant increases in the mean levels of lipid peroxides (+176%, p<.001), oxidized LDLs (+145%, p<.002), copper (+103%, p<.001), Cu/Zn ratio (+100%, p<.001) and a significant decrease in the mean level of beta-carotene (-41%, p<.01) were observed in the OCU compared to NCU. There was a highly significant positive correlation between the lipid peroxide levels and the copper-to-zinc ratio. From the 200 genes tested by microarray, one coding for HSP70 was significantly up-regulated (log(2) fold change=+ 0.45, p<.02) and one coding for inducible nitric oxide synthase significantly down-regulated (log(2) fold change=-0.24, p<.05) in the OCU compared to the NCU. The recently introduced combination of ethinylestradiol and drospirenone induced the heightening of lipid peroxidation correlated with high levels of copper, a situation that could be associated with increased cardiovascular risk.

Contraceptive social marketing in Albania - the NESMARK story.

PubMed

Paravani, Ardian; Orgocka, Aida

2013-06-01

To present the history of social marketing of modern contraceptives in Albania. We review documentation and activity of NESMARK, an Albanian non-governmental social marketing organisation, and national data on adoption of modern contraception. During 15 years of awareness raising, sales of affordable products, and provider training, NESMARK has impacted the introduction and adoption of modern contraception in Albania. NESMARK is the country's main distributor of emergency contraception (EC) and complements the public sector in the distribution of condoms and oral contraceptives. NESMARK has made major efforts to overcome prevalent taboos and misinformation held by medical and nursing personnel, pharmacists and the general public, regarding the effectiveness and safety of condoms, oral contraceptives, and EC. NESMARK has contributed to increasing the choices for modern contraception methods in Albania by providing affordable contraceptives, training providers, and educating the general population. However, widespread use of withdrawal coupled with the belief that it is as or more effective than modern contraception, continues to limit uptake of new methods and is a significant challenge to comprehensive and sustained social marketing programmes.

Knowledge about missed contraceptive pills among married women at King Abdulaziz University Hospital

PubMed Central

Iftikhar, Rahila; Aba Al Khail, Bahaa Abdulrahman

2015-01-01

Background Oral contraceptive pills (OCPs) are one of the most reliable methods of contraception. However, lack of knowledge about oral contraceptive use and inconsistent pill-taking might result in decreased efficacy. The study reported here aimed to explore women’s knowledge about oral contraceptive use and assess the factors associated with knowledge about OCPs among users. Methods This cross-sectional survey was conducted at King Abdulaziz University Hospital, Jeddah, Saudi Arabia between April and June 2014. We included married, non-pregnant women >18 years old who had used a combined 21-day OCP for at least 3 months prior to recruitment. A questionnaire was used to collect the participants’ demographic information. It also assessed their knowledge about OCPs. Data were entered into and analyzed using SPSS software. Results A total of 357 women were recruited. Of these, 57.7% reported they knew what to do after missing one or two pills, but only 18.3% knew exactly what to do after missing more than two pills consecutively. Postgraduate women had a significantly higher knowledge score than illiterate women (P=0.002) and those who had completed at least primary education (P=0.001). Conversely, there was no difference in knowledge scores between Saudi and expatriate women (P=0.2). Monthly incomes (P=0.2) and mode of OCP selection (P=0.2) were also not significantly associated with knowledge scores. Conclusion Women had poor knowledge about OCP use. Appropriate measures should be taken to educate women about proper oral contraceptive use. PMID:25792813

Hormonal contraceptive use and women's risk of HIV acquisition: priorities emerging from recent data.

PubMed

Ralph, Lauren J; Gollub, Erica L; Jones, Heidi E

2015-12-01

Understanding whether hormonal contraception increases women's risk of HIV acquisition is a public health priority. This review summarizes recent epidemiologic and biologic data, and considers the implications of new evidence on research and programmatic efforts. Two secondary analyses of HIV prevention trials demonstrated increased HIV risk among depot medroxyprogesterone acetate (DMPA) users compared with nonhormonal/no method users and norethisterone enanthate (NET-EN) users. A study of women in serodiscordant partnerships found no significant association for DMPA or implants. Two meta-analyses found elevated risks of HIV among DMPA users compared with nonhormonal/no method users, with no association for NET-EN or combined oral contraceptive pills. In-vitro and animal model studies identified plausible biological mechanisms by which progestin exposure could increase risk of HIV, depending on the type and dose of progestin, but such mechanisms have not been definitively observed in humans. Recent epidemiologic and biologic evidence on hormonal contraception and HIV suggests a harmful profile for DMPA but not combined oral contraceptives. In limited data, NET-EN appears safer than DMPA. More research is needed on other progestin-based methods, especially implants and Sayana Press. Future priorities include updating modeling studies with new pooled estimates, continued basic science to understand biological mechanisms, expanding contraceptive choice, and identifying effective ways to promote dual method use.

Added health benefits of the levonorgestrel contraceptive intrauterine system and other hormonal contraceptive delivery systems.

PubMed

Fraser, Ian S

2013-03-01

It has been recognized for well over half a century that hormonal preparations designed as contraceptives are also capable of offering health benefits through the treatment and prevention of benign gynecological disease and even some systemic conditions. Increasing attention is now being paid to the extent and detail of such added health benefits, and it is becoming clear that the long-acting, low-dose, hormonal contraceptive delivery systems may offer particular advantages in this regard. Conventional databases were thoroughly searched, especially for publications from 2006 to 2012, which addressed non-contraceptive-related indications for therapy and prevention. A considerable literature now exists to demonstrate the multiple and substantial noncontraceptive health benefits of long-acting progestogen-releasing systems, especially the levonorgestrel-releasing intrauterine system. These benefits mainly relate to disturbances of menstruation and related symptoms, such as heavy menstrual bleeding (due to many causes); iron deficiency; pelvic pain, especially around endometriosis; and endometrial hyperplasia. The long-acting estrogen-progestogen systems may carry similar added health benefits to those of the combined oral contraceptives, but data are still lacking. Added health benefits are now becoming an important part of the contraceptive choice equation, and the long-acting delivery systems are recognized as suitable primary therapies for a range of gynecological disorders. Copyright © 2013 Elsevier Inc. All rights reserved.

The Effects of Hormonal Contraception on the Voice: History of Its Evolution in the Literature.

PubMed

Rodney, Jennifer P; Sataloff, Robert Thayer

2016-11-01

Women of reproductive age commonly use hormonal contraceptives, the vocal effects of which have been studied. Otolaryngologists should be aware of this relationship to make recommendations on hormonal contraception as it relates to each patient's voice requirements. A comprehensive literature review of PubMed was completed. The terms "contraception," "vocal folds," "vocal cords," and "voice" were searched in various combinations. Articles from 1971 to 2015 that addressed the effects of contraception on the vocal folds were included. In total, 24 articles were available for review. Historically, contraception was believed to affect the voice negatively. However, more recent studies using low-dose oral contraceptive pills (OCPs) show that they stabilize the voice. However, stabilization generally occurs only during sustained vowel production; connected speech appears unaffected. Therefore, singers may be the only population that experiences clinically increased vocal stability as a result of taking hormonal contraceptives. Only combined OCPs have been studied; other forms of hormonal contraception have not been evaluated for effects on the voice. Significant variability exists between studies in the physical attributes of patients and parameters tested. Hormonal contraception likely has no clinically perceptible effects on the speaking voice. Singers may experience increased vocal stability with low-dose, combined OCP use. Other available forms of contraception have not been studied. Greater consistency in methodology is needed in future research, and other forms of hormonal contraception require study. Copyright © 2016 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Low Level of Knowledge of Contraceptive Methods among Pregnant Teens in Brazil.

PubMed

Brito, Milena Bastos; Alves, Fernanda Scoppetta Sampaio; Souza, Marlene Quadro; Requião, Samara Rezende

2018-06-01

To describe knowledge and use of contraceptive methods among pregnant teens in Brazil. A cross-sectional survey. A tertiary care center in Bahia, Brazil. Pregnant teens 10-19 years old. Participants were asked about contraceptive knowledge and previous contraceptive use. Contraceptive knowledge, previous contraceptive use, and contraceptive intentions for after pregnancy. Other survey topics included demographic characteristics, school attendance, and sexual history. A total of 90 participants wereincluded in the study, with an average age of 15.4 ± 1.7 years, and a mean age at first sexual intercourse of 13.8 ± 1.2 years. Most participants were unmarried (58/90), of mixed race (57/90), had a household income below minimum wage (59/83), lived with their parents (54/90), and unemployment (81/90). More than 80% were not using contraception or were using it irregularly whenthey became pregnant. Most participants reported knowledge of condoms (82/90), of the combined oral contraceptive pill (75/90) and of injectable contraceptives (68/90). However, less than half reported knowledge oflong-acting reversible contraceptive methods. In terms of contraceptive intentions after pregnancy, the most commonly cited methods were the contraceptive injection (36/90), the intrauterine device (17/90) and the combined pill (9/90). In this study we found a low level of knowledge of contraceptive methods, and especially of long-acting reversible contraceptive methods, among pregnant teens in Northeast Brazil. Low socioeconomic status and high rates of unplanned pregnancy might be reasons for insufficient sexual and reproductive health counseling in this population. Copyright © 2017 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

A study of cycle control, side effects and client's satisfaction of a low dose combined contraceptive containing ethinylestradiol/drospirenone (24/4 regimen).

PubMed

Chaiyasit, Noppadol; Taneepanichskul, Surasak

2010-05-01

To study cycle control, side effects, and satisfaction of low dose 24-day combined contraceptive containing 20 microg of Ethinylestradiol and 3 mg of Drospirenone. This was an open label, non-comparative study. The healthy females from the family planning clinic at King Chulalongkorn Memorial Hospital were assigned to receive six cycles of combined oral contraceptive containing 20 microg of ethinylestradiol and 3 mg of drospirenone administered daily for 24 days followed by 4-day hormone-free interval. Data were collected on cycle control, side effects, and satisfaction. Data were analyzed using descriptive statistics for descriptive data and Paired t test for comparison. One hundred fifty four women were assigned the study medication, including one (0.64%) who did not start medication. In the second reference period, the occurrence of frequent and infrequent bleeding was low (2.1% and 4.9%). Only one woman (0.65%) discontinued medication because of irregular bleeding. There was no pregnancy reported during the present study. Overall, the study medication was well tolerated and five subjects (3.24%) discontinued study because of side effects. No serious side effects related to the study medication were reported. The majority of women (84.2%) were satisfied and very satisfied with the treatment and most (73.3%) would continue the medication if it were available. The low dose combined contraceptive containing Ethinylestradiol/Drospirenone (24/4 regimen) has acceptable cycle control and good tolerability.

How Oral Contraceptives Impact Social-Emotional Behavior and Brain Function.

PubMed

Montoya, Estrella R; Bos, Peter A

2017-02-01

Millions of women worldwide use oral contraceptives ('the pill'; OCs), often starting at a pubertal age when their brains are in a crucial developmental stage. Research into the social-emotional effects of OCs is of utmost importance. In this review, we provide an overview of studies that have emerged over the past decade investigating how OCs, and their main ingredients estradiol (E) and progesterone (P), influence social-emotional behaviors and underlying brain functions. Based on this overview, we present a heuristic model that postulates that OCs modulate core social-emotional behaviors and brain systems. Research domains and challenges for the future, as well as implications, are discussed. Copyright © 2016 Elsevier Ltd. All rights reserved.

Chronic urticaria and irregular menstrual cycle: a case report of effective therapy with oral contraception.

PubMed

Kasperska-Zając, Alicja; Zamlynski, Jacek

2012-04-01

It has been reported that urticaria may be associated with some conditions characterized by sex hormone changes. The case presented concerns a 19-year-old patient who had severe symptoms of chronic urticaria for 3 years, concomitant with an irregular menstrual cycle and functional ovarian cysts. After a laparoscopic ovarian cystectomy the patient was treated with hormonal contraceptives. After 3 weeks the symptoms of urticaria withdrew. The patient continues to receive oral contraceptive treatment, has regular menstruation and shows no symptoms of urticaria. A diagnosis with an urticaria origin should take into consideration any changes in hormone balance as one of the possible reasons for the disease. In such cases, treatment with sex hormones may positively influence the course of the illness.

Oral contraceptives and the management of hyperandrogenism-polycystic ovary syndrome in adolescents.

PubMed

Hillard, Paula J Adams

2005-09-01

Appropriate management of polycystic ovary syndrome in adolescents depends on recognizing the syndrome, which can have a variety of presenting complaints and must be differentiated from other causes of hyperandrogenism, as well as not dismissed as "normal adolescence." Oral contraceptives have long been considered the first line of treatment by obstetrician/gynecologists and have many advantages in treating the aspects of PCOS that are most bothersome to teens. Because of the potential risk for cardiovascular disease, early diagnosis and management may be helpful in minimizing the risk of the early metabolic correlates of adult disease.

Effects of the oral contraceptive pill cycle on physiological responses to hypoxic exercise

NASA Technical Reports Server (NTRS)

Sandoval, Darleen A.; Matt, Kathleen S.

2003-01-01

To test whether the oral contraceptive pill cycle affects endocrine and metabolic responses to hypoxic (fraction of inspired oxygen = 13%, P(IO2): 95 mmHg; H) versus normoxic (P(IO2):153 mmHg; N) exercise, we examined eight women (28 +/- 1.2 yr) during the third (PILL) and placebo (PLA) weeks of their monthly oral contraceptive pill cycle. Cardiopulmonary, metabolic, and neuroendocrine measurements were taken before, during, and after three 5-min consecutive workloads at 30%, 45%, and 60% of normoxic V(O2peak) in H and N trials. Heart rate response to exercise was greater in H versus N, but was not different between PILL and PLA. Lactate levels were significantly greater during exercise, and both lactate and glucose levels were significantly greater for 30 min after exercise in H versus N (p < 0.0001). When expressed relative to baseline, lactate levels were lower in PILL versus PLA, but glucose was greater in PILL versus PLA (p < 0.001). Cortisol levels were also significantly greater in PILL versus PLA (p < 0.001). Norepinephrine levels were significantly increased during exercise (p < 0.0001) and in H versus N (p < 0.0001). However, epinephrine levels were not different over time or with trial. Thus, the presence of circulating estradiol and progesterone during the PILL phase reduces glucose and lactate responses to hypoxic exercise.

Polycystic ovary syndrome and combined oral contraceptive use: a comparison of clinical practice in the United States to treatment guidelines.

PubMed

Bird, Steven T; Hartzema, Abraham G; Etminan, Mahyar; Brophy, James M; Delaney, Joseph A C

2013-04-01

The October 2010 ESHRE/ASRM polycystic ovary syndrome (PCOS) workshop concluded: (1) all combined oral contraceptives (COC) appear to have equal efficacy for PCOS, (2) addition of antiandrogens (spironolactone) to COCs has little treatment benefit and (3) metformin does not improve the live-birth rate and should only be used with impaired glucose tolerance. We compared these guidelines to current practice in the United States IMS claims-database. Time-series analyses were conducted by calendar-year in women with PCOS to evaluate prescribing preferences for COCs, concomitant use of spironolactone, and utilization of metformin. Trends were analyzed with linear regression. Our cohort included 1.6 million women taking COCs, 46 780 with a PCOS claim. Drospirenone utilization increased by 1.52% (SE:0.48%, p = 0.007) per-year more in women with PCOS (4.16%, SE:0.45%, p < 0.001) than in women without PCOS (2.64%, SE:0.17%, p < 0.001)). Concomitant use of drospirenone and spironolactone was common (14.26%) and increased by 0.75% (SE:0.15%, p = 0.002) per-year. Although plasma glucose tests were unavailable, women with PCOS were more likely to take metformin than have a diabetes claim (45.8% versus 15.2%, p < 0.001), indicating some women likely receive metformin solely for PCOS. Our data suggests further attention is needed to medication management of PCOS to bridge the gap between guidelines and practice.

Effect of oral contraceptives containing estradiol and nomegestrol acetate or ethinyl-estradiol and chlormadinone acetate on primary dysmenorrhea.

PubMed

Grandi, Giovanni; Napolitano, Antonella; Xholli, Anjeza; Tirelli, Alessandra; Di Carlo, Costantino; Cagnacci, Angelo

2015-10-01

To study the three cycles effect on primary dysmenorrhea of the monophasic 24/4 estradiol/nomegestrol acetate (E2/NOMAC) and of the 21/7 ethinyl-estradiol/chlormadinone acetate (EE/CMA) oral contraceptive. The tolerability and the effect of both preparations on metabolism and health-related quality of life were also evaluated. Prospective observational cohort study. Tertiary gynecologic center for pelvic pain. Subjects with primary dysmenorrhea requiring an oral contraceptive, who spontaneously selected either E2/NOMAC (n = 20) or EE/CMA (n = 20). Visual Analogue Scale (VAS) score for dysmenorrhea, Short Form-36 questionnaire for health-related quality of life, lipoproteins and days of menstrual bleeding (withdrawal bleeding during oral contraceptive). Mean age and body mass index (BMI) were similar between the two groups. The final analysis was performed on 34 women, 15 in E2/NOMAC and 19 in EE/CMA group. Compliance with treatment was significantly higher with EE/CMA (100%) than E2/NOMAC (75%) (p = 0.02). Both treatments significantly (p < 0.0001) reduced VAS of primary dysmenorrhea, similarly (E2/NOMAC by a mean of 74.7%, EE/CMA by a mean of 78.4%; p = 0.973). Only E2/NOMAC significantly increased SF-36 score (p = 0.001), both in physical (p = 0.001) and mental domains (p = 0.004). The mean number of days of menstrual bleeding was significantly reduced in E2/NOMAC group (from 4.86 ± 1.20 d to 2.64 ± 1.59 d, p = 0.0005 versus baseline, p = 0.007 versus EE/CMA group). BMI did not vary in either group. E2/NOMAC did not change lipoproteins and apoproteins while EE/CMA increased total cholesterol (p = 0.0114), HDL-cholesterol (p = 0.0008), triglycerides (p = 0.002), apoprotein-A1 (Apo-A1; p = 0.0006) and apopoprotein-B (Apo-B; p = 0.008), decreasing LDL/HDL ratio (p = 0.024). Both oral contraceptives reduced similarly primary dysmenorrhea, with E2/NOMAC also reducing withdrawal bleedings and

Emergency Contraception.

PubMed

Batur, Pelin; Kransdorf, Lisa N; Casey, Petra M

2016-06-01

Emergency contraception (EC) may help prevent pregnancy in various circumstances, such as contraceptive method failure, unprotected sexual intercourse, or sexual assault, yet it remains underused. There are 4 approved EC options in the United States. Although ulipristal acetate requires a provider's prescription, oral levonorgestrel (LNG) is available over the counter for women of all ages. The most effective method of EC is the copper intrauterine device, which can be left in place for up to 10 years for efficacious, cost-effective, hormone-free, and convenient long-term primary contraception. Ulipristal acetate tends to be more efficacious in pregnancy prevention than is LNG, especially when taken later than 72 hours postcoitus. The mechanism of action of oral EC is delay of ovulation, and current evidence reveals that it is ineffective postovulation. Women who weigh more than 75 kg or have a body mass index greater than 25 kg/m(2) may have a higher risk of unintended pregnancy when using oral LNG EC; therefore, ulipristal acetate or copper intrauterine devices are preferable in this setting. Providers are often unaware of the range of EC options or are unsure of how to counsel patients regarding the access and use of EC. This article critically reviews current EC literature, summarizes recommendations, and provides guidance for counseling women about EC. Useful tips for health care providers are provided, with a focus on special populations, including breast-feeding women and those transitioning to long-term contraception after EC use. When treating women of reproductive age, clinicians should be prepared to counsel them about EC options, provide EC appropriately, and, if needed, refer for EC in a timely manner. Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

Knowledge-attitude-practice survey among Portuguese gynaecologists regarding combined hormonal contraceptives methods.

PubMed

Bombas, Teresa; Costa, Ana Rosa; Palma, Fátima; Vicente, Lisa; Sá, José Luís; Nogueira, Ana Maria; Andrade, Sofia

2012-04-01

ABSTRACT Objectives To evaluate knowledge, attitude and practices of Portuguese gynaecologists regarding combined hormonal contraceptives. Methods A cross-sectional survey was conducted among 303 gynaecologists. Results Ninety percent of the gynaecologists considered that deciding on contraceptive methods is a process wherein the woman has her say. Efficacy, safety and the woman's preference were the major factors influencing gynaecologists, while efficacy, tolerability and ease of use were the major factors perceived by the specialists to influence the women's choice. Gynaecologists believed that only 2% of women taking the pill were 100% compliant compared to 48% of those using the patch and 75% of those using the ring. The lower risk of omission was the strong point for the latter methods. Side effects were the main reason to change to another method. Vaginal manipulation was the most difficult topic to discuss. Conclusions Most gynaecologists decided with the woman on the contraceptive method. The main reasons for the gynaecologist's recommendation of a given contraceptive method and the women's choice were different. Counselling implies an open discussion and topics related to sexuality were considered difficult to discuss. Improving communication skills and understanding women's requirements are critical for contraceptive counselling.

Oral contraceptive plus antiandrogen therapy and cardiometabolic risk in polycystic ovary syndrome.

PubMed

Harmanci, Ayla; Cinar, Nese; Bayraktar, Miyase; Yildiz, Bulent Okan

2013-01-01

Oral contraceptives alone or in combination with antiandrogens are commonly used in the treatment for polycystic ovary syndrome (PCOS). We aimed to determine the effects of ethinyl estradiol/drospirenone (EE-DRSP) plus spironolactone therapy on inflammation and cardiometabolic risk in PCOS. Prospective cohort study. Twenty-three lean, normal glucose-tolerant patients with PCOS and 23 age- and body mass index (BMI)-matched healthy control women. Androgens, high-sensitivity C-reactive protein (hsCRP), homocysteine, lipids, fasting insulin, and glucose levels during a standard 75-g, 2-h oral glucose tolerance test were measured. Patients with PCOS were evaluated before and after receiving EE-DRSP (3 mg/30 μg) plus spironolactone (100 mg/day) for 6 months. Healthy controls were evaluated at baseline only. hsCRP, homocysteine, lipids, insulin and glucose levels were similar between patient and control groups at baseline. EE-DRSP plus spironolactone increased hsCRP and homocysteine levels in patients with PCOS (0.50 ± 0.28 vs 1.5 ± 1.3 mg/l, P < 0.05 and 13.1 ± 5.2 vs 17.6 ± 5.3 μm, P < 0.05, respectively). BMI, waist-to-hip ratio, LDL, HDL cholesterol and triglycerides, and glucose tolerance did not change. Modified Ferriman-Gallwey hirsutism scores, testosterone levels and free androgen index improved (9.1 ± 4.2 vs 6.2 ± 3.4, P = 0.001; 80.6 ± 31.1 47.8 ± 20.3 ng/dl, P < 0.05; and 10.5 ± 7.4 vs 1.1 ± 0.8, P < 0.001, respectively). EE-DRSP plus spironolactone therapy in 6 months improves androgen excess in lean PCOS women without any adverse effects on adiposity, glucose tolerance status or lipid profile. However, this combination increases hsCRP and homocysteine levels. © 2012 Blackwell Publishing Ltd.

The Role of Oral Contraceptive Pills on Increased Risk of Breast Cancer in Iranian Populations: A Meta-analysis.

PubMed

Soroush, Ali; Farshchian, Negin; Komasi, Saeid; Izadi, Neda; Amirifard, Nasrin; Shahmohammadi, Afshar

2016-12-01

Cancer is one of the main public health issues in the world. Breast cancer is one of the most common types of cancer among women. It is also the second cause of mortality in women. The association between the use of oral contraceptive pills and breast cancer is controversial and a main issue in public health. Some findings have shown that taking these pills does not have a significant effect in increasing the risk of breast cancer, while others have confirmed the carcinogenic effect of these products. These contradictory findings necessitated this meta-analysis, through of all correlated studies in Iran. All published studies were considered from June 2000 until June 2015, using reliable Latin databases like PubMed, Google Scholar, Google search, Scopus, and Science Direct, and Persian database like SID, Irandoc, IranMedex, and Magiran. Finally, 26 papers were selected: 24 studies were case control while two were population based studies. A total of 26 papers with 46,260 participants were assessed since 2001. Overall estimate of OR for the effect of oral contraceptive pills on breast cancer is 1.521 (CI = 1.25-1.85), which shows that the intervention group had more chance (52%) compared to the control group ( P = 0.001). Using these pills increased the risk of breast cancer up to 1.52 times. Because of directly increasing levels of estrogen and the role of estrogen in gaining weight indirectly, oral contraceptive pills can stimulate the occurrence of breast cancer. More studies should be conducted for controlling the period of pill use.

Effects of a contraceptive containing drospirenone and ethinyl estradiol on blood pressure and autonomic tone: a prospective controlled clinical trial.

PubMed

Nisenbaum, Marcelo Gil; de Melo, Nilson Roberto; Giribela, Cassiana Rosa Galvão; de Morais, Tércio Lemos; Guerra, Grazia Maria; de Angelis, Katia; Mostarda, Cristiano; Baracat, Edmund Chada; Consolim-Colombo, Fernanda Marciano

2014-04-01

The use of combined oral contraceptives has been associated with an increased risk of adverse cardiovascular events. Whether these drugs alter cardiac autonomic nervous system control is not completely determined. To evaluate the effect of a contraceptive containing 20mcg of ethinyl estradiol and 3mg of drospirenone on the heart rate variability, baroreflex sensitivity and blood pressure of healthy women. Prospective controlled trial with 69 healthy women allocated in two groups: 36 volunteers under oral combined contraceptive use and 33 volunteers using of non-hormonal contraceptive methods. Subjects were tested before the introduction of the contraceptive method and 6 months after its use. For data acquisition, we used continuous non-invasive beat-to-beat blood pressure curve recordings. Multiple ANOVA was used to determine differences between groups and moments and p< 0.05 was considered statistically significant. At baseline, there were no differences in demographic and autonomic parameters between groups. Comparing cardiac sympatho-vagal modulation, baroreceptor sensitivity and blood pressure measurements between baseline and after 6 months, no significant difference was detected in each group or between groups. A contraceptive containing 20mcg of ethinyl estradiol and 3mg of drospirenone causes no significant changes in clinical, hemodynamic and autonomic parameters of normal women. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Spermatogenetic inhibition in men taking a combination of oral medroxyprogesterone acetate and percutaneous testosterone as a male contraceptive method.

PubMed

Soufir, J-C; Meduri, G; Ziyyat, A

2011-07-01

We previously demonstrated in a small pilot study that oral medroxyprogesterone acetate and percutaneous testosterone (OMP/PT) induce reversible spermatogenesis suppression. The aims of this study were to determine the rate of spermatogenetic inhibition and recovery and to obtain preliminary data on efficacy for a larger population under OMP/PT. A total of 35 healthy men with normal spermiograms requesting male hormonal contraception were treated with OMP (20 mg/day) and PT (50-125 mg/day) for periods up to 18 months. Couples were included in a contraceptive efficacy phase after a value of ≤1 million/ml spermatozoa was reached between 1 and 3 months of treatment. Sperm counts decreased by 47% at 1 month, reaching 90% at 2 months and 98-100% between 4 and 8 months. At 3 months, 80% of men had ≤1 million/ml spermatozoa. Follicle-stimulating hormone and luteinizing hormone decreased to 35% of pretreatment levels after 1 month of treatment and to 75-80% at 2 and 6 months, respectively. Plasma testosterone and estradiol levels were in the eugonadal range at 3, 6, 9 and 12 months of treatment. Dihydrotestosterone concentrations were 2-4 times higher than pretreatment values. The rate of spermatogenetic recovery was rapid (73 ± 29.5 days). During the efficacy phase (211 months for 25 couples), one pregnancy attributable to poor compliance of the male partner was observed. OMP/PT efficiently inhibits spermatogenesis in 80% of men, maintains testosterone at physiological levels and avoids the need for parenteral administration, which is poorly accepted by French men. These results justify larger studies to define a more adequate dosage of OMP/PT and to confirm its efficacy and safety.

Contraception today.

PubMed

Benagiano, Giuseppe; Bastianelli, Carlo; Farris, Manuela

2006-12-01

Modern contraceptive methods represent more than a technical advance: they are the instrument of a true social revolution-the "first reproductive revolution" in the history of humanity, an achievement of the second part of the 20th century, when modern, effective methods became available. Today a great diversity of techniques have been made available and-thanks to them, fertility rates have decreased from 5.1 in 1950 to 3.7 in 1990. As a consequence, the growth of human population that had more than tripled, from 1.8 to more than 6 billion in just one century, is today being brought under control. At the turn of the millennium, all over the world, more than 600 million married women are using contraception, with nearly 500 million in developing countries. Among married women, contraceptive use rose in all but two developing countries surveyed more than once since 1990. Among unmarried, sexually active women, it grew in 21 of 25 countries recently surveyed. Hormonal contraception, the best known method, first made available as a daily pill, can today be administered through seven different routes: intramuscularly, intranasally, intrauterus, intravaginally, orally, subcutaneously, and transdermally. In the field of oral contraception, new strategies include further dose reduction, the synthesis of new active molecules, and new administration schedules. A new minipill (progestin-only preparation) containing desogestrel has been recently marketed in a number of countries and is capable of consistently inhibiting ovulation in most women. New contraceptive rings to be inserted in the vagina offer a novel approach by providing a sustained release of steroids and low failure rates. The transdermal route for delivering contraceptive steroids is now established via a contraceptive patch, a spray, or a gel. The intramuscular route has also seen new products with the marketing of improved monthly injectable preparations containing an estrogen and a progestin. After the first

Hormonal Contraception, Body Water Balance and Thermoregulation

DTIC Science & Technology

1997-10-01

Schreiber, and M. D. Lindheimer. Effect of ovarian sex steroids on osmoregulation and vasopressin secretion in the rat. Am. J. Physiol. 250 (Endocrinol...two widely used oral contraceptive preparations differ significantly in their estrogenicity. Estrogens have potent effects on the regulation of body...water balance (1, 4), so these two forms of oral contraceptive pills may differ in their effects on water regulation, and hence on physical performance

The effect of price increases on contraceptive sales in Bangladesh.

PubMed

Ciszewski, R L; Harvey, P D

1994-01-01

In April 1990, the prices of five brands of contraceptives in the Bangladesh social marketing project were increased, by an average of 60%. The impact on condom sales was immediate and severe, with sales for the following 12 months dropping by 46% from the average during the preceding 12 months. The effect on oral contraceptive sales was less dramatic: average sales in the year following the increases dropped slightly despite a previously established pattern of rapidly rising sales. There appears no reasonable combination of events other than the price increase itself to explain most of the difference.

Relative impact of smoking and oral contraceptive use on women in the US

DOE Office of Scientific and Technical Information (OSTI.GOV)

Goldbaum, G.M.; Kendrick, J.S.; Hogelin, G.C.

Women who smoke and use oral contraceptives (OCs) are at increased risk for cardiovascular and cerebrovascular disease. To study the prevalence of smoking and OC use and of other behaviors affecting health, 28 states and the District of Columbia conducted telephone surveys during 1981 through 1983. More than 22,000 US adults were interviewed, of whom 5779 women aged 18 to 44 years were studied. Data were weighted to represent the US population. Overall, 7.4% of US women aged 18 to 44 years reported smoking and using OCs' 1.1% reported smoking 25 or more cigarettes per day while using OCs. Althoughmore » women aged 18 to 24 years were most likely to smoke and use OCs, combined smoking and OC use contributed substantially to the number of excess cases of myocardial infarctions occurring among US women aged 35 to 44 years. However, regardless of OC use, smoking accounted for most of the excess cases. Therefore, health care providers need to intensity their efforts to reduce smoking among their patients.« less

The underutilization of emergency contraception.

PubMed

Devine, Kit S

2012-04-01

Despite the availability of effective contraceptive methods, unintended pregnancy continues to be a significant health problem for women throughout the world. The reasons for unplanned pregnancy include failure to use contraception, incorrect use of contraception, unplanned consensual intercourse, and rape. Emergency contraception was once heralded as a means of reducing the rates of unintended pregnancy, elective abortion, and unwanted childbirth. But more than three decades after the first oral form was introduced, the use of emergency contraception remains suboptimal-even in the United States, where it is available to most women of childbearing age without a prescription. Nurses can help narrow this clinical gap in women's health care by increasing awareness of emergency contraception, correcting common misconceptions about its mechanism of action and potential adverse effects, and facilitating patient access.

[Oral contraception, glucid metabolism and monitoring criteria].

PubMed

Gaspard, U

1988-02-01

Combined oral contraceptives (OCs) entail insulin resistence and decreased glucose tolerance proportional to their dose and type of progestin. Derivatives of 19-nortestosterone have more deleterious effects than do derivatives of 17-acetoxy progesterone. The effects are usually reversible and limited, and the diabetogenic role of currently available low-dose OCs is small. Metabolic and vascular risks must still be taken into account in prescribing OCs because hyperglycemia and hyperinsulinemia are significant vascular risk factors. Women with histories of OC use have increased risks of fatal and nonfatal myocardial infarct, cerebrovascular accidents, and peripheral vascular disease, but the increases are not always significant. Age and smoking are known to be primary risk factors whose effects are increased by OCs. Reduction of the estrogen dose of OCs may have resulted in a significant reduction of the venous thromboembolic risk, while reduction of the progestin dose may have resulted in a decreased incidence of venous accidents. The mechanisms of action by which OCs amplify existing vascular risks are largely unknown. Research with methods capable of quantifying insulin resistence suggests that a post-receptor intracellular effect is responsible for insulin resistence and diminished intracellular metabolism of glucose in users of OCs. Because OCs are ordinarily used by healthy young women over long periods of time with minimal medical supervision, it is desirable to identify cases in which cardiovascular and other undesirable secondary effects are likely. OCs are contraindicated for any woman with a history of cardiac accidents, venous or arterial vascular problems, or hypertension. Obesity is a relative contraindication because it may coexist with a problem of glucose metabolism and constitute a diabetic risk factor. Other diabetic risk factors that must be evaluated are age, family or personal history of gestational diabetics, and transitory problems of glucose

Determining the time androgens and sex hormone-binding globulin take to return to baseline after discontinuation of oral contraceptives in women with polycystic ovary syndrome: a prospective study.

PubMed

Sánchez, Luis A; Pérez, Marilda; Centeno, Indira; David, Marisa; Kahi, Doris; Gutierrez, Elizabeth

2007-03-01

In this study, discontinuation of oral contraceptive pills in women with polycystic ovary syndrome was followed by the return of all measured androgens and sex hormone-binding globulin levels to basal values after 8 weeks. These observations are pertinent to the measurement of androgens and sex hormone-binding globulin levels in subjects who currently are taking oral contraceptive pills and have symptoms that are related to polycystic ovary syndrome.

ACOG Committee Opinion Number 542: Access to emergency contraception.

PubMed

2012-11-01

Emergency contraception includes contraceptive methods used to prevent pregnancy in the first few days after unprotected intercourse, sexual assault, or contraceptive failure. Although the U.S. Food and Drug Administration approved the first dedicated product for emergency contraception in 1998, numerous barriers to access to emergency contraception remain. The purpose of this Committee Opinion is to examine the barriers to the use of oral emergency contraception methods and to highlight the importance of increasing access.

Effects of hormonal contraceptive use on HIV acquisition and transmission among HIV-discordant couples.

PubMed

Lutalo, Tom; Musoke, Richard; Kong, Xiangrong; Makumbi, Fred; Serwadda, David; Nalugoda, Fred; Kigozi, Godfrey; Sewankambo, Nelson; Sekasanvu, Joseph; Wawer, Maria; Gray, Ronald

2013-10-01