Two-pill regimens of misoprostol after mifepristone medical abortion through 63 days' gestational age: a randomized controlled trial of sublingual and oral misoprostol

Background

A 400 mcg dose of sublingual misoprostol has high efficacy and few side effects when used with 200 mg mifepristone for medical abortion through 63 days' gestation.

Study Design

Eligible and consenting women (n=480) were randomized to 400 mcg of misoprostol sublingually or orally, 24 h after 200 mg of mifepristone. Abortion status was assessed two weeks later.

Results

Complete abortion occurred in 98.7% of the sublingual group and 94.0% of the oral group (p value=.006, RR: 1.05, 95% CI=1.01--1.09). Over 90% of women in both arms expressed high satisfaction with the method. Side effects were similar in both groups, with only fever or chills reported by significantly more women in the sublingual arm.

Conclusions

The sublingual route appears superior to the regimen of 400 mcg misoprostol used orally and may be a good option for mifepristone medical abortion.     

Effects of progesterone, levonorgestrel and medroxyprogesterone acetate on apoptosis in human endometrial endothelial cells

Background

We evaluated apoptosis in human endometrial endothelial cells (HEECs) incubated with progesterone, levonorgestrel (LNG) and medroxyprogesterone acetate (MPA).

Study Design

HEECs were cultured to near confluence, and the progestogens were added.

Setting

Academic Department of Obstetrics and Gynecology.

Patients

No patients were involved.

Interventions

Progestogens at 5-, 250- and 500-ng/mL concentrations were added to incubations of HEECs for 12, 24 and 48 h.

Main Outcome Measure

Apoptosis based on terminal deoxynucleotidyl transferase-mediated deoxy-UTP nick-end labeling (TUNEL), and semiquantification of Bax and Bcl-2.

Results

No apoptosis was found by TUNEL, Bax and Bcl-2 after 12 h incubation with any progestogen. TUNEL increased after incubation for 24 and 48 h with progesterone 500 ng/mL; LNG 250, 500 ng/mL and all concentrations of MPA (p<.001), Bax increased and Bcl-2 decreased at all concentrations of MPA and the two highest concentrations of LNG at 48 h (p<.05).

Conclusion

MPA results in apoptosis of HEECs.     

Effects of two combined hormonal contraceptives with the same composition and different doses on female sexual function and plasma androgen levels

Background

This study was conducted to compare the effects of two contraceptive pills with different doses of the same components, on plasma androgen levels and female sexual function among women without previous sexual dysfunction.

Study Design

The participants were randomized into two groups, to receive pills containing ethynylestradiol (EE) 30 mcg and levonorgestrel (LNG) 150 mcg or EE 20 mcg and LNG 100 mcg, for six cycles. Sexual function was assessed using a standardized questionnaire [Female Sexual Function Index (FSFI)]. Hormone assays were performed at baseline and after the sixth cycle.

Results

Forty-nine women were included in the EE30/LNG150 group and 48 in the EE20/LNG100 group. EE30/LNG150 group presented 54% and 67% decreases of total testosterone and free androgen index, respectively, with statistical significance. EE20/LNG100 presented reductions of 20% and 42%, respectively, but without statistical significance. Both groups showed improvements in the FSFI “desire” score, but with statistical significance only for EE20/LNG100 group.

Conclusions

EE30/LNG150 decreased plasma androgen levels, but there was no impairment in sexual desire, on the other hand, sexual desire score increased with EE20/LNG100 formulation.     

Ovarian activity and safety of a novel levonorgestrel/ethinyl estradiol continuous oral contraceptive regimen

Background

A continuous regimen of oral levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg was evaluated for inhibition of ovulation, time to return to ovulation after stopping treatment and safety.

Study Design

This open-label study was conducted in healthy women aged 18-35 years. Ovulation was documented before treatment, and then participants received oral tablets containing LNG 90 mcg/EE 20 mcg to be taken continuously for three 28-day intervals. Ovarian activity was assessed three times per week during the treatment period with transvaginal ultrasound scans and measurements of serum 17β-estradiol, progesterone, follicle-stimulating hormone and luteinizing hormone concentrations. Safety assessments included physical examinations, laboratory evaluations and adverse event records.

Results

Thirty-seven of the 58 subjects who received treatment met predefined criteria for efficacy analysis. No on-treatment ovulations occurred in the efficacy or intent-to-treat population. There was evidence of ovulation within 37 days of stopping treatment for 46 (98%) of 47 subjects evaluated posttreatment. The final subject with a history of polycystic ovarian syndrome ovulated by Day 66. The safety profile observed during this 84-day continuous regimen was similar to that seen with other low-dose oral contraceptives administered in a cyclic regimen.

Conclusions

The continuous LNG/EE regimen completely inhibited ovulation, with little evidence of follicular development and with rapid return of ovulatory capacity after stopping treatment.     

Efficacy and safety of a low-dose combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 mcg in a 24/4-day regimen

Objective

The study was conducted to assess the efficacy of a low-dose combined oral contraceptive (COC) containing drospirenone (drsp) 3 mg/ethinylestradiol (EE) 20 mcg administered for 24 days of active treatment followed by a 4-day hormone-free interval (24/4 regimen).

Study Design

In this open-label uncontrolled study conducted in 50 European centers, healthy females aged 18-35 years with a body mass index of less than 30 kg/m² received drsp 3 mg/EE 20 mcg 24/4 over 13 cycles. The primary efficacy variable was the number of unintended pregnancies.

Results

Five pregnancies occurred among 1101 women over 13,248 treatment cycles, resulting in a Pearl Index (PI) of 0.49 with an upper two-sided 95% CI limit of 1.14. Of these pregnancies, three were attributed to noncompliance with tablet use resulting in an adjusted PI for ‘perfect use’ of 0.22 (upper limit of two-sided 95% CI: 0.80) based on 11,755 cycles.

Conclusion

Drospirenone 3 mg/EE 20 mcg 24/4 is a highly effective COC in nonobese women.     

Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel

Background

This study compared the bleeding pattern, cycle control and safety of an oral contraceptive (OC) comprising estradiol valerate/dienogest (E2V/DNG; administered using a dynamic dosing regimen) with a monophasic OC containing ethinyl estradiol 20 mcg/levonorgestrel 100 mcg (EE/LNG). E2V releases estradiol (E2), which is identical to endogenously produced 17β-estradiol.

Study design

This was a randomized, multicenter, double-blind, double-dummy trial lasting seven cycles in healthy women aged 18-50 years.

Results

Overall, 798 women were randomized and received allocated treatment (399 per group). There were significantly fewer bleeding/spotting days reported by women who received E2V/DNG than those who received EE/LNG [17.3±10.4 vs. 21.5±8.6, respectively, p<.0001, Reference Period 1 (Days 1-90); and 13.4±9.vs. 15.9±7.1, respectively, p<.0001, Reference Period 2 (Days 91-180)]. Through Cycles 1-7, the occurrence of scheduled withdrawal bleeding per cycle was 77.7-83.2% with E2V/DNG and 89.5-93.8% with EE/LNG (p<.0001 per cycle). The duration and intensity of scheduled withdrawal bleeding were reduced with E2V/DNG vs. EE/LNG. The incidence of intracyclic bleeding was similar with E2V/DNG (10.5%-18.6%) and EE/LNG (9.9%-17.1%) (p>.05 per cycle). No unintended pregnancies occurred with E2V/DNG, but there was one unintended pregnancy with EE/LNG. Adverse drug reactions occurred in 10.0% and 8.5% of women taking E2V/DNG and EE/LNG, respectively. Overall, 79.4% of women were satisfied with E2V/DNG and 79.9% with EE/LNG.

Conclusions

A novel OC composed of E2V/DNG is associated with an acceptable bleeding profile that is comparable to that of an EE-containing OC.     

Effect of contraceptive pill on the selenium and zinc status of healthy subjects

Background

The study was conducted to ascertain the influence of oral contraceptive pill (OCP) uptake on serum zinc and selenium in contraceptive pill users.

Study Design

The concentration of zinc and selenium was determined by atomic absorption spectrophotometer in 50 healthy women with normal menstrual cycles as a control group and 50 women taking low-dose OCP.

Results

The control reference values were 81.61±9.44 and 70.35±25.57 mcg/dL, which were obtained for zinc and selenium, respectively. Use of OCP resulted in a significant decrease in serum zinc levels (p≤.009, t=−3.666) and alteration of selenium levels but not significantly (p=.08, t=0.935). The duration of use beyond 3 months had no effect on the magnitude of the decrease in serum zinc levels.

Conclusions

These findings may be important because selenium is currently believed to offer protective benefits against carcinogenesis. It has been thought that the decrease in serum zinc could be reflected in a reduction of tissue zinc status due to changes in zinc absorption, excretion or tissue turnover. If these changes occur, the dietary zinc requirement would be greater in women using OCP.     

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

Background

The study was conducted to compare cycle control, bleeding pattern and efficacy of two low-dose combined oral contraceptives.

Study Design

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.

Results

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%).

Conclusion

Drsp 3 mg/EE 20 mcg 24/4 achieved an acceptable bleeding profile with reliable cycle control, comparable with an established formulation.     

Menstrual blood loss in women using the frameless FibroPlant LNG-IUS

Background

This study was conducted to report on a menstrual blood loss (MBL) study and iron stores in women with and without heavy menstrual bleeding using the frameless FibroPlant^® levonorgestrel-releasing intrauterine system (LNG-IUS) for contraception.

Study design

An open, prospective, noncomparative MBL study, using FibroPlant^® releasing 14 mcg of LNG/day for contraception. MBL was assessed by the quantitative alkaline hematin (QAH) technique.

Results

The MBL study was conducted in 40 heavy and normally menstruating Brazilian women seeking contraception. MBL was reduced from a mean baseline menstrual volume of 29.7 mL to a mean volume of 1.5 mL after 24 months, while ferritin values increased from a mean value of 31.1 ng/mL (at baseline) to a mean level of 72.5 ng/mL (after 24 months of use). Differences were highly significant (p<.0005). There were no significant differences between those who had normal menstrual bleeding and the heavy bleeders. The heavy bleeders had comparable MBL to the normal bleeders 3 months after insertion, and by 24 months post-insertion, their ferritin levels were comparable to those of the normal bleeders. Amenorrhea occurred in 80% of women out of 40 after 24 months of use. No pregnancies were recorded.

Conclusion

The LNG-IUS is effective in reducing MBL in normally menstruating women as well as in women with heavy menstrual bleeding. The authors agree with the recommendations by the UK National Institute for Clinical Effectiveness and the new Finnish guidelines for heavy menstrual bleeding that the LNG-IUS should be positioned as first-line treatment prior to endometrial ablation or hysterectomy.     

The efficacy and safety of a low-dose, 91-day, extended-regimen oral contraceptive with continuous ethinyl estradiol

Background

This clinical trial was conducted to demonstrate the efficacy and safety of a 91-day extended-regimen, low-dose combination oral contraceptive (OC) consisting of 84 days of ethinyl estradiol (EE) 20 mcg/levonorgestrel (LNG) 100 mcg, followed by 7 days of 10 mcg EE in place of placebo.

Study Design

A multicenter open-label, single-treatment, Phase 3 study evaluated women aged 18 through 40 years over a treatment period of up to 1 year (four 91-day extended cycles). All subjects completed daily paper diaries to monitor compliance, bleeding and additional forms of contraception used during the course of the study.

Results

A total of 1249 subjects completed the study. The Pearl Index was 2.74 (95% confidence interval, 1.92-3.78), based on 36 pregnancies that occurred after the onset of treatment and within 14 days after the last combination tablet in women aged 18-35 years. Among compliant-use subjects 18-35 years old, the Pearl Index was 1.73 based on 22 on-treatment pregnancies. The life table pregnancy rate for subjects 18-35 years of age was 2.39%. Cycle control and adverse events reported with this regimen were similar to those reported with other low-dose OCs.

Conclusions

This study demonstrated effective prevention of pregnancy with a 20-mcg EE, 91-day extended-regimen OC. In addition, the regimen was well tolerated and incidence of adverse events were consistent with what has been reported with other low-dose OCs.     

Urinary Isoflavones and Their Metabolites Validate the Dietary Isoflavone Intakes in US Adults

Background

Isoflavones are derived from dietary sources and considered to promote health by preventing the onset of such chronic diseases as cardiovascular disease, cancer, and osteoporosis. Valid and reliable estimation of isoflavone intake is a prerequisite to establishing biological functions of isoflavones on health risks.

Objective

This study aimed to validate the approach of estimating dietary isoflavone intake with respective urinary isoflavone concentrations in US adults.

Design

Data from the US Department of Agriculture isoflavone database and dietary recalls of 2,908 US adults with urinary isoflavone data in the 1999-2002 National Health and Nutrition Examination Survey were used.

Results

Dietary isoflavone was consumed by only 35% of adults in a day with an average intake of 3.1 mg/day, which resulted in a mean intake of 1.0 mg/day for all US adults. The isoflavone intakes were from genistein (55%), diadzein (35%), glycitein (7%), biochanin A (2%), and formononetin (2%). Both daily total and energy adjusted isoflavone intake differed by race/ethnicity subgroups (P<0.05) and was associated positively with income (P<0.01) and inversely with body mass index (P<0.05). Geometric mean urinary isoflavone concentration was 5.0 ng/mL among isoflavone consumers and the urinary genistein and daidzein excretion correlated with their isoflavone intake levels (P<0.01).

Conclusions

In large population-based studies, estimated dietary isoflavone intake can be validated by urinary isoflavones. Further studies are needed at an individual level to validate dietary isoflavone intake by urinary isoflavone concentration.     

Fracture risk in very young women using combined oral contraceptives

Background

Little is known on fracture risk in young women using oral contraceptives.

Study Design

Case-control study (64,548 cases, 193,641 controls).

Results

Overall, no major association with risk of fracture was present. Only in a few age groups a limited increase (OR 1.1-1.5) was seen in those using low average doses (less than one tablet per day — i.e., intermittent use). Neither 20 nor ≥30 mcg per day of ethinylestradiol was associated with risk of fractures, while changing from 20 to ≥30 mcg per day or vice versa was associated with a limited increase in fracture risk (OR 1.1-1.4) in some age groups.

Conclusions

In general, use of oral contraceptives in young women did not seem to be associated with an increased risk of fractures. The isolated increase seen in some strata with low average doses may be linked to factors associated with discontinuation of oral contraceptives rather than pharmacological effects.     

Uptake and adherence to long-acting reversible contraception post-abortion

Background

This study aimed to increase use of long-acting reversible contraceptive (LARC) methods by women post-abortion.

Study Design

Ten-week intervention at a public abortion clinic involving free access to three LARC methods (DMPA, LNG-IUS, Multiload Cu375); posters promoting LARC; updated information for clinic staff. Outcome measures: change in the proportion of women choosing LARC prior to and during the intervention; rate of follow-up and method retention at 6 weeks and at 6 months post-abortion.

Results

Use of post-abortion LARC increased significantly from 44% at baseline (226/510) to 61% (310/510) during the intervention (p<.001). Use of LNG-IUS increased almost sixfold from 6% to 36%. Follow-up rates were 71% at 6 weeks (221/310) and 74% at 6 months (184/249). Method retention was 89% at 6 weeks (197/221) and 86% at 6 months (159/184).

Conclusion

Uptake of LARC by women post-abortion can be achieved by increasing access to these methods — by eliminating cost and raising awareness and benefits of long-acting methods among both clinicians and patients.     

Effects of sex hormones in oral contraceptives on the female sexual function score: a study in German female medical students

Background

The survey was conducted to compare the influence of sex hormones in oral contraceptives (OCs) on female sexual function.

Methods

One thousand eighty-six female German medical students completed an online-based questionnaire incorporating the Female Sexual Function Index (FSFI). Oral contraceptives used were classified into those containing androgenic or antiandrogenic progestins and by ethinylestradiol (EE) dosage (20 mcg, 30 mcg and >30 mcg). Female Sexual Function Index scores in women using OCs were compared to those in nonusers.

Results

Seven hundred fifty-two of 1086 participating women used OCs. No statistically significant differences in FSFI scores were found among women using OCs containing androgenic or antiandrogenic progestins, nor were any seen between different EE dosages. In general, OC users had lower FSFI scores than nonusers.

Conclusion

Female Sexual Function Index scores were negatively influenced by the use of OCs. However, the impact of an androgenic or antiandrogenic progestin content or different dosages of EE as modulating factors of female sexual function seems negligible.     

Effectiveness of medical abortion with mifepristone and buccal misoprostol through 59 gestational days

Background

From 2001 to March 2006, Planned Parenthood Federation of America (Planned Parenthood) health centers throughout the United States provided medical abortions principally by a regimen of oral mifepristone, followed 24-48 h later by vaginal misoprostol. In late March 2006, analyses of serious uterine infections following medical abortions led Planned Parenthood to change the route of misoprostol administration and to employ additional measures to minimize subsequent serious uterine infections. In August 2006, we conducted an extensive audit of medical abortions with the new buccal misoprostol regimen so that patients could be given accurate information about the success rate of the new regimen.

Objectives

We sought to evaluate the effectiveness of the buccal medical abortion regimen and to examine correlates of its success during routine service delivery.

Methods

In 2006, audits were conducted in 10 large urban service points to estimate the success rates of the buccal regimen. Success was defined as medical abortion without vacuum aspiration. These audits also permitted estimates of success rates with oral misoprostol following mifepristone in a subset in which 98% of the subjects stemmed from two sites.

Results

The effectiveness of the buccal misoprostol-mifepristone regimen was 98.3% for women with gestational ages below 60 days. The oral misoprostol-mifepristone regimen, used by 278 women with a gestational age below 50 days, had a success rate of 96.8%.

Conclusion

In conjunction with 200 mg of mifepristone, use of 800 mcg of buccal misoprostol up to 59 days of gestation is as effective as the use of 800 mcg of vaginal misoprostol up to 63 days of gestation.     

Antimullerian hormone and obesity: insights in oral contraceptive users

Background

The study was conducted to examine the impact of oral contraceptives (OCs) on serum antimullerian hormone (AMH) levels by obesity status in reproductive-age women.

Study Design

Ovulatory women, ages 18-35 years, of normal (<25 kg/m²; n=10) and obese (>30 kg/m²; n=10) body mass index (BMI) received a low-dose OC (20 mcg ethinyl estradiol/100 mcg levonorgestrel) for two cycles. Serum samples obtained at several time points during active pill use and hormone-free intervals were analyzed for AMH, follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol and inhibin B.

Results

AMH levels did not differ by OC cycle day in either BMI group. On average, AMH levels were 34% lower in the obese group (2.9±2.1 vs. 4.4±1.8 ng/mL, p<.05). Modeling to determine differences in AMH throughout the cycle based on obesity status demonstrated significantly lower levels (p<.05), whereas serum AMH, FSH, LH, estradiol and inhibin B levels revealed no correlations when all time points were included.

Conclusions

In reproductive-age women, serum AMH levels do not appear to fluctuate during OC use, but AMH levels are significantly lower in obese women. Lower levels do not appear to be due to differences in gonadotropin levels or ovarian activity.     

Postmarketing study of ORTHO EVRA and levonorgestrel oral contraceptives containing hormonal contraceptives with 30 mcg of ethinyl estradiol in relation to nonfatal venous thromboembolism

Background

Concern has been raised that the risk of venous thromboembolism (VTE) in users of the ORTHO EVRA^® patch is higher compared to users of oral contraceptives (OCs).

Study Design

We identified idiopathic cases of VTE and controls, matched on age and index date, from among women in the United States PharMetrics/IMS and MarketScan databases who were current users of the patch or levonorgestrel-containing OCs with 30 mcg of ethinyl estradiol. We calculated odds ratios (ORs) and 95% confidence intervals (CIs).

Results

The ORs (95% CI) for VTE in users of the patch compared to levonorgestrel-containing OCs were 2.0 (0.9-4.1) and 1.3 (0.8-2.1) in the PharMetrics and MarketScan databases, respectively. ORs (95% CI) restricted to women aged 39 years or younger were 1.4 (0.6-3.0) and 1.2 (0.7-2.0), respectively.

Conclusion

These results provide evidence that the risk of idiopathic VTE in users of the patch is not materially different than that of users of levonorgestrel-containing OCs in women aged 39 years or younger. We cannot rule out some increase in the risk in women aged 40 years or older.     

Effect of sexual intercourse on the absorption of levonorgestrel after vaginal administration of 0.75 mg in Carraguard® gel: a randomized, cross-over, pharmacokinetic study

Background

The Population Council studied a pre-coital contraceptive microbicide vaginal product containing levonorgestrel (LNG) as active component and Carraguard® gel as a vehicle (Carra/LNG gel) for couples who engage in occasional unplanned intercourse. The objective of this study was to evaluate the effect of sexual intercourse after vaginal application of Carra/LNG gel on serum levels of LNG in women and to assess LNG absorption by the male partner.

Study Design

This was a randomized, cross-over, pharmacokinetic study including an abstinence arm and an arm in which couples engaged in sexual intercourse between 2 and 4 h after gel application. In each study arm, each woman received a single application of Carra/LNG gel (0.75 mg in 4 mL gel) followed by serial blood samples taken at 0, 1, 2, 4, 8, 24 and 48 h after gel application for LNG measurements. In the intercourse arm, LNG was measured in blood samples taken from the male partner before intercourse and at 4, 8 and 24 h after gel application in the female partner.

Results

Time concentration curves for serum LNG levels showed a mean C_max of 7.8±5.5 and 8.3±5.7 nmol/L, a mean T_max of 6.2±5.9 and 7.5±5.7, and comparable area under the curve for the intercourse and abstinence arm, respectively. Pharmacokinetic parameters presented large variability between subjects, but excellent reproducibility within each subject. LNG was undetectable in 10 out of 12 male partners.

Conclusion

Sexual intercourse does not appear to interfere with vaginal absorption of LNG after application of a Carra/LNG gel. A vaginal pre-coital contraceptive gel is feasible.     

Prevalence of psychiatric disorders and premenstrual dysphoric symptoms in patients with experience of adverse mood during treatment with combined oral contraceptives

Background

Negative mood symptoms remain one of the major reasons for discontinuation of combined oral contraceptive pills (COCs). The primary aim of this study was to compare the prevalence of mood and anxiety disorders in women with different experience of COCs.

Study Design

Thirty women currently on COCs with no report of adverse mood symptoms, 28 women currently on COCs and experiencing mood-related side effects, 33 women who had discontinued COC use due to adverse mood effects and 27 women who had discontinued COC use for reasons other than adverse mood symptoms were included. Ongoing psychiatric disorders were evaluated by a structured psychiatric interview and prevalence rates of premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD) were assessed by daily prospective ratings on the Cyclicity Diagnoser scale.

Results

Women with ongoing or past experience of COC-induced adverse mood, more often suffered from mood disorders than women with no reports of adverse mood while on COC. The prevalence of prospectively defined PMS or PMDD did not differ between prior users with positive or negative experience. Women who had discontinued COC use due to adverse mood symptoms more often had had a legal abortion in the past.

Conclusion

Women with ongoing or past self-reported adverse mood effects from COCs had a significantly increased prevalence of mood disorders.     

Effect of oral contraceptives on markers of hyperandrogenism and SHBG in women with polycystic ovary syndrome

Background

This randomized study's aim was to compare the effect of four oral contraceptives (OCs) containing 30 mcg of ethinylestradiol (EE) and different progestogens [drospirenone, (DRSP), chlormadinone acetate (CMA), desogestrel (DSG), gestodene (GSD)] on biochemical and hormonal parameters of hyperandrogenism and sex hormone-binding globulin (SHBG) in women with polycystic ovary syndrome (PCOS).

Study Design

Forty women with PCOS (age 16-35 years) were recruited and randomly assigned to one of four treatment groups of 10 women each, treated, respectively, with 3 mg DRSP/30 mcg EE (Yasmin, Bayer Shering), 2 mg CMA/30 mcg EE (Belara, Grunenthal), 75 mcg GSD/30 mcg EE (Minulet, Wyeth Lederle) and 150 mcg DSG/30 mcg EE (Practil 21, Organon Italia). Blood samples were obtained on day 6-8 of the control cycle and day 6-8 of the third treatment cycle for assay of the following hormones: androsteredione (A), total testosterone (T), free T, SHBG, dehydroepiandrosterone sulphate (DHEAS).

Results

In all groups, mean concentrations of free T, total T and A dropped by 40-60%, and concentrations of DHEAS dropped by 20-50%. Formulations with DRSP and CMA caused a greater reduction of androgens and a progressive increase in serum concentrations of SHBG than those with DSG and GSD.

Conclusions

Clinical studies need to be performed to determine effects of these OCs upon clinical signs of hyperandrogenism.