Effect of Drospirenone-Ethinyl Estradiol (20microgram vs 30 Microgram) on Free Androgen Index in PCOS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-06-30

Brief Summary

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Combined hormonal contraceptive (CHC) improves androgen parameter in women with PCOS. High-dose CHC increases insulin resistance, whereas low dose CHC has minimal effects on carbohydrate metabolism. This quasi experimental study was conducted to compare the effects of Drospirenone-Ethinyl Estradiol (20µg) to that with Drospirenone-Ethinyl Estradiol (30µg) on free androgen index (FAI) in polycystic ovary syndrome. Medication was given for 3 months. FAI, HOMA-IR was measured in baseline and after treatment and results were compared.

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Detailed Description

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This quasi-experimental study was conducted in the Department of Reproductive Endocrinology and Infertility, Bangladesh Medical University (BMU), from July 2024 to June 2025. Ethical clearance was obtained from the Institutional Review Board (Approval no. 5162). A total number of 60 subfertile women with PCOS (according to Rotterdam criteria) (Oligomenorrhoea-defined as delayed menses \>35 days or \<8 spontaneous menstrual cycle/ year, hyperandrogenism (hirsutism using modified Ferriman-Gallway score of \>8, polycystic ovarian morphology on ultrasonography \>12 follicles in each ovary measuring 2-9 mm in diameter and/or increased ovarian volumes \> 10 cm3) and aged from 20 to 35 years were enrolled in the study. Exclusion criteria encompassed: contraindication to CHC (History of thromboembolic disorder, cerebrovascular disease, coronary artery disease, carcinoma of breast or other estrogen dependent neoplasm, undiagnosed abnormal genital bleeding, known or suspected pregnancy, benign or malignant liver neoplasm, cholestatic jaundice on previous pregnancy, abnormal liver and renal function, uncontrolled DM and HTN, dyslipidemia, history of migraine with focal aura), recent use of androgen and anti-androgens within 3 months, BMI ≥30 kg/m2,oligovulation other than PCOS. Sampling was done by convenient sampling.

The patients were explained in details regarding the objectives, rationale and potential benefits of the study and were counseled regarding the drugs and unexpected side-effects. An informed written consent was taken.

Data was collected through interview, physical examinations and laboratory investigations. Baseline clinical, endocrine and biochemical variables were measured.Laboratory investigations like fasting insulin(determined by chemiluminescent microparticleimmunoassay-CMIA)), fasting blood glucose (done by enzymatic method using commercially available reagent kit), total testosterone (Chemiluminescence immunoassay by LIAISON XL Analyzer), SHBG (determined by DiaSorin LIAISON SHBG assay -Chemiluminescence immunoassay) were done.Blood samples were collected in the early morning, after an overnight fasting of 10 hours, for the measurement of fasting insulin and fasting glucose level.

Participants were divided into two groups without randomization by their alternate day of attendance. Interventional groupreceived DRSP-EE (20 µg) 1tablet for consecutive 24 days followed by 4 days placebo whilecomparatorgroup received DRSP-EE (30 µg) once daily for 21 days followed by 7 days placebo for 3 cycles.All participants were instructed not to take any other medications during the study except after consulting the physician. Patients were called every month over telephone to check for compliance or any side effects.

After 3 months of treatment, blood samples were taken for biochemical studies and FAI, HOMA-IR were calculated. Comparison was made between the effect of DRSP-EE (20 µg) and DRSP-EE (30 µg) in subfertile women with polycystic ovary syndrome.

The mean ± SD values were calculated for continuous variables and percentages were calculated for categorical variables.When the data is not normally distributed then Median (IQR) values were calculated for continuous variables,Mann-Whitney U test was used to compare the medians of two independent groups, Wilcoxon signed rank sum test was used for quantitative variables. For comparing categorical data, the Chi-square (x2) test was performed. Comparison of quantitative variables between the study groups was done using unpaired t-test for independent samples when they are normally distributed. Paired t-test was used for quantitative variables within the group, when compared pre-treatment vs post treatment. P values \<0.05 was considered as statistically significant.Statistical analyses were carried out by using the Statistical Package for Social Sciences version 26.0 for Windows.

Conditions

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PCOS (Polycystic Ovary Syndrome)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Quasi Experimental

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental arm

participants received 1 tablet Drospirenone-Ethinyl Estradiol(20µg), once daily for 24 days followed by 4 days placebo for 3cycles

Group Type EXPERIMENTAL

Drospirenone Ethinyl Estradiol (20 microgram)

Intervention Type DRUG

1tablet for consecutive 24 days followed by 4 days placebo for 3 months

Comparator arm

Comparator arm received Drospirenone-Ethinyl Estradiol (30 µg) once daily for 21 days followed by 7 days placebo for 3 cycles

Group Type ACTIVE_COMPARATOR

Drospirenone Ethinyl Estradiol (30 microgram)

Intervention Type DRUG

once daily for 21 days followed by 7 days placebo for 3 months

Interventions

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Drospirenone Ethinyl Estradiol (20 microgram)

1tablet for consecutive 24 days followed by 4 days placebo for 3 months

Intervention Type DRUG

Drospirenone Ethinyl Estradiol (30 microgram)

once daily for 21 days followed by 7 days placebo for 3 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed case of PCOS patients according to Rotterdam criteria
* women with PCOS

Exclusion Criteria

* Contraindication of OCP such as history of thromboembolic disorder, cerebrovascular disease, coronary artery disease, carcinoma of breast or other estrogen dependent neoplasm, undiagnosed abnormal genital bleeding, known or suspected pregnancy, benign or malignant liver neoplasm, cholestatic jaundice on previous pregnancy, abnormal liver and renal function, uncontrolled DM and HTN, dyslipidemia, history of migraine with focal aura
* Recent use of androgen and antiandrogens within 3months
* BMI\>30kg/m2
* Cause of oligovulation other than PCOS

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No