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

January 8, 2026 updated by: Mst.Sumyara Khatun

Effect of Drospirenone-Ethinyl Estradiol (20µg) in Comparison to Drospirenone-Ethinyl Estradiol (30µg) on Free Androgen Index in Polycystic Ovary Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • Bangladesh Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: •Age:20-35 years

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
participants received 1 tablet Drospirenone-Ethinyl Estradiol(20µg), once daily for 24 days followed by 4 days placebo for 3cycles
Drug: Drospirenone Ethinyl Estradiol (20 microgram)
1tablet for consecutive 24 days followed by 4 days placebo for 3 months
Active Comparator: Comparator arm
Comparator arm received Drospirenone-Ethinyl Estradiol (30 µg) once daily for 21 days followed by 7 days placebo for 3 cycles
Drug: Drospirenone Ethinyl Estradiol (30 microgram)
once daily for 21 days followed by 7 days placebo for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Free Androgen Index
Time Frame: 12 weeks
Free Androgen index was calculated from serum total testosterone and sex hormone binding globulin
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HOMA-IR
Time Frame: 12 weeks
HOMA-IR was calculated from serum fasting glucose and serum fasting insulin
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mst.Sumyara Khatun

Collaborators

Bangladesh Medical University

Investigators

  • Study Director: Shakeela Ishrat, FCPS, Bangladesh Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Estimated)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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