NCT07318337

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

December 23, 2025

Last Update Submit

January 8, 2026

Conditions

PCOS (Polycystic Ovary Syndrome)

Keywords

PCOSCOCFree androgen indexDrospirenone Ethinyl Estradiol

Outcome Measures

Primary Outcomes (1)

  • Free Androgen Index

    Free Androgen index was calculated from serum total testosterone and sex hormone binding globulin

    12 weeks

Secondary Outcomes (1)

  • HOMA-IR

    12 weeks

Study Arms (2)

Experimental arm

EXPERIMENTAL

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)

Comparator arm

ACTIVE COMPARATOR

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)

Interventions

Drospirenone Ethinyl Estradiol (20 microgram)DRUG

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

Experimental arm
Drospirenone Ethinyl Estradiol (30 microgram)DRUG

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

Comparator arm

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bangladesh Medical University

Dhaka, 1000, Bangladesh

Location

Related Publications (2)

  • Rajashekar S, Giri Ravindran S, Kakarla M, Ausaja Gambo M, Yousri Salama M, Haidar Ismail N, Tavalla P, Uppal P, Mohammed SA, Hamid P. Spironolactone Versus Oral Contraceptive Pills in the Treatment of Adolescent Polycystic Ovarian Syndrome: A Systematic Review. Cureus. 2022 May 25;14(5):e25340. doi: 10.7759/cureus.25340. eCollection 2022 May.

    PMID: 35774693RESULT

  • Bhattacharya SM, Jha A, DasMukhopadhyay L. Comparison of two contraceptive pills containing drospirenone and 20 mug or 30 mug ethinyl estradiol for polycystic ovary syndrome. Int J Gynaecol Obstet. 2016 Feb;132(2):210-3. doi: 10.1016/j.ijgo.2015.06.065. Epub 2015 Nov 6.

    PMID: 26613823RESULT

Related Links

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

drospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Shakeela Ishrat, FCPS

    Bangladesh Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Quasi Experimental
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Officer

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 6, 2026

Study Start

July 1, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

January 9, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)