Clinical trial · Interventional
Effect of Drospirenone-Ethinyl Estradiol (20microgram vs 30 Microgram) on Free Androgen Index in PCOS
Effect of Drospirenone-Ethinyl Estradiol (20µg) in Comparison to Drospirenone-Ethinyl Estradiol (30µg) on Free Androgen Index in Polycystic Ovary Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCOS (Polycystic Ovary Syndrome) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drospirenone Ethinyl Estradiol (20 microgram) | Drug | — | UNRESOLVED |
| Drospirenone Ethinyl Estradiol (30 microgram) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- participants received 1 tablet Drospirenone-Ethinyl Estradiol(20µg), once daily for 24 days followed by 4 days placebo for 3cycles
- interventionNames
- Drug: Drospirenone Ethinyl Estradiol (20 microgram)
- type
- ACTIVE_COMPARATOR
- label
- Comparator arm
- description
- Comparator arm received Drospirenone-Ethinyl Estradiol (30 µg) once daily for 21 days followed by 7 days placebo for 3 cycles
- interventionNames
- Drug: Drospirenone Ethinyl Estradiol (30 microgram)
Primary outcomes (1)
- measure
- Free Androgen Index
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTRajashekar 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 35774693
- RESULTBhattacharya 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 26613823