Comparing Birth-Control Pills and Metformin in Women With PCOS: Effects on Hormones, Symptoms and Health.

The effect of Combined Oral Contraceptive Pill and Metformin on serum AMH, Clinical, Hormonal, Metabolic and Radiological outcomes in PCOS patients: ARandomized Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097965

Enrollment

Registered

2025-11-24

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: Combined oral contraceptive pills: 1st group (Group A): Patients will receive COCP(Tab Ethinylestradiol 30mcg and Levonorgestrel 0.15mg) once daily from day 1 to day 21 of the cycle an

Eligibility

Inclusion criteria

Inclusion criteria: 1)Adult females aged 18-40 years 2)Diagnosed with PCOS by the 2003 Rotterdam criteria.

Exclusion criteria

Exclusion criteria: 1) Pregnancy/ Lactation 2) Treatment with OCPs/Sex steroids or Metformin in the last 6 months 3) Contraindications for OCP use (WHO CAT-4) 4) History of Intolerance to Metformin or OCP.

Design outcomes

Primary

Measure	Time frame
Serum Anti-Mullerian Hormone (AMH)Timepoint: Baseline, 3 months, and 6 months	—

Secondary

Measure	Time frame
1. Regularization of menstrual cycle 2.Modified Ferriman-Gallwey score for hirsutism. 3.BMI / Waist circumference.Timepoint: Baseline, 3 months and 6 months;1. HOMA-IR 2. T. Cholesterol/ S. Triglycerides/ LDL-Cholesterol & HDL-Cholesterol. 3. Serum Total testosterone& DHEAS levels 2. Serum LH : FSH Ratio Timepoint: Baseline, 3 months, and 6 months;1. Ovarian Volume Follicle No. per section (FNPS) or Follicle number per Ovary (FNPO) on either Transabdominal or Transvaginal sonographyTimepoint: Baseline, 3 months, and 6 months;1. Serum Progesterone 2. Endometrial ThicknessTimepoint: post 2 months of contraceptive pill withdrawal after 6 months of therapy in case of spontaneous onset of menstruation	—

Measure

Time frame

1. Regularization of menstrual cycle 2.Modified Ferriman-Gallwey score for hirsutism. 3.BMI / Waist circumference.Timepoint: Baseline, 3 months and 6 months;1. HOMA-IR 2. T. Cholesterol/ S. Triglycerides/ LDL-Cholesterol & HDL-Cholesterol. 3. Serum Total testosterone& DHEAS levels 2. Serum LH : FSH Ratio Timepoint: Baseline, 3 months, and 6 months;1. Ovarian Volume Follicle No. per section (FNPS) or Follicle number per Ovary (FNPO) on either Transabdominal or Transvaginal sonographyTimepoint: Baseline, 3 months, and 6 months;1. Serum Progesterone 2. Endometrial ThicknessTimepoint: post 2 months of contraceptive pill withdrawal after 6 months of therapy in case of spontaneous onset of menstruation

—

Countries

India

Contacts

Public ContactDr BIJIT BHARALI

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHOPAL

rekha.endo@aiimsbhopal.edu.in9435553555

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026