Clinical trial · Interventional
OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women
- 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)
Objective: To assess effectiveness of ISD (Insulin sensitizing drugs) Vs OCP (Combined E\&P cyproterone acetate) in improving clinical, hormonal and metabolic features of PCOS( polycystic ovary syndrome)women from India. Intervention: Randomized to receive Metformin 1500 mg / day OR OCP (EE+CA) Life style advice to women with BMI ( body mass index) more than 28 , in both groups (PS: progesterone can be added for getting withdrawal bleeding for amenorrhoea of more than two months, or for prolonged menstrual bleeding. ) Study period: 6 months Clinical evaluation points and tests at enrollment and again after 6 month. Clinical: BMI, Waist circumference, Hip circumference, Acne score, FG (modified Ferriman Gallwey score ) (after no epilation for last 6 weeks), Menstrual History Biochemical: Thyroid function tests, Prolactin,Total Testosterone, Lipid Profile, FAsting blood sugar \& 75 gm 2 hr Glucose tolerance test (GTT), Sr Insulin, 25- hydroxy vitamin D (optional), (Only Radioimmunoassay / Chemiluminescence assays) Acronyms: OCP(oral contraceptive pills); PCOS (polycystic ovary syndrome); FBS(fasting blood sugar); GTT(glucose tolerance test)
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 |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin 1500mgs per day | Drug | — | UNRESOLVED |
| Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- OCP
- description
- Arm 1: oral contraceptive pill, combination pill of ethyl estradiol 20 micro gram with Cyproterone acetate.
- interventionNames
- Drug: Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate
- type
- ACTIVE_COMPARATOR
- label
- Metformin
- description
- Arm 2: Metformin . Oral insulin sensitising drug in the dose of 1500gms daily.
- interventionNames
- Drug: Metformin 1500mgs per day
Primary outcomes (8)
- measure
- Improvements in Menstrual cycle in women with polycystic ovary syndrome.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * PCOS Women diagnosed by Rotterdam criteria * Age \> 16 or menarche of at least 2 yr upto age 40. * Diagnosed by Rotterdam Anovulation F.G. Score ≥ 8 or Total testosterone ≥ 40 ngms/dl ovarian volume ≥ 10 cc BMI\>23 * Women not attempting pregnancy at present. Exclusion Criteria: * PCOS Women with BMI ≤ 23 * Undergoing any treatment for acne hirsutism. Including Homeopathic, Ayurvedic * Known diabetic or hypertension .
References
Publications (3)
- BACKGROUNDKar S. Clomiphene citrate or letrozole as first-line ovulation induction drug in infertile PCOS women: A prospective randomized trial. J Hum Reprod Sci. 2012 Sep;5(3):262-5. doi: 10.4103/0974-1208.106338. PMID 23531705
- BACKGROUNDKar S, Sanchita S. Clomiphene citrate, metformin or a combination of both as the first line ovulation induction drug for Asian Indian women with polycystic ovarian syndrome: A randomized controlled trial. J Hum Reprod Sci. 2015 Oct-Dec;8(4):197-201. doi: 10.4103/0974-1208.170373. PMID 26752854
- BACKGROUNDKumar P, Nawani N, Malhotra N, Malhotra J, Patil M, Jayakrishnan K, Kar S, Jirge PR, Mahajan N. Assisted reproduction in polycystic ovarian disease: A multicentric trial in India. J Hum Reprod Sci. 2013 Jan;6(1):49-53. doi: 10.4103/0974-1208.112382. PMID 23869152