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Efficacy of different drugs like Clomiphene with or without Metformin/ Pioglitazone/ Spironolactone in Polycystic Ovary syndrome.

Efficacy of Clomiphene with or without Metformin/Pioglitazone/ Spironolactone in patients with Polycystic Ovary syndrome.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/08/002845
Enrollment
120
Registered
2012-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Polycystic ovary syndrome

Interventions

Intervention1: Metformin, pioglitazone, spironolactone: Tablet Metformin 750 mg per day orally increased to 1500mg per day orally if desired for 3 months Tablet Pioglitazone 15 mg per day orally for

Sponsors

Dr Sunita J Ramanand
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A) Clinical criteria: 1.oligomenorrhea or menstrual disturbances 3.S/S of Hyperandrogenism viz, acne, hirsuitism, alopecia. 4.Acanthosis nigricans. B) Hormonal criteria: 1.LH/FSH ratio >1.5 2.Serum Testosterone >1.1 ng/ml C) Abdominal USG: At least 10 follicles (2-8 mm in diameter) arranged peripherally around a dense core of ovarian stroma or scattered throughout an increased amount of stroma. Patient of PCOD having hypothyroidism will be treated with thyroxine. After achieving euthyroid states, patient will be included in the study.

Exclusion criteria

Exclusion criteria: 1) Systemic diseases- Renal, hepatic cardiac, RS , frank DM, hypertension , congenital adrenal hyperplasia, ,hyperprolactinemia, acromegaly, functional hypothalamic amenorrhea. 2) Past H/O lactic acidosis. 3) Patients undergoing IV contrast media study or surgical procedures. 4) BMI ( >30 mg/) kg

Design outcomes

Primary

MeasureTime frame
Regularisation of mensesTimepoint: 3 months

Secondary

MeasureTime frame
Improvement in clinical features of PCOSTimepoint: 3 months

Countries

India

Contacts

Public ContactDr Sunita J Ramanand

Govt. Medical College, Miraj

pharmac.ctri@gmail.com09850547900

Outcome results

None listed

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