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

Phase 4

• Conditions: Health Condition 1: null- Polycystic ovary syndrome

• Registration Number: CTRI/2012/08/002845
• Lead Sponsor: Dr Sunita J Ramanand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Regularisation of mensesTimepoint: 3 months

Secondary Outcome Measures

Name	Time	Method
Improvement in clinical features of PCOSTimepoint: 3 months