A clinical trial to compare the effects of Drospirenone containing oral pills with 20 mcg of ethinyl oestradiol with and without 500 mg of metformin in Polycystic ovary syndrome.
Not Applicable
- Conditions
- Health Condition 1: null- POLYCYSTIC OVARY SYNDROME
- Registration Number
- CTRI/2013/02/003411
- Lead Sponsor
- SCDAS MEMORIAL MEDICAL AND RESEARCH CENTER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
women with oligomenorrhoea diagnosed as having Polycystic ovary syndrome as per the Rotterdam criteria 2003; age- minimum gynaecological age of 3 years(age since menarche) to 35 years
Exclusion Criteria
secondary causes of hyperandrogenism like gross hypothyroidism, hyperprolactinaemia, Cushing syndrome, late onset congenital adrenal hyperplasia, contraindications of oral pill therapy,severe liver/ renal/cardiac disease; those already taken oral pills in the preceding 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method primary outcome- changes in clinical markers- BMI,Abdominal circumference, hirsutism score, acne, acanthosis nigricans and biochemical markers like serum testosterone level, SHBG level and free androgen index; PP sugar and PP insulin levels( 2 hours after taking 75 gm glucose) At 6 months and finally after 12 months of treatment. <br/ ><br>Timepoint: 6 months and 12 months. <br/ ><br>
- Secondary Outcome Measures
Name Time Method any side effectsTimepoint: 6 months after completion of treatment and finally after 12 months of treatment