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
Not yet recruiting
- 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
- Not 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