A clnical trial to study the effects of an oral pill containing cyproterone acetate on various clinical and biochemical parameters of polycystic ovary syndrome.
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Polycystic ovary syndrome, clinical and biochemical changes
- Registration Number
- CTRI/2009/091/000392
- Lead Sponsor
- DRSUDHINDRA MOHAN BHATTACHARYAConsultant SCDas Memorial Medical and Research Center Kolkata
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Polycystic ovary syndrome, as per Rotterdam criteria. age- 16-40 years.
Exclusion Criteria
Secondary causes of hyperandrogenism, as per Rotterdam criteria; history of hormone intake in the preceding 3 months; medical conditions contraindicated for combined hormone therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Chages in clinical parameters like BMI, Waist-hip ratio; acbominal circumference; hirsutism score ; acne lesions; changes in serum total testosterone, SHBG(sex hormone binding globulin levels), Free androgen index,; insulin resistance as measured by fasting glucose- insulin ratio.Timepoint: First time of assessment - 6 months <br/ ><br>Second time of assessment - 12 months after start of the treatment
- Secondary Outcome Measures
Name Time Method side effects and compliance with the medicationTimepoint: first after 6 months and finally after 12 months.