A clinical trial to study the effect of two drugs metformin and spironolactone in polycystic ovarian syndrome
Phase 3
Completed
- Registration Number
- CTRI/2009/091/000031
- Lead Sponsor
- ICMR Funded Project I-465(Ref No. 58/11/2001-BMS)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Inclusion-
Females 15-45 years age with menstrual irregularities, hirsuitism and or infertility
Diagnosis of PCOS according to Rotterdam criteria
Exclusion Criteria
Exclusion criteria- Hypothyroidism, hyperprolactinemia , Cushing?s syndrome and CAH and history of intake of drugs aldactone/ metformin or history of OCP use or intake of drugs known to interfere with carbohydrate metabolism prior 4 weeks before enrolment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in hirsuitism score and menstrual cycles<br>Timepoint: 0 and 6 months
- Secondary Outcome Measures
Name Time Method Change in body weight, androgens, glycemic status and insulin levels.Timepoint: 0 and 6 months