Metformin Versus Orlistat in Obese Polycystic Ovary Syndrome (PCOS) Patients
- Registration Number
- NCT01003483
- Lead Sponsor
- Yazd Research & Clinical Center for Infertility
- Brief Summary
The purpose of this study is to compare the influence of Orlistat and Metformin on obesity treatment in obese PCOS women.
- Detailed Description
In a randomized clinical trial study, 80 obese women with BMI≥30, oligomenorrhae, hirsutism and presence of \> 12 ovarian follicles (2-10mm diameter), were evaluated. In metformin group , metformin was administered for patients 1500 mg daily for three months. In orlistate group, patients used orlistat tablets (120 mg, 3 times a day) for three months. BMI, serum LH and FSH levels, serum triglyceride and cholesterol levels and also patients' ovulation was compared before and after treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
- BMI>= 30
- PCOS
- Drug use during last three months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin orlistat The dose of metformin was increased step - wise, from 500 mg once daily for the first week to 500 mg twice daily for the next week, and to 500 mg three times daily for the remaining study period . Orlistat orlistat The dose of 120 mg orlistat was taken three times daily and the dose remained constant throughout the study period.
- Primary Outcome Measures
Name Time Method Body Mass Index (BMI) 3 months
- Secondary Outcome Measures
Name Time Method Ovulatory 3 months
Trial Locations
- Locations (1)
Research and Clinical Center for Infertility
🇮🇷Yazd, Iran, Islamic Republic of