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Metformin Versus Orlistat in Obese Polycystic Ovary Syndrome (PCOS) Patients

Phase 2
Completed
Conditions
Obesity
Interventions
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
Inclusion Criteria
  • BMI>= 30
  • PCOS
Exclusion Criteria
  • Drug use during last three months

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
MetforminorlistatThe 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 .
OrlistatorlistatThe dose of 120 mg orlistat was taken three times daily and the dose remained constant throughout the study period.
Primary Outcome Measures
NameTimeMethod
Body Mass Index (BMI)3 months
Secondary Outcome Measures
NameTimeMethod
Ovulatory3 months

Trial Locations

Locations (1)

Research and Clinical Center for Infertility

🇮🇷

Yazd, Iran, Islamic Republic of

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