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

Yazd Research & Clinical Center for Infertility

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: orlistat

Study type: Interventional

Funder types: Other

Identifiers

NCT01003483

616

Details and patient eligibility

About

The purpose of this study is to compare the influence of Orlistat and Metformin on obesity treatment in obese PCOS women.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI>= 30
• PCOS

Exclusion criteria

• Drug use during last three months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Orlistat

Experimental group

Description:

The dose of 120 mg orlistat was taken three times daily and the dose remained constant throughout the study period.

Treatment:

Drug: orlistat

Metformin

Experimental group

Description:

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 .

Treatment:

Drug: orlistat