COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01003483
Recruitment Status : Completed
First Posted : October 28, 2009
Last Update Posted : October 28, 2009
Yazd Medical University
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Obesity Drug: orlistat Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Orlistat Administration Facilitates the Obesity Treatment Among Obese PCOS Women
Study Start Date : November 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Orlistat

Arm Intervention/treatment
Experimental: orlistat Drug: orlistat
Tablet,120mg,three times a day,three months
Other Name: Xenical

Primary Outcome Measures :
  1. Body Mass Index (BMI) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Ovulatory [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   15 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • BMI>= 30
  • PCOS

Exclusion Criteria:

  • Drug use during last three months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01003483

Layout table for location information
Iran, Islamic Republic of
Research and Clinical Center for Infertility
Yazd, Iran, Islamic Republic of, 8916877391
Sponsors and Collaborators
Yazd Research & Clinical Center for Infertility
Yazd Medical University
Layout table for investigator information
Principal Investigator: Abbas Aflatoonian, Professor Research and Clinical center for Infertility
Layout table for additonal information
Responsible Party: Department of Obstetrics and Gynecology, Yazd Research & Clinical Center for Infertility Identifier: NCT01003483    
Other Study ID Numbers: 616
First Posted: October 28, 2009    Key Record Dates
Last Update Posted: October 28, 2009
Last Verified: October 2009
Keywords provided by Yazd Research & Clinical Center for Infertility:
Additional relevant MeSH terms:
Layout table for MeSH terms
Nutrition Disorders
Body Weight
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Lipid Regulating Agents