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

March 25, 2021 updated by: Nasim Tabibnejad, Yazd Research & Clinical Center for Infertility

Orlistat Administration Facilitates the Obesity Treatment Among Obese PCOS Women

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • BMI>= 30
  • PCOS

Exclusion Criteria:

  • Drug use during last three months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orlistat
The dose of 120 mg orlistat was taken three times daily and the dose remained constant throughout the study period.
Drug: orlistat
Tablet,120mg,three times a day,three months
Other Names:
  • Xenical
Experimental: Metformin
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 .
Drug: orlistat
Tablet,120mg,three times a day,three months
Other Names:
  • Xenical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body Mass Index (BMI)
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Ovulatory
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yazd Research & Clinical Center for Infertility

Collaborators

Yazd Medical University

Investigators

  • Principal Investigator: Abbas Aflatoonian, Professor, Research and clinical center for infertility

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

October 27, 2009

First Submitted That Met QC Criteria

October 27, 2009

First Posted (Estimate)

October 28, 2009

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 25, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 616

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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