- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01003483
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
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
-
-
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Yazd, Iran, Islamic Republic of, 8916877391
- Research and clinical center for infertility
-
-
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.
|
Tablet,120mg,three times a day,three months
Other Names:
|
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 .
|
Tablet,120mg,three times a day,three months
Other Names:
|
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.
Collaborators
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
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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