Back to resultsMetformin Versus Orlistat in Obese Polycystic Ovary Syndrome (PCOS) Patients
Primary Purpose
Obesity
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
orlistat
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring metformin, orlistat, pcos, obese
Eligibility Criteria
Inclusion Criteria:
- BMI>= 30
- PCOS
Exclusion Criteria:
- Drug use during last three months
Sites / Locations
- Research and Clinical Center for Infertility
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Orlistat
Metformin
Arm Description
The dose of 120 mg orlistat was taken three times daily and the dose remained constant throughout the study period.
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 .
Outcomes
Primary Outcome Measures
Body Mass Index (BMI)
Secondary Outcome Measures
Ovulatory
Full Information
NCT ID
NCT01003483
First Posted
October 27, 2009
Last Updated
March 25, 2021
Sponsor
Yazd Research & Clinical Center for Infertility
Collaborators
Yazd Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01003483
Brief Title
Metformin Versus Orlistat in Obese Polycystic Ovary Syndrome (PCOS) Patients
Official Title
Orlistat Administration Facilitates the Obesity Treatment Among Obese PCOS Women
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2008 (Actual)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yazd Research & Clinical Center for Infertility
Collaborators
Yazd Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
metformin, orlistat, pcos, obese
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Orlistat
Arm Type
Experimental
Arm Description
The dose of 120 mg orlistat was taken three times daily and the dose remained constant throughout the study period.
Arm Title
Metformin
Arm Type
Experimental
Arm 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 .
Intervention Type
Drug
Intervention Name(s)
orlistat
Other Intervention Name(s)
Xenical
Intervention Description
Tablet,120mg,three times a day,three months
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Ovulatory
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI>= 30
PCOS
Exclusion Criteria:
Drug use during last three months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abbas Aflatoonian, Professor
Organizational Affiliation
Research and Clinical center for Infertility
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research and Clinical Center for Infertility
City
Yazd
ZIP/Postal Code
8916877391
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Metformin Versus Orlistat in Obese Polycystic Ovary Syndrome (PCOS) Patients
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