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

This study has been completed.
Sponsor:
Collaborator:
Yazd Medical University
Information provided by:
Yazd Research & Clinical Center for Infertility
ClinicalTrials.gov Identifier:
NCT01003483
First received: October 27, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Obesity
 Drug: orlistat
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Orlistat Administration Facilitates the Obesity Treatment Among Obese PCOS Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yazd Research & Clinical Center for Infertility:

Primary Outcome Measures:
  • Body Mass Index (BMI) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ovulatory [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: November 2008
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: orlistat Drug: orlistat
Tablet,120mg,three times a day,three months
Other Name: Xenical

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.

  Eligibility

Ages Eligible for Study:   15 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI>= 30
  • PCOS

Exclusion Criteria:

  • Drug use during last three months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003483

Locations
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
Investigators
Principal Investigator: Abbas Aflatoonian, Professor Research and Clinical center for Infertility
  More Information

No publications provided

Responsible Party: Department of Obstetrics and Gynecology, Yazd Research & Clinical Center for Infertility
ClinicalTrials.gov Identifier: NCT01003483     History of Changes
Other Study ID Numbers: 616
Study First Received: October 27, 2009
Last Updated: October 27, 2009
Health Authority: Iran: Ministry of Health

Keywords provided by Yazd Research & Clinical Center for Infertility:
metformin
orlistat
pcos
obese

Additional relevant MeSH terms:
Obesity
Polycystic Ovary Syndrome
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Gonadal Disorders
Endocrine System Diseases
Metformin
Orlistat
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013