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

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ClinicalTrials.gov Identifier: NCT01003483
Recruitment Status : Completed
First Posted : October 28, 2009
Last Update Posted : October 28, 2009
Sponsor:
Collaborator:
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.

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
Primary Completion Date : August 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Orlistat
U.S. FDA Resources

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

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

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 ClinicalTrials.gov identifier (NCT number): 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

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
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:
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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents