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

This study has been completed.
Yazd Medical University
Information provided by:
Yazd Research & Clinical Center for Infertility Identifier:
First received: October 27, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Orlistat Administration Facilitates the Obesity Treatment Among Obese PCOS Women

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Body Mass Index (BMI) [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Ovulatory [ Time Frame: 3 months ]

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.

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

Inclusion Criteria:

  • BMI>= 30
  • PCOS

Exclusion Criteria:

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

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

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

Keywords provided by Yazd Research & Clinical Center for Infertility:

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Nutrition Disorders
Body Weight
Signs and Symptoms
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents processed this record on September 21, 2017