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Completed

NCT Number: NCT01003483

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

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

Completed

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Key information

Conditions

Obesity Adnexal Diseases Body Weight Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Polycystic Ovary Syndrome Signs and Symptoms Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research and Clinical Center for Infertility

Yazd, 8916877391, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI>= 30
  • PCOS

Exclusion criteria

  • Drug use during last three months

Treatment and study plan

Orlistat

Drug

Tablet,120mg,three times a day,three months

Other names: Xenical

Primary outcomes

  1. Body Mass Index (BMI)

    Time frame: 3 months

Secondary outcomes

  1. Ovulatory

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Yazd Research & Clinical Center for Infertility

Other

Collaborators

  • Yazd Medical University

Registry information

Official study title

Orlistat Administration Facilitates the Obesity Treatment Among Obese PCOS Women

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 28, 2009
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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