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Effect of Diet Plus Sibutramine on Hormonal and Metabolic Features in Overweight and Obese Women With PCOS

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ClinicalTrials.gov Identifier: NCT00463112
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : April 20, 2007
Information provided by:
Hippocration General Hospital

Brief Summary:

Studies on the effect of sibutramine, an anti-obesity drug, on hormonal and metabolic features of women with polycystic ovary syndrome (PCOS) are lacking.

The objective of this study is to examine the effect of sibutramine plus hypocaloric diet on body composition, hormonal and metabolic parameters and insulin resistance in obese patients with PCOS.

Overweight and obese women with PCOS were placed in a hypocaloric diet plus sibutramine (10 mg/day) for the first month and then on a hypocaloric diet plus sibutramine (10 mg/day) or hypocaloric diet only for the subsequent 6 months.

The main outcome measures are: Body composition, hormonal and metabolic features and insulin sensitivity (OGTT) at baseline, at 3 and 6 months of treatment.

Condition or disease Intervention/treatment Phase
Obesity Polycystic Ovary Syndrome Drug: Sibutramine Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Diet Plus Sibutramine on Hormonal and Metabolic Features in Overweight and Obese Women With PCOS: a Randomized, 24-Week Study
Study Start Date : March 2004
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. weight loss

Secondary Outcome Measures :
  1. FAI, insulin resistance and other metabolic parameters

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • overweight and obese women with PCOS

Exclusion Criteria:

  • Nonclassical 21-hydroxylase deficiency, hyperprolactinemia, adrenal or ovarian tumor and Cushing’s disease, hypertension, thyroid dysfunction, overt diabetes mellitus and concomitant treatment such as antihypertensive drugs, SSRI or other SNRI drug, oral contraceptive pills or any other antiandrogen treatment (cyproterone acetate, spirolactone, LHRH agonist) and insulin sensitizing agents (metformin, pioglitazone, roziglitazone) that may interact with insulin sensitivity and lipid profile.

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): NCT00463112

Hippocratio General Hospital
Thessaloniki, Greece, 54642
Sponsors and Collaborators
Hippocration General Hospital
Principal Investigator: Dimos Florakis, MD Divison of Endocrinology and Human Reproduction, Second Department of Obstetrics and Gynecology, Medical School, Aristotle University of Thessaloniki, Greece

ClinicalTrials.gov Identifier: NCT00463112     History of Changes
Other Study ID Numbers: 511/8-1-04
First Posted: April 20, 2007    Key Record Dates
Last Update Posted: April 20, 2007
Last Verified: December 2003

Keywords provided by Hippocration General Hospital:
Polycystic Ovary Syndrome
weight loss

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Body Weight
Signs and Symptoms
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Antidepressive Agents
Psychotropic Drugs
Appetite Depressants
Anti-Obesity Agents