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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00463112
First Posted: April 20, 2007
Last Update Posted: April 20, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hippocration General Hospital
  Purpose

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 Intervention Phase
Obesity Polycystic Ovary Syndrome Drug: Sibutramine Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hippocration General Hospital:

Primary Outcome Measures:
  • weight loss

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

Estimated Enrollment: 80
Study Start Date: March 2004
Study Completion Date: September 2006
  Show Detailed Description

  Eligibility

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
Criteria

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.
  Contacts and Locations
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


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

ClinicalTrials.gov Identifier: NCT00463112     History of Changes
Other Study ID Numbers: 511/8-1-04
First Submitted: April 19, 2007
First Posted: April 20, 2007
Last Update Posted: April 20, 2007
Last Verified: December 2003

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

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


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