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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:
Information provided by:
Hippocration General Hospital
ClinicalTrials.gov Identifier:
NCT00463112
First received: April 19, 2007
Last updated: NA
Last verified: December 2003
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00463112     History of Changes
Other Study ID Numbers: 511/8-1-04
Study First Received: April 19, 2007
Last Updated: April 19, 2007
Health Authority: Greece: National Organization of Medicines

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

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

ClinicalTrials.gov processed this record on May 23, 2013