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Sponsored by: |
Hippocration General Hospital |
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Information provided by: | Hippocration General Hospital |
ClinicalTrials.gov Identifier: | NCT00463112 |
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 |
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Obesity Polycystic Ovary Syndrome |
Drug: Sibutramine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Diet Plus Sibutramine on Hormonal and Metabolic Features in Overweight and Obese Women With PCOS: a Randomized, 24-Week Study |
Estimated Enrollment: | 80 |
Study Start Date: | March 2004 |
Study Completion Date: | September 2006 |
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Greece | |
Hippocratio General Hospital | |
Thessaloniki, Greece, 54642 |
Principal Investigator: | Dimos Florakis, MD | Divison of Endocrinology and Human Reproduction, Second Department of Obstetrics and Gynecology, Medical School, Aristotle University of Thessaloniki, Greece |
Study ID Numbers: | 511/8-1-04 |
Study First Received: | April 19, 2007 |
Last Updated: | April 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00463112 |
Health Authority: | Greece: National Organization of Medicines |
Obesity Polycystic Ovary Syndrome weight loss Hyperadrogonemia Sibutramine |
Obesity Gonadal Disorders Endocrine System Diseases Overweight Ovarian Diseases Cysts Sibutramine Body Weight |
Genital Diseases, Female Signs and Symptoms Polycystic Ovary Syndrome Weight Loss Nutrition Disorders Overnutrition Endocrinopathy Ovarian Cysts |
Anti-Obesity Agents Neoplasms Pathologic Processes Disease Therapeutic Uses Syndrome |
Psychotropic Drugs Appetite Depressants Central Nervous System Agents Antidepressive Agents Pharmacologic Actions Adnexal Diseases |