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| Sponsored by: |
Hippocration General Hospital |
| Information provided by: | Hippocration General Hospital |
| ClinicalTrials.gov Identifier: | NCT00463112 |
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 IV |
| MedlinePlus related topics: | Obesity Weight Control |
| Drug Information available for: | Sibutramine Sibutramine hydrochloride monohydrate |
| 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 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Greece | |||||
| Hippocratio General Hospital | |||||
| Thessaloniki, Greece, 54642 | |||||
| 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 |
More Information
| Study ID Numbers: | 511/8-1-04 |
| First Received: | April 19, 2007 |
| Last Updated: | April 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00463112 |
| Health Authority: | Greece: National Organization of Medicines |
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