Effect of Diet Plus Sibutramine on Hormonal and Metabolic Features in Overweight and Obese Women With PCOS
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.
|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|
- weight loss
- FAI, insulin resistance and other metabolic parameters
|Study Start Date:||March 2004|
|Study Completion Date:||September 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463112
|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|