Effect of Diet Plus Sibutramine on Hormonal and Metabolic Features in Overweight and Obese Women With PCOS
Status:
Completed
Trial end date:
2006-09-01
Target enrollment:
Participant gender:
Summary
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.