Status:
COMPLETED
Effect of Diet Plus Sibutramine on Hormonal and Metabolic Features in Overweight and Obese Women With PCOS
Lead Sponsor:
Hippocration General Hospital
Conditions:
Obesity
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief 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 th...
Detailed Description
The Polycystic Ovary Syndrome (PCOS) is one of the most common hormonal disorders in women of reproductive age. As a syndrome it has multiple components, such as reproductive (chronic anovulation and ...
Eligibility Criteria
Inclusion
- overweight and obese women with PCOS
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00463112
Start Date
March 1 2004
End Date
September 1 2006
Last Update
April 20 2007
Active Locations (1)
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1
Hippocratio General Hospital
Thessaloniki, Thessaloniki, Greece, 54642