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Effect of Diet Plus Sibutramine on Hormonal and Metabolic Features in Overweight and Obese Women With PCOS

NCT00463112 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2007-04-20

No results posted yet for this study

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.

Conditions

  • Obesity
  • Polycystic Ovary Syndrome

Interventions

DRUG

Sibutramine

Sponsors & Collaborators

  • Hippocration General Hospital

    lead OTHER

Principal Investigators

  • Dimos Florakis, MD · Divison of Endocrinology and Human Reproduction, Second Department of Obstetrics and Gynecology, Medical School, Aristotle University of Thessaloniki, Greece

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-03-31
Completion
2006-09-30

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00463112 on ClinicalTrials.gov