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Treatment of Obesity With Topiramate in Patients With Polycystic Ovary Syndrome: a Double-blind Placebo-controlled Clinical Trial
Treatment of obesity related to Polycystic Ovary Syndrome with topiramate or placebo to assess improvement of clinical and laboratory parameters after 6 months of follow-up
Details
| Lead sponsor | Hospital de Clinicas de Porto Alegre |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 80 |
| Start date | 2014-05 |
| Completion | 2021-12 |
Conditions
- Obesity
- Polycystic Ovary Syndrome
- Hyperandrogenism
Interventions
- Topiramate
- Placebo
Primary outcomes
- Change of Body Mass index (BMi) at 6 months — 6 months
change of Body Mass index (BMi) in kg/m² from the baseline; weight and height will be combined to report BMI - change in the modified Ferriman-Gallwey Hirsutism Score (mFG) at 6 months — 6 months
In the modified method, hair growth is rated from 0 (no growth of terminal hair) to 4 (extensive hair growth) in each of the nine locations (Upper lip, Chin, Chest, Upper back, Lower back, Upper abdomen, Lower abdomen, Upper arms, Thighs). A patient's score may therefore range from a minimum score of 0 to a maximum score of 36. A score of 6 or higher will be adopted as indicative of androgen excess. - Change of testosterone at 6 months — 6 months
Change of testosterone (ng/mL) at 6 months from the baseline - Change of glucose at 6 months — 6 months
Change of glucose(mg/dL) at 6 months from the baseline - Change of triglyceride at 6 months — 6 months
Change of triglyceride (mg/dL) at 6 months from the baseline - Change of High-density lipoprotein (HDL) at 6 months — 6 months
Change of HDL cholesterol (mg/dL) at 6 months from the baseline
Countries
Brazil