Status:
UNKNOWN
Treatment of Obesity With Topiramate in Patients With Polycystic Ovary Syndrome
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Conditions:
Obesity
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
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
Detailed Description
Randomized double blind placebo-controlled clinical trial. Polycystic ovary syndrome (PCOS) is a frequent endocrinopathy, affecting more than 10% of women of reproductive age. It is associated with a ...
Eligibility Criteria
Inclusion
- age between 18 and 40 years
- diagnostic criteria for PCOS
- overweight with a BMI ≥ 27 kg / m² associated with at least one comorbidity (hypertension, type 2 diabetes mellitus, dyslipidemia) or obesity with a BMI between 30 and 45 kg / m² with or without comorbidities
Exclusion
- severe systemic arterial hypertension (≥180 / 100 mmHg)
- pregnant or lactating women
- diabetics using sulfonylurea or insulin
- any known allergy or intolerance to topiramate medication
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04453306
Start Date
May 1 2014
End Date
December 1 2021
Last Update
July 1 2020
Active Locations (1)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-007