Status:
UNKNOWN
Effects of Metformin and Oral Hormonal Contraceptive in Adolescents With Polycystic Ovary Syndrome
Lead Sponsor:
Federal University of São Paulo
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
11-19 years
Phase:
NA
Brief Summary
The polycystic ovary syndrome is the most common endocrinopathy in reproductive age women. The pathophysiology of this syndrome remains unclear, but there are evidences that a decreased in insulin sen...
Detailed Description
Design: 90 patients will be selected to a prospective, randomized and double-blinded study. They will be assigned to two groups: A) 45 patients, treated with OC (oral contraceptive) and metformin 1500...
Eligibility Criteria
Inclusion
- Patients until 19 years-old, at least 2 years after menarche
- Patients with Polycystic Ovary Syndrome based on Rotterdan criteries
Exclusion
- Patients with Diabetes Mellitus, hypertension, hyperprolactinemia, adrenal enzymatic deficiency, Cushing syndrome, thyroidopathy, renal or hepatic disfunction
- Use of OC or insulin-sensitising drugs in the last 90 days before
- Pregnancy
- Androgen tumors, hormonal-sensitive tumors in the past
- Contra-indication to the medications used in the study
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00988078
Start Date
July 1 2011
End Date
December 1 2013
Last Update
June 26 2012
Active Locations (1)
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1
Federal University of Sao Paulo
São Paulo, São Paulo, Brazil