Status:
COMPLETED
Effects of Metformin vs Oral Contraceptives on CV Risk Markers in PCOS
Lead Sponsor:
Hospital Universitario Ramon y Cajal
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
12-45 years
Phase:
PHASE4
Brief Summary
Cardiovascular risk factors cluster in hyperandrogenic women - including those presenting with the polycystic ovary syndrome - in association with insulin resistance, obesity, and other metabolic diso...
Eligibility Criteria
Inclusion
- Women of fertile age presenting with PCOS
- Non-hyperandrogenic women of fertile age (these women will not receive the interventions and will serve only to obtain normative data for some variables)
Exclusion
- Severe disease not related to the condition under study
- Pregnancy
- Medical or surgical treatment of PCOS during the previous 3 months
- Contraindication for the use of oral contraceptives or metformin
- Inability to understand the proposal of the study precluding effective informed consent
- Minors who are not accompanied by their legal representative
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00428311
Start Date
April 1 2004
End Date
October 1 2006
Last Update
January 31 2007
Active Locations (1)
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1
Department of Endocrinology, Hospital Ramón y Cajal
Madrid, Madrid, Spain, E-28034