Trial Information
The Cardiovascular Risk Profile Associated With The Polycystic Ovary Syndrome And With Ovulatory Hyperandrogenism, And Its Changes During Treatment With Metformin Or Oral Contraceptives
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Serum androgen levels
Principal Investigator
Héctor F Escobar-Morreale, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospital Universitario Ramón y Cajal
Authority:
Spain: Spanish Agency of Medicines
Study ID:
ENDOPCOS 01/2003
NCT ID:
NCT00428311
Start Date:
April 2004
Completion Date:
October 2006
Related Keywords:
- Polycystic Ovary Syndrome
- Polycystic ovary syndrome
- Hyperandrogenism
- Hirsutism
- Cardiovascular risk
- Chronic inflammation
- Metformin
- Cyproterone acetate
- Oral contraceptives
- Polycystic Ovary Syndrome
- Hyperandrogenism