Effects of Metformin vs Oral Contraceptives on CV Risk Markers in PCOS

Madrid Health Service

Status and phase

Completed

Phase 4

Conditions

Polycystic Ovary Syndrome

Treatments

Drug: Ethynyl-estradiol plus cyproterone acetate

Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT00428311

ENDOPCOS 01/2003

Details and patient eligibility

About

Cardiovascular risk factors cluster in hyperandrogenic women - including those presenting with the polycystic ovary syndrome - in association with insulin resistance, obesity, and other metabolic disorders.

The present clinical trial intends to compare the effects of oral contraceptives and metformin on PCOS patients, focusing on classic and non-classic cardiovascular risk markers and indexes of cardiovascular performance, in order to whether or not, as suspected by previous data obtained in non-hyperandrogenic women, oral contraceptives worsen the cardiovascular risk profile of PCOS women, favoring the use of metformin if the latter actually ameliorates such a risk.

Sex

Female

Ages

12 to 45 years old

Volunteers

Accepts Healthy Volunteers

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