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

Condition(s) targeted: Polycystic Ovary Syndrome

Intervention: Metformin (Drug); Ethynyl-estradiol plus cyproterone acetate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hospital Universitario Ramon y Cajal

Official(s) and/or principal investigator(s):
Héctor F Escobar-Morreale, MD, PhD, Principal Investigator, Affiliation: Hospital Universitario Ramón y Cajal

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.

Official title: The Cardiovascular Risk Profile Associated With The Polycystic Ovary Syndrome And With Ovulatory Hyperandrogenism, And Its Changes During Treatment With Metformin Or Oral Contraceptives

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

Serum androgen levels

Lipid profiles

Blood pressure

Cardiovascular performance

Non-classic cardiovascular risk markers

Indexes of insulin secretion and sensitivity

Minimum age: 12 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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

Department of Endocrinology, Hospital Ramón y Cajal, Madrid E-28034, Spain

Starting date: April 2004
Ending date: October 2006
Last updated: January 30, 2007