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

Sponsor

Hospital Universitario Ramon y Cajal (Other)

Overall Status

Completed

CT.gov ID

NCT00428311

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: Metformin Drug: Ethynyl-estradiol plus cyproterone acetate	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2004

Study Completion Date :

Oct 1, 2006

Outcome Measures

Primary Outcome Measures

Serum androgen levels []
Lipid profiles []
Blood pressure []
Cardiovascular performance []
Non-classic cardiovascular risk markers []
Indexes of insulin secretion and sensitivity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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