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

Hospital Universitario Ramon y Cajal50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

Eligibility

Sex: FEMALEMin age: 12 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Serum androgen levels

Lipid profiles

Blood pressure

Cardiovascular performance

Non-classic cardiovascular risk markers

Indexes of insulin secretion and sensitivity