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

NCT00428311 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2007-01-31

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

Metformin

DRUG

Ethynyl-estradiol plus cyproterone acetate

Sponsors & Collaborators

  • Hospital Universitario Ramon y Cajal

    lead OTHER

Principal Investigators

  • Héctor F Escobar-Morreale, MD, PhD · Hospital Universitario Ramón y Cajal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-04-30
Completion
2006-10-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00428311 on ClinicalTrials.gov