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

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00428311
• Other study ID #: ENDOPCOS 01/2003
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2007
• Last updated: January 30, 2007
• Start date: April 2004
• Est. completion date: October 2006

Study information

• Verified date: January 2007
• Source: Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperandrogenism
• Polycystic Ovary Syndrome

Intervention

Drug:
• Metformin

• Ethynyl-estradiol plus cyproterone acetate

Locations

Country	Name	City	State
Spain	Department of Endocrinology, Hospital Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum androgen levels
Primary	Lipid profiles
Primary	Blood pressure
Primary	Cardiovascular performance
Primary	Non-classic cardiovascular risk markers
Primary	Indexes of insulin secretion and sensitivity