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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00428311

Enrollment

Registered

2007-01-30

Start date

2004-04-30

Completion date

2006-10-31

Last updated

2007-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndrome, Hyperandrogenism, Hirsutism, Cardiovascular risk, Chronic inflammation, Metformin, Cyproterone acetate, Oral contraceptives

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.

Interventions

DRUGMetformin

DRUGEthynyl-estradiol plus cyproterone acetate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

12 Years to 45 Years

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

Design outcomes

Primary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026