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

NCT ID: NCT00428311

Last Updated: 2007-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Metformin

Intervention Type DRUG

Ethynyl-estradiol plus cyproterone acetate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role lead

Principal Investigators

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Héctor F Escobar-Morreale, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramón y Cajal

Locations

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Department of Endocrinology, Hospital Ramón y Cajal

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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Luque-Ramirez M, Escobar-Morreale HF. Treatment of polycystic ovary syndrome (PCOS) with metformin ameliorates insulin resistance in parallel with the decrease of serum interleukin-6 concentrations. Horm Metab Res. 2010 Oct;42(11):815-20. doi: 10.1055/s-0030-1262855. Epub 2010 Aug 20.

Reference Type DERIVED
PMID: 20730705 (View on PubMed)

Luque-Ramirez M, Alvarez-Blasco F, Escobar-Morreale HF. Antiandrogenic contraceptives increase serum adiponectin in obese polycystic ovary syndrome patients. Obesity (Silver Spring). 2009 Jan;17(1):3-9. doi: 10.1038/oby.2008.491. Epub 2008 Nov 6.

Reference Type DERIVED
PMID: 18997670 (View on PubMed)

Luque-Ramirez M, Alvarez-Blasco F, Uriol Rivera MG, Escobar-Morreale HF. Serum uric acid concentration as non-classic cardiovascular risk factor in women with polycystic ovary syndrome: effect of treatment with ethinyl-estradiol plus cyproterone acetate versus metformin. Hum Reprod. 2008 Jul;23(7):1594-601. doi: 10.1093/humrep/den095. Epub 2008 Mar 27.

Reference Type DERIVED
PMID: 18375410 (View on PubMed)

Luque-Ramirez M, Alvarez-Blasco F, Botella-Carretero JI, Sanchon R, San Millan JL, Escobar-Morreale HF. Increased body iron stores of obese women with polycystic ovary syndrome are a consequence of insulin resistance and hyperinsulinism and are not a result of reduced menstrual losses. Diabetes Care. 2007 Sep;30(9):2309-13. doi: 10.2337/dc07-0642. Epub 2007 May 29.

Reference Type DERIVED
PMID: 17536071 (View on PubMed)

Other Identifiers

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ENDOPCOS 01/2003

Identifier Type: -

Identifier Source: org_study_id