Effects of Metformin vs Oral Contraceptives on CV Risk Markers in PCOS - Full Text View

Sponsor:	Hospital Universitario Ramon y Cajal
Information provided by:	Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:	NCT00428311

Purpose

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.

Condition	Intervention	Phase
Polycystic Ovary Syndrome	Drug: Metformin Drug: Ethynyl-estradiol plus cyproterone acetate	Phase IV

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

Resource links provided by NLM:

Genetics Home Reference related topics: 21-hydroxylase deficiency 3-beta-hydroxysteroid dehydrogenase deficiency congenital adrenal hyperplasia due to 11-beta-hydroxylase deficiency persistent Müllerian duct syndrome

MedlinePlus related topics: Diabetes Medicines Polycystic Ovary Syndrome

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Cyproterone acetate Metformin Estradiol valerate Metformin hydrochloride Cyproterone Estradiol acetate

U.S. FDA Resources

Further study details as provided by Hospital Universitario Ramon y Cajal:

Primary Outcome Measures:

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

Estimated Enrollment:	50
Study Start Date:	April 2004
Estimated Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	12 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428311

Locations

Spain
Department of Endocrinology, Hospital Ramón y Cajal
Madrid, Spain, E-28034

Sponsors and Collaborators

Hospital Universitario Ramon y Cajal

Investigators

Principal Investigator:

Héctor F Escobar-Morreale, MD, PhD

Hospital Universitario Ramón y Cajal

More Information

No publications provided by Hospital Universitario Ramon y Cajal

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Luque-Ramírez 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. Epub 2010 Aug 20.

Luque-Ramírez 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. Epub 2008 Nov 6.

Luque-Ramírez 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. Epub 2008 Mar 27.

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. Epub 2007 May 29.

ClinicalTrials.gov Identifier:	NCT00428311 History of Changes
Other Study ID Numbers:	ENDOPCOS 01/2003
Study First Received:	January 29, 2007
Last Updated:	January 30, 2007
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitario Ramon y Cajal:

Polycystic ovary syndrome
Hyperandrogenism
Hirsutism
Cardiovascular risk

Chronic inflammation
Metformin
Cyproterone acetate
Oral contraceptives

Additional relevant MeSH terms:

Polycystic Ovary Syndrome
Hyperandrogenism
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities

Contraceptive Agents
Cyproterone Acetate
Contraceptives, Oral
Cyproterone
Diane
Estradiol
Ethinyl Estradiol
Metformin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Androgen Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012