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

Sponsored by:	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

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

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 National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	ENDOPCOS 01/2003
Study First Received:	January 29, 2007
Last Updated:	January 30, 2007
ClinicalTrials.gov Identifier:	NCT00428311 History of Changes
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

Study placed in the following topic categories:

Gonadal Disorders
Contraceptive Agents
Hormone Antagonists
Estradiol valerate
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Cyproterone
Hyperandrogenism
Ovarian Diseases
Estradiol 17 beta-cypionate
Contraceptive Agents, Male
Hormones
Sex Differentiation Disorders
Polycystic Ovarian Syndrome

Genital Diseases, Female
Hypoglycemic Agents
Estradiol 3-benzoate
Polyestradiol phosphate
Diane
Estrogens
Cyproterone Acetate
Metformin
Endocrine System Diseases
Ethinyl Estradiol
Cysts
Estradiol
Inflammation
Hirsutism
Androgen Antagonists

Additional relevant MeSH terms:

Antineoplastic Agents
Gonadal Disorders
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Cyproterone
Hyperandrogenism
Ovarian Diseases
Reproductive Control Agents
Contraceptive Agents, Male
Hormones
Sex Differentiation Disorders

Genital Diseases, Female
Hypoglycemic Agents
Pathologic Processes
Syndrome
Therapeutic Uses
Diane
Estrogens
Disease
Cyproterone Acetate
Metformin
Endocrine System Diseases
Ethinyl Estradiol
Cysts
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on May 07, 2009