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

NCT00428311 | Completed Phase 4

• 1 other identifier: ENDOPCOS 01/2003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Serum androgen levels

• Lipid profiles

• Blood pressure

• Cardiovascular performance

• Non-classic cardiovascular risk markers

• Indexes of insulin secretion and sensitivity

Interventions

Metformin DRUG

Ethynyl-estradiol plus cyproterone acetate DRUG

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Department of Endocrinology, Hospital Ramón y Cajal

Madrid, Madrid, E-28034, Spain

Location

Related Publications (4)

• 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.

  PMID: 20730705 DERIVED

• 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.

  PMID: 18997670 DERIVED

• 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.

  PMID: 18375410 DERIVED

• 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.

  PMID: 17536071 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Hyperandrogenism; Hirsutism

Interventions

Metformin; Ethinyl Estradiol; Cyproterone Acetate

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Virilism; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Cyproterone; Pregnadienes; Pregnanes; Steroids, Chlorinated

Study Officials

• Héctor F Escobar-Morreale, MD, PhD

  Hospital Universitario Ramón y Cajal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 29, 2007
• First Posted: January 30, 2007
• Study Start: April 1, 2004
• Study Completion: October 1, 2006
• Last Updated: January 31, 2007

Record last verified: 2007-01

Locations

ES (1)