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

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT00428311
First received: January 29, 2007
Last updated: January 30, 2007
Last verified: January 2007
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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:
Syndrome
Polycystic Ovary Syndrome
Hyperandrogenism
Disease
Pathologic Processes
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
Metformin
Contraceptive Agents
Cyproterone Acetate
Contraceptives, Oral
Ethinyl Estradiol
Cyproterone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 18, 2014