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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Metformin
Ethynyl-estradiol plus cyproterone acetate
Sponsored by
Hospital Universitario Ramon y Cajal
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary syndrome, Hyperandrogenism, Hirsutism, Cardiovascular risk, Chronic inflammation, Metformin, Cyproterone acetate, Oral contraceptives

Eligibility Criteria

12 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Endocrinology, Hospital Ramón y Cajal

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 29, 2007
Last Updated
January 30, 2007
Sponsor
Hospital Universitario Ramon y Cajal
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1. Study Identification

Unique Protocol Identification Number
NCT00428311
Brief Title
Effects of Metformin vs Oral Contraceptives on CV Risk Markers in PCOS
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Universitario Ramon y Cajal

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic ovary syndrome, Hyperandrogenism, Hirsutism, Cardiovascular risk, Chronic inflammation, Metformin, Cyproterone acetate, Oral contraceptives

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Type
Drug
Intervention Name(s)
Ethynyl-estradiol plus cyproterone acetate
Primary Outcome Measure Information:
Title
Serum androgen levels
Title
Lipid profiles
Title
Blood pressure
Title
Cardiovascular performance
Title
Non-classic cardiovascular risk markers
Title
Indexes of insulin secretion and sensitivity

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Héctor F Escobar-Morreale, MD, PhD
Organizational Affiliation
Hospital Universitario Ramón y Cajal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology, Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
E-28034
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
20730705
Citation
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.
Results Reference
derived
PubMed Identifier
18997670
Citation
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.
Results Reference
derived
PubMed Identifier
18375410
Citation
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.
Results Reference
derived
PubMed Identifier
17536071
Citation
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.
Results Reference
derived

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

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