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The Cardiovascular Risk Profile Associated With The Polycystic Ovary Syndrome And With Ovulatory Hyperandrogenism, And Its Changes During Treatment With Metformin Or Oral Contraceptives


Phase 4
12 Years
45 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

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Trial Information

The Cardiovascular Risk Profile Associated With The Polycystic Ovary Syndrome And With Ovulatory Hyperandrogenism, And Its Changes During Treatment With Metformin Or Oral Contraceptives


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Serum androgen levels

Principal Investigator

Héctor F Escobar-Morreale, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Universitario Ramón y Cajal

Authority:

Spain: Spanish Agency of Medicines

Study ID:

ENDOPCOS 01/2003

NCT ID:

NCT00428311

Start Date:

April 2004

Completion Date:

October 2006

Related Keywords:

  • Polycystic Ovary Syndrome
  • Polycystic ovary syndrome
  • Hyperandrogenism
  • Hirsutism
  • Cardiovascular risk
  • Chronic inflammation
  • Metformin
  • Cyproterone acetate
  • Oral contraceptives
  • Polycystic Ovary Syndrome
  • Hyperandrogenism

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