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OpenTrials
Completed

NCT Number: NCT00428311

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

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.

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Key information

Conditions

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

Age range

12 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Endocrinology, Hospital Ramón y Cajal

Madrid, E-28034, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

Ethynyl-estradiol plus cyproterone acetate

Drug

Primary outcomes

  1. Serum androgen levels

  2. Lipid profiles

  3. Blood pressure

  4. Cardiovascular performance

  5. Non-classic cardiovascular risk markers

  6. Indexes of insulin secretion and sensitivity

Sponsors and collaborators

Lead sponsor

Hospital Universitario Ramon y Cajal

Other

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2006
First posted
Jan 30, 2007
Registry last updated
Jan 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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