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OpenTrials
Completed

NCT Number: NCT01072097

The Effect of Atorvastatin on Androgens, Glucose Metabolism and Inflammation in Polycystic Ovary Syndrome (PCOS) Women

This is a placebo controlled trial investigating the effect of 6 months atorvastatin 20mg/day therapy on androgens, glucose metabolism and inflammatory markers in women with PCOS.

We assume that during 6 months atorvastatin therapy a significant improvement in hyperandrogenism, glucose metabolism and inflammatory markers is observed.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynaecology, University of Oulu

Oulu, 90014, Finland

About this study

30 women diagnosed for PCOS (aged 30-50 years) are enrolled for the study. 15 women are randomized in the atorvastatin group and 15 in the placebo group. The women with PCOS participating in the study are required to use safe non-hormonal contraception during the medication.

The study includes transvaginal ultrasonography, serum samples, oral glucose tolerance test (OGTT) and intra venous tolerance test (IVGTT) before and after receiving 6 months atorvastatin 20mg/day therapy or placebo.

Measurements for androgen levels, pituitary hormones, glucose, insulin and inflammatory markers are performed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosed for PCOS (Rotterdam criteria)
  • aged 30-50 years
  • safe non-hormonal contraception

Exclusion criteria

  • use of cholesterol lowering agents
  • use of antidepressants
  • use of cortisone medication (p.o.)
  • use of hormonal contraception
  • nursing
  • pregnancy
  • DM-T2
  • liver disease
  • menopause
  • kidney or liver failure

Treatment and study plan

atorvastatin

Drug

Atorvastatin 20mg/day for 6 months

Other names: Lipitor 20mg, Pfizer

Placebo

Drug

Placebo for 6 months

Primary outcomes

  1. Androgen secretion

    Time frame: 0, 3, 6 months

  2. Glucose metabolism

    Time frame: 0, (3), 6 months

Secondary outcomes

  1. Inflammatory markers

    Time frame: 0, 3, 6 months

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Pfizer

Registry information

Official study title

The Effect of Atorvastatin on Androgen Synthesis, Glucose Metabolism and Inflammation in Women With Polycystic Ovary Syndrome (PCOS). A Placebo Controlled Trial

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Feb 19, 2010
Registry last updated
Sep 7, 2011

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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