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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01072097
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : September 7, 2011
Information provided by:
University of Oulu

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Atorvastatin Drug: Placebo Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Atorvastatin on Androgen Synthesis, Glucose Metabolism and Inflammation in Women With Polycystic Ovary Syndrome (PCOS). A Placebo Controlled Trial
Study Start Date : September 2006
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Arm Intervention/treatment
Active Comparator: Atorvastatin
6 months atorvastatin 20mg/day treatment
Drug: Atorvastatin
Atorvastatin 20mg/day for 6 months
Other Name: Lipitor 20mg, Pfizer

Placebo Comparator: Placebo
6 months placebo treatment
Drug: Placebo
Placebo for 6 months

Primary Outcome Measures :
  1. Androgen secretion [ Time Frame: 0, 3, 6 months ]
  2. Glucose metabolism [ Time Frame: 0, (3), 6 months ]

Secondary Outcome Measures :
  1. Inflammatory markers [ Time Frame: 0, 3, 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01072097

Department of Obstetrics and Gynaecology, University of Oulu
Oulu, Finland, 90014
Sponsors and Collaborators
University of Oulu
Study Director: Terhi T. Piltonen, MD, PhD Dept Ob-Gyn, University of Oulu
Principal Investigator: Johanna Puurunen, MD Dept Ob-Gyn, University of Oulu
Study Chair: Juha S. Tapanainen, Professor Dept Ob-Gyn, Univeristy of Oulu

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Juha Tapanainen/Professor, Dept Ob-Gyn, University of Oulu Identifier: NCT01072097     History of Changes
Other Study ID Numbers: 85/2006
First Posted: February 19, 2010    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: September 2011

Keywords provided by University of Oulu:
Glucose metabolism
Inflammatory markers

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs