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

This study has been completed.
Information provided by:
University of Oulu Identifier:
First received: February 18, 2010
Last updated: September 6, 2011
Last verified: September 2011

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 Intervention
Polycystic Ovary Syndrome
Drug: Atorvastatin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Androgen secretion [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]
  • Glucose metabolism [ Time Frame: 0, (3), 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory markers [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2006
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   30 Years to 50 Years
Genders 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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

No publications provided by University of Oulu

Additional 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 
Study First Received: February 18, 2010
Last Updated: September 6, 2011
Health Authority: Finland: Ethics Committee
Finland: Finnish Medicines Agency

Keywords provided by University of Oulu:
Glucose metabolism
Inflammatory markers

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Adnexal Diseases
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Anticholesteremic Agents
Enzyme Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 09, 2016