Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT01072097
First received: February 18, 2010
Last updated: September 6, 2011
Last verified: September 2011
History of Changes

February 18, 2010
September 6, 2011
September 2006
January 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01072097 on ClinicalTrials.gov Archive Site
Inflammatory markers [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of Atorvastatin on Androgens, Glucose Metabolism and Inflammation in Polycystic Ovary Syndrome (PCOS) Women
The Effect of Atorvastatin on Androgen Synthesis, Glucose Metabolism and Inflammation in Women With Polycystic Ovary Syndrome (PCOS). A Placebo Controlled Trial

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Polycystic Ovary Syndrome
  • Drug: Atorvastatin
    Atorvastatin 20mg/day for 6 months
    Other Name: Lipitor 20mg, Pfizer
  • Drug: Placebo
    Placebo for 6 months
  • Active Comparator: Atorvastatin
    6 months atorvastatin 20mg/day treatment
    Intervention: Drug: Atorvastatin
  • Placebo Comparator: Placebo
    6 months placebo treatment
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Female
30 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01072097
85/2006
No
Juha Tapanainen/Professor, Dept Ob-Gyn, University of Oulu
University of Oulu
Pfizer
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
University of Oulu
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP