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.
|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|
- 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 ]
- Inflammatory markers [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Atorvastatin
6 months atorvastatin 20mg/day treatment
Atorvastatin 20mg/day for 6 months
Other Name: Lipitor 20mg, Pfizer
Placebo Comparator: Placebo
6 months placebo treatment
Placebo for 6 months
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072097
|Department of Obstetrics and Gynaecology, University of Oulu|
|Oulu, Finland, 90014|
|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|