The Effect of Atorvastatin on Androgens, Glucose Metabolism and Inflammation in Polycystic Ovary Syndrome (PCOS) Women
|ClinicalTrials.gov Identifier: NCT01072097|
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : September 7, 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 or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome||Drug: Atorvastatin Drug: Placebo||Not Applicable|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
- Androgen secretion [ Time Frame: 0, 3, 6 months ]
- Glucose metabolism [ Time Frame: 0, (3), 6 months ]
- Inflammatory markers [ Time Frame: 0, 3, 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|