A Six-week Double Blinded, Randomized Trial of Atorvastatin for the Treatment of PCOS Women With Elevated LDL Cholesterol
The investigators hypothesize that improving the lipid profile with atorvastatin will
improve vascular function, increase the frequency of ovulation, decrease androgen levels,
improve insulin sensitivity, and improve the lipid profile more efficiently than placebo.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Brachial Artery Flow-mediated Dilation (FMD)
Brachial artery FMD, the percent change in brachial artery diameter following release of transient occlusion, was selected as the primary outcome because it is the most widely used research tool for evaluating the effects of interventions on endothelial function. FMD has been shown to predict longterm cardiovascular events, even in patients with no apparent heart disease.
baseline and 6 weeks
Richard S Legro, MD
Penn State College of Medicine
United States: Food and Drug Administration
|Penn State Milton S Hershey Medical Center, College of Medicine||Hershey, Pennsylvania 17033|