A Trial of Lipitor (Atorvastatin) for the Treatment of Polycystic Ovary Syndrome (PCOS) in Women With Elevated Low-density Lipoprotein (LDL) Cholesterol
- Registration Number
- NCT00529542
- Lead Sponsor
- Milton S. Hershey Medical Center
- Brief Summary
The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the treatment of PCOS with elevated LDL cholesterol.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
Women with PCOS
- 8 or fewer menstrual periods per year
- elevated serum total testosterone
- elevated LDL cholesterol
- current pregnancy or breastfeeding
- current use of oral contraceptives, progestins
- insulin sensitizing medications
- thyroid disease, hyperprolactinemia, active liver disease, type 1 or type 2 diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Atorvastatin Lipitor -
- Primary Outcome Measures
Name Time Method Brachial Artery Flow-mediated Dilation (FMD) baseline and 6 weeks 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.
- Secondary Outcome Measures
Name Time Method Total Testosterone baseline and 6 weeks Peak Brachial Artery Conductance (BAC) baseline and 6 weeks Pneumatic cuffs were positioned on the upper arm and wrist of the experimental arm. The brachial artery was imaged using an ATL Doppler ultrasound probe (5-12MHz linear array scanhead, HDI 5000, Advanced Technology Laboratories, Bothell, WA). Mean blood flow velocity (MBV) and brachial artery diameter (BAD) were recorded at baseline. Then the wrist cuff was inflated to 200-250 mmHg. After a minute, with the wrist cuff still inflated, the arm cuff was inflated to 200-250 mmHg. After 10 minutes the arm cuff was released to induce reactive hyperemia in the brachial artery. Upon release of the arm cuff, we continuously measured blood pressure (BP), heart rate (HR), and MBV, and intermittently measured BAD in the experimental arm. Brachial artery conductance (BAC)was calculated as MBV/MAP and FMD was calculated as percent change in BAD from baseline.
Total Cholesterol baseline and 6 weeks LDL Cholesterol baseline and 6 weeks HDL Cholesterol baseline and 6 weeks Triglycerides baseline and 6 weeks Fasting Glucose baseline and 6 weeks Fasting Insulin baseline and 6 weeks Area Under the Curve (AUC) for Glucose During OGTT baseline and 6 weeks A 75 gram oral glucose tolerance test (OGTT) was performed with blood draws at 0, 30, 60, 90 and 120 minutes.
AUC for Insulin baseline and 6 weeks Area under the curve for insulin during OGTT: A 75 gram oral glucose tolerance test was performed with blood draws at 0, 30, 60, 90 and 120 minutes.
Androstenedione baseline and 6 weeks DHEAS baseline and 6 weeks Dehydroepiandrosterone sulfate
Trial Locations
- Locations (1)
Penn State Milton S Hershey Medical Center, College of Medicine
🇺🇸Hershey, Pennsylvania, United States