A Trial of Lipitor (Atorvastatin) for the Treatment of Polycystic Ovary Syndrome (PCOS) in Women With Elevated Low-density Lipoprotein (LDL) Cholesterol

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the treatment of PCOS with elevated LDL cholesterol.

Detailed Description
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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.

Official Title
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A Six-week Double Blinded, Randomized Trial of Atorvastatin for the Treatment of PCOS Women With Elevated LDL Cholesterol

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Lipitor
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with PCOS 8 or fewer menstrual periods per year elevated serum total testosterone elevated LDL cholesterol Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin<br> | Drug: Lipitor<br>* 40mg caplets per day for six weeks<br>* Other names: Atorvastatin;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1 placebo caplet per day for six weeks.<br>* Other names: Sugar Pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Brachial Artery Conductance (BAC) | 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. | baseline and 6 weeks | 
| 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 | A 75 gram oral glucose tolerance test (OGTT) was performed with blood draws at 0, 30, 60, 90 and 120 minutes. | baseline and 6 weeks | 
| AUC for Insulin | 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. | baseline and 6 weeks | 
| Total Testosterone |  | baseline and 6 weeks | 
| Androstenedione |  | baseline and 6 weeks | 
| DHEAS | Dehydroepiandrosterone sulfate | baseline and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic Ovary Syndrome