A Trial of Lipitor (Atorvastatin) for the Treatment of Polycystic Ovary Syndrome (PCOS) in Women With Elevated Low-density Lipoprotein (LDL) Cholesterol
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|ClinicalTrials.gov Identifier: NCT00529542|
Recruitment Status : Completed
First Posted : September 14, 2007
Results First Posted : May 8, 2013
Last Update Posted : September 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome||Drug: Lipitor Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Six-week Double Blinded, Randomized Trial of Atorvastatin for the Treatment of PCOS Women With Elevated LDL Cholesterol|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
40mg caplets per day for six weeks
Other Name: Atorvastatin
|Placebo Comparator: Placebo||
1 placebo caplet per day for six weeks.
Other Name: Sugar Pill
- Brachial Artery Flow-mediated Dilation (FMD) [ Time Frame: 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.
- Peak Brachial Artery Conductance (BAC) [ Time Frame: 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 [ Time Frame: baseline and 6 weeks ]
- LDL Cholesterol [ Time Frame: baseline and 6 weeks ]
- HDL Cholesterol [ Time Frame: baseline and 6 weeks ]
- Triglycerides [ Time Frame: baseline and 6 weeks ]
- Fasting Glucose [ Time Frame: baseline and 6 weeks ]
- Fasting Insulin [ Time Frame: baseline and 6 weeks ]
- Area Under the Curve (AUC) for Glucose During OGTT [ Time Frame: 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 [ Time Frame: 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.
- Total Testosterone [ Time Frame: baseline and 6 weeks ]
- Androstenedione [ Time Frame: baseline and 6 weeks ]
- DHEAS [ Time Frame: baseline and 6 weeks ]Dehydroepiandrosterone sulfate
- High-sensitivity C-reactive Protein (hsCRP) [ Time Frame: baseline and 6 weeks ]high sensitive C-reactive protein as a measure of inflammation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529542
|United States, Pennsylvania|
|Penn State Milton S Hershey Medical Center, College of Medicine|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Richard S Legro, MD||Penn State College of Medicine|