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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529542
• Other study ID #: 19286
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2007
• Last updated: September 15, 2014
• Start date: December 2004
• Est. completion date: August 2010

Study information

• Verified date: September 2014
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Drug:
• Lipitor
40mg caplets per day for six weeks
• Placebo
1 placebo caplet per day for six weeks.

Locations

Country	Name	City	State
United States	Penn State Milton S Hershey Medical Center, College of Medicine	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	High-sensitivity C-reactive Protein (hsCRP)	high sensitive C-reactive protein as a measure of inflammation	baseline and 6 weeks	No
Primary	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	No
Secondary	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	No
Secondary	Total Cholesterol		baseline and 6 weeks	No
Secondary	LDL Cholesterol		baseline and 6 weeks	No
Secondary	HDL Cholesterol		baseline and 6 weeks	No
Secondary	Triglycerides		baseline and 6 weeks	No
Secondary	Fasting Glucose		baseline and 6 weeks	No
Secondary	Fasting Insulin		baseline and 6 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Total Testosterone		baseline and 6 weeks	No
Secondary	Androstenedione		baseline and 6 weeks	No
Secondary	DHEAS	Dehydroepiandrosterone sulfate	baseline and 6 weeks	No

External Links

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