A Six-Week Randomized Trial of Lipitor(Atorvastatin) for the Treatment of PCOS Women With Elevated LDL Cholesterol
Information source: Penn State University
Information obtained from ClinicalTrials.gov on February 12, 2009 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polycystic Ovary Syndrome
Intervention: Lipitor (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Penn State University Official(s) and/or principal investigator(s): Richard S Legro, MD, Principal Investigator, Affiliation: Penn State College of Medicine
Overall contact: Barb Scheetz, BS, Phone: 717-531-4483, Email: bscheetz@psu.edu
Summary
The purpose of this study is to determine the efficacy of Lipitor(Atorvastatin) for the
treatment of PCOS with elevated LDL cholesterol.
Clinical Details
Official title: A Six-Week Double Blinded, Randomized Trial of Atorvastatin for the Treatment of PCOS Women With Elevated LDL Cholesterol
Study design: Treatment, Open Label, Single Group Assignment
Primary outcome: We 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.
Detailed description:
We 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
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, hyperprolactemia, active liver
disease, type 1 or type 2 diabetes
Locations and Contacts
Barb Scheetz, BS, Phone: 717-531-4483, Email: bscheetz@psu.edu
Penn State Milton S Hershey Medical Center, College of Medicine, Hershey, Pennsylvania 17033, United States; Recruiting Barb Scheetz, BS, Phone: 717-531-4483, Email: bscheetz@psu.edu Richard S Legro, MD, Principal Investigator
Additional Information
Starting date: December 2004
Last updated: February 3, 2009
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