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


Phase 2
18 Years
40 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Brachial Artery Flow-mediated Dilation (FMD)

Outcome Description:

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.

Outcome Time Frame:

baseline and 6 weeks

Safety Issue:

No

Principal Investigator

Richard S Legro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State College of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

19286

NCT ID:

NCT00529542

Start Date:

December 2004

Completion Date:

August 2010

Related Keywords:

  • Polycystic Ovary Syndrome
  • Polycystic Ovary Syndrome
  • Polycystic Ovary Syndrome

Name

Location
Penn State Milton S Hershey Medical Center, College of Medicine Hershey, Pennsylvania  17033