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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00529542
First Posted: September 14, 2007
Last Update Posted: September 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center
  Purpose
The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the treatment of PCOS with elevated LDL cholesterol.

Condition Intervention Phase
Polycystic Ovary Syndrome Drug: Lipitor Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Six-week Double Blinded, Randomized Trial of Atorvastatin for the Treatment of PCOS Women With Elevated LDL Cholesterol

Resource links provided by NLM:


Further study details as provided by Richard S. Legro, M.D., Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • High-sensitivity C-reactive Protein (hsCRP) [ Time Frame: baseline and 6 weeks ]
    high sensitive C-reactive protein as a measure of inflammation


Enrollment: 20
Study Start Date: December 2004
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin Drug: Lipitor
40mg caplets per day for six weeks
Other Name: Atorvastatin
Placebo Comparator: Placebo Drug: Placebo
1 placebo caplet per day for six weeks.
Other Name: Sugar Pill

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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, hyperprolactinemia, active liver disease, type 1 or type 2 diabetes
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Pennsylvania
Penn State Milton S Hershey Medical Center, College of Medicine
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Richard S Legro, MD Penn State College of Medicine
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00529542     History of Changes
Other Study ID Numbers: 19286
First Submitted: September 12, 2007
First Posted: September 14, 2007
Results First Submitted: February 15, 2013
Results First Posted: May 8, 2013
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by Richard S. Legro, M.D., Milton S. Hershey Medical Center:
Polycystic Ovary Syndrome

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors


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