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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:
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00529542
First received: September 12, 2007
Last updated: September 15, 2014
Last verified: September 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Brachial Artery Flow-mediated Dilation (FMD) [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • LDL Cholesterol [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • HDL Cholesterol [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Fasting Glucose [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Fasting Insulin [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Area Under the Curve (AUC) for Glucose During OGTT [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Androstenedione [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
  • DHEAS [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    Dehydroepiandrosterone sulfate


Other Outcome Measures:
  • High-sensitivity C-reactive Protein (hsCRP) [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided by Milton S. Hershey Medical Center

Additional 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
Study First Received: September 12, 2007
Results First Received: February 15, 2013
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Milton S. Hershey Medical Center:
Polycystic Ovary Syndrome

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

ClinicalTrials.gov processed this record on September 29, 2014