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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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lipitor
Placebo
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Milton S Hershey Medical Center, College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atorvastatin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Total Cholesterol
LDL Cholesterol
HDL Cholesterol
Triglycerides
Fasting Glucose
Fasting Insulin
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.
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.
Total Testosterone
Androstenedione
DHEAS
Dehydroepiandrosterone sulfate

Full Information

First Posted
September 12, 2007
Last Updated
September 15, 2014
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00529542
Brief Title
A Trial of Lipitor (Atorvastatin) for the Treatment of Polycystic Ovary Syndrome (PCOS) in Women With Elevated Low-density Lipoprotein (LDL) Cholesterol
Official Title
A Six-week Double Blinded, Randomized Trial of Atorvastatin for the Treatment of PCOS Women With Elevated LDL Cholesterol
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lipitor
Other Intervention Name(s)
Atorvastatin
Intervention Description
40mg caplets per day for six weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
1 placebo caplet per day for six weeks.
Primary Outcome Measure Information:
Title
Brachial Artery Flow-mediated Dilation (FMD)
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.
Time Frame
baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Peak Brachial Artery Conductance (BAC)
Description
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.
Time Frame
baseline and 6 weeks
Title
Total Cholesterol
Time Frame
baseline and 6 weeks
Title
LDL Cholesterol
Time Frame
baseline and 6 weeks
Title
HDL Cholesterol
Time Frame
baseline and 6 weeks
Title
Triglycerides
Time Frame
baseline and 6 weeks
Title
Fasting Glucose
Time Frame
baseline and 6 weeks
Title
Fasting Insulin
Time Frame
baseline and 6 weeks
Title
Area Under the Curve (AUC) for Glucose During OGTT
Description
A 75 gram oral glucose tolerance test (OGTT) was performed with blood draws at 0, 30, 60, 90 and 120 minutes.
Time Frame
baseline and 6 weeks
Title
AUC for Insulin
Description
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.
Time Frame
baseline and 6 weeks
Title
Total Testosterone
Time Frame
baseline and 6 weeks
Title
Androstenedione
Time Frame
baseline and 6 weeks
Title
DHEAS
Description
Dehydroepiandrosterone sulfate
Time Frame
baseline and 6 weeks
Other Pre-specified Outcome Measures:
Title
High-sensitivity C-reactive Protein (hsCRP)
Description
high sensitive C-reactive protein as a measure of inflammation
Time Frame
baseline and 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard S Legro, MD
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S Hershey Medical Center, College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21144505
Citation
Raja-Khan N, Kunselman AR, Hogeman CS, Stetter CM, Demers LM, Legro RS. Effects of atorvastatin on vascular function, inflammation, and androgens in women with polycystic ovary syndrome: a double-blind, randomized, placebo-controlled trial. Fertil Steril. 2011 Apr;95(5):1849-52. doi: 10.1016/j.fertnstert.2010.11.040. Epub 2010 Dec 8.
Results Reference
derived
Links:
URL
http://www.pennstatehershey.org/web/obgyn/research
Description
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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

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