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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

Sponsor
Milton S. Hershey Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00529542
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
68
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
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
Study Start Date :
Dec 1, 2004
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Atorvastatin

Drug: Lipitor
40mg caplets per day for six weeks
Other Names:
  • Atorvastatin

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    1 placebo caplet per day for six weeks.
    Other Names:
  • Sugar Pill

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Brachial Artery Flow-mediated Dilation (FMD) [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

    1. Peak Brachial Artery Conductance (BAC) [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.

    2. Total Cholesterol [baseline and 6 weeks]

    3. LDL Cholesterol [baseline and 6 weeks]

    4. HDL Cholesterol [baseline and 6 weeks]

    5. Triglycerides [baseline and 6 weeks]

    6. Fasting Glucose [baseline and 6 weeks]

    7. Fasting Insulin [baseline and 6 weeks]

    8. Area Under the Curve (AUC) for Glucose During OGTT [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.

    9. AUC for Insulin [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.

    10. Total Testosterone [baseline and 6 weeks]

    11. Androstenedione [baseline and 6 weeks]

    12. DHEAS [baseline and 6 weeks]

      Dehydroepiandrosterone sulfate

    Other Outcome Measures

    1. High-sensitivity C-reactive Protein (hsCRP) [baseline and 6 weeks]

      high sensitive C-reactive protein as a measure of inflammation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center
    ClinicalTrials.gov Identifier:
    NCT00529542
    Other Study ID Numbers:
    • 19286
    First Posted:
    Sep 14, 2007
    Last Update Posted:
    Sep 25, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center
    Polycystic Ovary Syndrome
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Syndrome
    Atorvastatin

    Study Results

    Participant Flow

    Recruitment Details Participants were recruited through the clinics of the Departments of Medicine and Obstetrics and Gynecology at Penn State Hershey Medical Center from October 20, 2006 to September 8, 2008.
    Pre-assignment Detail
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Period Title: Overall Study
    STARTED 9 11
    COMPLETED 8 10
    NOT COMPLETED 1 1

    Baseline Characteristics

    Arm/Group Title Atorvastatin Placebo Total
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd Total of all reporting groups
    Overall Participants 9 11 20
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    9
    100%
    11
    100%
    20
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    9
    100%
    11
    100%
    20
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    9
    100%
    11
    100%
    20
    100%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    12.0
    (7.3)
    9.8
    (5.8)
    After treatment
    10.4
    (4.6)
    10.2
    (2.9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments This study was initiated as a pilot study with the goal of enrolling 19 women in each group, which we hypothesized would provide 80% power to detect an absolute difference in the change in FMD from baseline between the two groups (Atorvastatin vs. Placebo) of 3.75%, assuming a common standard deviation (SD) of 4%, using a two-sided, two-sample t-test with α=0.05. Recruitment was slow due to strict inclusion/ exclusion criteria so we analyzed our data after the first 20 women completed the study.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.58
    Comments All hypotheses tests were two-sided.
    Method Linear mixed-effects models
    Comments Linear mixed-effects models were fit to continuous outcomes to assess the change from baseline to 6 weeks between groups.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -2.0
    Confidence Interval (2-Sided) 95%
    -9.3 to 5.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments This analysis revealed that the required sample size was 235 subjects per group for 80% power to detect an absolute 2% increase in FMD with Atorvastatin vs. Placebo. We stopped the trial because we had insufficient funds for the required sample size.
    2. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    5.4
    (2.9)
    3.6
    (3.0)
    After treatment
    6.9
    (2.8)
    4.3
    (3.3)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.39
    Comments
    Method Linear mixed-effects models
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.7
    Confidence Interval (2-Sided) 95%
    -0.9 to 2.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Total Cholesterol
    Description
    Time Frame baseline and 6 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    215.8
    (39.0)
    202.8
    (28.3)
    After treatment
    132.0
    (19.7)
    192.1
    (33.6)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Linear mixed-effects models
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -70.8
    Confidence Interval (2-Sided) 95%
    -95.2 to -46.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title LDL Cholesterol
    Description
    Time Frame baseline and 6 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    140.7
    (24.6)
    131.3
    (21.6)
    After treatment
    68.5
    (19.3)
    118.8
    (26.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Linear mixed-effects models
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -57.6
    Confidence Interval (2-Sided) 95%
    -79.3 to -35.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title HDL Cholesterol
    Description
    Time Frame baseline and 6 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    44.4
    (14.6)
    46.5
    (8.6)
    After treatment
    47.8
    (11.8)
    46.8
    (8.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.26
    Comments
    Method Linear mixed-effects models
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 3.4
    Confidence Interval (2-Sided) 95%
    -2.7 to 9.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Triglycerides
    Description
    Time Frame baseline and 6 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    153.3
    (84.9)
    125.5
    (54.2)
    After treatment
    78.5
    (24.8)
    132.5
    (45.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Linear mixed-effects models
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -82.2
    Confidence Interval (2-Sided) 95%
    -126.2 to -38.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title Fasting Glucose
    Description
    Time Frame baseline and 6 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    87.7
    (9.0)
    85.3
    (8.0)
    After treatment
    87.8
    (8.5)
    88.9
    (10.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.45
    Comments
    Method Linear mixed-effects models
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -3.3
    Confidence Interval (2-Sided) 95%
    -12.4 to 5.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Fasting Insulin
    Description
    Time Frame baseline and 6 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    18.6
    (10.1)
    16.8
    (9.5)
    After treatment
    21.0
    (11.8)
    15.9
    (6.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.33
    Comments
    Method Linear mixed-effects models
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 2.5
    Confidence Interval (2-Sided) 95%
    -2.8 to 7.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    15693
    (2162)
    15309
    (3692)
    After treatment
    16136
    (2569)
    15448
    (3165)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.61
    Comments
    Method Linear mixed-effects models
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 586
    Confidence Interval (2-Sided) 95%
    -1811 to 2983
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    12738
    (10010)
    9338
    (5208)
    After treatment
    17479
    (11929)
    9132
    (4466)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.07
    Comments
    Method Linear mixed-effects models
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 3385
    Confidence Interval (2-Sided) 95%
    -287 to 7056
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    Title Total Testosterone
    Description
    Time Frame baseline and 6 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    61.3
    (16.9)
    92.3
    (49.8)
    After treatment
    47.1
    (21.4)
    75.7
    (43.6)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.88
    Comments
    Method Linear mixed-effects models
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 1.8
    Confidence Interval (2-Sided) 95%
    -24.1 to 27.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    12. Secondary Outcome
    Title Androstenedione
    Description
    Time Frame baseline and 6 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    3.4
    (0.8)
    3.8
    (1.2)
    After treatment
    2.5
    (0.9)
    4.1
    (1.2)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Linear mixed-effects models
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -1.6 to -0.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. Secondary Outcome
    Title DHEAS
    Description Dehydroepiandrosterone sulfate
    Time Frame baseline and 6 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    1630.0
    (873.1)
    1701.5
    (681.3)
    After treatment
    1326.4
    (854.3)
    1739.5
    (781.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.02
    Comments
    Method Linear mixed-effects models
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -364.3
    Confidence Interval (2-Sided) 95%
    -655.3 to -73.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    14. Other Pre-specified Outcome
    Title High-sensitivity C-reactive Protein (hsCRP)
    Description high sensitive C-reactive protein as a measure of inflammation
    Time Frame baseline and 6 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    8.0
    (9.6)
    7.2
    (7.7)
    After treatment
    4.3
    (5.4)
    6.0
    (7.3)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.21
    Comments
    Method Linear mixed-effects models
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -2.4
    Confidence Interval (2-Sided) 95%
    -6.4 to 1.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    15. Post-Hoc Outcome
    Title Systolic Blood Pressure
    Description
    Time Frame baseline and 6 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    119.8
    (15.8)
    114.5
    (14.4)
    After treatment
    112.0
    (13.2)
    111.4
    (8.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.27
    Comments
    Method Linear mixed-effects models
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -5.9
    Confidence Interval (2-Sided) 95%
    -16.9 to 5.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    16. Post-Hoc Outcome
    Title Diastolic Blood Pressure
    Description
    Time Frame baseline and 6 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    70.8
    (14.8)
    64.6
    (8.0)
    After treatment
    64.3
    (12.3)
    65.4
    (8.1)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.05
    Comments
    Method Linear mixed-effects models
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -7.8
    Confidence Interval (2-Sided) 95%
    -15.8 to 0.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    17. Post-Hoc Outcome
    Title Mean Ovarian Volume
    Description Pelvic ultrasound was performed using the 6.5 megahertz (MHz) probe of an ATL 400 machine to characterize ovarian size and morphology. Since in vitro studies demonstrate that statins inhibit ovarian theca-interstitial cell proliferation, we hypothesized that statins might reduce ovarian volume in PCOS.
    Time Frame baseline and 6 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    15.1
    (8.8)
    25.4
    (13.7)
    After treatment
    19.2
    (7.0)
    25.2
    (9.9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.48
    Comments
    Method Linear mixed-effects models
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 3.5
    Confidence Interval (2-Sided) 95%
    -6.8 to 13.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    18. Post-Hoc Outcome
    Title Body Mass Index
    Description
    Time Frame baseline and 6 weeks

    Outcome Measure Data

    Analysis Population Description
    All analyses were performed by intention-to-treat.
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    Measure Participants 9 11
    Before treatment
    40.1
    (11.8)
    36.0
    (10.4)
    After treatment
    38.2
    (8.4)
    35.8
    (10.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atorvastatin, Placebo
    Comments What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.63
    Comments
    Method Linear mixed-effects models
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.2
    Confidence Interval (2-Sided) 95%
    -0.6 to 1.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame 6 weeks
    Adverse Event Reporting Description
    Arm/Group Title Atorvastatin Placebo
    Arm/Group Description Atorvastatin, 40 mg qd Placebo qd
    All Cause Mortality
    Atorvastatin Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Atorvastatin Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/9 (11.1%) 0/11 (0%)
    Hepatobiliary disorders
    gallbladder removal 1/9 (11.1%) 1 0/11 (0%) 0
    Other (Not Including Serious) Adverse Events
    Atorvastatin Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/9 (11.1%) 2/11 (18.2%)
    General disorders
    swelling 0/9 (0%) 0 1/11 (9.1%) 1
    Musculoskeletal and connective tissue disorders
    muscle pain 1/9 (11.1%) 1 0/11 (0%) 0
    Nervous system disorders
    headache 0/9 (0%) 0 1/11 (9.1%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Richard S. Legro
    Organization Milton S. Hershey Medical Center
    Phone 717-531-8478
    Email rsl1@psu.edu
    Responsible Party:
    Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center
    ClinicalTrials.gov Identifier:
    NCT00529542
    Other Study ID Numbers:
    • 19286
    First Posted:
    Sep 14, 2007
    Last Update Posted:
    Sep 25, 2014
    Last Verified:
    Sep 1, 2014