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Completed

NCT Number: NCT00529542

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

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

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Penn State Milton S Hershey Medical Center, College of Medicine

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lipitor

Drug

40mg caplets per day for six weeks

Other names: Atorvastatin

Placebo

Drug

1 placebo caplet per day for six weeks.

Other names: Sugar Pill

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Total Cholesterol

    Time frame: baseline and 6 weeks

  3. LDL Cholesterol

    Time frame: baseline and 6 weeks

  4. HDL Cholesterol

    Time frame: baseline and 6 weeks

  5. Triglycerides

    Time frame: baseline and 6 weeks

  6. Fasting Glucose

    Time frame: baseline and 6 weeks

  7. Fasting Insulin

    Time frame: baseline and 6 weeks

  8. 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.

  9. 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.

  10. Total Testosterone

    Time frame: baseline and 6 weeks

  11. Androstenedione

    Time frame: baseline and 6 weeks

  12. DHEAS

    Time frame: baseline and 6 weeks

    Dehydroepiandrosterone sulfate

Other outcomes

  1. High-sensitivity C-reactive Protein (hsCRP)

    Time frame: baseline and 6 weeks

    high sensitive C-reactive protein as a measure of inflammation

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Sep 14, 2007
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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