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

Sponsor:	Penn State University
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00529542

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
Polycystic Ovary Syndrome	Drug: Lipitor Drug: Placebo

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label 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:

MedlinePlus related topics: Cholesterol Diabetes Medicines Polycystic Ovary Syndrome

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:

Improvement of vascular function androgen levels [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Increase the frequency of ovulation [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
Change in androgen levels [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
Improvement in insulin sensitivity [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
Improvement in the lipid profile more efficiently than placebo [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	December 2004
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Intervention Details:

40mg caplets per day for six weeks

Other Name: Atorvastatin

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

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

Penn State University

Investigators

Principal Investigator:

Richard S Legro, MD

Penn State College of Medicine

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Penn State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Dec 8.

Responsible Party:	Richard S. Legro, M.D., The Penn State University
ClinicalTrials.gov Identifier:	NCT00529542 History of Changes
Other Study ID Numbers:	19286
Study First Received:	September 12, 2007
Last Updated:	September 14, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Penn State University:

Polycystic Ovary Syndrome

Additional relevant MeSH terms:

Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Atorvastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012