NCT00529542

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

May 8, 2013

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

5.7 years

First QC Date

September 12, 2007

Results QC Date

February 15, 2013

Last Update Submit

September 15, 2014

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline and 6 weeks

Secondary Outcomes (12)

  • Peak Brachial Artery Conductance (BAC)

    baseline and 6 weeks

  • Total Cholesterol

    baseline and 6 weeks

  • LDL Cholesterol

    baseline and 6 weeks

  • HDL Cholesterol

    baseline and 6 weeks

  • Triglycerides

    baseline and 6 weeks

  • +7 more secondary outcomes

Other Outcomes (1)

  • High-sensitivity C-reactive Protein (hsCRP)

    baseline and 6 weeks

Study Arms (2)

Atorvastatin

EXPERIMENTAL
Drug: Lipitor

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

LipitorDRUG

40mg caplets per day for six weeks

Also known as: Atorvastatin
Atorvastatin
PlaceboDRUG

1 placebo caplet per day for six weeks.

Also known as: Sugar Pill
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • or fewer menstrual periods per year
  • elevated serum total testosterone
  • elevated LDL cholesterol

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S Hershey Medical Center, College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (2)

  • Xiong T, Fraison E, Kolibianaki E, Costello MF, Venetis C, Kostova EB. Statins for women with polycystic ovary syndrome not actively trying to conceive. Cochrane Database Syst Rev. 2023 Jul 18;7(7):CD008565. doi: 10.1002/14651858.CD008565.pub3.

    PMID: 37462232DERIVED

  • 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.

    PMID: 21144505DERIVED

Related Links

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

AtorvastatinSugars

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsCarbohydrates

Results Point of Contact

Title
Richard S. Legro
Organization
Milton S. Hershey Medical Center
rsl1@psu.edu
717-531-8478

Study Officials

  • Richard S Legro, MD

    Penn State College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Obstetrics and Gynecology and Public Health Sciences

Study Record Dates

First Submitted

September 12, 2007

First Posted

September 14, 2007

Study Start

December 1, 2004

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

September 25, 2014

Results First Posted

May 8, 2013

Record last verified: 2014-09

Locations

US(1)