drugset / Trial / NCT00529542
A Trial of Lipitor (Atorvastatin) for the Treatment of Polycystic Ovary Syndrome (PCOS) in Women With Elevated Low-density Lipoprotein (LDL) Cholesterol
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the treatment of PCOS with elevated LDL cholesterol.
Timeline
- Start
- 2004-12
- Primary completion
- 2010-08
- Completion
- 2010-08
Outcome
Missed primary endpoint
registry Atorvastatin vs Placebo; p = 0.58; Mean Difference (Net) -2.0 (95% CI -9.3 to 5.3) NCT00529542 ↗
paper failed to improve brachial artery flow-mediated dilation PMID 21144505 ↗
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 40 mg | — |