Phase 2
N=20
A Trial of Lipitor (Atorvastatin) for the Treatment of Polycystic Ovary Syndrome (PCOS) in Women With Elevated Low-density Lipoprotein (LDL) Cholesterol
Polycystic Ovary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00529542 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
May 2013
Primary outcome: Primary: Brachial Artery Flow-mediated Dilation (FMD) — 12.0; 9.8; 10.4; 10.2 % change in brachial artery diameter — p=0.58
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lipitor (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brachial Artery Flow-mediated Dilation (FMD) |
12.0; 9.8; 10.4; 10.2 | 0.58 |
| SECONDARY Peak Brachial Artery Conductance (BAC) |
5.4; 3.6; 6.9; 4.3 | 0.39 |
| SECONDARY Total Cholesterol |
215.8; 202.8; 132.0; 192.1 | <0.001 sig |
| SECONDARY LDL Cholesterol |
140.7; 131.3; 68.5; 118.8 | <0.001 sig |
| SECONDARY HDL Cholesterol |
44.4; 46.5; 47.8; 46.8 | 0.26 |
| SECONDARY Triglycerides |
153.3; 125.5; 78.5; 132.5 | <0.001 sig |
| SECONDARY Fasting Glucose |
87.7; 85.3; 87.8; 88.9 | 0.45 |
| SECONDARY Fasting Insulin |
18.6; 16.8; 21.0; 15.9 | 0.33 |
| SECONDARY Area Under the Curve (AUC) for Glucose During OGTT |
15693; 15309; 16136; 15448 | 0.61 |
| SECONDARY AUC for Insulin |
12738; 9338; 17479; 9132 | 0.07 |
| SECONDARY Total Testosterone |
61.3; 92.3; 47.1; 75.7 | 0.88 |
| SECONDARY Androstenedione |
3.4; 3.8; 2.5; 4.1 | <0.001 sig |
| SECONDARY DHEAS |
1630.0; 1701.5; 1326.4; 1739.5 | 0.02 sig |
Summary
The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the treatment of PCOS with elevated LDL cholesterol.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00529542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.