NCT00809068

High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone

Effects of Tibolone and PPARα-agonist on HDL Metabolism in Postmenopausal Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Keogh Institute for Medical Research · Academic / Other
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Tibolone (Livial) has been shown in previous studies to lower HDL cholesterol by up to 40%. This study aims to study the effects of fenofibrate on HDL and subfractions in women taking tibolone.

Detailed description

Tibolone decreases plasma concentrations of HDL cholesterol and HDL-apoA1 and pre-beta HDL, consistent with a pro-atherogenic effect. The mechanism of tibolone on HDL cholesterol has been suggested to result from an acceleration of the catabolism of HDL by stimulation of hepatic lipase with no effect on cellular cholesterol efflux. PPAR-a agonists, in particular fenofibrate, improve HDL metabolism by increasing the expression and hepatic secretion of HDL apoAI and apoAII. We hypothesise that fenofibrate will rectify the perturbations on HDL metabolism wrought by tibolone.

Conditions

• HDL Cholesterol

Interventions

Type	Name	Description
DRUG	fenofibrate and tibolone	fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks
DRUG	tibolone	tibolone 2.5 mg daily 23 weeks

Timeline

• Start date: 2005-08-01
• Primary completion: 2009-08-01
• Completion: 2009-10-01
• First posted: 2008-12-16
• Last updated: 2010-02-02

Locations

1 site across 1 country: Australia