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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00809068
Study type Interventional
Source Keogh Institute for Medical Research
Contact
Status Completed
Phase Phase 4
Start date August 2005
Completion date October 2009

See also
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