High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone (TibFen)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effects of Tibolone and PPARα-agonist on HDL Metabolism in Postmenopausal Women|
- HDL subpopulation analysis [ Time Frame: August 2009 ] [ Designated as safety issue: No ]
- Increase in HDL subpopulations [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Study Completion Date:||October 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
fenofibrate and tibolone
Drug: fenofibrate and tibolone
fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks
Sham Comparator: 2
tibolone 2.5 mg daily 23 weeks
Other Name: Livial
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809068
|Australia, Western Australia|
|Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands|
|Perth, Western Australia, Australia, 6009|
|Principal Investigator:||Bronwyn G Stuckey, MBBS FRACP||Keogh Institute for Medical Research|
|Principal Investigator:||Gerald F Watts, MD PhD FRACP||School pf Medicine and Pharmacology, Royal Perth Hospital.|
|Principal Investigator:||Rosalind Hampton, BSc MBBS||Keogh Institute for Medical Research|
|Principal Investigator:||Hugh Barrett, BAgSc PhD||School of Medicine and Pharmacology, Royal Perth Hospital|