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

Phase 4

Completed

• Conditions: HDL Cholesterol
• Interventions: Drug: fenofibrate and tibolone; Drug: tibolone

• Registration Number: NCT00809068
• Lead Sponsor: Keogh Institute for Medical Research

Brief 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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2008-06-10
• Study First Submitted QC: 2008-12-15
• Study First Posted: 2008-12-16
• Primary Completion: 2009-08
• Study Completion: 2009-10
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-31
• Last Update Posted: 2010-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Post-menopausal women
• More than 6 months of amenorrhoea
• Raised FSH and low oestradiol level
• If hysterectomised, raised FSH and low oestradiol level

Exclusion Criteria

• Diabetes
• Renal failure
• Proteinuria
• High alcohol intake
• Regular endurance exercise
• Active weight loss of dieting
• Smokers
• Agents known to influence lipid metabolism
• Major systemic illness
• Intolerance to tibolone and fenofibrate
• Cholelithiasis
• CK and ALT > 2ULN
• Bleeding disorders
• Peptic ulcer disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	fenofibrate and tibolone	fenofibrate and tibolone
2	tibolone	tibolone

Primary Outcome Measures

Name	Time	Method
HDL subpopulation analysis	August 2009

Secondary Outcome Measures

Name	Time	Method
Increase in HDL subpopulations	December 2009

Trial Locations

Locations (1)

Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands; 🇦🇺 Perth, Western Australia, Australia