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

Overview

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.

Full Title of Study: “Effects of Tibolone and PPARĪ±-agonist on HDL Metabolism in Postmenopausal Women”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 2009

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.

Interventions

  • Drug: fenofibrate and tibolone
    • fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks
  • Drug: tibolone
    • tibolone 2.5 mg daily 23 weeks

Arms, Groups and Cohorts

  • Active Comparator: 1
    • fenofibrate and tibolone
  • Sham Comparator: 2
    • tibolone

Clinical Trial Outcome Measures

Primary Measures

  • HDL subpopulation analysis
    • Time Frame: August 2009

Secondary Measures

  • Increase in HDL subpopulations
    • Time Frame: December 2009

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 40 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Keogh Institute for Medical Research
  • Provider of Information About this Clinical Study
    • Clinical Professor Bronwyn Stuckey, Keogh Institute for Medical Research
  • Overall Official(s)
    • Bronwyn G Stuckey, MBBS FRACP, Principal Investigator, Keogh Institute for Medical Research
    • Gerald F Watts, MD PhD FRACP, Principal Investigator, School pf Medicine and Pharmacology, Royal Perth Hospital.
    • Rosalind Hampton, BSc MBBS, Principal Investigator, Keogh Institute for Medical Research
    • Hugh Barrett, BAgSc PhD, Principal Investigator, School of Medicine and Pharmacology, Royal Perth Hospital

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