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

This study has been completed.
Sponsor:
Information provided by:
Keogh Institute for Medical Research
ClinicalTrials.gov Identifier:
NCT00809068
First received: June 10, 2008
Last updated: January 31, 2010
Last verified: January 2010
History of Changes

June 10, 2008
January 31, 2010
August 2005
August 2009   (final data collection date for primary outcome measure)
HDL subpopulation analysis [ Time Frame: August 2009 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00809068 on ClinicalTrials.gov Archive Site
Increase in HDL subpopulations [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone
Effects of Tibolone and PPARα-agonist on HDL Metabolism in Postmenopausal Women

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
HDL Cholesterol
  • Drug: fenofibrate and tibolone
    fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks
    Other Names:
    • Lipidil
    • Livial
  • Drug: tibolone
    tibolone 2.5 mg daily 23 weeks
    Other Name: Livial
  • Active Comparator: 1
    fenofibrate and tibolone
    Intervention: Drug: fenofibrate and tibolone
  • Sham Comparator: 2
    tibolone
    Intervention: Drug: tibolone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2009
August 2009   (final data collection date for primary outcome measure)

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.
Female
40 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00809068
ID: 2005-001, SCGH Research Grant
Yes
Clinical Professor Bronwyn Stuckey, Keogh Institute for Medical Research
Keogh Institute for Medical Research
Not Provided
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
Keogh Institute for Medical Research
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP