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Completed

NCT Number: NCT00809068

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

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.

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Key information

Conditions

HDL Cholesterol

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands

Perth, Western Australia, 6009, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fenofibrate and tibolone

Drug

fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks

Other names: Lipidil, Livial

Tibolone

Drug

tibolone 2.5 mg daily 23 weeks

Other names: Livial

Primary outcomes

  1. HDL subpopulation analysis

    Time frame: August 2009

Secondary outcomes

  1. Increase in HDL subpopulations

    Time frame: December 2009

Sponsors and collaborators

Lead sponsor

Keogh Institute for Medical Research

Other

Registry information

Official study title

Effects of Tibolone and PPARα-agonist on HDL Metabolism in Postmenopausal Women

Acronym: TibFen

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Dec 16, 2008
Registry last updated
Feb 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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