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

January 31, 2010 updated by: Keogh Institute for Medical Research

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
fenofibrate and tibolone
Drug: fenofibrate and tibolone
fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks
Other Names:
  • Livial
  • Lipidil
Sham Comparator: 2
tibolone
Drug: tibolone
tibolone 2.5 mg daily 23 weeks
Other Names:
  • Livial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HDL subpopulation analysis
Time Frame: August 2009
August 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
Increase in HDL subpopulations
Time Frame: December 2009
December 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keogh Institute for Medical Research

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

June 10, 2008

First Submitted That Met QC Criteria

December 15, 2008

First Posted (Estimate)

December 16, 2008

Study Record Updates

Last Update Posted (Estimate)

February 2, 2010

Last Update Submitted That Met QC Criteria

January 31, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID: 2005-001
  • SCGH Research Grant

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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