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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00809068
Recruitment Status : Completed
First Posted : December 16, 2008
Last Update Posted : February 2, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
HDL Cholesterol Drug: fenofibrate and tibolone Drug: tibolone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Tibolone and PPARα-agonist on HDL Metabolism in Postmenopausal Women
Study Start Date : August 2005
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate

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:
  • Lipidil
  • Livial

Sham Comparator: 2
Drug: tibolone
tibolone 2.5 mg daily 23 weeks
Other Name: Livial

Primary Outcome Measures :
  1. HDL subpopulation analysis [ Time Frame: August 2009 ]

Secondary Outcome Measures :
  1. Increase in HDL subpopulations [ Time Frame: December 2009 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00809068

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Australia, Western Australia
Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands
Perth, Western Australia, Australia, 6009
Sponsors and Collaborators
Keogh Institute for Medical Research
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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
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Responsible Party: Clinical Professor Bronwyn Stuckey, Keogh Institute for Medical Research Identifier: NCT00809068    
Other Study ID Numbers: ID: 2005-001
SCGH Research Grant
First Posted: December 16, 2008    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: January 2010
Keywords provided by Keogh Institute for Medical Research:
menopausal symptoms
Additional relevant MeSH terms:
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Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antihypertensive Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Modulators
Anabolic Agents