This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

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

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 Intervention Phase
HDL Cholesterol Drug: fenofibrate and tibolone Drug: tibolone Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Keogh Institute for Medical Research:

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

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

Estimated Enrollment: 20
Study Start Date: August 2005
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00809068

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
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
  More Information

Responsible Party: Clinical Professor Bronwyn Stuckey, Keogh Institute for Medical Research Identifier: NCT00809068     History of Changes
Other Study ID Numbers: ID: 2005-001
SCGH Research Grant
Study First Received: June 10, 2008
Last Updated: January 31, 2010

Keywords provided by Keogh Institute for Medical Research:
menopausal symptoms

Additional relevant MeSH terms:
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
Hormones processed this record on September 20, 2017