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

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ClinicalTrials.gov Identifier: NCT00809068
Recruitment Status : Completed
First Posted : December 16, 2008
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:

Study Description
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.


Study Design

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
Primary Completion Date : August 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate
U.S. FDA Resources

Arms and Interventions

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
tibolone
Drug: tibolone
tibolone 2.5 mg daily 23 weeks
Other Name: Livial


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00809068


Locations
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
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
More Information

Responsible Party: Clinical Professor Bronwyn Stuckey, Keogh Institute for Medical Research
ClinicalTrials.gov Identifier: NCT00809068     History of Changes
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:
Menopause
menopausal symptoms
tibolone
HDL-C
fenofibrate

Additional relevant MeSH terms:
Fenofibrate
Tibolone
Hypolipidemic Agents
Antimetabolites
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