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

This study has been completed.
Sponsor:
Information provided by:
Keogh Institute for Medical Research
ClinicalTrials.gov Identifier:
NCT00809068
First received: June 10, 2008
Last updated: January 31, 2010
Last verified: January 2010
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increase in HDL subpopulations [ Time Frame: December 2009 ] [ Designated as safety issue: No ]

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
tibolone
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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders 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
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 ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 10, 2008
Last Updated: January 31, 2010
Health Authority: Australia: Human Research Ethics Committee

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
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Modulators
Anabolic Agents
Hormones

ClinicalTrials.gov processed this record on July 26, 2014