High-Density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone
Information source: Keogh Institute for Medical Research
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HDL Cholesterol
Intervention: fenofibrate and tibolone (Drug); tibolone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Keogh Institute for Medical Research Official(s) and/or principal investigator(s):
Bronwyn G Stuckey, MBBS FRACP, Principal Investigator, Affiliation: Keogh Institute for Medical Research
Gerald F Watts, MD PhD FRACP, Principal Investigator, Affiliation: School pf Medicine and Pharmacology, Royal Perth Hospital.
Rosalind Hampton, BSc MBBS, Principal Investigator, Affiliation: Keogh Institute for Medical Research
Hugh Barrett, BAgSc PhD, Principal Investigator, Affiliation: School of Medicine and Pharmacology, Royal Perth Hospital
Overall contact:
Bronwyn G Stuckey, MBBS,FRACP, Phone: +61 (08)93462008, Email: kimr.research@wn.com.au
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.
Clinical Details
Official title: Effects of Tibolone and PPARĪ±-Agonist on HDL Metabolism in Postmenopausal Women
Study design: Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
Primary outcome: HDL subpopulation analysis
Secondary outcome: Increase in HDL subpopulations
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
Minimum age: 40 Years.
Maximum age: 70 Years.
Gender(s): Female.
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.
Locations and Contacts
Bronwyn G Stuckey, MBBS,FRACP, Phone: +61 (08)93462008, Email: kimr.research@wn.com.au
Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands, Perth, Western Australia 6009, Australia; Recruiting
Bronwyn G Stuckey, MBBS,FRACP, Phone: +61 08 93462008, Email: kimr.research@wn.com.au
Helena Ching, Phone: +61 08 93462008, Ext: 2842, Email: kimr.research@wn.com.au
Bronwyn G Stuckey, MBBS,FRACP, Principal Investigator
Additional Information
Starting date: August 2005
Ending date: August 2009
Last updated: December 15, 2008
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