High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone - Full Text View

Sponsor:	Keogh Institute for Medical Research
Information provided by:	Keogh Institute for Medical Research
ClinicalTrials.gov Identifier:	NCT00809068

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
Official Title:	Effects of Tibolone and PPARα-agonist on HDL Metabolism in Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

Drug Information available for: Procetofen Tibolone

U.S. FDA Resources

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
1: Active Comparator fenofibrate and tibolone	Drug: fenofibrate and tibolone fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks
2: Sham Comparator tibolone	Drug: tibolone tibolone 2.5 mg daily 23 weeks

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

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

Antimetabolites
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antilipemic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Agents

Antihypertensive Agents
Hormones
Procetofen
Pharmacologic Actions
Estrogen Receptor Modulators
Anabolic Agents
Tibolone
Androgen Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2010