NCT00809068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2008

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 16, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 2, 2010

Status Verified

January 1, 2010

Enrollment Period

4 years

First QC Date

June 10, 2008

Last Update Submit

January 31, 2010

Conditions

HDL Cholesterol

Keywords

Menopausemenopausal symptomstiboloneHDL-Cfenofibrate

Outcome Measures

Primary Outcomes (1)

  • HDL subpopulation analysis

    August 2009

Secondary Outcomes (1)

  • Increase in HDL subpopulations

    December 2009

Study Arms (2)

1

ACTIVE COMPARATOR

fenofibrate and tibolone

Drug: fenofibrate and tibolone

2

SHAM COMPARATOR

tibolone

Drug: tibolone

Interventions

fenofibrate and tiboloneDRUG

fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks

Also known as: Lipidil, Livial
1
tiboloneDRUG

tibolone 2.5 mg daily 23 weeks

Also known as: Livial
2

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post-menopausal women
  • More than 6 months of amenorrhoea
  • Raised FSH and low oestradiol level
  • If hysterectomised, raised FSH and low oestradiol level

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands

Perth, Western Australia, 6009, Australia

Location

MeSH Terms

Interventions

Fenofibratetibolone

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetones

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 10, 2008

First Posted

December 16, 2008

Study Start

August 1, 2005

Primary Completion

August 1, 2009

Study Completion

October 1, 2009

Last Updated

February 2, 2010

Record last verified: 2010-01

Locations

AU(1)