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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00809068




Registration number
NCT00809068
Ethics application status
Date submitted
10/06/2008
Date registered
16/12/2008
Date last updated
2/02/2010

Titles & IDs
Public title
High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone
Scientific title
Effects of Tibolone and PPARa-agonist on HDL Metabolism in Postmenopausal Women
Secondary ID [1] 0 0
SCGH Research Grant
Secondary ID [2] 0 0
ID: 2005-001
Universal Trial Number (UTN)
Trial acronym
TibFen
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HDL Cholesterol 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - fenofibrate and tibolone
Treatment: Drugs - tibolone

Active comparator: 1 - fenofibrate and tibolone

Sham comparator: 2 - tibolone


Treatment: Drugs: fenofibrate and tibolone
fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks

Treatment: Drugs: tibolone
tibolone 2.5 mg daily 23 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HDL subpopulation analysis
Timepoint [1] 0 0
August 2009
Secondary outcome [1] 0 0
Increase in HDL subpopulations
Timepoint [1] 0 0
December 2009

Eligibility
Key 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
Minimum age
40 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2009
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Keogh Institute for Medical Research
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bronwyn G Stuckey, MBBS FRACP
Address 0 0
Keogh Institute for Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00809068