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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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 website
https://clinicaltrials.gov/ct2/show/NCT00809068
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00809068