HDL CholesterolPhase 4TibFenNCT00809068
High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone
A Phase 4 study testing fenofibrate and tibolone and tibolone in people with HDL Cholesterol, run by Keogh Institute for Medical Research at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HDL Cholesterol
- What is being tested?
- fenofibrate and tibolone and tibolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2005to Oct 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post-menopausal women
- More than 6 months of amenorrhoea
- Raised FSH and low oestradiol level
- If hysterectomised, raised FSH and low oestradiol level
Who cannot join
- Diabetes
- Renal failure
- Proteinuria
- High alcohol intake
- Regular endurance exercise
- Active weight loss of dieting
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands
Perth, Western Australia, 6009
About this study
Official title: Effects of Tibolone and PPARα-agonist on HDL Metabolism in Postmenopausal Women
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.
Read the 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.
- Conditions
- HDL Cholesterol
- Being tested
- fenofibrate and tibolone, tibolone
- Keywords
- Menopause, menopausal symptoms, tibolone, HDL-C, fenofibrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenofibrate and tiboloneDrug
Also called Lipidil, Livial
fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks
tiboloneDrug
Also called Livial
tibolone 2.5 mg daily 23 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | fenofibrate and tibolone Receives: Drug: fenofibrate and tibolone |
| 2 | Sham comparator | tibolone Receives: Drug: tibolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL subpopulation analysis
Measured: August 2009
Secondary outcomes (1)
Increase in HDL subpopulations
Measured: December 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startAug 2005
- Primary completionAug 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HDL CholesterolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keogh Institute for Medical Research
- Sponsor type
- University, hospital or other
- Investigators
- Bronwyn G Stuckey, MBBS FRACP, Principal investigator, Keogh Institute for Medical ResearchGerald F Watts, MD PhD FRACP, Principal investigator, School pf Medicine and Pharmacology, Royal Perth Hospital.Rosalind Hampton, BSc MBBS, Principal investigator, Keogh Institute for Medical ResearchHugh Barrett, BAgSc PhD, Principal investigator, School of Medicine and Pharmacology, Royal Perth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809068
- Sponsor's protocol ID
- ID: 2005-001
- Other IDs
- SCGH Research Grant
- Acronym
- TibFen
- Status last verified
- Jan 2010
- First submitted
- 10 Jun 2008
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tibolone and PPARα-agonist on HDL Metabolism in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00809068
- Acronym / sponsor ID
- TibFen / ID: 2005-001
- Conditions
- HDL Cholesterol
- Keywords
- Menopause, menopausal symptoms, tibolone, HDL-C, fenofibrate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Keogh Institute for Medical ResearchUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 16 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: fenofibrate and tibolonefenofibrate and tibolone |
| 2 | Sham comparator | Drug: tibolonetibolone |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Post-menopausal women
- More than 6 months of amenorrhoea
- Raised FSH and low oestradiol level
- If hysterectomised, raised FSH and low oestradiol level
Key exclusion criteria (14 listed)
- Diabetes
- Renal failure
- Proteinuria
- High alcohol intake
- Regular endurance exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fenofibrate and tiboloneAlso: Lipidil, Livialfenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks | Drug | 1 |
| tiboloneAlso: Livialtibolone 2.5 mg daily 23 weeks | Drug | 2 |
Primary outcome
HDL subpopulation analysis
Time frame: August 2009
1 secondary outcome
Increase in HDL subpopulations
Time frame: December 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bronwyn G Stuckey, MBBS FRACP principal investigator
Keogh Institute for Medical Research
Gerald F Watts, MD PhD FRACP principal investigator
School pf Medicine and Pharmacology, Royal Perth Hospital.
Rosalind Hampton, BSc MBBS principal investigator
Keogh Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fenofibrate and tibolone and tibolone in people with HDL Cholesterol, run by Keogh Institute for Medical Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HDL subpopulation analysis (time frame: August 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2010.