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Sponsored by: |
Keogh Institute for Medical Research |
---|---|
Information provided by: | Keogh Institute for Medical Research |
ClinicalTrials.gov Identifier: | NCT00809068 |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | December 2008 (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
|
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.
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bronwyn G Stuckey, MBBS,FRACP | +61 (08)93462008 | kimr.research@wn.com.au |
Australia, Western Australia | |
Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands | Recruiting |
Perth, Western Australia, Australia, 6009 | |
Contact: Bronwyn G Stuckey, MBBS,FRACP +61 08 93462008 kimr.research@wn.com.au | |
Contact: Helena Ching +61 08 93462008 ext 2842 kimr.research@wn.com.au | |
Principal Investigator: Bronwyn G Stuckey, MBBS,FRACP |
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 |
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: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00809068 |
Health Authority: | Australia: Human Research Ethics Committee |
Menopause menopausal symptoms tibolone HDL-C fenofibrate |
Tibolone Procetofen Menopause |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Antilipemic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Cardiovascular Agents Antihypertensive Agents Hormones Pharmacologic Actions Estrogen Receptor Modulators Anabolic Agents Androgen Antagonists Therapeutic Uses |