Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-27 @ 12:31 PM
Study NCT ID:
NCT00809068
Status:
COMPLETED
Last Update Posted:
2010-02-02
First Post:
2008-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone
Sponsor:
Keogh Institute for Medical Research
Organization:
Study Overview
Official Title:
Effects of Tibolone and PPARĪ±-agonist on HDL Metabolism in Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TibFen
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SCGH Research Grant | None | None | View |