High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone

Effects of Tibolone and PPARα-agonist on HDL Metabolism in Postmenopausal Women

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00809068

Acronym

TibFen

Enrollment

Registered

2008-12-16

Start date

2005-08-31

Completion date

2009-10-31

Last updated

2010-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HDL Cholesterol

Keywords

Menopause, menopausal symptoms, tibolone, HDL-C, fenofibrate

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.

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.

Interventions

DRUGfenofibrate and tibolone

fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks

DRUGtibolone

tibolone 2.5 mg daily 23 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 70 Years

Healthy volunteers

Yes

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

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.

Design outcomes

Primary

Measure	Time frame
HDL subpopulation analysis	August 2009

Secondary

Measure	Time frame
Increase in HDL subpopulations	December 2009

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026