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

Keogh Institute for Medical Research

Status and phase: Completed; Phase 4

Conditions: HDL Cholesterol

Treatments: Drug: tibolone; Drug: fenofibrate and tibolone

Study type: Interventional

Funder types: Other

Identifiers

NCT00809068

SCGH Research Grant

ID: 2005-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

1

Active Comparator group

Description:

fenofibrate and tibolone

Treatment:

Drug: fenofibrate and tibolone

2

Sham Comparator group

Description:

tibolone

Treatment:

Drug: tibolone