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

HDL Cholesterol Clinical Trial

— TibFen  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809068
• Other study ID #: ID: 2005-001
• Secondary ID: SCGH Research Gr
• Status: Completed
• Phase: Phase 4
• First received: June 10, 2008
• Last updated: January 31, 2010
• Start date: August 2005
• Est. completion date: October 2009

Study information

• Verified date: January 2010
• Source: Keogh Institute for Medical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HDL Cholesterol

Intervention

Drug:
• fenofibrate and tibolone
fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks
• tibolone
tibolone 2.5 mg daily 23 weeks

Locations

Country	Name	City	State
Australia	Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands	Perth	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Keogh Institute for Medical Research

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HDL subpopulation analysis		August 2009	No
Secondary	Increase in HDL subpopulations		December 2009	No