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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Keogh Institute for Medical Research
• Treatments: Fenofibrate; Tibolone

Criteria

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.