Status:
COMPLETED
High-density Lipoprotein (HDL) Cholesterol in Women Taking Tibolone
Lead Sponsor:
Keogh Institute for Medical Research
Conditions:
HDL Cholesterol
Eligibility:
FEMALE
40-70 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- Post-menopausal women
- More than 6 months of amenorrhoea
- Raised FSH and low oestradiol level
- If hysterectomised, raised FSH and low oestradiol level
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00809068
Start Date
August 1 2005
End Date
October 1 2009
Last Update
February 2 2010
Active Locations (1)
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1
Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands
Perth, Western Australia, Australia, 6009