High-density Lipoprotein (HDL) Cholesterol in Women Takin... | NCT00809068

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

NCT00809068

Sponsor

Keogh Institute for Medical Research

Status

Completed

Last Update Posted

Feb 2, 2010Estimated

Enrollment

20Estimated

Phase

Phase 4

Conditions

HDL Cholesterol

Interventions

fenofibrate and tibolone
tibolone

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SCGH Research Grant

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Aug 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Jun 10, 2008

First Submission Date that Met QC Criteria

Dec 15, 2008

First Posted Date

Dec 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2010

Last Update Posted Date

Feb 2, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	fenofibrate and tibolone	Drug: fenofibrate and tibolone
2	Sham Comparator	tibolone	Drug: tibolone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fenofibrate and tibolone	Drug	fenofibrate 160mg daily 8 weeks tibolone 2.5mg daily 23 weeks	1

Measure	Description	Time Frame
HDL subpopulation analysis		August 2009

Measure	Description	Time Frame
Increase in HDL subpopulations		December 2009

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bronwyn G Stuckey, MBBS FRACP	Keogh Institute for Medical Research	Principal Investigator
Gerald F Watts, MD PhD FRACP	School pf Medicine and Pharmacology, Royal Perth Hospital.	Principal Investigator
Rosalind Hampton, BSc MBBS	Keogh Institute for Medical Research	Principal Investigator
Hugh Barrett, BAgSc PhD	School of Medicine and Pharmacology, Royal Perth Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Keogh Institute for Medical Research, 'A' Block 3rd Floor, QE II Medical Centre, Nedlands		Perth	Western Australia	6009	Australia

Intervention Browse Module

MeSH Terms

ID	Term
D011345	Fenofibrate
C027385	tibolone

Ancestor Terms

ID	Term
D058607	Fibric Acids
D058610	Isobutyrates
D002087	Butyrates
D000144	Acids, Acyclic

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