Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000429358
Ethics application status
Approved
Date submitted
12/09/2007
Date registered
26/08/2008
Date last updated
26/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase II open-label pilot study to assess the effects of Testosterone Metered Dose Transdermal System (MDTS) administration on cognitive function in women
Scientific title
A Phase II open-label pilot study to assess the effects of Testosterone Metered Dose Transdermal System (MDTS) administration on cognitive function in women
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognition 2369 0
Condition category
Condition code
Neurological 2474 2474 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
administration of 180microlitres transdermal testosterone spray daily for 26 weeks
Intervention code [1] 2090 0
Treatment: Drugs
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3371 0
effects on cognition as measured by functional MRI (magnetic resonance imaging)
Timepoint [1] 3371 0
0 weeks and 26 weeks
Secondary outcome [1] 5592 0
effects on cognition as measured by CogState and pre-pulse inhibition testing
Timepoint [1] 5592 0
screening, 0, 12 and 26 weeks for CogState; 0 and 26 weeks for prepulse inhibition testing

Eligibility
Key inclusion criteria
Healthy postmenopausal women on stable non-oral oestrogen for at least 8 weeks
Minimum age
45 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
history of cancer exluding non-melanotic skin cancer, significant heart, liver, kidney, endocrine disease or neurological disease, androgenic alopecia, current androgen or anti-androgen therapy, epilepsy, seizures, psychiatric illness, previous neurological or head injury, intellectual disability, uncontrolled hypertension, recent major gynaecological surgery, total tesosterone levels higher than the upper limit of the normal reference range for young premenopausal women, alcohol consumption of greater than 3 standard drinks per day, if uterus in situ use of progestin other than Mirena intra-uterine device, presence of implanted metallic material or devices, severe claustrophobia

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
18/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 432 0
3181

Funding & Sponsors
Funding source category [1] 2621 0
Government body
Name [1] 2621 0
National Health and Medical Research Council
Country [1] 2621 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
FemPharm Pty Ltd
Address
103-113 Stanley Street
West Melbourne VIC 3003
Country
Australia
Secondary sponsor category [1] 2370 0
Charities/Societies/Foundations
Name [1] 2370 0
Royal Australasian College of Physicians Research and Education Foundation
Address [1] 2370 0
Macquarie Street
Sydney NSW 2000
Country [1] 2370 0
Australia
Other collaborator category [1] 38 0
University
Name [1] 38 0
Howard Florey Institute
Address [1] 38 0
University of Melbourne
Parkville VIC 3010
Country [1] 38 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4541 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 4541 0
The Alfred Hospital
Commercial Road
Prahran VIC 3181
Ethics committee country [1] 4541 0
Australia
Date submitted for ethics approval [1] 4541 0
28/05/2007
Approval date [1] 4541 0
04/09/2007
Ethics approval number [1] 4541 0
125/07

Summary
Brief summary
A 26 week study to assess the effects of transdermal testosterone spray on cognitive function in healthy postmenopausal women aged 45-60 years.
Trial website
http://womenshealth.med.monash.edu.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28051 0
Address 28051 0
Country 28051 0
Phone 28051 0
Fax 28051 0
Email 28051 0
Contact person for public queries
Name 11208 0
Dr Sonia Davison
Address 11208 0
Women's Health Program,
Department of Medicine,
Monash Medical School,
Alfred Hospital,
Commercial Road
Prahran VIC 3181
Country 11208 0
Australia
Phone 11208 0
03 9903 0827
Fax 11208 0
03 9903 0828
Email 11208 0
[email protected]
Contact person for scientific queries
Name 2136 0
Dr Sonia Davison
Address 2136 0
Women's Health Program,
Department of Medicine,
Monash Medical School,
Alfred Hospital,
Commercial Road
Prahran VIC 3181
Country 2136 0
Australia
Phone 2136 0
03 9903 0827
Fax 2136 0
03 9903 0828
Email 2136 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.