Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000029099
Ethics application status
Approved
Date submitted
6/01/2010
Date registered
11/01/2010
Date last updated
5/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of transdermal testosterone patch (Intrinsa registered trademark) on cognitive performance in older postmenopausal women: a randomized placebo controlled trial over 26 weeks.
Scientific title
The effect of transdermal testosterone patch (Intrinsa registered trademark) on cognitive performance in older postmenopausal women: a randomized placebo controlled trial over 26 weeks.
Secondary ID [1] 1259 0
nil known
Universal Trial Number (UTN)
U1111-1113-1784
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognition 252242 0
Condition category
Condition code
Mental Health 252428 252428 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
transdermal testosterone patch (Intrinsa) 300 mcg, 1 patch applied twice weekly (patch applied to skin for 3.5 days), duration 26 weeks
Intervention code [1] 241575 0
Treatment: Drugs
Intervention code [2] 255784 0
Prevention
Comparator / control treatment
transdermal placebo patch applied twice weekly (patch applied to skin for 3.5 days), duration 26 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 253304 0
cognitive performance as assessed by a computerised cognitive battery (CogState)
Timepoint [1] 253304 0
6 months following randomisation
Secondary outcome [1] 262346 0
nil
Timepoint [1] 262346 0
nil

Eligibility
Key inclusion criteria
Healthy postmenopausal women aged 65 to 70 years, on no hormone therapy (HRT).
Minimum age
65 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any hormone therapy in the past 12 months (i.e. systemic oestrogen, testosterone, tibolone, or dehydroepiandrosterone acetate [DHEA]) excluding topical vaginal oestrogens. Past or present history of cancer, significant disease of the heart, liver, or kidneys, serious endocrine (hormone) disorder, androgenic alopecia (loss of scalp hair in a male pattern) or use of anti-androgen therapy, epilepsy, seizures, psychiatric illness including depression, neurological (nerve, spinal cord or brain) injury including head injury, intellectual disability, uncontrolled hypertension (high blood pressure), major gynaecological (ovarian, vaginal, cervical, womb or uterus) surgery in the preceding 3 months, levels of testosterone higher than the normal reference range for young premenopausal women, use of androgen or anti-androgen therapy, the use of other medication that may interfere with the results of the study. Regular consumption of an excess of alcohol (more than 3 standard drinks per day)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization by using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2010
Actual
27/07/2010
Date of last participant enrolment
Anticipated
Actual
15/03/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256253 0
University
Name [1] 256253 0
Monash University
Country [1] 256253 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road, Clayton, Victoria, 3800
Country
Australia
Secondary sponsor category [1] 251585 0
None
Name [1] 251585 0
Address [1] 251585 0
Country [1] 251585 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258346 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 258346 0
Building 3E, Room 111,
Monash University, Clayton, Victoria, 3800
Ethics committee country [1] 258346 0
Australia
Date submitted for ethics approval [1] 258346 0
07/01/2010
Approval date [1] 258346 0
Ethics approval number [1] 258346 0

Summary
Brief summary
Circulating testosterone levels in young healthy women exceed those of oestrogen and by the time women reach their 40s, their blood testosterone levels are about half those of women in their 20s. Restoration of testosterone levels in postmenopausal women to those of younger women improves several aspects of cognitive function using conventional tests of cognitive performance. More recently, in a pilot study of postmenopausal women given transdermal testosterone over a period of 26 weeks we observed improved verbal and visual learning and memory using highly sensitive measures of cognitive performance. The aim of this study is to use these sensitive measures of cognitive function, which can detect subtle changes in cognitive performance in well older individuals, in a randomised placebo-controlled trial to determine whether restoration of blood testosterone levels in older women to those of premenopausal women over 26 weeks enhances cognitive performance when compared with placebo therapy.
Trial website
Trial related presentations / publications
1. Davis SR, Davison SL, Gavrilescu M, Searle K, Gogos A, Rossell SL, Egan GF, Bell RJ. Effects of testosterone on visuospatial function and verbal fluency in postmenopausal women: results from a functional magnetic resonance imaging pilot study. Menopause. 2013 Sep 2. [Epub ahead of print]


2. US Endocrine Society Annual Congress June 2013 - poster presentation of preliminary data
Public notes

Contacts
Principal investigator
Name 30529 0
Dr Sonia Davison
Address 30529 0
Women's Health Research Program
Department of Epidemiology and Preventive Medicine
Level 6 The Alfred Hospital
99 Commercial Rd
Melbourne Victoria 3004
Country 30529 0
Australia
Phone 30529 0
+61399030827
Fax 30529 0
Email 30529 0
[email protected]
Contact person for public queries
Name 13776 0
Prof Susan Davis
Address 13776 0
Women's Health Research Program
Department of Epidemiology and Preventive Medicine
Level 6 The Alfred Hospital
99 Commercial Rd
Melbourne Victoria 3004
Country 13776 0
Australia
Phone 13776 0
+61399030827
Fax 13776 0
+61399030828
Email 13776 0
[email protected]
Contact person for scientific queries
Name 4704 0
Prof Susan Davis
Address 4704 0
Women's Health Research Program
Department of Epidemiology and Preventive Medicine
Level 6 The Alfred Hospital
99 Commercial Rd
Melbourne Victoria 3004
Country 4704 0
Australia
Phone 4704 0
+61399030827
Fax 4704 0
+61399030828
Email 4704 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
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