Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000981224
Ethics application status
Approved
Date submitted
11/11/2009
Date registered
13/11/2009
Date last updated
18/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of transdermal testosterone gel300mcg daily on cognitive performance in older postmenopausal women: a placebo controlled trial over 26 weeks
Scientific title
The effect of transdermal testosterone gel300mcg daily on cognitive performance in older postmenopausal women: a placebo controlled trial over 26 weeks
Secondary ID [1] 283867 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognition in older postmenopausal women 252169 0
Condition category
Condition code
Mental Health 252371 252371 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
administration of 300mcg of transdermal testosterone gel once daily to the upper arm for 6 months
Intervention code [1] 241535 0
Treatment: Drugs
Comparator / control treatment
The placebo is a clear, colorless gel in a hydroalcoholic solution intended for topical application and is an identical match to the active study drug.
0.22 g of gel is delivered with each actuation, and applied on the skin of the upper arm daily for 6 months
Control group
Placebo

Outcomes
Primary outcome [1] 253245 0
To determine whether treatment of older postmenopausal women (55 to 65 years old) with transdermal testosterone gel (LibiGel) which delivers 300mcg of testosterone/day improves cognitive performance.
The outcome is assessed using CogState ? a highly sensitive measure of cognitive performance.
Timepoint [1] 253245 0
26 weeks following randomization
Secondary outcome [1] 262207 0
nil
Timepoint [1] 262207 0
nil

Eligibility
Key inclusion criteria
Women:
1. who are aged 55 to 65 years and have not used systemic oestrogen, testosterone, tibolone or dehydroepiandrosterone(DHEA) therapy for at least 12 months.
2. who are at least 12 months postmenopausal. Postmenopausal status will be defined as surgical menopause, natural menopause and >12months of amenorrhea. Hysterectomised women with intact ovaries will be classified as postmenopausal if 58 years and over and if <58 years will require a follicle stimulating hormone (FSH) level > 20IU/L.
3. who have evidence of a Pap smear and mammographic screening in the past 24 months with no changes of concern.
4. who have provided informed consent by signing the International Regulatory Board (IRB)-approved consent agreement.
Minimum age
55 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Women with any of the following:
(a) history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation
(b) any clinically significant skin abnormalities in the area of study drug application (Skin Irritation Scale must < 1 at Visit 2).
(c) hot flushes and/or night sweats for which the potential participant wants treatment
(d) Sex Hormone Binding Globulin (SHBG) level < 12nmol/L
(e) undiagnosed genital bleeding
(f) Body Mass Index (BMI) <18 or > 40kg/m2
(g) found on the screening to have a Center for Epidemiological Studies Depression Scale (CES-D) score =16.
(h) any mammogram results in the past 24 months with pre-cancerous or cancerous findings or any finding that requires follow up in the next 12 months.
(i) any abnormal Pap Smear results in the past last 24 months
(j) have received anti-androgen therapy or topical minoxidil for alopecia within the last 5 years.
(k) have taken any systemic estrogen, including vaginal conjugated equine estrogen, or estrogen progestin therapy within 12 months prior to screening. (Current use of non-systemic vaginal estrogen or phytoestrogens is acceptable.)
(l) have received oral, topical, vaginal or patch, implantable or injectable androgen therapy within 12 months prior to screening
(m) have used within the 12 weeks prior to screening any of the following medications/preparations that may interfere with the study purpose: systemic corticosteroids (acute use for fewer than 7 days is accepted) or Selective Estrogen Receptor Modulators (SERMs), including tamoxifen.
(n) a known severe psychiatric illness.
(o) current use of an anti-depressant therapy or antidepressant treatment within the last 3 months
(p) neurological disorder that would affect cognition, including history of significant head injury with loss of consciousness, epilepsy, cerebral tumor, stroke and previous intracranial surgery of any kind, Parkinson’s disease, multiple sclerosis.
(q) intellectual disability
(r) uncontrolled hypertension, Systolic blood pressure (BP) > 160 and/or Diastolic BP > 90
(s) a history of cancer except for treated superficial basal cell carcinoma and squamous cell carcinoma of the skin.
(t) any history of deep venous thrombosis, pulmonary embolism, or retinal vein thrombosis
(u) any serious endocrine disorder with systemic disease. Women with a history of thyroid disease should provide evidence that they are currently euthyroid.
(v) known acute or chronic liver disease (bilirubin > x2 the upper limit of normal (ULN), and/or alanine transferase > x3 ULN, aspartate aminotransferase AST> x3 ULN, and/or alkaline phosphatase > x3 ULN
(w) insulin dependent diabetes mellitus, acute / chronic renal, liver, cardiovascular disease or any other chronic major illness which would impair overall health and wellbeing
2. Women who, in the opinion of the investigator, are a poor medical or psychiatric risk for treatment in a research protocol.
3. Women who have participated in a medical or surgical research protocol in the preceding 28 days.

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)
Participants will be recruited from advertisements in the media and from flyers within the Alfred Hospital and Monash University web site. All participants will have voluntarily provided their telephone details before being contacted by the Research Unit.
Participants will initially be contacted by telephone by researchers working on the study. They will be assessed with regards to their suitability to be involved in the study. Those who are deemed suitable will be mailed the participant information sheet to read at their leisure. Those patients who wish to participate will be instructed to contact the Trial Co-ordinator to arrange a visit to the Women’s Health Program, Monash Medical School, Alfred Hospital, for a screening visit.
Allocation concealment will be done by central randomization by fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomization schedule will be computer generated.
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
1/01/2010
Actual
24/03/2010
Date of last participant enrolment
Anticipated
Actual
2/04/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 244004 0
Commercial sector/Industry
Name [1] 244004 0
BioSante Pharmaceuticals
Country [1] 244004 0
United States of America
Primary sponsor type
University
Name
Monash University
Address
Monash University
Women's Health Research Program
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne Victoria 3004
Country
Australia
Secondary sponsor category [1] 251355 0
None
Name [1] 251355 0
Address [1] 251355 0
Country [1] 251355 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244109 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 244109 0
Human Ethics Office
First Floor, Building 3E, Room 111
Monash University VIC 3800
Ethics committee country [1] 244109 0
Australia
Date submitted for ethics approval [1] 244109 0
09/09/2009
Approval date [1] 244109 0
02/11/2009
Ethics approval number [1] 244109 0
CF09/2520 - 2009001460

Summary
Brief summary
The Primary Objective of this study is to determine whether treatment of older postmenopausal women (55 to 65 years old) with transdermal testosterone gel (Libigel Registered Trademark) which delivers 300mcg of testosterone/day, improves cognitive performance.

Study Hypotheses
That restoration of testosterone levels in older postmenopausal women to levels seen in younger women will result in improved verbal and visual learning and memory using a highly sensitive measure of cognitive performance (Cogstate Trademark).
That this research will provide the first substantial data indicating that restoration of testosterone levels to those of younger women may protect against/delay the onset of cognitive decline.
Trial website
Trial related presentations / publications
Davis SR , Jane F, Robinson PJ, Davison SL, Worsley R, Maruff P, Bell RJ. Transdermal Testosterone Improves Verbal Learning and Memory in Postmenopausal Women Not on Estrogen therapy. Clin Endocrinol (Oxf). 2014 Apr 9. doi: 10.1111/cen.12459. [Epub ahead of print]
Public notes

Contacts
Principal investigator
Name 30493 0
Prof Susan Davis
Address 30493 0

Women's Health Research Program Monash University Level 6,The Alfred Centre 99 Commercial Road Melbourne VIC 3004
Country 30493 0
Australia
Phone 30493 0
+61 3 9903 0827
Fax 30493 0
+61 3 9903 0828
Email 30493 0
[email protected]
Contact person for public queries
Name 13740 0
Prof Susan Davis
Address 13740 0
Women's Health Research Program Monash University Level 6,The Alfred Centre 99 Commercial Road Melbourne VIC 3004
Country 13740 0
Australia
Phone 13740 0
+61 3 9903 0827
Fax 13740 0
+61 3 9903 0828
Email 13740 0
[email protected]
Contact person for scientific queries
Name 4668 0
Prof susan davis
Address 4668 0
Women's Health Research Program Monash University Level 6,The Alfred Centre 99 Commercial Road Melbourne VIC 3004
Country 4668 0
Australia
Phone 4668 0
+61 3 9903 0827
Fax 4668 0
+61 3 9903 0828
Email 4668 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

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