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Trial registered on ANZCTR


Registration number
ACTRN12614000962639
Ethics application status
Approved
Date submitted
26/08/2014
Date registered
9/09/2014
Date last updated
18/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
An open-label, phase 2, single centre, randomised, crossover pharmacokinetic study assessing two application areas of 0.5ml (5mg) of a testosterone 1% cream, ANDROFEME(Registered trademark) in healthy postmenopausal women
Scientific title
An open-label, phase 2, single centre, randomised, crossover pharmacokinetic study assessing two application areas of 0.5ml (5mg) testosterone 1% cream, ANDROFEME(Registered trademark) in healthy postmenopausal women
Secondary ID [1] 285191 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgen deficiency in postmenopausal women 292797 0
Condition category
Condition code
Reproductive Health and Childbirth 293091 293091 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
5 mg (0.5ml) of testosterone 1% cream, ANDROFEME(Registered trademark) to be applied daily for 6 weeks ( 3 weeks for each application area) to two different sized applications areas- Application Site A is a small area, palm size, of the upper lateral thigh/ lower gluteal region and Application Site B is a broad application over the lateral thigh/ lower gluteal region.
There is no wash out between treatments.
Compliance determined by return of used tubes of cream and blood levels at each visit.
Intervention code [1] 290058 0
Treatment: Drugs
Comparator / control treatment
We are investigating the pharmacokinetics of two different areas of application of the same drug in the same dose to decide which has the best clinical effect.
Control group
Active

Outcomes
Primary outcome [1] 292954 0
We will used testosterone levels measured by LCMS to calculate AUC(0-24) (the area under plasma concentration versus time plot from time 0 to 24 hours for two different sized application areas of 5mg testosterone 1% cream
Timepoint [1] 292954 0
The pharmacokinetic assessment will be done on day 21-22 of treatment for each treatment cycle
Primary outcome [2] 293011 0
To assess Cavg (the average plasma concentration of total and free testosterone during the 24 hour sampling period) using blood samples following application of 5 mg testosterone cream to two different sized application areas
Timepoint [2] 293011 0
This assessment will be done on day 21-22 of treatment for each treatment cycle
Primary outcome [3] 293012 0
To assess Tmax (the time at which Cmax occurred) of total and free testosterone using blood samples following application of 5 mg testosterone 1% cream to two different sized application areas
Timepoint [3] 293012 0
This assessment will be done on day 21-22 of treatment for each treatment cycle
Secondary outcome [1] 310002 0
To assess Cmin (the minimum plasma concentration during the 24 hour sampling period) of total and free testosterone using blood samples following application of 5 mg testosterone 1% cream to two different sized application areas
Timepoint [1] 310002 0
This assessment will be done on day 21-22 of treatment for each treatment cycle
Secondary outcome [2] 310142 0
To assess Cmax (the maximum plasma concentration during the 24 hour sampling period) of total and free testosterone using blood samples following application of 5 mg 1% testosterone cream to two different sized application areas
Timepoint [2] 310142 0
This assessment will be done on day 21-22 of treatment for each treatment cycle
Secondary outcome [3] 310143 0
To assess % Fluctuation (with and without baseline correction) of total and free testosterone using blood samples following following application of 5 mg testosterone 1% cream to two different sized application areas
Timepoint [3] 310143 0
This assessment will be done on day 21-22 of treatment for each treatment cycle
Secondary outcome [4] 310144 0
To compare the profiles of other reproductive hormones including E1 (estrone), E2 (estradiol), DHT (Dihydrotestosterone )and the DHT metabolites 3 alpha and 3 beta diols in addition to SHBG (Sex Hormone Binding Globulin) using blood samples following application of 5 mg testosterone 1%cream to two different sized application areas

Timepoint [4] 310144 0
This assessment will be done on day 21-22 of treatment for each treatment cycle

Eligibility
Key inclusion criteria
Healthy naturally postmenopausal women aged 45-65 years
Minimum age
45 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Allergy to almonds, major medical conditions or on recent hormonal treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from the general community using advertising in the media and flyers and invited to contact the Women’s Health Research Program (WHRP). If eligible to participate they will attend the WHRP for 6 visits.
Participants are required to apply 0.5ml (5mg) of testosterone cream to two different sized application areas during the study periods in a random order. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The centre will be allocated an initial computer generated randomization order by a statistician. Participants will be randomized to one of two treatment sequences AB or BA, where Application Site A is a small area, palm size, of the upper lateral thigh/ lower gluteal region and Application Site B is a broad application over the lateral thigh/ lower gluteal region. Participants will be assigned to sequence in a 1:1 ratio in a pre-determined block size.
Treatment should commence on the day of randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2014
Actual
3/02/2015
Date of last participant enrolment
Anticipated
1/06/2015
Actual
25/08/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 8622 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 289803 0
Commercial sector/Industry
Name [1] 289803 0
Lawley Pharmaceuticals
Country [1] 289803 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Lawley Pharmaceuticals
Address
Unit 2/15A Harrogate Street, West Leederville, Western Australia 6007
Country
Australia
Secondary sponsor category [1] 288493 0
None
Name [1] 288493 0
Address [1] 288493 0
Country [1] 288493 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291537 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 291537 0
Human Ethics Office
First Floor, Building 3e
Room 111
Monash Research Office
Clayton Campus
Monash University VIC 3800
Ethics committee country [1] 291537 0
Australia
Date submitted for ethics approval [1] 291537 0
12/08/2014
Approval date [1] 291537 0
15/10/2014
Ethics approval number [1] 291537 0

Summary
Brief summary
ANDROFEME (Registered trademark) cream is currently the only available testosterone product in Australia with widespread use in clinical practice. The available pharmacokinetics indicate the most appropriate dose for women is 0.5ml (5mg)/day. However the absorption of transdermal preparations is known to vary according to the area of application. This was not controlled for in prior studies. Furthermore, the investigators believe the upper arm is not an appropriate site for the drug application as 1) there is a greater risk of transfer of the applied drug to others; 2) contamination when blood is drawn for measuring testosterone levels is common (resulting in falsely elevated levels) and 3) the possibility of increased blood levels of testosterone in the ipsilateral breast.

In this study we will evaluate the pharmacokinetics of two application sites of 0.5ml (5mg) of this testosterone 1% cream in postmenopausal women: an area on the upper outer thigh/ lower buttock approximately the size of the palm (approximately 80cm2) and a broad area on the outer thigh/ lower buttock (approximately 300cm2).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50786 0
Prof Susan Davis
Address 50786 0
Women's Health Research Program
Monash University
Level 6, The Alfred Centre
99 Commercial Rd
Melbourne Victoria 3004
Country 50786 0
Australia
Phone 50786 0
+61 3 9903 0827
Fax 50786 0
+61 3 9903 0828
Email 50786 0
[email protected]
Contact person for public queries
Name 50787 0
Susan Davies
Address 50787 0
Women's Health Research Program
Monash University
Level 6, The Alfred Centre
99 Commercial Rd
Melbourne Victoria 3004
Country 50787 0
Australia
Phone 50787 0
+61 3 9903 0827
Fax 50787 0
+61 3 99030828
Email 50787 0
[email protected]
Contact person for scientific queries
Name 50788 0
Susan Davis
Address 50788 0
Women's Health Research Program
Monash University
Level 6, The Alfred Centre
99 Commercial Rd
Melbourne Victoria 3004
Country 50788 0
Australia
Phone 50788 0
+61 3 9903 0827
Fax 50788 0
+61 3 9903 0828
Email 50788 0
[email protected]

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No Supporting Document Provided



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