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Trial registered on ANZCTR


Registration number
ACTRN12612001250820
Ethics application status
Approved
Date submitted
14/11/2012
Date registered
26/11/2012
Date last updated
7/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
An open-label, phase 2, single centre, randomised, crossover study of two doses of Androfeme in healthy postmenopausal women
Scientific title
Assessment and comparison of the pharmacokinetics of two doses of Androfeme using an open-label, phase 2, single centre, randomised, crossover study in healthy postmenopausal women
Secondary ID [1] 281529 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
determination of blood testosterone levels using two doses of Androfem cream in postmenopausal women 287793 0
Condition category
Condition code
Reproductive Health and Childbirth 288145 288145 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of 0.5ml (5mg) testosterone 1% cream (Androfeme) in postmenopausal women for two months. Patients will be required to apply the topical cream once daily . There is no washout between two periods of study.
Intervention code [1] 286044 0
Treatment: Drugs
Comparator / control treatment
Administration of 1.0ml (10mg) Androfeme cream in postmenopausal women for two months. Patients will be required to apply the topical cream once daily . There is no washout between two periods of study.
Control group
Dose comparison

Outcomes
Primary outcome [1] 288347 0
To assess Pharmacokinetic variables: AUC(0-24) (the area under plasma concentration versus time plot from time 0 to 24 hours using blood samples following application of two doses of Androfeme
Timepoint [1] 288347 0
4 months
Primary outcome [2] 288418 0
To assess Cavg (the average plasma concentration during the 24 hour sampling period) using blood samples following application of two doses of Androfeme
Timepoint [2] 288418 0
4 months
Primary outcome [3] 288419 0
To assess Tmax (the time at which Cmax occurred) using blood samples following application of two doses of Androfeme
Timepoint [3] 288419 0
4 month
Secondary outcome [1] 299930 0
To assess Cmin (the minimum plasma concentration during the 24 hour sampling period) using blood samples following application of two doses of Androfeme
Timepoint [1] 299930 0
4 months
Secondary outcome [2] 300106 0
To assess Cmax (the maximum plasma concentration during the 24 hour sampling period) using blood samples following application of two doses of Androfeme
Timepoint [2] 300106 0
4 months
Secondary outcome [3] 300115 0
To assess % Fluctuation (with and without baseline correction) for two doses of 5 and 10mg of Androfeme cream using blood samples following application of two doses of Androfeme
Timepoint [3] 300115 0
4 months
Secondary outcome [4] 300116 0
To compare the profiles of other reproductive hormones including E1, E2, DHT and the DHT metabolites 3 alpha and 3 beta diols in addition to SHBG using blood samples following application of two doses of Androfeme
Timepoint [4] 300116 0
4 months

Eligibility
Key inclusion criteria
Healthy naturally postmenopausal women aged 50-65 years
Minimum age
50 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Allergy to almonds, major medical disorders 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. They will be invited to contact the Women’s Health Research Program (WHRP). If eligible to participate they will be required to attend the WHRP for 6 visits. The study medication is Androfeme testosterone cream manufactured by Lawley Pharmaceuticals. Participants are required to use both doses of 0.5ml (5mg) and 1.0ml (10mg) of Androfeme 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. After all screening evaluations are complete and inclusion and exclusion criteria are met, participants will be randomized to one of two treatment sequences AB or BA, where A represents 5mg of Androfeme cream and B represents 10mg of the cream. 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
20/02/2013
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
6/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286322 0
Commercial sector/Industry
Name [1] 286322 0
Lawley Pharmaceuticals
Country [1] 286322 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Women's Health Research Program, Monash University, Level 6, the Alfred Centre, 99 Commercial Road, Melbourne, Vic 3004
Country
Australia
Secondary sponsor category [1] 285110 0
None
Name [1] 285110 0
Address [1] 285110 0
Country [1] 285110 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288393 0
Monash University Human Research Ethics Committee (MUHREC)).
Ethics committee address [1] 288393 0
First Floor, Building 3e, Wellington Road
Monash Research Office
Clayton Campus
Monash University VIC 3800
Ethics committee country [1] 288393 0
Australia
Date submitted for ethics approval [1] 288393 0
02/11/2012
Approval date [1] 288393 0
25/02/2013
Ethics approval number [1] 288393 0

Summary
Brief summary
In healthy reproductive-aged women, circulating testosterone is produced by the ovaries and adrenal glands. The main cause of lowered testosterone levels in women is the natural decline with age, hypopituitarism, adrenal insufficiency, premature ovarian failure, bilateral oophorectomy, oral glucocorticosteroid therapy, and oral oestrogen therapy.
Biological data support important physiological effects of testosterone in women. Studies have shown testosterone therapy in women who have low testosterone levels and a reduced libido improves sexual desire and general well-being.
Testosterone replacement therapy has been used for many years utilising different routes such as injection, cream, gel and implant. Transdermal administration of testosterone has the advantages of avoiding the potential hepatic toxicity of oral androgens, is easily discontinued, and allows more physiological control of testosterone levels than subcutaneous implants. However, transdermal administration of testosterone in the form of a cream has the potential advantages of greater flexibility of dose adjustment and the absence of discomfort and irritation which may occur with other transdermal therapy such as a patch.
Androfeme cream is currently the only available testosterone product in Australia with widespread use in clinical practice. No study has investigated the pharmacokinetics of the current dispensing method for Androfeme. Androfeme is supplied with a dose applicator calibrated in 0.5ml graduations. Each 0.5ml delivers a 5mg dose of testosterone. The patient should be directed to measure the appropriate dose using the graduated applicator and then apply to the skin.
Presently patients are asked to commence with a 0.5ml dose (5mg) but we have no idea whether this dose is sufficient or whether a 1.0ml dose (10mg) is needed to achieve the desired blood levels for a therapeutic effect. This study will, for the first time, compare the pharmacokinetics of two doses of Androfeme in postmenopausal women: 0.5ml (5mg) and 1.0ml (10mg).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34942 0
Prof Susan Davis
Address 34942 0
Level 6, The Alfred Centre, 99 Commercial road, Melbourne 3004 VIC Australia
Country 34942 0
Australia
Phone 34942 0
+61 3 99030827
Fax 34942 0
Email 34942 0
[email protected]
Contact person for public queries
Name 18189 0
Mrs Mrs Ensieh Fooladi
Address 18189 0
Women's Health Research Program
School of Public Health and Preventive Medicine
Department of Epidemiology and Preventive Medicine
Monash University
Level 6 Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country 18189 0
Australia
Phone 18189 0
+61 3 99030 374
Fax 18189 0
+61 3 99030 828
Email 18189 0
[email protected]
Contact person for scientific queries
Name 9117 0
Prof Professor Susan Davis
Address 9117 0
Women's Health Research Program
School of Public Health and Preventive Medicine
Department of Epidemiology and Preventive Medicine
Monash University
Level 6 Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country 9117 0
Australia
Phone 9117 0
+61 3 99030 827
Fax 9117 0
+61 3 99030 828
Email 9117 0
[email protected]

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