ANZCTR - Registration

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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]

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

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

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]

4 months

Primary outcome [2]

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]

4 months

Primary outcome [3]

To assess Tmax (the time at which Cmax occurred) using blood samples following application of two doses of Androfeme

Timepoint [3]

4 month

Secondary outcome [1]

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]

4 months

Secondary outcome [2]

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]

4 months

Secondary outcome [3]

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]

4 months

Secondary outcome [4]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Lawley Pharmaceuticals

Address [1]

Unit 2 / 15a Harrogate Street, West Leederville
Perth, Western Australia, Australia 6007

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee (MUHREC)).

Ethics committee address [1]

First Floor, Building 3e, Wellington Road
Monash Research Office
Clayton Campus
 Monash University VIC 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/11/2012

Approval date [1]

25/02/2013

Ethics approval number [1]

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

Prof Susan Davis

Address

Level 6, The Alfred Centre, 99 Commercial road, Melbourne 3004 VIC Australia

Country

Australia

Phone

+61 3 99030827

Fax

susan.davis@monash.edu

Contact person for public queries

Name

Mrs Ensieh Fooladi

Address

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

Australia

Phone

+61 3 99030 374

Fax

+61 3 99030 828

ensieh.fooladi@monash.edu

Contact person for scientific queries

Name

Professor Susan Davis

Address

Country

Australia

Phone

+61 3 99030 827

Fax

+61 3 99030 828

susan.davis@monash.edu

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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