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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000962639

Enrollment

Registered

2014-09-09

Start date

2015-02-03

Completion date

2015-08-25

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

45 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy naturally postmenopausal women aged 45-65 years

Exclusion criteria

Allergy to almonds, major medical conditions or on recent hormonal treatment

Outcome results