Testosterone Cream Study
An open-label, phase 2, single centre, randomised, crossover pharmacokinetic study assessing two application areas of 0.5ml (5mg) ANDROFEME® cream in healthy postmenopausal women.
This trial has been initiated by Principal Investigator, Professor Susan Davis. Lawley Pharmaceuticals will sponsor this study and supply study medication.
Recruitment is CLOSED
Principle researchers: Prof Susan Davis
Co Investigators: Professor Robin Bell & Dr Fiona Jane
Testosterone is a sex steroid hormone found in women and men. In women testosterone is produced in the ovaries and in other tissues and converted into other hormones including oestrogen. Levels of testosterone in women are approximately a tenth of male levels. Testosterone levels in women decline with age.
Studies have shown that the use of testosterone therapy in women, in doses appropriate for women, can improve libido and the feeling of wellbeing. Testosterone is in clinical use in Australia and worldwide for low libido in women. In Australia, ANDROFEME® cream is currently the only available testosterone product for women prescribed by doctors. Research has indicated the appropriate dose for women is 0.5ml of Androfeme® per day, but we know absorption can vary according to the site of application. We do not know if the application area should be large or small to achieve the desired blood levels for a therapeutic effect.
The purpose of this project is to assess the absorption of testosterone using two different sized application areas of ANDROFEME® cream and any effects on other sex hormone levels.
For this study we will recruit women who are:
- Post-menopausal and in general good health
- Aged between 45-65 years
- Able to attend the Women's Health Research Program located at the Alfred Centre, Prahran for 6 visits over a 2 month period including two appointments of 11 hour duration
- Willing to have blood samples will be taken at each visit
This study requires you to use ANDROFEME® cream daily over 2 different sized application areas over a 45 day period.
Participants will be seen at the Women's Health Research Program at the Alfred Centre (Alfred Hospital) Melbourne.
Participants will be reimbursed $200 for the completion of each full day visit (visits 3 and 5).
For more information regarding inclusion and exclusion criteria please contact Jenny (03) 9903 0833 or Corallee (03) 9903 0836, or email the Women's Health Research Program at firstname.lastname@example.org