Serum Testosterone Levels in Women on Testosterone Replacement
Research type
Research Study
Full title
Testosterone study: Monitoring Serum levels of Testosterone in Women receiving Testosterone replacement
IRAS ID
287599
Contact name
Adrian Heald
Contact email
Sponsor organisation
Salford Royal Foundation Trust
Clinicaltrials.gov Identifier
21/WS/0018, REC reference
Duration of Study in the UK
0 years, 3 months, 30 days
Research summary
The study will be conducted at Salford Royal Hospital and the Chelsea & Westminster Hospital, London.
Testosterone supplementation for low libido and low energy in menopausal women has been undertaken since the 1970s, when the testosterone was administered as implants. Benefit has been shown from testosterone therapy given to postmenopausal women with reduced sexual desire. Specifically, an increased frequency of satisfying sexual encounters and intensity of sexual desire and better sexual response has been shown with testosterone therapy in a number of studies spanning more than 30 years.
In this study we propose to determine the correct dosing regime of Testogel administered by pump, by monitoring of serum testosterone in relation to varying dose intervals. This is a pharmacokinetic study in women who have been started on Testogel pump as part of their usual care.
How we will do this
This is an open label study in women in which we propose to monitor serum testosterone levels pre- and post- application of Testogel 5.5mg by pump daily or Testogel 20.25mg by pump every 4 days (after a 2 week run in period to enable achievement of steady state). This will involve attendance for a day curve (10 hours) and day after the day curve (one hour) on 2 separate occasions.
We will also carry out a qualitative evaluation of how women on Testogel Pump feel on this treatment.
Expected Outcome
As a result of this study we expect to have a good understanding of the pharmacokinetics of testosterone in women on the Testogel Pump and therefore be clear about the correct dosing regime to be prescribed and/or to be investigated further.REC name
West of Scotland REC 1
REC reference
21/WS/0018
Date of REC Opinion
4 Feb 2021
REC opinion
Unfavourable Opinion