Serum Testosterone Profile After Application of Testogel
Research type
Research Study
Full title
A Single Centre Study to Describe the Changes in Serum Testosterone Concentration Following Application of Testogel in Post-Menopausal Women with Hypoactive Sexual Desire Disorder Already Receiving this as Part of Usual Care
IRAS ID
324631
Contact name
Adrian Heald
Contact email
Sponsor organisation
Northern Care Alliance NHS Foundation Trust
Duration of Study in the UK
0 years, 6 months, 17 days
Research summary
The study will be conducted at Salford Royal Hospital.
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 - together with improved concentration and enhanced clarity of thinking.
In this study we propose monitoring of serum testosterone in relation to its usual dose prescription. This is an observational study in women who have been started on Testogel pump as part of their usual care. This is not a clinical trial.
How we will do this:
This is a study in women in which we propose to monitor serum testosterone levels pre- and post- application of Testogel 20.25mg administered as a gel via pump actuations every 3 or every 4 days (ie the usual care regime). This will involve attendance for a day curve (10 hours) 24 hours after gel application on 1 occasion.
Expected Outcome:
As a result of this study we expect to have a good understanding of the blood levels 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
London - Fulham Research Ethics Committee
REC reference
23/LO/0912
Date of REC Opinion
17 Jan 2024
REC opinion
Further Information Favourable Opinion