Both women and men naturally produce the hormone testosterone and, although women have much lower levels than men, it is just as important to their sexual health. At menopause, levels of testosterone can fall in a similar way to other hormones, estrogen and progesterone. Reduced levels of all these hormones can lead to a wide range of symptoms in menopausal women. Current forms of hormone replacement therapy (HRT) address the falls in estrogen and progesterone, but testosterone has been neglected.
However, NICE guidance issued in 2015 recommends that testosterone therapy be considered for treating low libido if standard HRT is not effective. This requires clinicians to prescribe male testosterone gel products off-label, which many are reluctant to do. Furthermore, the dose required by men is far higher than that required by women and this imposes a burden on women to try to apply the correct small fraction of the male dose.
The testosterone TEPI Patch will provide women with a product that is specifically formulated to deliver the appropriate dose. It will be a twice-weekly patch, which is simililar to other HRT patch products that many women are familiar with.
Medherant has had a scientific advice meeting with MHRA and anticipates a short clinical development pathway prior to approval in UK and then Europe and other countries. Data from a Phase I pharmacokinetic study is expected by the end of 2023.
We are not currently recruiting for studies for the testosterone patch. However, if you are interested in participating in future planned trials, please contact firstname.lastname@example.org.