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news.The Food and Drug Administration (FDA) has allowed Canada-baded Trimel Pharmaceuticals to start a Phase III study to evaluate CompleoTRT as a treatment for male hypogonadism.
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CompleoTRT’s delivery technology is designed to provide patients with the therapeutic effect of supplementing testosterone levels while doing so with a small amount of drug in the form of a bio-adhesive intranasal gel.
The company plans to start patient enrollment at more than 30 sites in the US and also expects to start dosing soon.
Trimel’s research program to date has demonstrated that CompleoTRT is safe and effective, with over 3500 drug exposures studied thus far in the US.