Trimel Pharmaceuticals Corp. (TRL.TO: Quote) announced the completion of enrolment and randomization of 304 patients in the Phase III clinical trial evaluating CompleoTRT in patients with male hypogonadism or more commonly referred to as "Low T". The unique delivery of CompleoTRT is designed to provide hypogonadal men with the therapeutic effect of restoring testosterone levels while doing so with a micro volume amount of drug in the form of a bioadhesive intranasal gel.
The pivotal Phase III clinical trial, which was initiated in October 2011, is a randomized study in which patients are administered CompleoTRT and evaluated for efficacy after 90 days of treatment using the pharmacokinetic endpoint established for Low T therapies.
The Phase III study in its entirety represents the final stage of product development prior to the submission of a New Drug Application to the Food and Drug Administration for marketing approval in the United States.
Efficacy results from the Phase III clinical trial are expected to be available in the fourth quarter of 2012.
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by RTT Staff Writer
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