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Trimel's Tefina - Nasal testosterone gel being tested on frigid women.
Trimel Pharmaceuticals Corporation (TSX:TRL) (the "Company" or "Trimel") today announced the initiation of patient enrolment into one of the largest clinical studies to ever explore a "use-as-required" treatment for women experiencing anorgasmia. Anorgasmia is defined as the persistent or recurrent delay in, or absence of, orgasm following a normal sexual excitement phase which can result in marked personal distress or interpersonal difficulties. Anorgasmia affects 1 in 5 women worldwide. Currently there are no approved treatments for anorgasmia and therefore this condition represents a significant unmet need for women suffering distress from this condition.
The Company intends to enroll 240 patients in this Phase II study being initiated in the United States, with additional sites in Canada and Australia expected to join the study in the third quarter of 2012. The Tefina™ Phase II study design will involve pre-menopausal women experiencing anorgasmia and will be conducted as an ambulatory trial. As part of this double-blinded placebo-controlled study, patients will receive Tefina™ or placebo at home instead of in a hospital setting. The primary efficacy endpoint of the ambulatory trial will be the increase in the occurrence of orgasm over the treatment period compared against baseline levels.
S.B.C
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