Health Canada has permitted Trimel Pharmaceuticals' to enroll patients in Canada for the Tefina Phase II Ambulatory study.
The double-blinded, placebo-controlled study will enroll 240 pre-menopausal women patients with female orgasmic disorder in the United States, Canada and Australia.
Patients in the study will receive Tefina or placebo at home instead of in a hospital setting.
The primary efficacy endpoint of the trial will be the increase in the occurrence of orgasm over the treatment period compared against baseline levels.
Tefina is a bioadhesive ‘no touch’ intranasal low-dose gel formulation of testosterone and is expected to present an attractive safety profile, with virtually no androgen-related side effects such as acne, facial and body hair growth or deepening of the voice.