Trimel Pharmaceuticals Corporation (TSX: TRL) announced today top-line results of its Phase II clinical trial evaluating the efficacy and safety of Tefina™, a “use-as-required” testosterone nasal gel for the treatment of Female Orgasmic Disorder (FOD).
FOD, also known as anorgasmia, is characterized by a delay, absence or reduced intensity of orgasm, causing clinically significant distress.
The double-blind, placebo-controlled study enrolled 253 pre- and post-menopausal women experiencing acquired FOD in the United States, Canada and Australia. Participants were randomized to one of three dosage strengths (0.6 mg, 1.2 mg, 1.8 mg) or a placebo group and treated over the course of 84 days. The primary endpoint of the study was to compare the effects of the three dose strengths of Tefina™ nasal testosterone gel to placebo on the occurrence of orgasm. Secondary endpoints included the change from baseline in distress due to orgasmic disorder, change in sexual functioning and sexual event satisfaction. Safety and tolerability were also assessed.
Tefina™ 0.6 mg led to a statistically significant increase in the average number of orgasms during the 84-day treatment period of 2.3 versus 1.7 for the placebo arm (p=0.0015). In addition, improvements in all of the secondary endpoints were observed; however, further analysis is underway to assess statistical significance. Tefina™ was found to be well-tolerated with no reported serious adverse events.
“Female Orgasmic Disorder is the second most prevalent sexual disorder affecting women. Approximately one in five women report difficulty with orgasm and one quarter of these show marked distress, a key criterion in a clinical diagnosis,” said Dr. Sheryl Kingsberg, the U.S. principal investigator for the Tefina™ Phase II clinical trial, chief of behavioral medicine at University Hospitals Case Medical Center and professor of reproductive biology and psychiatry at Case Western Reserve University in Cleveland, Ohio. “Currently, there are no approved pharmacological treatment options, leaving an unmet need that Tefina™ hopes to remedy.”
“These results mark an important milestone in the development of Tefina™,” said Tom Rossi, Trimel President and CEO. “They provide further evidence that Tefina™ could represent an important treatment option for the many women who suffer from this disorder. On behalf of Trimel and its various stakeholders, I am extremely excited about this positive outcome and look forward to advancing this product towards commercialization. ”