The Tefina PK study was designed to measure the levels of testosterone in the blood stream at prescribed time points post-administration and to provide supportive evidence related to the safety of the PK profile of Tefina from both single and multiple dose exposures in a cohort of healthy women.
The study finds that average levels of testosterone in the blood stream over a 24 hour period remained within the normal range.
All women in the study also demonstrated a return to their starting testosterone blood levels within 24 hours after the last administration of Tefina.
The company expects to implement a second Phase II study of anorgasmia involving Tefina.
Trimel chairman and chief executive officer Bruce Brydon said the study demonstrates the safety of Trimel’s novel use as required treatment approach.