Premature Ejaculation Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Two-session Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an 16448 in Healthy Males With Premature Ejaculation.
16448 is being investigated for the treatment of primary premature ejaculation (PE) using a
novel mode of action. There are no approved therapies for premature ejaculation, and novel
therapies are needed for this syndrome.
16448 has been shown to increase ejaculatory latency in the PCA rat model of premature
ejaculation.
A novel instrument, the Sexual Assessment Monitor (SAM), will be used to measure ejaculatory
latency time in this study. This device, which measures ELT under standard conditions, has
been shown to provide a more reliable measure of ejaculatory latency compared to the use of
a stopwatch during sexual intercourse
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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