Premature Ejaculation Clinical Trial
Official title:
A Phase 2b, 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effects of 3 Different Dose Levels of IX-01 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (PE)
A Phase 2b, 8-week, double-blind, placebo-controlled, parallel group study to evaluate the
effect of 3 different dose levels of IX-01 on IELT and patient-reported outcome in men with
lifelong PE.
Men with self-reported lifelong PE (International Society for Sexual Medicine (ISSM)
definition) and in stable heterosexual relationship will undergo a 4-week run-in period
during which they will be asked to attempt intercourse at least 4 times. Men with IELT ≤ 1
minute on at least 75% of attempts at intercourse during the no-treatment run-in period will
be randomized for the double-blind phase of the study.
In the double-blind phase of the study, men will be asked to take study drug 1 to 6 hours
prior to sexual activity. Men and partners will be asked to attempt intercourse a minimum of
8 times during the 8 week double-blind study treatment. The patient or partner will record
the IELT on each occasion by use of a stopwatch.
n/a
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