Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT)… (NCT07434271) | Clinical Trial Compass
RecruitingPhase 2
Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)
Australia40 participantsStarted 2025-12-01
Plain-language summary
This is a Phase 2a, double-blind, placebo-controlled, crossover study evaluating the efficacy, safety, and patient-reported outcomes of KH-001 in men with lifelong premature ejaculation (LPE). Approximately 40 participants will receive KH-001 or placebo in two 4-week treatment periods separated by a washout.
Who can participate
Age range18 Years – 65 Years
SexMALE
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Inclusion criteria
✓. Male participants aged 18 to 65 years (inclusive) at the time of informed consent.
✓. In a stable (≥6 months) monogamous heterosexual relationship.
✓. Self-reported lifelong premature ejaculation (LPE), meeting the ISSM definition.
✓. Intravaginal Ejaculatory Latency Time (IELT) ≤1 minute on at least 75% of intercourse attempts during the 4-week run-in period.