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.
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.
IELT >1 minute on more than 25% of attempts during the run-in period.
Fewer than 4 intercourse attempts during the run-in period.
Self-rated control of ejaculation as fair, good, or very good on the PEP.
Low personal distress ("not at all" or "a little bit") on the PEP.