Explorative Double-Blind Placebo Controlled Crossover 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)
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.
• PEDT (Premature Ejaculation Diagnostic Tool) score ≥11.
• Normal erectile function (IIEF Questions 1-5 sum score ≥21).
• Personal distress rated at least moderate on the Premature Ejaculation Profile (PEP) after the run-in period.
• In good general health and medically stable as per investigator's judgment.
• Willing to attempt intercourse at least 4 times during each 4-week treatment period.
⁃ For partners of childbearing potential: agreement to use acceptable contraception methods from Screening until 30 days post last dose.
⁃ Willing to avoid sperm donation from first dose until at least 90 days after the last dose.
⁃ Willing to limit alcohol intake on dosing days.
⁃ Ability to provide written informed consent and comply with study requirements.