Clinical Trial

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)

Recruiting Phase 2
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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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-05-03 -> 2026-10-31 2026-08-13
minor Completion pushed: 2026-08-30 -> 2026-11-30 2026-08-13
Trial Details
NCT Number NCT07434271
Lead Sponsor Kadence Bio
Conditions Premature Ejaculation
Enrollment 40 participants
Start Date 2025-12-01
Primary Completion 2026-10-31 (estimated)
Study Completion 2026-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-12