NCT07434271

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)

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Kadence Bio · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Phase 2a, multicenter, double-blind, placebo-controlled, crossover study is designed to evaluate the efficacy, safety, and patient-reported outcomes of KH-001, a selective serotonin transporter (SERT) inhibitor, in men with lifelong premature ejaculation (LPE). Approximately 40 participants will be enrolled across sites in Australia. Each participant will receive both KH-001 and placebo during two separate 4-week treatment periods, with a 4-week washout in between. KH-001 will be administered sublingually as an orally disintegrating tablet (ODT), taken on demand 15 minutes before vaginal penetration, with intake limited to one dose (2 tablets) per day. The primary endpoint is change in intravaginal ejaculatory latency time (IELT). Secondary endpoints include assessments of patient global impression, premature ejaculation profile, and safety parameters.

Conditions

• Premature Ejaculation

Interventions

Type	Name	Description
DRUG	KH-001 ODT	KH-001 besylate formulated as an orally disintegrating tablet (ODT), administered sublingually on demand 15 minutes before vaginal penetration, with intake limited to one dose (2 tablets) per day during the treatment periods.
DRUG	Placebo ODT	Matching placebo orally disintegrating tablet (ODT), administered sublingually on demand 15 minutes before vaginal penetration, with intake limited to one dose (2 tablets) per day during the treatment periods.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-05-03
• Completion: 2026-08-30
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study