Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time
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.
| Condition(s) | Premature Ejaculation |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 | Inclusion Criteria: 1. Male participants aged 18 to 65 years (inclusive) at the time of informed consent. 2. In a stable (≥6 months) monogamous heterosexual relationship. 3. Self-reported lifelong premature ejaculation (LPE), meeting the ISSM definition. 4. Intravaginal Ejaculatory Latency Time (IELT) ≤1 minute on at least 75% of intercourse attempts during the 4-week run-in period. 5. PEDT (Premature Ejaculation Diagnostic Tool) score ≥11. 6. Normal erectile function (IIEF Questions 1-5 sum score ≥21). 7. Personal distress rated at least "moderate" on the Premature Ejaculation Profile (PEP) after the run-in period. 8. In good general health and medically stable as per investigator's judgment. 9. Willing to attempt intercourse at least 4 times during each 4-week treatment period. 10. For p |
| Ages | 18 Years to 65 Years |
| Sex | Male |
| Lead sponsor | Kadence Bio |
| Locations | Botany, New South Wales, Australia |
| Start date | 2025-12-01 |
| NCT ID | NCT07434271 |
| Official listing | https://clinicaltrials.gov/study/NCT07434271 |