Recruiting
Phase 2
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)
Condition(s) studied
Premature Ejaculation
Investigational drug(s) / intervention(s)
KH-001 ODTPlacebo ODT
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.
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.
Study 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.
Eligibility
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 partners of childbearing potential: agreement to use acceptable contraception methods from Screening until 30 days post last dose.
11. Willing to avoid sperm donation from first dose until at least 90 days after the last dose.
12. Willing to limit alcohol intake on dosing days.
13. Ability to provide written informed consent and comply with study requirements.
Exclusion Criteria:
1. IELT \>1 minute on more than 25% of attempts during the run-in period.
2. Fewer than 4 intercourse attempts during the run-in period.
3. Self-rated control of ejaculation as fair, good, or very good on the PEP.
4. Low personal distress ("not at all" or "a little bit") on the PEP.
5. Erectile dysfunction (IIEF Questions 1-5 sum score \<21).
6. Significant anatomical penile deformities or history of penile surgery affecting erection.
7. History of other forms of sexual dysfunction.
8. Untreated or unstable thyroid dysfunction.
9. Recent use (within 4 weeks) of SSRIs, SNRIs, PDE5 inhibitors, MAO inhibitors, alpha blockers, 5-alpha reductase inhibitors, topical anesthetics, or tramadol.
10. History of sexual dysfunction treatments like Botox for PE in the past 6 months.
11. Active or uncontrolled sexually transmitted infections.
12. Severe psychiatric disorders, major depression, or suicidal ideation.
13. Clinically significant laboratory abnormalities or cardiovascular risk factors.
14. Positive drug screen (unless explained by prescription use).
15. Positive for HIV, Hepatitis B, or Hepatitis C.
16. Planned major surgery during study period.
17. BMI outside 18.0-35.0 kg/m² or weight \<50 kg.
Primary outcome measure(s)
- Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) from Baseline — Study Week 4 and Study Week 12
The primary endpoint is the change in geometric mean IELT from baseline during each 4-week treatment period (KH-001 vs. placebo). IELT will be measured using a stopwatch by the participant's partner.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Emeritus Research Sydney |
Botany |
New South Wales |
Recruiting |
