KH-001 to increase time to ejaculation in men with lifelong premature ejaculation

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 test tries KH-001, an on-demand sublingual medicine, to see if it lengthens time to ejaculation and reduces distress in men with lifelong premature ejaculation.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Male
• Sponsor: Kadence Bio (Industry-sponsored)
• Locations: 1 site (Botany, New South Wales)
• Trial ID: NCT07434271 on ClinicalTrials.gov

What this trial studies

This Phase 2a, double-blind, placebo-controlled crossover study will enroll about 40 men with lifelong premature ejaculation at sites in Australia. Each participant will receive both KH-001 and matching placebo in two separate 4-week treatment periods separated by a 4-week washout, taking the drug as an orally disintegrating sublingual tablet on demand 15 minutes before vaginal penetration with a limit of one dose (2 tablets) per day. The primary endpoint is change in intravaginal ejaculatory latency time (IELT), and secondary endpoints include patient global impression, premature ejaculation profile measures, and safety assessments. Safety, tolerability, and patient-reported outcomes will be collected throughout the study.

Who should consider this trial

Good fit: Men aged 18–65 in a stable monogamous heterosexual relationship with lifelong premature ejaculation by ISSM criteria, an IELT ≤1 minute on at least 75% of intercourse attempts, PEDT ≥11, normal erectile function, and willingness to attempt intercourse at least four times per treatment period are the intended participants.

Not a fit: Men with acquired premature ejaculation, significant erectile dysfunction, those not in a stable heterosexual relationship, those unable to meet the sexual activity or visit requirements, outside the age range, or with contraindications to SERT inhibitors may not receive benefit from this intervention.

Why it matters

Potential benefit: If successful, KH-001 could increase intravaginal ejaculatory latency and reduce distress, improving sexual satisfaction for men with lifelong premature ejaculation.

How similar studies have performed: Other serotonin transporter inhibitors, including on-demand agents such as dapoxetine, have previously shown benefit for delaying ejaculation, so the mechanism is established though KH-001's sublingual formulation and dosing regimen are newer.

Eligibility criteria

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.

Where this trial is running

Botany, New South Wales

• Emeritus Research Sydney — Botany, New South Wales, Australia (Recruiting)

Study contacts

• Study coordinator: Maya Worth

Conditions Premature Ejaculation