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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Emeritus Research Sydney
  Botany, New South Wales, Australia Recruiting

Study contacts

• Study coordinator: Maya Worth
• Email: mayaworth@emeritusresearch.com
• Phone: 0395096166

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.