Actively Recruiting
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)
Led by Kadence Bio · Updated on 2026-02-25
40
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 to 65 years at the time of consent
- In a stable (6 months or more) monogamous heterosexual relationship
- Self-reported lifelong premature ejaculation meeting ISSM definition
- Intravaginal Ejaculatory Latency Time (IELT) of 1 minute or less on at least 75% of intercourse attempts during the 4-week run-in
- Premature Ejaculation Diagnostic Tool (PEDT) score of 11 or higher
- Normal erectile function with IIEF Questions 1-5 sum score of 21 or higher
- Personal distress rated at least "moderate" on the Premature Ejaculation Profile after run-in
- In good general health and medically stable per investigator
- Willing to attempt intercourse at least 4 times during each 4-week treatment period
- Partners of childbearing potential agree to use contraception from screening until 30 days after last dose
- Willing to avoid sperm donation from first dose until at least 90 days after last dose
- Willing to limit alcohol intake on dosing days
- Able to provide written informed consent and comply with study requirements
You will not qualify if you...
- IELT greater than 1 minute on more than 25% of attempts during run-in
- Fewer than 4 intercourse attempts during the run-in period
- Self-rated ejaculation control as fair, good, or very good on the Premature Ejaculation Profile
- Low personal distress ("not at all" or "a little bit") on Premature Ejaculation Profile
- Erectile dysfunction with IIEF Questions 1-5 sum score below 21
- Significant penile deformities or history of penile surgery affecting erection
- History of other sexual dysfunctions
- Untreated or unstable thyroid dysfunction
- Recent use (within 4 weeks) of SSRIs, SNRIs, PDE5 inhibitors, MAO inhibitors, alpha blockers, 5-alpha reductase inhibitors, topical anesthetics, or tramadol
- Treatment for premature ejaculation like Botox within past 6 months
- Active or uncontrolled sexually transmitted infections
- Severe psychiatric disorders, major depression, or suicidal thoughts
- Significant laboratory abnormalities or cardiovascular risks
- Positive drug screen unless explained by prescription
- Positive for HIV, Hepatitis B, or Hepatitis C
- Planned major surgery during study period
- Body mass index outside 18.0-35.0 kg/m2 or weight less than 50 kg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Emeritus Research Sydney
Botany, New South Wales, Australia, 2019
Actively Recruiting
Research Team
M
Maya Worth
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here