Actively Recruiting
Study to Evaluate the Effects of KH-001 on Ejaculatory Latency Time, Patient-Reported Outcomes, and Safety in Men with Lifelong Premature Ejaculation
Led by Kadence Bio · Updated on 2026-02-25
40
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating KH-001, a selective serotonin transporter inhibitor, in men with lifelong premature ejaculation (LPE) to assess its effects on ejaculatory latency time, safety, and patient-reported outcomes. This Phase 2a, double-blind, placebo-controlled, crossover study involves approximately 40 men aged 18 to 65 in stable monogamous heterosexual relationships with self-reported LPE. The study aims to compare KH-001 with placebo to better understand its potential impact on intravaginal ejaculatory latency time (IELT) and related measures. Participants will receive KH-001 as an orally disintegrating tablet taken sublingually on demand 15 minutes before vaginal penetration, limited to one dose of two tablets per day during each 4-week treatment period. The study includes two 4-week treatment periods separated by a 4-week washout. Each participant will receive both KH-001 and placebo in a randomized order. The trial measures changes in IELT and collects patient impressions and safety data throughout. During the study, participants will be monitored for changes in IELT at weeks 4 and 12, as well as patient global impressions, premature ejaculation profile scores, and safety indicators like adverse events, laboratory tests, vital signs, ECGs, and suicide severity ratings. Participants are expected to attempt intercourse at least four times during each treatment period. The total participation time per individual is approximately 4.5 months, including treatment and washout phases.
CONDITIONS
Brief 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 consent
- In a stable monogamous heterosexual relationship for at least 6 months
- 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 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
- Moderate or higher personal distress on Premature Ejaculation Profile after run-in
- Good general health and medically stable
- Willing to attempt intercourse at least 4 times during each 4-week treatment period
- Agreement to use acceptable contraception if partner is of childbearing potential
- Willingness to avoid sperm donation from first dose until 90 days after last dose
- Willing to limit alcohol intake on dosing days
- Ability 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 run-in
- Self-rated ejaculation control as fair, good, or very good on Premature Ejaculation Profile
- Low personal distress on Premature Ejaculation Profile
- Erectile dysfunction with IIEF Questions 1-5 sum score below 21
- Significant anatomical 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
- Sexual dysfunction treatments like Botox for PE in past 6 months
- Active or uncontrolled sexually transmitted infections
- Severe psychiatric disorders, major depression, or suicidal thoughts
- Clinically significant lab abnormalities or cardiovascular risk factors
- Positive drug screen unless explained by prescription
- Positive for HIV, Hepatitis B, or Hepatitis C
- Planned major surgery during study
- BMI outside 18.0-35.0 kg/m² or weight under 50 kg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks (two 4-week treatment periods with a 4-week washout)
Participants receive KH-001 and placebo in two separate 4-week treatment periods, with a 4-week washout in between. KH-001 and placebo are taken sublingually on demand 15 minutes before vaginal penetration, limited to one dose per day.
Weekly visits during each 4-week treatment period
Trial Site Locations
Total: 1 location
1
Emeritus Research Sydney
Botany, New South Wales, Australia, 2019
Actively Recruiting
Research Team
M
Maya Worth
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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