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Tests treatment safety and results for Premature Ejaculation
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)
ClinicalTrials.gov ID: NCT07434271
What this study is testing
What is KH-001 ODT?
KH-001 ODT is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for premature ejaculation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, men only
You may be able to join if
- Male participants aged 18 to 65 years (inclusive) at the time of informed consent.
- In a stable (≥6 months) monogamous heterosexual relationship.
- Self-reported lifelong premature ejaculation (LPE), meeting the ISSM definition.
- Intravaginal Ejaculatory Latency Time (IELT) ≤1 minute on at least 75% of intercourse attempts during the 4-week run-in period.
- PEDT (Premature Ejaculation Diagnostic Tool) score ≥11.
You likely can't join if
- IELT \>1 minute on more than 25% of attempts during the run-in period.
- Fewer than 4 intercourse attempts during the run-in period.
- Self-rated control of ejaculation as fair, good, or very good on the PEP.
- Low personal distress ("not at all" or "a little bit") on the PEP.
- Erectile dysfunction (IIEF Questions 1-5 sum score \<21).
- Significant anatomical penile deformities or history of penile surgery affecting erection.
See the full eligibility criteria
- Male participants aged 18 to 65 years (inclusive) at the time of informed consent.
- In a stable (≥6 months) monogamous heterosexual relationship.
- Self-reported lifelong premature ejaculation (LPE), meeting the ISSM definition.
- Intravaginal Ejaculatory Latency Time (IELT) ≤1 minute on at least 75% of intercourse attempts during the 4-week run-in period.
- PEDT (Premature Ejaculation Diagnostic Tool) score ≥11.
- Normal erectile function (IIEF Questions 1-5 sum score ≥21).
- Personal distress rated at least "moderate" on the Premature Ejaculation Profile (PEP) after the run-in period.
- In good general health and medically stable as per investigator's judgment.
- Willing to attempt intercourse at least 4 times during each 4-week treatment period.
- For partners of childbearing potential: agreement to use acceptable contraception methods from Screening until 30 days post last dose.
- Willing to avoid sperm donation from first dose until at least 90 days after the last dose.
- Willing to limit alcohol intake on dosing days.
- Ability to provide written informed consent and comply with study requirements.
- IELT \>1 minute on more than 25% of attempts during the run-in period.
- Fewer than 4 intercourse attempts during the run-in period.
- Self-rated control of ejaculation as fair, good, or very good on the PEP.
- Low personal distress ("not at all" or "a little bit") on the PEP.
- Erectile dysfunction (IIEF Questions 1-5 sum score \<21).
- Significant anatomical penile deformities or history of penile surgery affecting erection.
- History of other forms of sexual dysfunction.
- 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.
- History of sexual dysfunction treatments like Botox for PE in the past 6 months.
- Active or uncontrolled sexually transmitted infections.
- Severe psychiatric disorders, major depression, or suicidal ideation.
- Clinically significant laboratory abnormalities or cardiovascular risk factors.
- Positive drug screen (unless explained by prescription use).
- Positive for HIV, Hepatitis B, or Hepatitis C.
- Planned major surgery during study period.
- BMI outside 18.0-35.0 kg/m² or weight \<50 kg.
The study team makes the final eligibility decision.
Where it's taking place
- Botany, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Botany, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.