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)

NCT07434271 | Recruiting Phase 2 FDA Drug

• 1 other identifier: KH-001-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

• Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) from Baseline

  The primary endpoint is the change in geometric mean IELT from baseline during each 4-week treatment period (KH-001 vs. placebo). IELT will be measured using a stopwatch by the participant's partner.

  Study Week 4 and Study Week 12

Secondary Outcomes (8)

• Fold Change in Geometric Mean IELT from Baseline

  Study Week 4 and Study Week 12

• Change in Arithmetic Mean IELT from Baseline

  Study Week 4 and Study Week 12

• Improvement in Patient Global Impression of Change (PGIC)

  Study weeks 4 and 12 - Single question, 7 point Likert scale (1-7) - maximum value = worse outcome

• Improvement in Patient Global Impression of Severity (PGIS)

  Study weeks 4 and 12 - Single question, 5 point Likert scale (1-5) - maximum value = worse outcome

• Improvement in Premature Ejaculation Profile (PEP) Scores

  Study weeks 4 and 12 - Four questions, 5 point Likert scale (0-4) - maximum value = best outcome

Study Arms (2)

KH-001 First / Placebo Second

EXPERIMENTAL

Participants will receive KH-001 orally disintegrating tablet (ODT) sublingually on demand 15 minutes before vaginal penetration, with intake limited to one dose (2 tablets) per day, during the first 4-week treatment period, followed by placebo ODT during the second 4-week period after a 4-week washout.

Drug: KH-001 ODT

Placebo First / KH-001 Second

PLACEBO COMPARATOR

Participants will receive placebo ODT sublingually on demand 15 minutes before vaginal penetration, with intake limited to one dose (2 tablets) per day, during the first 4-week treatment period, followed by KH-001 ODT during the second 4-week period after a 4-week washout.

Drug: Placebo ODT

Interventions

KH-001 ODT DRUG

KH-001 besylate formulated as an orally disintegrating tablet (ODT), administered sublingually on demand 15 minutes before vaginal penetration, with intake limited to one dose (2 tablets) per day during the treatment periods.

KH-001 First / Placebo Second

Placebo ODT DRUG

Matching placebo orally disintegrating tablet (ODT), administered sublingually on demand 15 minutes before vaginal penetration, with intake limited to one dose (2 tablets) per day during the treatment periods.

Placebo First / KH-001 Second

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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.

You may not qualify 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.
• 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.

Sponsors & Collaborators

• Kadence Bio: lead

Study Sites (1)

Emeritus Research Sydney

Botany, New South Wales, 2019, Australia

RECRUITING

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Maya Worth

CONTACT

0395096166; mayaworth@emeritusresearch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: February 25, 2026
• Study Start: December 1, 2025
• Primary Completion: May 3, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)