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)

Explorative Double-Blind Placebo Controlled Crossover 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)

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.

Study Overview

• Status: Recruiting
• Conditions: Premature Ejaculation
• Intervention / Treatment: Drug: KH-001 ODT; Drug: Placebo ODT

Detailed Description

This Phase 2a, multicenter, double-blind, placebo-controlled, crossover study is designed to evaluate the efficacy, safety, and patient-reported outcomes of KH-001, a selective serotonin transporter (SERT) inhibitor, in men with lifelong premature ejaculation (LPE). Approximately 40 participants will be enrolled across sites in Australia. Each participant will receive both KH-001 and placebo during two separate 4-week treatment periods, with a 4-week washout in between. KH-001 will be administered sublingually as an orally disintegrating tablet (ODT), taken on demand 15 minutes before vaginal penetration, with intake limited to one dose (2 tablets) per day. The primary endpoint is change in intravaginal ejaculatory latency time (IELT). Secondary endpoints include assessments of patient global impression, premature ejaculation profile, and safety parameters.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Maya Worth; Phone Number: 0395096166; Email: mayaworth@emeritusresearch.com

Study Locations

• Australia
  • New South Wales
    • Botany, New South Wales, Australia, 2019
      • Recruiting
      • Emeritus Research Sydney
      • Principal Investigator: Juliet Freeborn, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KH-001 First / Placebo Second; 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; 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.
Placebo Comparator: Placebo First / KH-001 Second; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fold Change in Geometric Mean IELT from Baseline	Assessment of the fold change in geometric mean IELT for KH-001 compared to baseline and placebo.	Study Week 4 and Study Week 12
Change in Arithmetic Mean IELT from Baseline	Assessment of the arithmetic mean IELT change from baseline for each treatment period.	Study Week 4 and Study Week 12
Improvement in Patient Global Impression of Change (PGIC)	Proportion of patients reporting at least "better" on the PGIC scale following KH-001 treatment compared to placebo.	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)	Proportion of patients showing at least a one-category improvement in PGIS if baseline severity was moderate or worse.	Study weeks 4 and 12 - Single question, 5 point Likert scale (1-5) - maximum value = worse outcome
Improvement in Premature Ejaculation Profile (PEP) Scores	Assessment of changes in PEP domains including control over ejaculation, personal distress, interpersonal difficulty, and satisfaction with sexual intercourse. Composite responder analysis for control and distress improvement will also be assessed.	Study weeks 4 and 12 - Four questions, 5 point Likert scale (0-4) - maximum value = best outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Number and percentage of participants experiencing TEAEs and SAEs during the study.	Throughout study duration (Approx. 4.5 months per participant)
Changes in Laboratory Parameters, Vital Signs, and ECGs from Baseline	Evaluation of changes in safety laboratory tests, vital signs, and ECG parameters from baseline to post-treatment.	Throughout study duration
Change in Columbia Suicide Severity Rating Scale (C-SSRS) Scores	Assessment of changes in suicidal ideation and behavior using the C-SSRS compared to baseline.	Study weeks 4 and 12 - up to 45 question assessment (number of total questions depends on answers), multiple answer formats, where 5 point Likert scales are used in answers (1-5), maximum value = worse outcome

Collaborators and Investigators

• Sponsor: Kadence Bio

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): May 3, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Ejaculatory Dysfunction; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Premature Ejaculation
• Other Study ID Numbers: KH-001-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No