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)

August 11, 2026 updated by: Kadence Bio

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) from Baseline
Time Frame: Study Week 4 and Study Week 12
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fold Change in Geometric Mean IELT from Baseline
Time Frame: Study Week 4 and Study Week 12
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
Time Frame: Study Week 4 and Study Week 12
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)
Time Frame: Study weeks 4 and 12 - Single question, 7 point Likert scale (1-7) - maximum value = worse outcome
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)
Time Frame: Study weeks 4 and 12 - Single question, 5 point Likert scale (1-5) - maximum value = worse outcome
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
Time Frame: Study weeks 4 and 12 - Four questions, 5 point Likert scale (0-4) - maximum value = best outcome
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)
Time Frame: Throughout study duration (Approx. 4.5 months per participant)
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
Time Frame: Throughout study duration
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
Time Frame: 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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kadence Bio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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