Premature EjaculationPhase 2NCT07434271
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)
A Phase 2 study testing KH-001 ODT in people with Premature Ejaculation, run by Kadence Bio at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- KH-001 ODT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Dec 2025to 30 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Emeritus Research Sydney
Botany, New South Wales, 2019
Juliet Freeborn, Dr
About this study
Official title: 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.
Read the 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.
- Conditions
- Premature Ejaculation
- Being tested
- KH-001 ODT, Placebo ODT
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KH-001 ODTDrug
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 ODTDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo ODT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study Week 4 and Study Week 12
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Dec 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kadence Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434271
- Sponsor's protocol ID
- KH-001-02
- Status last verified
- Aug 2026
- First submitted
- 10 Dec 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07434271
- Acronym / sponsor ID
- KH-001-02
- Conditions
- Premature Ejaculation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kadence BioIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KH-001 First / Placebo Second | Experimental | Drug: KH-001 ODTParticipants 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. |
| Placebo First / KH-001 Second | Placebo comparator | Drug: Placebo ODTParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KH-001 ODTKH-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. | Drug | KH-001 First / Placebo Second |
| Placebo ODTMatching 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. | Drug | Placebo First / KH-001 Second |
Primary outcome
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.
8 secondary outcomes
Fold Change in Geometric Mean IELT from Baseline
Time frame: Study Week 4 and Study Week 12
Change in Arithmetic Mean IELT from Baseline
Time frame: 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
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
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
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Throughout study duration (Approx. 4.5 months per participant)
Changes in Laboratory Parameters, Vital Signs, and ECGs from Baseline
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KH-001 ODT in people with Premature Ejaculation, run by Kadence Bio at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Worth (0395096166, mayaworth@emeritusresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) from Baseline (time frame: Study Week 4 and Study Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.