Premature Ejaculation
Conditions
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.
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.
Interventions
DRUGKH-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.
DRUGPlacebo 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.
Sponsors
Kadence Bio
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) from Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fold Change in Geometric Mean IELT from Baseline | Study Week 4 and Study Week 12 | Assessment of the fold change in geometric mean IELT for KH-001 compared to baseline and placebo. |
| Change in Arithmetic Mean IELT from Baseline | Study Week 4 and Study Week 12 | Assessment of the arithmetic mean IELT change from baseline for each treatment period. |
| 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 | Proportion of patients reporting at least "better" on the PGIC scale following KH-001 treatment compared to placebo. |
| 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 | Proportion of patients showing at least a one-category improvement in PGIS if baseline severity was moderate or worse. |
| Improvement in Premature Ejaculation Profile (PEP) Scores | 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. |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Throughout study duration (Approx. 4.5 months per participant) | Number and percentage of participants experiencing TEAEs and SAEs during the study. |
| Changes in Laboratory Parameters, Vital Signs, and ECGs from Baseline | Throughout study duration | Evaluation of changes in safety laboratory tests, vital signs, and ECG parameters from baseline to post-treatment. |
| Change in Columbia Suicide Severity Rating Scale (C-SSRS) Scores | 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. |
Countries
Australia
Contacts
CONTACTMaya Worth
Outcome results
None listed