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)
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Kadence Bio
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) from Baseline
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 ≥
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: KH-001 ODT (Drug)
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.
Intervention: Placebo ODT (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Throughout study duration (Approx. 4.5 months per participant))
- Changes in Laboratory Parameters, Vital Signs, and ECGs from Baseline(Throughout study duration)
- 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)