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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
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.
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.
Emeritus Research Sydney
Botany, New South Wales, Australia
RECRUITINGChange 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.
Time frame: Study Week 4 and Study Week 12
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.
Time frame: 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.
Time frame: 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.
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)
Proportion of patients showing at least a one-category improvement in PGIS if baseline severity was moderate or worse.
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
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.
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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)
Number and percentage of participants experiencing TEAEs and SAEs during the study.
Time frame: 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.
Time frame: 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.
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