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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)

ConditionPremature Ejaculation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-65
SponsorKadence Bio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • KH-001 ODT

    Drug

    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 ODT

    Drug

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: KH-001 First / Placebo SecondExperimental treatment 1 intervention
Group B: Placebo First / KH-001 SecondPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Study Week 4 and Study Week 12

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kadence Bio

Lead sponsor

Source ClinicalTrials.gov
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