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Trial Radar IA
Lo studio clinico NCT07434271 per Eiaculazione precoce è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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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) Fase II 40 Doppio cieco Controllato con placebo Studio incrociato

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07434271 è uno studio interventistico di Fase II volto a esaminare il trattamento per Eiaculazione precoce, attualmente in arruolamento. Avviato il 1 dicembre 2025, prevede di arruolare 40 partecipanti. Sotto la guida di Kadence Bio, dovrebbe concludersi entro il 30 agosto 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 25 febbraio 2026.
Sommario breve
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.
Descrizione dettagliata
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-wee...Mostra di più
Titolo ufficiale

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)

Patologie
Eiaculazione precoce
Altri ID dello studio
  • KH-001-02
Numero NCT
NCT07434271
Data di inizio (effettiva)
2025-12-01
Ultimo aggiornamento pubblicato
2026-02-25
Data di completamento (stimata)
2026-08-30
Arruolamento (previsto)
40
Tipo di studio
Interventistico
FASE
Fase II
Stato
In arruolamento
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
Studio incrociato
Mascheramento
Doppio
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleKH-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.
KH-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.
Comparatore placeboPlacebo 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.
Placebo 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.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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.
Study Week 4 and Study Week 12
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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.
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.
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.
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.
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.
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.
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.
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.
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
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Maschio
  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.

  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.
Kadence Bio logoKadence Bio
Contatti principali dello studio
Contatto: Maya Worth, 0395096166, [email protected]
1 Centri dello studio in 1 paesi

New South Wales

Emeritus Research Sydney, Botany, New South Wales, 2019, Australia
Juliet Freeborn, Dr, Investigatore principale
In arruolamento