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This study will test the effectiveness and the safety of KH-001 in men with lifelong premature ejaculation. It will also test whether KH-001 is well tolerated. 

Research Objectives

Status

Current

Recruitment

Closed

Total participants required

10

Study location

Wesley Research Institute, The Wesley Hospital, St Andrew's War Memorial Hospital

Study type

Industry Sponsored

Patient group

Male aged between 18 and 65 years of age, inclusive, with lifelong premature ejaculation

About this clinical trial

KH-001 is a new type of treatment being developed for PE by Kanna Health Pty Ltd (known as Kadence Bio). KH-001 targets SERT, or the serotonin reuptake transporter, which is a protein responsible for the reuptake of a chemical in the brain called serotonin. It acts quickly—within 10 to 30 minutes—and is cleared from the body within a few hours, which may support more spontaneous use. While the effectiveness of KH-001 in treating PE has not yet been tested in patients, it showed promising results in early laboratory studies. It is hoped that KH-001 will be effective, with fewer side effects, and more convenient to use than other treatment options.

 In order to take part in this study, you are required to be in a stable monogamous heterosexual relationship that has lasted at least 6 months. Your female partner will also be asked to take part in this study in support of your participation.

Eligibility

  • Male aged between 18 and 65 years
  • Lifelong premature ejaculation
  • Be in a stable monogamous heterosexual relationship that has lasted at least 6 months (Your female partner will also be asked to take part in this study in support of your participation)

Lead investigators

  • Professor Eric Chung
  • Dr Joy Hussain

Technical title

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)

This  clinical trial is now closed for recruitment

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