Trial intelligence / Profile preview

tRNS vs Dapoxetine in Lifelong Premature Ejaculation

NCT04850703Phase 2

Key facts

Status
Completed
Start
Feb 2021
Primary completion
May 2022
Countries
1
Modality
Small Molecules
Conditions
premature ejaculation (PE)
01

Overview

Phase 2, randomised, double-blind trial of dapoxetine in premature ejaculation (PE) (4 arms). Primary endpoints: Wavelet Changes in Brain Biomarker at 1 month, EEG Coherence at 3 months and 1 more. Started Feb 2021; status: completed.

02

Design

4 arms
Study design
RandomizedDouble-blind
  • tRNS Arm

    Active tRNS stimulation at IFG cortex.

  • Dapoxetine Arm

    Oral dapoxetine tablet.

  • Placebo/Sham Arm

    No active medication or stimulation.

  • Healthy Controls

    Non-LPE participants for baseline mapping.

03

Who it enrols

Adult males aged 18-70 with a best-practice diagnosis of lifelong premature ejaculation for at least one year, excluding those with significant neurological or sensory impairments.

04

Endpoints

Primary

  • Wavelet Changes in Brain Biomarker

  • EEG Coherence

  • Adverse Events

Secondary

  • Event-Related Potential Novelty Wave

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