NCT04850703

Brain Networks Implicated in Lifelong Premature Ejaculation Patients

Comparative Study of the Clinical Response Between tDCS and Dapoxetine, Define a Very Effective Therapeutic Target, That Improves the LPE in the Medium Long Term

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Moises Domingo · Academic / Other
• Sex: Male
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Using Brain Mapping and Cognitive ERPs, the investigatos have searched for a Brain Networks involved during Inhibitory Control in Lifelong Premature Ejaculation (LPE) participants. The investigators have designed a clinical trial comparing placebo with tDCS and blacebo group against Dapoxetine, studying the effects on LPE, as well as side effects and their medium and long-term duration.

Detailed description

Lifelong premature ejaculation (LPE) is a very common male sexual dysfunction like erectile dysfunction. It produces great distress to sexual harmony and even fertility. Previous neurophysiology studies revealed an ejaculation-related control mechanism in the brain: left inferior frontal gyrus (IFG) activation during successful inhibition. If we use the left IFG as a seed, participants showed weaker resting-state functional connectivity (FC) activity, between the seed and two areas (left dentate nucleus (DN) and right frontal pole) compared with controls. The main goal is to compare whether the brain biomarker only exists in participants with LPD and how it responds to treatment with Dapoxetine and with tDCS against the IFG networks and lDN, measuring the connectivity changes in these brain networks and FC.

Conditions

• Premature Ejaculation
• Sexual Dysfunction

Interventions

Type	Name	Description
DEVICE	Transcranial Radom Noise Stimulation	tRNS against Dapoxetine in LPE patients
DRUG	Take Dapoxetine	Dapoxetine against tRNS in LPE patients
COMBINATION_PRODUCT	Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants	Compare EEG parameters like Theta Rhythm and Coherence between three groups of participants: sham, tRNS participants and Dapoxetine participants groups.
DIAGNOSTIC_TEST	Compare LPE EEG endophenotype between participants and healthy controls	Define as precisely as possible the electrophysiological endophenotype of Longlife Premature Ejaculation, using healthy humans who do not express the LPE EEG endophenotype

Timeline

• Start date: 2021-02-02
• Primary completion: 2022-05-21
• Completion: 2023-02-04
• First posted: 2021-04-20
• Last updated: 2023-04-12

Locations

1 site across 1 country: Spain