CClinicalTrials.gg
Status unknownNCT03583112Updated Aug 24, 2018

Investigation of the Changes of Brain Structure and Function in Premature Ejaculation Patients and the Effects of Dapoxetine on Central Neural Activity in Premature Ejaculation Patients

An interventional study of Dapoxetine Hydrochloride Tablet and Placebo Tablet in Premature Ejaculation, sponsored by Xidian University. Status unknown at 1 site in China. Open to male participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-24.

Sponsored by Xidian University · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
Male
01

Study summary

Lifelong premature ejaculation (LPE) is a common male sexual dysfunction with a high prevalence in global. Up to now, the etiology of LPE remains unclear. In recent years, dapoxetine, a highly potent serotonin-transporter inhibitor, has been used for treating premature ejaculation. However, the underlying mechanism of dapoxetine was unknown. Recently, with widespread use of neuroimaging techniques, like positron emission tomography and magnetic resonance imaging (MRI) in basic science, researchers can acquire human data on cerebral base of human sexual behavior, not only in normal subjects but also in patients with sexual dysfunction. Therefore, in order to further understand the biological mechanism of LPE and the brain targets of dapoxetine, the present study would investigate the brain changes of LPE and the effect of dapoxetine on brain activation by using MRI technology.

02

Conditions studied

  • Premature Ejaculation
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's planned enrollment of 100 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Xidian University is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • right-handed male Chinese volunteers
  • intravaginal ejaculatory latency time within 1 min
  • premature ejaculation diagnostic tool score >11 for patients, but \<5 for each control.
  • patients who never received dapoxetine hydrochloride or other SSRI drugs

Exclusion criteria

Exclusion Criteria:

  • smokers
  • had medical,neurological or psychiatric disorders
  • had alcohol, nicotine, or drug abuse
  • received any treatment at least 2 weeks before the experiment
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Dapoxetine

    In this group, patients received one dapoxetine hydrochloride tablet before MRI scan.

    Drug: Dapoxetine Hydrochloride Tablet

  • Placebo comparator
    Placebo

    In this group, patients received placebo tablet before MRI scan.

    Drug: Placebo Tablet

Interventions

  • DrugDapoxetine Hydrochloride Tablet

    oral one dapoxetine hydrochloride tablet before MRI scan

  • DrugPlacebo Tablet

    oral one placebo tablet before MRI scan.

06

What researchers measure

Primary outcomes

  1. Resting-state brain function measured by Functional magnetic resonance imaging

    We will use several indicators to assess the resting-state brain function based on fMRI analysis, including regional homogeneity,Amplitude of Low Frequency Fluctuations, and functional connectivity.

    Time frame: One day

07

Study locations

1 of 1 sites recruiting
  • The ART Center, The Northwest Women's and Children's Hospital,
    Xi'an, Shaanxi 710003, China
    • Xuejuan Yang · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03583112
Lead sponsor
Xidian University
Responsible party
Sponsor
First posted
Jul 11, 2018
Start date
Jul 10, 2018
Primary completion
Dec 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Aug 24, 2018

Study contacts

xuejuan Yang
Contact
82502972@qq.com
8602981891070
Gao
principal investigator · The ART Center, The Northwest Women's and Children's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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