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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03583112
Enrollment
100
Registered
2018-07-11
Start date
2018-07-10
Completion date
2018-12-31
Last updated
2018-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ejaculation

Brief 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.

Interventions

DRUGDapoxetine Hydrochloride Tablet

oral one dapoxetine hydrochloride tablet before MRI scan

DRUGPlacebo Tablet

oral one placebo tablet before MRI scan.

Sponsors

Xidian University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 64 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Resting-state brain function measured by Functional magnetic resonance imagingOne dayWe 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.

Countries

China

Contacts

Primary Contactxuejuan Yang
82502972@qq.com8602981891070

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026