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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Premature Ejaculation

Intervention / Treatment
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* Drug: Dapoxetine Hydrochloride Tablet
* Drug: Placebo Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dapoxetine<br>In this group, patients received one dapoxetine hydrochloride tablet before MRI scan. | Drug: Dapoxetine Hydrochloride Tablet<br>* oral one dapoxetine hydrochloride tablet before MRI scan<br>|
| Placebo Comparator: Placebo<br>In this group, patients received placebo tablet before MRI scan. | Drug: Placebo Tablet<br>* oral one placebo tablet before MRI scan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One day |