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
- Premature Ejaculation
- Interventions
- Drug: Placebo Tablet
- Registration Number
- NCT03583112
- Lead Sponsor
- Xidian University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 100
- 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
- smokers
- had medical，neurological or psychiatric disorders
- had alcohol, nicotine, or drug abuse
- received any treatment at least 2 weeks before the experiment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Tablet In this group, patients received placebo tablet before MRI scan. Dapoxetine Dapoxetine Hydrochloride Tablet In this group, patients received one dapoxetine hydrochloride tablet before MRI scan.
- Primary Outcome Measures
Name Time Method Resting-state brain function measured by Functional magnetic resonance imaging One day 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The ART Center, The Northwest Women's and Children's Hospital,
🇨🇳Xi'an, Shaanxi, China