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

Premature Ejaculation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03583112
• Other study ID #: 81471811
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: Xidian University
• Contact: xuejuan Yang
• Phone: 8602981891070
• Email: 82502972[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

Drug:
• Dapoxetine Hydrochloride Tablet
oral one dapoxetine hydrochloride tablet before MRI scan
• Placebo Tablet
oral one placebo tablet before MRI scan.

Locations

Country	Name	City	State
China	The ART Center, The Northwest Women's and Children's Hospital,	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xidian University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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