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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03583112
Other study ID # 81471811
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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