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
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 |
Verified date | May 2018 |
Source | Xidian University |
Contact | xuejuan Yang |
Phone | 8602981891070 |
82502972[@]qq.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | The ART Center, The Northwest Women's and Children's Hospital, | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Xidian University |
China,
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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