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

Xidian University

Status: Unknown

Conditions: Premature Ejaculation

Treatments: Drug: Dapoxetine Hydrochloride Tablet; Drug: Placebo Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03583112

81471811

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Dapoxetine

Active Comparator group

Description:

In this group, patients received one dapoxetine hydrochloride tablet before MRI scan.

Treatment:

Drug: Dapoxetine Hydrochloride Tablet

Placebo

Placebo Comparator group

Description:

In this group, patients received placebo tablet before MRI scan.

Treatment:

Drug: Placebo Tablet