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 ID: NCT03583112

Last Updated: 2018-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-10
• Study Completion Date: 2018-12-31

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.

Conditions

Premature Ejaculation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Dapoxetine

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

Group Type: ACTIVE_COMPARATOR

Dapoxetine Hydrochloride Tablet

Intervention Type: DRUG

oral one dapoxetine hydrochloride tablet before MRI scan

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo Tablet

Intervention Type: DRUG

oral one placebo tablet before MRI scan.

Interventions

Dapoxetine Hydrochloride Tablet

oral one dapoxetine hydrochloride tablet before MRI scan

Intervention Type: DRUG

Placebo Tablet

oral one placebo tablet before MRI scan.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Xidian University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gao

Role: PRINCIPAL_INVESTIGATOR

The ART Center, The Northwest Women's and Children's Hospital

Locations

The ART Center, The Northwest Women's and Children's Hospital,

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

xuejuan Yang

Role: CONTACT

82502972@qq.com

8602981891070

Facility Contacts

Xuejuan Yang

Role: primary

Other Identifiers

81471811

Identifier Type: -

Identifier Source: org_study_id