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

Sponsor

Xidian University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03583112

Collaborator

(none)

100

Enrollment

Location

Arms

4.7

Anticipated Duration (Months)

21.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Ejaculation	Drug: Dapoxetine Hydrochloride Tablet Drug: Placebo Tablet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Jul 10, 2018

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dapoxetine In this group, patients received one dapoxetine hydrochloride tablet before MRI scan.	Drug: Dapoxetine Hydrochloride Tablet oral one dapoxetine hydrochloride tablet before MRI scan
Placebo Comparator: Placebo In this group, patients received placebo tablet before MRI scan.	Drug: Placebo Tablet oral one placebo tablet before MRI scan.

Arm

Intervention/Treatment

Active Comparator: Dapoxetine

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

Drug: Dapoxetine Hydrochloride Tablet

oral one dapoxetine hydrochloride tablet before MRI scan

Placebo Comparator: Placebo

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

Drug: Placebo Tablet

oral one placebo tablet before MRI scan.

Outcome Measures

Primary Outcome Measures

Resting-state brain function measured by Functional magnetic resonance imaging [One day]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The ART Center, The Northwest Women's and Children's Hospital,	Xi'an	Shaanxi	China	710003

Sponsors and Collaborators

Xidian University

Investigators

Principal Investigator: Gao, The ART Center, The Northwest Women's and Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xidian University

ClinicalTrials.gov Identifier:

NCT03583112

Other Study ID Numbers:

81471811

First Posted:

Jul 11, 2018

Last Update Posted:

Aug 24, 2018

Last Verified:

May 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Premature Birth

Premature Ejaculation

Study Results

No Results Posted as of Aug 24, 2018