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

August 23, 2018 updated by: Xidian University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710003
        • Recruiting
        • The ART Center, The Northwest Women's and Children's Hospital,
        • Contact:
          • Xuejuan Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting-state brain function measured by Functional magnetic resonance imaging
Time Frame: 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.
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xidian University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 10, 2018

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

May 30, 2018

First Submitted That Met QC Criteria

June 26, 2018

First Posted (ACTUAL)

July 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81471811

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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