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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

Primary Purpose

Premature Ejaculation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dapoxetine Hydrochloride Tablet
Placebo Tablet
Sponsored by
Xidian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Premature Ejaculation

Eligibility Criteria

18 Years - 64 Years (Adult)MaleAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dapoxetine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 30, 2018
Last Updated
August 23, 2018
Sponsor
Xidian University
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1. Study Identification

Unique Protocol Identification Number
NCT03583112
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xidian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dapoxetine
Arm Type
Active Comparator
Arm Description
In this group, patients received one dapoxetine hydrochloride tablet before MRI scan.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
In this group, patients received placebo tablet before MRI scan.
Intervention Type
Drug
Intervention Name(s)
Dapoxetine Hydrochloride Tablet
Intervention Description
oral one dapoxetine hydrochloride tablet before MRI scan
Intervention Type
Drug
Intervention Name(s)
Placebo Tablet
Intervention Description
oral one placebo tablet before MRI scan.
Primary Outcome Measure Information:
Title
Resting-state brain function measured by Functional magnetic resonance imaging
Description
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.
Time Frame
One day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xuejuan Yang
Phone
8602981891070
Email
82502972@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao
Organizational Affiliation
The ART Center, The Northwest Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The ART Center, The Northwest Women's and Children's Hospital,
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuejuan Yang

12. IPD Sharing Statement

Learn more about this trial

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

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