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Trial record 6 of 23 for:    priligy

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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ClinicalTrials.gov Identifier: NCT03583112
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Xidian University

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 10, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583112


Contacts
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Contact: xuejuan Yang 8602981891070 82502972@qq.com

Locations
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China, Shaanxi
The ART Center, The Northwest Women's and Children's Hospital, Recruiting
Xi'an, Shaanxi, China, 710003
Contact: Xuejuan Yang         
Sponsors and Collaborators
Xidian University
Investigators
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Principal Investigator: Gao The ART Center, The Northwest Women's and Children's Hospital

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Responsible Party: Xidian University
ClinicalTrials.gov Identifier: NCT03583112     History of Changes
Other Study ID Numbers: 81471811
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: May 2018

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

Additional relevant MeSH terms:
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Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders