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

NCT03583112 | Unknown

• 1 other identifier: 81471811
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  One day

Study Arms (2)

Dapoxetine

ACTIVE COMPARATOR

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

Drug: Dapoxetine Hydrochloride Tablet

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Tablet

Interventions

Dapoxetine Hydrochloride Tablet DRUG

oral one dapoxetine hydrochloride tablet before MRI scan

Dapoxetine

Placebo Tablet DRUG

oral one placebo tablet before MRI scan.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• smokers
• had medical，neurological or psychiatric disorders
• had alcohol, nicotine, or drug abuse
• received any treatment at least 2 weeks before the experiment

Sponsors & Collaborators

• Xidian University: lead

Study Sites (1)

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

Xi'an, Shaanxi, 710003, China

RECRUITING

MeSH Terms

Conditions

Premature Ejaculation

Interventions

dapoxetine

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Gao

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xuejuan Yang

CONTACT

8602981891070; 82502972@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: July 11, 2018
• Study Start: July 10, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 24, 2018

Record last verified: 2018-05

Locations

CN (1)