Status:

RECRUITING

Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial

Lead Sponsor:

Xijing Hospital

Conditions:

Premature Ejaculation

Eligibility:

MALE

18-45 years

Phase:

NA

Brief Summary

This is a controlled study of patients with and without primary premature ejaculation. It is based on near-infrared spectroscopy (NIRS) functional brain imaging to detect and compare changes in brain ...

Eligibility Criteria

Inclusion Criteria (primary premature ejaculation subjects):

  • patients' age varied from 18 to 45 years;
  • patients met the 2014 International Society for Sexual Medicine (ISSM) definition criteria for PPE;
  • patients had a stable, heterosexual relationship with a single sexually active female partner for at least 6 months and with at least two sexual intercourses a week and kept stable during the study period;
  • Patients with premature ejaculation lasting longer than 6 months;
  • patients were identified if their scores were higher than 9 on the Chinese version of Premature Ejaculation Diagnostic Tool (PEDT);
  • patients had no history of any previous therapies for PE or had recently stopped the therapies for at least 3 months
  • patients had fully informed consent, signed informed consent form

Inclusion Criteria (Non-premature ejaculation subjects):

  • Men between the ages of 18-45 years were included according to an age difference of <3 years between each patient and the primary premature ejaculation group, and if more than one volunteer was eligible at the same time, the one with the closest age was selected;
  • Patient does not meet the 2014 International Society for Sexual Medicine (ISSM) criteria for defining premature ejaculation;
  • patients had a stable, heterosexual relationship with a single sexually active female partner for at least 6 months and with at least two sexual intercourses a week and kept stable during the study period;
  • patients had fully informed consent, signed informed consent form;

Exclusion Criteria:

  • patients were diagnosed with secondary PE, variable PE, and subjective PE;
  • patients were using medications for endocrinological, metabolic, chronic systemic, or psychiatric diseases;
  • patients were abusing alcohol or illegal drugs;
  • patients were diagnosed with erectile dysfunction (ED) if their scores were <21 on the abridged five-item International Index of Erectile Function (IIEF-5)
  • patients were diagnosed with sexual hormone abnormalities, hyperthyroidism, hypothyroidism, Peyronie's disease, prostatitis, urethritis, or urinary tract infection;
  • patients with head injuries that prevent them from completing near-infrared light brain function imaging
  • Patients with severe schizophrenia, anxiety, depression or other neurological symptoms or poor compliance

Key Trial Info

Start Date :

April 8 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 30 2025

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT06570135

Start Date

April 8 2025

End Date

December 30 2025

Last Update

April 17 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Air Force Military Medical University

Xi'an, Shaanxi, China, 70032

2

Air Force Military Medical University

Xi'an, Shaanxi, China, 70032

Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial | DecenTrialz