ClinicalTrials.gg
RecruitingNCT06570135Updated Apr 17, 2025

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

An interventional study of Detecting Brain Activity with Functional Near Infrared Spectroscopy in Premature Ejaculation, sponsored by Xijing Hospital. Recruiting at 2 sites in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-17.

Sponsored by Xijing Hospital · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Apr 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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 activity in resting and task states (Simulated Sex) between the two groups of patients.

02

Conditions studied

  • Premature Ejaculation

Browse trials for

03

In context

Premature Ejaculation

106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.

This study's planned enrollment of 20 is below the median of 84 across 89 interventional studies indexed under Premature Ejaculation.

Browse Premature Ejaculation studies →

Lead sponsor

Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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 , 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    premature ejaculation group

    Diagnostic Test: Detecting Brain Activity with Functional Near Infrared Spectroscopy

  • Experimental
    Non-premature ejaculation group

    Diagnostic Test: Detecting Brain Activity with Functional Near Infrared Spectroscopy

Interventions

  • Diagnostic testDetecting Brain Activity with Functional Near Infrared Spectroscopy

    Use a functional near-infrared spectroscopy to detect brain activity in the two groups of subjects during resting state and task state.

06

What researchers measure

Primary outcomes

  1. Results of near-infrared brain functional imaging

    Data on changes in oxygenated hemoglobin concentration

    Time frame: 1 hours

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06570135
Lead sponsor
Xijing Hospital
Responsible party
Sponsor
First posted
Aug 26, 2024
Start date
Apr 8, 2025
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Apr 17, 2025

Study contacts

Weijun Qin, M.D
Contact
qinwj@fmmu.edu.cn
13572501300

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion