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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06570135
Enrollment
20
Registered
2024-08-26
Start date
2025-04-08
Completion date
2025-12-30
Last updated
2025-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ejaculation

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

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.

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Results of near-infrared brain functional imaging1 hoursData on changes in oxygenated hemoglobin concentration

Countries

China

Contacts

Primary ContactWeijun Qin, M.D
qinwj@fmmu.edu.cn13572501300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026