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

NCT ID: NCT06570135

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-08
• Study Completion Date: 2025-12-30

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.

Conditions

Premature Ejaculation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

premature ejaculation group

Group Type: EXPERIMENTAL

Detecting Brain Activity with Functional Near Infrared Spectroscopy

Intervention Type: DIAGNOSTIC_TEST

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

Non-premature ejaculation group

Group Type: EXPERIMENTAL

Detecting Brain Activity with Functional Near Infrared Spectroscopy

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Detecting 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Air Force Military Medical University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Air Force Military Medical University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Weijun Qin, M.D

Role: CONTACT

qinwj@fmmu.edu.cn

13572501300

Facility Contacts

Weijun Qin, Dr

Role: primary

Weijun Qin, M.D

Role: primary

mengxl69@163.com

13730192056 ext. 13730192056

Other Identifiers

KY20242242

Identifier Type: -

Identifier Source: org_study_id