Premature EjaculationNCT06570135
Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial
A study testing Detecting Brain Activity with Functional Near Infrared Spectroscopy in people with Premature Ejaculation, run by Xijing Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Detecting Brain Activity with Functional Near Infrared Spectroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 8 Apr 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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；
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Air Force Military Medical University
Xi'an, Shaanxi, 70032
Weijun Qin, Dr
- Recruiting
Air Force Military Medical University
Xi'an, Shaanxi, 70032
Weijun Qin, M.D, 13730192056 ext. 13730192056, mengxl69@163.com
About this study
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
- Being tested
- Detecting Brain Activity with Functional Near Infrared Spectroscopy
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detecting Brain Activity with Functional Near Infrared SpectroscopyDiagnostic test
Use a functional near-infrared spectroscopy to detect brain activity in the two groups of subjects during resting state and task state.
| Study group | Role | What they receive |
|---|---|---|
| premature ejaculation group | Experimental | Not described Receives: Diagnostic Test: Detecting Brain Activity with Functional Near Infrared Spectroscopy |
| Non-premature ejaculation group | Experimental | Not described Receives: Diagnostic Test: Detecting Brain Activity with Functional Near Infrared Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of near-infrared brain functional imaging
Data on changes in oxygenated hemoglobin concentration
Measured: 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start8 Apr 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570135
- Sponsor's protocol ID
- KY20242242
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2024
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial
- ClinicalTrials.gov ID
- NCT06570135
- Acronym / sponsor ID
- KY20242242
- Conditions
- Premature Ejaculation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| premature ejaculation group | Experimental | Diagnostic Test: Detecting Brain Activity with Functional Near Infrared Spectroscopy |
| Non-premature ejaculation group | Experimental | Diagnostic Test: Detecting Brain Activity with Functional Near Infrared Spectroscopy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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；
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detecting Brain Activity with Functional Near Infrared SpectroscopyUse a functional near-infrared spectroscopy to detect brain activity in the two groups of subjects during resting state and task state. | Diagnostic test | Non-premature ejaculation group, premature ejaculation group |
Primary outcome
Results of near-infrared brain functional imaging
Time frame: 1 hours
Data on changes in oxygenated hemoglobin concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detecting Brain Activity with Functional Near Infrared Spectroscopy in people with Premature Ejaculation, run by Xijing Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weijun Qin, M.D (13572501300, qinwj@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of near-infrared brain functional imaging (time frame: 1 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.