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New treatment option for Premature Ejaculation
Official title Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial
ClinicalTrials.gov ID: NCT06570135
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, men only. Healthy volunteers may be eligible.
You may be able to join if
- (primary premature ejaculation people):
- 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...
- Patients with premature ejaculation lasting longer than 6 months；
You likely can't join if
- 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...
- patients were diagnosed with sexual hormone abnormalities, hyperthyroidism, hypothyroidism, Peyronie's disease, prostatitis, urethritis, or urinary...
- patients with head injuries that prevent them from completing near-infrared light brain function imaging
See the full eligibility criteria
- (primary premature ejaculation people):
- 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 (Non-premature ejaculation people):
- 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...
- 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；
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.