Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT03942367
Eligibility Criteria:
INCLUSION CRITERIA:
1. Male Patients, aged ≥ 18 and ≤ 60 years old.
2. Patients who are diagnosed with clinical premature ejaculation or with self-perceived ELT \< 3 minutes.
3. Patients with stable, heterosexual, monogamous, sexual relationship for at least 3 months at the time of the enrolment.
4. Patients planning to maintain the relationship for the whole duration of the study.
5. Patients with 75% of IELT baseline measurement \< 2 minutes and 25% of IELT baseline measurement \< 3 minutes at Visit 2.
6. Patients with PEDT (Premature Ejaculation Diagnostic Tool) measurement ≥ 11 at the time of enrolment.
7. Patients with IIEF-5 (International Index of Erectile Function) measurement ≥ 22 at the time of enrolment.
8. Patients understanding the nature of the study and providing their informed consent to participation.
9. Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol.
EXCLUSION CRITERIA:
1. Patients with history of cardiovascular disorders.
2. Patients with history of other sexual dysfunction (other than PE).
3. Patients suffering of erectile dysfunction.
4. Patients carrying any type of implanted pacemaker/defibrillator.
5. Patients suffering of diagnosed Diabetes Mellitus with peripheral neuropathy.
6. Patients suffering of perineal dermatological diseases.
7. Patients suffering of perineal skin irritation / lesions.
8. Patients suffering of any psychiatric major disease (axis 1) and/or taking any relevant medications.
9. Patients taking antidepressant therapy, topical anesthetic agents or sexual-related cognitive behavioral therapy within the 4 weeks before the enrolment.
10. Patients with past occurrences of ejaculation before intromission.
11. Patients with history of genital or anorectal neoplastic illness in the 2 years before the enrolment.
12. Patients with pregnant partner.
13. Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
14. Patients with any medical incidence where the use of the device may jeopardize the Patient's safety per Investigator's discretion.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03942367
Study Brief:
Protocol Section:
NCT03942367