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:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT06264635
Eligibility Criteria:
Inclusion Criteria:
* The patient must be able willing and able to provide informed consent. The investigators wil enroll males between \>30 and \<70 years of age who have ED based on IIEF scores (score between 16 and 25.) with patients suffering from erectile dysfunction lasting for over 6 months and not more than 5 years as per history provided by patient.
The patient has been in a stable relationship for over 3 months prior to enrollment with a minimum of 2 sexual attempts per month for at least one month prior to enrollment.
A1C level ≤ 7% within 1 month prior to enrollment.
Exclusion Criteria:
* Participating in another study within the past three months that may interfere with the results or conclusions of this study, under judicial protection (prison or custody), adult under guardianship, or patient refuses to sign the consent.
History of radical prostatectomy or extensive pelvic surgery, past radiation therapy of the pelvic region within 12 months prior to enrolment, recovering from any cancer within 12 months prior to enrollment.
Neurological disease such as Alzheimer's or Parkinson's disease which affects erectile function at the discretion of the investigator, psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications at the discretion of the investigator.
Anatomical malformation of the penis, including Peyronie's disease.
A1C level \> 7% within 1 month prior to enrollment or history of Insulin dependent diabetes.
The patient is taking blood thinners and has an international normalized ratio (INR) \>3.
Received shockwave treatment at least 6 months before enrollment.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT06264635
Study Brief:
Protocol Section:
NCT06264635