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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT02746094
Eligibility Criteria:
Inclusion Criteria:
* The patient has given his informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is a man at least 18 years old and less than 80 years old
* The patient has been in a stable, sexual relationship with only one other person for at least the past three months
* The patient is consulting for erectile dysfunction lasting for over 6 months
* The patient had a prostatectomy 18 to 60 months ago
* The patient has an erectile function domain score on the International Index of Erectile Function questionnaire between 6 and 25
* The patient has at least a natural tumescence during sexual stimulation (erection hardness score ≥ 1)
* The patient has not had phosphodiesterase type 5 inhibitor treatment for the month preceding inclusion
* The patient is available for 8 months of follow-up and agrees to participate in all study visits
Exclusion Criteria:
* The patient is participating in another interventional study, or has participated in another interventional study within the past 3 months
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, or is an adult under guardianship
* It is impossible to correctly inform the patient, or the patient refuses to sign the consent
* Complete anerection
* Untreated testosterone deficiency
* Neurological disease
* Psychiatric disease
* Anatomical malformation of the penis
* Chronic haematological pathology with significant clinical impact
* Oral or injectable antiandrogen treatment
* The patient is taking blood thinners and has an international normalized ratio \> 3
* History of erectile dysfunction before the prostatectomy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT02746094
Study Brief:
Protocol Section:
NCT02746094