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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT04488068
Eligibility Criteria:
Inclusion Criteria:
* men over 50 years old who are enrolled for prostate surgery,
* have serum testosterone within normal limits, and
* are without prior bilateral orchiectomy, chemotherapy, external radiotherapy, brachytherapy, surgical, or other ablative therapy for prostate cancer.
Exclusion Criteria:
* patients with ED caused by psychological, neurogenic (after non-nerve sparing prostate surgery), or hormonal disorders,
* patients with genital abnormalities precluding intercourse, prior penile implantation, ongoing erectile aid use, or use of nitrate medications.
* Androgen suppression within the past 6 months or as part of protocol-specified radiotherapy or brachytherapy will be excluded.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT04488068
Study Brief:
Protocol Section:
NCT04488068