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 @ 4:40 AM
Ignite Modification Date:
2025-12-25 @ 4:40 AM
NCT ID:
NCT01026818
Eligibility Criteria:
Inclusion Criteria:
* scheduled to undergo Bilateral nerve-sparing radical prostatectomy (BNSRP) for organ-confined, non-metastatic prostate cancer
* have a normal preoperative erectile function score of more or equal to 22 at screening(as evaluated by International Index of Erectile Function - Erectile Function domain (IIEF-EF))
* develop Erectile Dysfunction (ED) (defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) after surgery
* have an interest in resuming sexual activity as soon as possible after surgery and anticipate having the same adult female sexual partner during the study
* agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study
* does not require the initiation of adjuvant therapy for prostate cancer
Exclusion Criteria:
* history of ED
* have received previous or current treatment with tadalafil or any other Phosphodiesterase Type 5 (PDE5) inhibitor
* have undergone, or plan to undergo, radiation or hormonal therapy for prostate cancer
* have a history of prostatic surgery or prostatic physical treatments
* have a history of diabetes mellitus
* have a history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
* have clinically significant renal insufficiency as determined by the investigator
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
67 Years
Study:
NCT01026818
Study Brief:
Protocol Section:
NCT01026818