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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT02916693
Eligibility Criteria:
Inclusion Criteria:
* presence of mild ED \[Erectile Function domain of the International Index of Erectile Function (IIEF EF) score 22-25\], mild to moderate ED (IIEF EF domain score 17-21) or moderate ED (IIEF EF domain score 11-16)
* presence of OAB symptoms for at least 3 months
* at least 3 micturitions per day
* at least 3 episodes of urgency in a 3 day period
Exclusion Criteria:
* history of pelvic surgery
* concurrent ED therapy
* history of penile surgery
* history of priapism (unwanted, prolonged painful erection)
* history of neurologic disease
* uncontrolled hypertension: systolic blood pressure (BP) \> 140 mmHg or diastolic BP \> 90 mmHg
* Stage 4 or 5 chronic kidney disease, Creatinine clearance rate \< 30ml/min
* moderate or severe hepatic impairment
* concomitant use of CYP2D6-metabolized drugs or digoxin
* post void residual greater than 150 ml
* evidence of urinary tract infection on urinalysis and/or urine culture
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02916693
Study Brief:
Protocol Section:
NCT02916693