Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction Radical Prostatectomy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 583
Healthy volunteers: no

Brief summary:
The study will include patients with localized prostate cancer who experience erectile dysfunction following bilateral nerve-sparing radical prostatectomy. Patients will be randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on demand (prior to anticipated sexual activity), and placebo. Patients will stay on therapy for 9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for recovery of unassisted erectile function (without medication). An open-label extension for three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day. Further objectives are to evaluate the treatment satisfaction of the respective therapies.

Detailed description:

Arms:
arm 1: After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period. arm 2: After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period. arm 3: After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.

Interventions: intervention 1: Tadalafil intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by mouth for 9 months intervention 2: Administered by mouth, daily or on demand for 9 months

Protocol document: