Conditions: Benign Prostatic Hyperplasia
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 171
Healthy volunteers: no

Brief summary:
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as tadalafil in participants with benign prostatic hyperplasia who are being treated with an alpha1 blocker. This study has two treatment periods. Participants will receive tadalafil or placebo in each treatment period.

Detailed description:

Arms:
arm 1: 5 milligrams (mg) tadalafil administered once daily orally for 8 weeks in one of two treatment periods.

0.2 mg tamulosin once daily or 4 mg silodosin twice daily.

Participants will remain on stable dose of alpha1 blocker through both treatment periods. arm 2: Placebo administered once daily orally for 8 weeks in one of two treatment periods.

0.2 mg tamulosin once daily or 4 mg silodosin twice daily.

Participants will remain on stable dose of alpha1 blocker through both treatment periods.

Interventions: intervention 1: Tadalafil intervention 2: Placebo intervention 3: Alpha1 Blocker
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally

Protocol document: