Conditions: Benign Prostatic Hyperplasia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1
Healthy volunteers: no

Brief summary:
This study is designed to compare safety and efficacy of monotherapy finasteride to combination therapy (finasteride and tamsulosin) in Asian men with benign prostatic hyperplasia (BPH) who are at least 50 years of age or older. The primary hypotheses are that concomitantly-dosed finasteride 5 mg and tamsulosin 0.2 mg will be superior with respect to BPH symptoms compared to monotherapy with finasteride 5 mg as measured by change from baseline on the International Prostate Symptoms Score (IPSS) and will be superior with respect to prostate volume reduction compared to montherapy with tamsulosin 0.2 mg as measured by percent change from baseline in prostate volume.

Detailed description:

Arms:
arm 1: Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together. arm 2: Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together. arm 3: Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.

Interventions: intervention 1: Finasteride intervention 2: Tamsulosin intervention 3: Finasteride-matching placebo intervention 4: Tamsulosin-matching placebo
Intervention descriptions: intervention 1: Finasteride 5 mg oral tablet taken once daily. intervention 2: Tamsulosin 0.2 mg oral capsule taken once daily. intervention 3: Matching placebo to finasteride 5 mg oral tablet taken once daily. intervention 4: Matching placebo to tamsulosin 0.2 mg oral capsule taken once daily.

Protocol document: