A Study of Tadalafil in Men With Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia (BPH)
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Tadalafil 5 mg; Placebo tablet; Tamsulosin; Placebo capsule
Intervention description: Tadalafil 5 mg po QD for 12 weeks; Placebo tablet po QD for 12 weeks; Tamsulosin 0.4 mg po QD for 12 weeks; Placebo capsule po QD for 12 weeks
Intervention MeSH terms: Tadalafil; Tamsulosin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 511.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether an experimental drug known as tadalafil
      given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia
      (straining, urinary frequency, feeling like your bladder is still full etc.)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men 45 years of age or older with benign prostatic hyperplasia (BPH) also referred to
             as BPH-lower urinary tract symptoms (LUTS) on the disease diagnostic criteria at the
             start of study.

          -  Provide signed informed consent at the start of the study.

          -  Agree not to use any other approved or experimental pharmacologic BPH, overactive
             bladder (OAB), or erectile dysfunction (ED) treatments anytime during the study.

          -  Have not taken finasteride therapy for at least 3 months before study drug is
             dispensed and dutasteride therapy for at least 6 months before study drug is
             dispensed.

          -  Have not taken other BPH therapy (including herbal preparations), OAB therapy, ED
             therapy for at least 4 weeks prior to study drug is dispensed.

          -  Have LUTS with a total International Prostate Symptom Score (IPSS) greater than or
             equal to 13 when study drug is dispensed.

          -  Have reduced urine flow (measured by special toilet equipment).

          -  Demonstrate compliance with study drug administration requirements.

        Exclusion Criteria:

          -  Treated with nitrates

          -  Have unstable angina or angina that requires treatment.

          -  Have had any of the following in the past 90 days: Heart attack, also known as a
             myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft
             surgery); Had a procedure to open up blood vessels in the heart known as angioplasty
             or stent placement (percutaneous coronary intervention).

          -  Have very high or very low blood pressure.

          -  Have certain neurological conditions associated with bladder problems or injuries to
             brain or spinal cord within a specified time of starting this study.

          -  Have uncontrolled diabetes.

          -  Have prostate cancer, are being treated for cancer.

          -  Have prostate specific antigen (PSA) greater than 10 nanograms per milliliter (ng/mL)
             at the start of study.