Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Placebo; tadalafil
Intervention description: Following a 4-week placebo lead-in period, subjects received placebo tablet by mouth once daily over a 12-week period.; Following a 4-week placebo lead-in period, subjects received tadalafil 5 mg tablet by mouth once daily over a 12-week period.
Intervention MeSH terms: Tadalafil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 325.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Signs and Symptoms; Prostatic Hyperplasia; Hyperplasia; Genital Diseases, Male; Prostatic Diseases; BPH-LUTS

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-LUTS [lower urinary tract symptoms] based on the disease diagnostic criteria at
             the start of study.

          -  Provide signed informed consent at the start of 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), overactive bladder
             (OAB) therapy, or erectile dysfunction (ED) therapy for at least 4 weeks prior to
             study drug is dispensed.

          -  Agree not to use any other approved or experimental pharmacologic BPH, OAB, or ED
             treatments anytime during the study

          -  Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or
             equal to 13 when study drug is dispensed.

          -  Have reduced peak urine flow rate when study drug is dispensed (measured by a special
             toilet equipment).

          -  Demonstrate compliance with study drug administration requirements.

        Exclusion Criteria:

          -  Treated with nitrates for a cardiac conditions.

          -  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 problems with kidneys, liver, or nervous system.

          -  Have uncontrolled diabetes.

          -  Have had a stroke or a significant injury to brain or spinal cord.

          -  Have prostate cancer, are being treated for cancer or have clinical evidence of
             prostate cancer (Prostate-Specific Antigen [PSA] greater than 10 nanograms/milliliter
             [ng/ml] at the start of study).