A Study of Tadalafil in Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Tadalafil
Intervention description: 5 mg, administered orally, daily for 10 days
Intervention MeSH terms: Tadalafil
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the pharmacokinetics of tadalafil in Japanese and
      non-Japanese men with Benign Prostatic Hyperplasia (BPH).

      The safety of tadalafil will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had lower urinary tract symptoms secondary to benign prostatic hyperplasia
             (BPH-LUTS) (as diagnosed by a qualified physician) >6 months at screening visit. Lower
             urinary tract symptoms (LUTS) include those associated with voiding (obstructive
             symptoms, such as incomplete emptying, intermittency, weak stream, straining) and/or
             storage (irritative symptoms, such as frequency, urgency, nocturia).

          -  Have BPH-LUTS with moderate-to-severe symptoms confirmed by an International Prostate
             Symptom Score (IPSS) >12. (The IPSS total score is defined as the sum of Questions 1
             through 7 and does not include the IPSS Quality of Life.)

          -  Taking into account the age and disease status, subjects determined to be in good
             health according to medical history, physical examination, electrocardiogram (ECG),
             and laboratory safety assessments.

          -  Body mass index between 18 and 30 kg/m^2 inclusive.

          -  Agree not to use any other approved or experimental pharmacologic BPH, erectile
             dysfunction (ED), and/or overactive bladder (OAB) treatments, including alpha
             blockers, phosphodiesterase type 5 (PDE5) inhibitors, or herbal preparations at least
             1 week prior to dosing and through to follow-up.

          -  Subjects with a serum prostate-specific antigen (PSA) <10.0 ng/mL. Subjects with a
             serum PSA greater than or equal to 4.0 and <10.0 ng/mL must have documentation of a
             negative histologic biopsy of carcinoma of the prostate within 12 months prior to
             screening.

        Exclusion Criteria:

          -  History of radical prostatectomy, or other pelvic surgery or procedure, including any
             pelvic surgical procedure on the urinary tract apart from transurethral resection,
             pelvic surgery for malignancy or bowel resection, or a history of lower urinary tract
             malignancy or trauma. History of urinary retention or lower urinary tract (bladder)
             stones within 6 months of screening.

          -  Current or previous history of malignant disease of the prostate.

          -  Concomitant treatment with or ingestion of cytochrome P 450 3A4 (CYP3A4)-inducing or
             -inhibiting agents from 2 weeks prior to dosing and through the end of the study.
             Including herbal/food and other supplements, fruit, or fruit juices containing
             grapefruit or pomegranate components.

          -  History of loss of vision in one eye because of nonarteritic anterior ischemic optic
             neuropathy (NAION), regardless of whether this episode was in connection or not with
             previous PDE5 inhibitor exposure.

          -  Subjects with chronic stable angina treated with long-acting nitrates, subjects with
             chronic stable angina who required short-acting nitrates in the 90 days prior to
             screening visit, or subjects with angina occurring during sexual intercourse in the 6
             months prior to screening.

          -  Subjects having met the criteria for unstable angina within 6 months prior to
             screening, history of myocardial infarction or coronary artery bypass graft surgery
             within 90 days prior to screening, or percutaneous coronary intervention (for example,
             angioplasty or stent placement) within 90 days prior to screening.

          -  Any evidence of heart disease (New York Heart Association [NYHA] greater than or equal
             to Class III) within 6 months of screening.

          -  A history of cardiac arrest.