Prospective Sexual Function Study for BPH Subjects

Inclusion Criteria

• Males aged ≥50 years.
• Men must be sexually active. A man is considered sexually active if he has been engaged in sexual activity with a partner during the past 4 weeks (at least once) and plans to be active during the next 4 weeks (unless due to travel or other practical reasons). Men should confirm that they are in a stable relationship and expect to maintain their sexual activity over the next year.
• A confirmed clinical diagnosis of BPH.
• International Prostate Symptom Score (IPSS) ≥12 at Visit 1 (screening), with bother score 4 or less (score from the IPSS Quality of Life question 8).
• Prostate volume ≥30 cc (by transrectal ultrasonography; TRUS). Measurement should be available by the baseline visit and should have been made /arranged at the screening visit or within the previous 6 months.
• Total serum prostate specific antigen (PSA ≥1.5 ng/mL (see exclusion criteria 1) at Visit 1 (screening).
• Willing and able to give signed written informed consent and comply with study procedures, including the ability to participate in the study for the full 1 year (or 18 months if necessary because of a persistent sexual AE).
• Fluent and literate in local language with the ability to read, comprehend and record information on the MSHQ, IPSS, PPSM, BPH Impact Index (BII) and C-SSRS questionnaires.
• Able to swallow and retain oral medication.
• Men with a female partner of childbearing potential must either agree to use effective contraception or have had a prior vasectomy. Contraception must be used from 2 weeks prior to administration of the first dose of study treatment until at least 5 half-lives for the drug (45 days) plus 3 months (i.e. a total of 4.5 months) to allow clearance of any altered sperm after the last dose of study treatment.
• French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria

• Total serum PSA >10.0 ng/mL at Visit 1 (screening).
• History or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious DRE and/or rising PSA). Subjects with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study.

Note: If total serum PSA is >4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, including consideration of prostate biopsy.

Excluded medication and therapies

• Current or prior use (within the periods given) of the following prohibited medications
• Any prior use of a 5α-reductase inhibitor (finasteride or dutasteride),
• Anti-cholinergics (e.g. oxybutynin, propantheline, tolerodine, solifenacin or darifenacin) within 1 month prior to visit 2 (baseline)
• An alpha-adrenoreceptor blocker (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 1 month prior to visit 2 (baseline)
• Use of any drugs with anti-androgenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents) within the 6 months prior to visit 1 (screening).
• Use of any drugs noted for propensity to cause gynaecomastia, or which could affect prostate volume, within 6 months prior to Visit 1 (screening).
• Use of any investigational or marketed study drug within 30 days or 5 half-lives of the drug in question, (whichever is longer), preceding visit 2 (baseline).
• Current use (at the baseline visit or within the prior 1month) of:
• PDE-5 inhibitors for Erectile Dysfunction.
• Anabolic steroids.
• Drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin.
• Use of phytotherapy for BPH within 2 weeks prior to Visit 1 (screening) and/or predicted to need phytotherapy during the study.
• History of a known (immediate or delayed) hypersensitivity reaction or idiosyncratic reaction to d