FDC116115: A prospective study of sexual function in sexually active men treated for BPH - FDC116115

GlaxoSmithKline BV0 个研究点目标入组 83 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•Sexually active males aged >=50 years with confirmed clinical diagnosis of BPH.
•IPSS >=12.
•Prostate volume >=30 cc (TRUS).
•PSA >=1.5 ng/mL.
•Men with a female partner of childbearing potential must agree to use effective contraception.

•Total serum PSA >10.0 ng/mL.
•History or evidence of prostate cancer.
•Current or any prior use of the following prohibited medications (for details see protocol page 19-20):
•o a 5a-reductase inhibitor,
•o anti-cholinergics within 1 month prior to baseline,
•o an alpha-adrenoreceptor blocker within 1 month prior to baseline.
•Any drugs with anti-androgenic properties within the previous 6 months.
•Any drugs noted for gynaecomastia effects, or could affect prostate volume, within 6 months of the Visit 1.
•Current (within 1 month) use of PDE-5 inhibotors for erectile dysfunction, anabolic steroids, drugs know to interact with tamsulosine (e.g. cimetidine, warfarin).
•Use of phytotherapy for BPH within 2 weeks prior to Visit 1.
•Previous prostate surgery.
•Instrumentation of the urethra within 7 days prior to Visit 1 (screening). Catheterisation (<10F) is acceptable with no time restriction.
•History of AUR.
•Post-void residual volume >100 mL

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