NL-OMON38047已完成4 期
Study FDC114615: Comparative efficacy of DuodartTM plus lifestyle advice versus watchful waiting plus lifestyle advice with step-up therapy to tamsulosin in the management of treatment naïve men with moderately symptomatic benign prostatic hyperplasia and prostate enlargement. - CONDUCT
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Males aged *50 years with confirmed clinical diagnosis of BPH.
- •* International Prostate Symptom Score (IPSS) 8*19.
- •* Prostate volume *30 cc (TRUS).
- •* PSA *1.5 ng/mL.
- •* Men with a female partner of childbearing potential must agree to use effective contraception.
排除标准
- •* Total serum PSA >10.0 ng/mL.
- •* History or evidence of prostate cancer.
- •* Current or any prior use of the following prohibited medications
- •o a 5*-reductase inhibitor,
- •o anti-cholinergics,
- •o an alpha-adrenoreceptor blocker for BPH or LUTS.
- •* 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.
- •* 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 within 3 months prior to Visit 1.
- •* Post-void residual volume >250 mL
- •* History of postural hypotension, dizziness, vertigo or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin.
- •* History of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy.
研究者
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