NL-OMON31439尚未招募2 期
A phase II, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Org 3236 tablets in men with Lower Urinary Tract Symptoms (LUTS) suggestive of Benign Prostatic Hyperplasia (BPH) - Efficacy- and safety trial in men with LUTS/BPH
Organon Nederland BV0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Men diagnosed with LUTS suggestive of BPH
- •- Age at least 50 but not older than 80 years at screening
- •- PSA < 10 ng/mL and exclusion of prostate cancer to the satisfaction of the investigator
排除标准
- •- A postvoid residual volume >250 mL
- •- Use of anti-androgens, androgens, Gonadotropin Releasing Hormone (GnRH) antagonists, or 5alfa-reducatase inhibitors within six months prior to start trial medication
- •- Presence of hypogonadism as judged by the investigator
- •- Acute urinary retention within the past 12 months
- •- History of surgery for BPH, including other minimally invasive procedures
- •- Presence of urinary tract infection
- •- Presence or history of (subclinical ) prostate cancer, bladder cancer, urethral stricture, or pelvic irradiation
- •- Presence or history of any neurological disease associated with primary bladder dysfunction.
研究者
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