NCT07270432尚未招募3 期
Randomized Clinical Trial to Evaluate the Safety and Efficacy of Product DNN.65.21.005 in Alleviating Lower Urinary Tract Symptoms in Patients With Benign Prostatic Hyperplasia
Ache Laboratorios Farmaceuticos S.A.0 个研究点目标入组 218 人开始时间: 2026年1月1日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 218
- 主要终点
- Change in International Prostate Symptom Score (IPSS)
研究概览
简要总结
To evaluate the safety and efficacy of DNN.65.21.005 versus Combodart® in the treatment of benign prostatic hyperplasia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male participants aged 50 years and older.
- •Ability to understand the study and provide informed consent, documented by signing the Informed Consent Form (ICF).
- •Participants presenting lower urinary tract symptoms (LUTS) associated with prostate enlargement, without neurological or infectious causes.
排除标准
- •History or evidence of prostate cancer.
- •Urinary retention ≥100 mL, as assessed by abdominal prostate ultrasound.
- •Previous diagnosis of Parkinson's disease or other neurological disorders that may lead to neurogenic bladder.
- •Use of herbal treatments for prostate enlargement within 14 days prior to the screening visit.
- •Current use or use of alpha-blocker medications within 7 days prior to the start of study treatment.
- •Current use or use of 5-alpha reductase inhibitors (5ARIs) within 180 days prior to the start of study treatment.
- •Use of any prohibited medications within the timeframe specified in the study protocol.
- •Any clinical findings or observations (clinical or physical evaluation) that, in the investigator's judgment, pose a risk to participation in the study.
研究组 & 干预措施
Combodart®
Active Comparator
干预措施: Combodart® (Drug)
Product DNN.65.21.005
Experimental
干预措施: Product DNN.65.21.005 (Drug)
结局指标
主要结局
Change in International Prostate Symptom Score (IPSS)
时间窗: 180 days
Change in International Prostate Symptom Score (IPSS) evaluated 180 days after starting treatment compared to the baseline
次要结局
未报告次要终点
研究者
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