A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Ozarelix, in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change From Baseline International Prostate Symptom Score (IPSS) Score at Week 14
研究概览
简要总结
This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy of ozarelix compared to placebo in the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) in men as assessed by the International Prostate Symptom Score (IPSS) at Week 14.
详细描述
This is a multi-center, randomized, double-blind, placebo-controlled study.
Participants who meet the entry IPSS inclusion criteria at Week 0 will be randomized and enroll in the double-blind treatment period. Participants will be randomized to one of three treatment arms and will receive two 6-month courses of study drug administered on Days 0 and 14 of each 6-month course. Treatment arms include: ozarelix 30mg + 15mg, ozarelix 15mg + 15mg or placebo + placebo. Safety and efficacy assessments will be performed at defined intervals throughout the study. At Week 52 all participants on study will be eligible to receive ozarelix for two additional courses in the open-label treatment period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo + Placebo
Participants will receive Placebo + Placebo on Days 0 and 14 of each 6-month course.
干预措施: Placebo (Drug)
15 mg Ozarelix + 15 mg Ozarelix
Participants will receive 15 mg Ozarelix + 15 mg Ozarelix on Days 0 and 14 of each 6-month course.
干预措施: ozarelix (Drug)
30 mg Ozarelix + 15 mg Ozarelix
Participants will receive 30 mg Ozarelix + 15 mg Ozarelix on Days 0 and 14 of each 6-month course.
干预措施: ozarelix (Drug)
结局指标
主要结局
Change From Baseline International Prostate Symptom Score (IPSS) Score at Week 14
时间窗: Week 14
IPSS is a validated self-administered index for grading benign prostatic hyperplasia (BPH)-related signs and symptoms. It consists of a set of seven questions. A total score of 1-7 indicates mild disease, 8-19 moderate disease and 20-35 severe disease.
次要结局
- Change From Baseline IPSS (Including Sub-scores) at Week 52(Week 52)
- Change From Baseline Benign Prostatic Hyperplasia Impact Index (BPHII) Score at Week 14 and Week 52(Weeks 14 and 52)
- Change From Baseline International Index of Erectile Function-15 (IIEF-EF) Score at Week 14 and Week 52(Week 14 and Week 52)
- Change From Baseline International Prostate Symptom Score - Quality of Life (IPSS-QOL) at Week 14 and Week 52(Week 14 and Week 52)
- Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ) Response at Week 52(Week 52)
- Change From Baseline Maximum Urine Flow (Qmax) at Week 14 and Week 52(Week 14 and Week 52)
- Number of Participants With Treatment-Emergent Adverse Events(Up to 104 weeks)