Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: an Open-Labeled Safety and Efficacy Assessment Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 528
- 试验地点
- 69
- 主要终点
- IPSS Change From Baseline
研究概览
简要总结
Benign Prostatic Hyperplasia (BPH) is the most common hyperplastic disease occuring in human males over the age of 50 which increases in prevalence with age and 40% of males reported moderate or severe urinary symptoms of prostatism by the age of 50 to 80. The purpose of this study is to collect safety and efficacy data for this dosage regimen of cetrorelix pamoate.
For this study, study medication (Cetrorelix pamoate) is administered by injection in the buttocks (Intramuscular).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Benign Prostatic Hyperplasia, based on medical history
- •Voiding symptoms
- •Uroflow (max) 5-15mL/sec
排除标准
- •Urgent need for prostate surgery
- •History of allergic reaction to peptide
- •Major organ dysfunction
- •Prior surgical treatment of the prostate or bladder
- •Current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior to trial medication at Week 0 or with α blockers or saw palmetto within the last 6 weeks prior to trial medication at Week 0
- •Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy
- •History of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months
研究组 & 干预措施
Cetrorelix 78 mg
Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
干预措施: Cetrorelix Pamoate (Drug)
结局指标
主要结局
IPSS Change From Baseline
时间窗: Baseline and Week 26
International Prostate Symptom Score (IPSS) Patient Questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 - 35 points; absolute change from baseline to Week 26
次要结局
未报告次要终点