Cetrorelix Pamoate Intermittent Intramuscular (IM) Dosage Regimens in Patients With Symptomatic BPH: a 1 Year Placebo-controlled Efficacy Study and Long-term Safety Assessment
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 667
- 试验地点
- 68
- 主要终点
- International Prostate Symptoms Score (IPSS)
研究概览
简要总结
Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve patients' quality of life which primarily depends on the severity of the symptoms of BPH. Current treatments of BPH have a benefit / risk ratio which leaves room for improvement.
For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to 52) are eligible to receive the active drug during the open-label part of the study (Week 52 to 90).
详细描述
The objectives of the study are to develop a safe and tolerable intermittent dosage regimen of cetrorelix pamoate that provides prolonged improvement in BPH-related signs and symptoms.
Patients will enter a 4-week run-in no-treatment observation period to confirm severity and stability of voiding symptoms based on the International Prostate Symptom Score (IPSS).
Patients will then be allocated to study drug in a double-blind, randomized, double-dummy, placebo-controlled fashion.
Patients will be administered an IM injection of study drug at Week 0, 2, 26 and 28 and will be followed up to Week 52.
Then, in an open label fashion, patients will be administered an IM injection of study drug at Week 52, 54, 78 and 80 and will be followed up to Week 90.
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
- •Benign Prostatic Hyperplasia, based on medical history
- •Voiding symptoms
排除标准
- •Urgent need for prostate surgery or prior surgical treatment of the prostate or bladder
- •Major organ dysfunction
- •Eczema (atopic dermatitis) treated during the last 6 months
- •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 randomization or with α blockers or saw palmetto within the last 6 weeks prior to randomization
- •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
Treatment Group A: CET 78 mg + 78 mg
Treatment course 1: Cetrorelix 78 mg + 78 mg
- Week 0: 52 mg CET (2 injections)
- Week 2: 26 mg CET (1 injection)
Treatment course 2:
- Week 26: 52 mg CET (2 injections)
- Week 28: 26 mg CET(1 injection)
4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.
干预措施: Cetrorelix 78 mg + 78 mg (Drug)
Treatment Group B: CET 78 mg + 52 mg
Treatment course 1: Cetrorelix 78 mg + 52 mg
- Week 0: 52 mg CET (2 injections)
- Week 2: 26 mg CET (1 injection)
Treatment course 2:
- Week 26: 52 mg CET (2 injections)
- Week 28: Placebo (1 injection)
4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.
干预措施: Cetrorelix 78 mg + 52 mg (Drug)
Treatment Group B: CET 78 mg + 52 mg
Treatment course 1: Cetrorelix 78 mg + 52 mg
- Week 0: 52 mg CET (2 injections)
- Week 2: 26 mg CET (1 injection)
Treatment course 2:
- Week 26: 52 mg CET (2 injections)
- Week 28: Placebo (1 injection)
4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.
干预措施: Placebo (Drug)
Treatment Group C: Placebo
Treatment course 1:
- Week 0: placebo (2 injections)
- Week 2: placebo (1 injection)
Treatment course 2:
- Week 26: placebo (2 injections)
- Week 28: placebo (1 injection)
4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.
干预措施: Placebo (Drug)
结局指标
主要结局
International Prostate Symptoms Score (IPSS)
时间窗: Baseline and 52 weeks
The International Prostate Symptoms Score (IPSS) score of benign prostata hyperplasia (BPH) symptoms is calculated based on a 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 points (best) to 35 points (worst)
次要结局
- Time Course of Quality of Life(Quality of life assessment in the following weeks: 4,12,26,30,38,46,52)