A 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 Hypertrophy (BPH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 13
- 主要终点
- Change From Baseline in International Prostate Symptom Score (IPSS)
研究概览
简要总结
This study is to compare the efficacy and safety of ozarelix 15 mg given intramuscular (IM) 2 weeks apart on the improvement of symptoms and the duration of improvement for up to 6 months in men with Benign Prostatic Hypertrophy (BPH) who are over 50 years of age.
详细描述
This study is to compare the improvement in symptom scores, peak flow rate and quality of life in men suffering from lower urinary tract symptoms (LUTS) secondary to Benign Prostatic Hypertrophy (BPH) following treatment with ozarelix. Ozarelix is compared to placebo and injections given 14 days apart. Patients are followed for 6 months and both safety and efficacy assessed at monthly visits. Additionally, the impact of treatment on erectile function, if any, as well as Prostate-Specific Antigen (PSA) and Testosterone levels will be monitored.
The screening period of 7 days. The duration of the study is 40 weeks, including a 28-day placebo run-in phase (eligible participants entered a placebo run-in phase in which placebo is administered twice over a 2 week period [Day -28 and Day -14] and participants are assessed to establish baseline values approximately 14 days following the second placebo injection), study drug is administered on Days 0 and 14 followed by 34 weeks of observation after the last dose of study drug.
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
- •All of the following questions must be answered "Yes" at Visit 1 in order for the participant to participate in the study.
- •Is the participant at least 50 years old?
- •Does the participant have clinical signs and symptoms consistent with BPH?
- •Does the participant have an IPSS 13 at screening (prior to placebo run in)?
- •Does the participant have a peak urinary flow rate (Qmax) of 4-15 milliliter/second (mL/sec) established on a voided volume of at least 125 mL?
- •Is the participant willing to agree not to use any other approved or experimental pharmacologic BPH treatments including alpha blockers, 5-alpha reductase inhibitors, anti-cholinergic preparations or herbal preparations at any time during the study?
排除标准
- •All of the following questions must be answered "No" at Visit 1 in order for the participant to participate in the study.
- •Does the participant have a history of prostate cancer or a serum PSA >10 nanograms per milliliter (ng/mL)?
- •Has the participant had prior prostate or bladder surgery, pelvic surgery (excluding hernia repair), pelvic radiation or lower urinary tract malignancy?
- •Does the participant have a prevoid total bladder volume assessed by ultrasound > 550 mL?
- •Does the participant have a residual urine volume > 350 mL by ultrasound?
研究组 & 干预措施
Ozarelix
All participants completing the placebo run in period were randomized to enter the treatment phase of the study and received ozarelix on Day 0 and Day 14.
干预措施: Ozarelix (Drug)
Placebo
All participants completing the placebo run in period were randomized to enter the treatment phase of the study and received placebo Day 0 and Day 14.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in International Prostate Symptom Score (IPSS)
时间窗: 12 weeks
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
- International Prostate Symptom Score - Quality of Life (IPSS-QOL)(36 weeks)
- Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ)(36 weeks)
- International Index of Erectile Function-15 (IIEF-15)(36 weeks)
- Maximum Urinary Flow Rate (Qmax)(36 weeks)
- BPH Impact Index (BPHII)(36 weeks)
- Number of Participants With Adverse Events(36 weeks)