Randomized Crossover Trial to Assess the Tolerability of GnRH Analogue Administration in Patients With Advanced Prostate Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Patient Bother From Injection Site Burning and/or Stinging
研究概览
简要总结
The purpose of this study is to compare how subjects feel after receiving injections of two different types of GnRH six months apart. One injection is given under the skin of the abdomen, and the other one into the muscle of the buttock or thigh.
详细描述
GnRH is given as an injection. Injections of GnRH can be uncomfortable, causing a feeling of burning or stinging. The uncomfortable feeling may be caused by differences in the types of GnRH and the site of the injection (under the skin of the abdomen, or into the muscle of the buttock or thigh).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients with a diagnosis of advanced prostate cancer for whom treatment with triptorelin pamoate or leuprolide acetate is indicated;
- •At least 18 years of age;
- •Life expectancy of at least 1 year;
- •Capable of completing the study questionnaires without assistance.
排除标准
- •Patients for whom treatment with triptorelin pamoate or leuprolide acetate is contraindicated;
- •Known hypersensitivity to triptorelin, leuprolide or any other GnRH or luteinizing hormone releasing hormone (LHRH) agonists, or GnRH or LHRH;
- •Clinically significant systemic disease or condition that would, in the investigator's opinion, lead to undue risk following administration of either triptorelin or leuprolide;
- •History of alcohol/drug abuse within the past year;
- •History of significant medical problems that may confound the outcome of this study;
- •Requires concomitant medications that may affect study assessments (e.g., topical medications used for pretreatment of injection site pain);
- •Participated in another investigational drug study within 30 days
- •Judged by the investigator to be unsuitable for enrollment in this study for any reason
研究组 & 干预措施
Leuprolide acetate
Polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) injected subcutaneously in upper or mid-abdominal area. Injection occurred either 6 months before or 6 months after injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock.
干预措施: Leuprolide acetate (Drug)
Triptorelin pamoate
Triptorelin pamoate suspension (Trelstar 22.5 mg) injected intramuscularly in the buttock. Injection occurred either 6 months before or 6 months after injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) subcutaneously in upper or mid-abdominal area.
干预措施: Triptorelin pamoate (Drug)
结局指标
主要结局
Patient Bother From Injection Site Burning and/or Stinging
时间窗: 15 minutes
Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection
次要结局
- Discomfort From Injection(15 minutes)