Open-Label, 40-weeks Extension of Protocol MCS-2-TWN-a to Further Evaluate the Efficacy and Safety of MCS-2 for the Treatment of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naïve Male Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
This is an open-label extension study of another study protocol, MCS-2-TWN-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for this study.
详细描述
This open-label extension study is designed to further assess the long-term safety and efficacy of MCS-2. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for another 40 weeks of MCS-2 treatment at the same daily dosage as the active treatment given under the protocol MCS-2-TWN-a. Subjects are limited to those who are currently not being treated medically for BPH or LUTS.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject has completed 12 weeks of treatment under the protocol MCS-2-TWN-a.
- •Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form for participation in this extension study.
排除标准
- •Subject has severe LUTS at the last visit under the protocol MCS-2-TWN-a.
- •Subject is considered ineligible for the study by the investigator(s).
研究组 & 干预措施
MCS-2
2 soft-gel capsules Qd for 40 weeks
干预措施: MCS-2 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: 40 weeks
次要结局
- Changes from baseline in International Prostate Symptom Scores (I-PSS)(40 weeks)