A Multicenter, Parallel-Group Extension Study to Evaluate the Safety of Two Doses of DR-3001 in Women With Overactive Bladder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Safety, by investigating post void residual volume, physical exams, vital signs, and clinical laboratory values. The outcome of any pregnancy will be followed and reported
研究概览
简要总结
This is a safety extension study of DR-OXY-301 at pre-selected sites. Subjects who complete the DR-OXY-301 study are eligible to participate. The duration of this extension study will be up to approximately 42 weeks. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit and colposcopic examination of the vagina and cervix. As in DR-OXY-301, subjects will be required to insert a vaginal ring; replacing it every 4 weeks. Subjects will also be required to keep a daily record of the number of times and the total amount of time the ring was outside the body each day and the reason for voluntary removal.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Completed the 12 weeks of treatment in the DR-OXY-301 study
- •Willing to limit medications for overactive bladder to investigational product only
- •Able to understand and complete all study procedures including the required diary
排除标准
- 未提供
研究组 & 干预措施
Oxybutinyn Vaginal Ring 4mg
inserted daily and replaced every 4 weeks
干预措施: Oxybutinyn Vaginal Ring 4mg (Drug)
Oxybutinyn Vaginal Ring 6mg
inserted daily and replaced every 4 weeks
干预措施: Oxybutinyn Vaginal Ring 6mg (Drug)
结局指标
主要结局
Safety, by investigating post void residual volume, physical exams, vital signs, and clinical laboratory values. The outcome of any pregnancy will be followed and reported
时间窗: Duration of Study
次要结局
未报告次要终点