Phase 2 Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- GTx
- 试验地点
- 46
- 主要终点
- Durability of Response, stress incontinence
研究概览
简要总结
The study will enroll only from the first 225 subjects who were randomly assigned to treatment in G201002 (irrespective of the treatment allocation, i.e., GTx-024 or placebo) and who have completed the 12-week treatment period and 16-week durability period to assess the long-term durability of response to GTx-024 on SUI symptoms. The extension study will follow subjects for an additional 20 weeks to help better assess the durability of response in these subjects and will provide additional efficacy and safety data for the subjects. Subjects will not be provided with any study treatments and will be off-drug during this extension study.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be one of the first 225 subjects who were randomly assigned to treatment in G201002 (Phase 2 study) and have completed the 12-week treatment and 16-week durability periods
- •Be able to read, understand, and provide written, dated informed consent prior to enrollment in the current study (within 2 weeks of completing G201002) and be likely to comply with the study protocol and communicate with study personnel about AEs and other clinically important information
- •Agree to maintain a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, beta-3 adrenergic agonists, or α-adrenergic blockers, throughout the duration of the study
排除标准
- •Starts any new treatment (medication, pelvic floor physical therapy, or other treatment known to impact the pelvic floor) after completing G201002 that is known or suspected to affect lower urinary tract function, including vaginal rejuvenation
- •Has a current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with interpretation of study results
研究组 & 干预措施
Matching Placebo
Subjects previously enrolled in the placebo arm of study G201002.
干预措施: Matching Placebo (Drug)
1 mg GTx-024
Subjects previously enrolled in the 1 mg GTx-024 arm of study G201002.
干预措施: GTx-024 (Drug)
3 mg GTx-024
Subjects previously enrolled in the 3 mg GTx-024 arm of study G201002.
干预措施: GTx-024 (Drug)
结局指标
主要结局
Durability of Response, stress incontinence
时间窗: baseline to 20 weeks
Change from G201002 baseline in the mean number of stress incontinence episodes per day
Durability of Response, patient global impression of severity
时间窗: baseline to 20 weeks
Change from G201002 baseline in patient global impression of severity scale (PGI-S; scale: 1-normal, 2-mild, 3-moderate, 4-severe; representing severity of urinary tract dysfunction)
Durability of Response, patient global impression of improvement
时间窗: baseline to 20 weeks
Change from G201002 baseline in patient global impression of improvement scale (PGI-I; scale: 1-very much better, 2-much better, 3-a little better, 4-no change, 5-a little worse, 6-much worse, 7-very much worse; representing change in urinary tract dysfunction from initiation of therapy)
次要结局
- Durability of Response, total incontinence(baseline to 20 weeks)
- Durability of Response, urge incontinence(baseline to 20 weeks)