NCT02658448已完成2 期
GTx-024 as a Treatment for Stress Urinary Incontinence in Women: A Proof of Concept Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- GTx
- 入组人数
- 19
- 试验地点
- 3
- 主要终点
- The Mean Percent Change in Number of Stress Incontinence Episodes/Day as Assessed by Patient Completion of the 3 Day Voiding Diary
研究概览
简要总结
The purpose of this study is to determine whether GTx-024 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Give voluntary, written and signed, informed consent
- •Age18 to 80 years old be clinically confirmed as postmenopausal. Subjects must have undergone the onset of spontaneous, medically induced or surgical menopause prior to the start of this study. Spontaneous menopause is defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy
- •SUI symptoms for at least 6 months duration
- •Predominant SUI (MESA questionnaire)
- •24 hour pad weight >3 gms at baseline
- •A minimum of 1 SUI episode per day, in the 3 day diary
- •3-15 SUI episodes per day, averaged over 3 days, in the 3 day diary
- •Serum AST and ALT within normal limits
- •Total bilirubin within normal limits
- •Positive Bladder Stress Test during screening
- •Subject agrees to not start any new treatment (medication or otherwise) that is known to affect lower urinary tract function throughout the treatment and follow up periods
- •Subject agrees to maintain on a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, or alpha-adrenergic blockers, throughout the treatment and follow-up period
排除标准
- •Pelvic floor physical therapy in a clinical setting within 30 days prior to screening
- •History of pelvic radiation treatment
- •History of urethral diverticula
- •History of urethral sling, anterior prolapse repair, ureteral bulking agents and/or other SUI procedure or surgery
- •Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant urological findings, including pelvic floor abnormalities which, in the judgement of the investigator, could impact treatment
- •Urinary incontinence of neurogenic etilogy
- •Patient is morbidly obese (defined as 100 pounds over their ideal body weight, or body mass index 40 or greater)
- •Chronic hepatitis
- •Hepatic cirrhosis
- •HIV and/or hepatitis A, B, or C
- •Subjects taking systemic hormone products
- •Subjects with a history of breast or endometrial cancer
- •Myocardial infarction or arterial thromboembolic events within 6 months prior to Baseline, severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA, uncontrolled hypertension (systolic > 150 and/or diastolic > 100 mm Hg)
- •Subjects with an entry measurement of > 5 mm endometrial stripe thickness
- •Clinically confirmed urinary tract infection
- •Any other condition which per investigators' judgment may increase subject risk
研究组 & 干预措施
GTx-024 3 mg
Experimental
GTx-024 softgel capsules will be administered once daily to a total dose of 3 mg for up to 12 weeks.
干预措施: GTx-024 (Drug)
结局指标
主要结局
The Mean Percent Change in Number of Stress Incontinence Episodes/Day as Assessed by Patient Completion of the 3 Day Voiding Diary
时间窗: 12 weeks
To describe the effect of 12 weeks of treatment of GTx-024 on the number of stress incontinence episodes/day as assessed by patient completion of the 3 day voiding diary
次要结局
- Stress Urinary Incontinence as Assessed by 24 Hour Pad Weight Test. Mean Percent Change in Pad Weight(12 weeks)
研究者
研究点 (3)
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