A Phase IIa, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of Orally Administered TU2670 in Subjects With Mod to Severe Endometriosis-Associated Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 80
- 主要终点
- overall pelvic pain
研究概览
简要总结
This Protocol for TU2670 is to investigate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of TU2670 in subjects with moderate to severe endometriosis-associated pain.
详细描述
Treatment Groups and Duration:
Following a washout period of up to 12 weeks, subjects will enter a screening period of up to 12 weeks including an observation period consisting of a complete menstrual cycle.
Subjects will be randomly assigned in a 1:1:1:1 ratio to receive either 12 weeks of TU2670 320 mg QD, TU2670 240 mg QD, TU2670 120 mg QD, or matching placebo. TU2670 or a matching placebo will be administered in the clinic on Day 1. Subjects in the PK subset population will also receive the following additional doses in the clinic: Day 2 (after collection of the 24-hour PK sample); the dose on the day scheduled for subsequent serial PK sample collection (Week 4 or Week 5); and the next scheduled dose (after collection of the 24-hour PK sample). All other doses can be taken by the subject at home. Following the end of treatment, subjects will be followed up for safety for 12 weeks.
Statistical Methods:
All formal statistical tests will be done at the 5% 2-sided significance level. Point estimates will have 2 sided 95% confidence intervals (CIs) where applicable.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Independent Ethics Committee (IEC)-approved written informed consent/assent and privacy language as per national regulations must be voluntarily obtained from the subject.
- •Premenopausal female subject, 18 to 45 years, inclusive
- •Subject has moderate to severe endometriosis-related pain
排除标准
- •Subject has used hormonal contraceptives or other drugs with effects on gynecological endocrinology within 12 weeks
- •Subject has been nonresponsive to GnRH-agonist or antagonist therapy for the management of endometriosis.
结局指标
主要结局
overall pelvic pain
时间窗: 12 weeks
Change from baseline to 12 weeks of treatment of the mean dysmenorrhea score (defined as mean overall pelvic pain score on menstrual bleeding days) as measured by the Numeric Rating Scale(minimum 0, maximum 10, higher score mean a worse outcome) over the past month.
次要结局
- rescue medication(12 weeks)
- Time to increase of dose of rescue medication(12 weeks)
- Patient Global Impression of Change(12 weeks)
- mean Numeric Rating Scale dyspareunia score(12 weeks)
- Modified Biberoglu and Behrman sign and symptom scores(12 weeks)
- mean overall pelvic pain Numeric Rating Scale pain score(12 weeks)
- Time to decrease of dose of rescue medication(12 weeks)
- Work Productivity and Activity Impairment Questionnaire: General Health(12 weeks)
- mean Numeric Rating Scale pain score(12 weeks)
- Endometriosis Health Profile-5(12 weeks)
- 36-Item Short Form Health Survey(12 weeks)