NCT03840993已完成2 期
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of MT-2990 in Women With Endometriosis Experiencing Endometrial Related Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 50
- 主要终点
- Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe)
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of MT-2990 for treatment of moderate to severe endometriosis-related pain in women with surgically diagnosed endometriosis.
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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent to participate in this study
- •Agree to approximately 30-90 day washout interval of hormonal therapies, if applicable
- •Have a history of regular menstrual cycles
- •Have a body mass index < 45 kg/m^2 (inclusive)
- •Have documented surgical/laparoscopy diagnosis of endometriosis with 10 years
- •Agree to use 2 forms of nonhormonal contraception throughout the study
- •In the Investigator's opinion, subject is able to understand the nature of the study and any risk involved in participation, and is willing to cooperate and comply with the protocol restrictions and requirements including transvaginal ultrasound.
- •Have moderate to severe endometrial related pain
排除标准
- •Subject is pregnant, breast feeding, or planning a pregnancy.
- •Subject is < 6 months postpartum, postabortion, or post-pregnancy.
- •Willing to remove a hormonal intrauterine device (IUD) at least 30 days prior to screening. (Non hormonal IUDs do not have to be removed)
- •Aspartate aminotransferase (AST), alanine aminotransferase (ALT) , or total bilirubin ≥ 2.0 × upper limit of normal (ULN) above the reference range
- •Have immunosuppression due to underlying medical condition
- •Corrected QT interval using Fridericia's formula (QTcF) or Corrected QT interval using Bazett's formula (QTcB) ≥ 450 msec or clinically important abnormal findings on the ECG
- •Subject is not up-to-date on breast screening according to current guidelines.
- •Has a surgical history of hysterectomy, bilateral oophorectomy and any other recent major surgery
- •Subject is required more than 2 weeks of continuous use of prohibited long-acting narcotic or immediate release narcotic for treatment of endometriosis-associated pain.
- •Have chronic pelvic pain for nonendometriosis related causes, which require systemic pharmaceutical chronic therapy for pain
- •Have other chronic pain syndrome which require chronic analgesic or other chronic therapy
- •Have a clinically significant gynecologic condition identified on the transvaginal ultrasound (TVU) (e.g., complex ovarian cyst > 3 cm or simple ovarian cyst > 5 cm, clinically significant endometrial pathology, single fibroid ≥ 4 cm or multiple (> 4) fibroids that measure ≥ 2 cm or symptomatic submucosal fibroid of any size
- •Have a current history of undiagnosed abnormal genital bleeding
研究组 & 干预措施
MT-2990
Experimental
MT-2990, over 16 weeks
干预措施: MT-2990 (Drug)
Placebo
Placebo Comparator
Placebo, over 16 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe)
时间窗: Baseline to Week 16
次要结局
- Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From None (0) to 3 (Severe)(Baseline to Week 16)
- Time to Use of Rescue Medication (Analgesic)(Baseline to Week 16)
- Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)(Baseline to Week 16)
- Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)(Baseline to Week 16)
- Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)(Baseline to Week 16)
- Mean Change From Baseline to Week 16 in Non-Menstrual Pelvic Pain (NMPP) Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain)(Baseline to Week 16)
- Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain)(Baseline to Week 16)
- Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranges From 0 (None) to 3 (Severe)(Baseline to Week 16)
- Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranging From 0 (no Pain) to 10 (Worst Pain)(Baseline to Week 16)
- Mean Change From Baseline Through Week 16 in the Number of Any Analgesic Pills Used(Baseline to Week 16)
- Mean Change From Baseline Through Week 16 in the Number of Opioid Pills Used(Baseline to Week 16)
- Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)(Baseline to Week 16)
- Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)(Baseline to Week 16)
- Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (None) to 3 (Severe)(Baseline to Week 16)
- Mean Percentage Change From Baseline Through Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)(Baseline to Week 16)
- Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)(Baseline to Week 16)
- Mean Percentage Change From Baseline Through Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)(Baseline to Week 16)
- Number of Responders Using Endometriosis Specific 7-point Scale(Baseline to Week 16)
- Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Emotional Well-Being Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)(From Baseline to Weeks 4, 8, 12, and 16)
- Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Social Support Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)(From Baseline to Weeks 4, 8, 12, and 16)
- Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Self-Image Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)(From Baseline to Weeks 4, 8, 12, and 16)
- Percentage of Responders Using Global 7-point Scale(Baseline to Week 16)
- Mean Change From Baseline to Weeks 4, 8, 12 and 16 on the Pain Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)(From Baseline to Weeks 4, 8, 12, and 16)
- Percentage of Responders Using Endometriosis Specific 7-point Scale(Baseline to Week 16)
- Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)(Baseline to Week 16)
- Number of Responders Using Global 7-point Scale(Baseline to Week 16)
- Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)(Baseline to Week 16)
- Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Control and Powerlessness Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)(From Baseline to Weeks 4, 8, 12, and 16)
- Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)(Baseline to Week 16)
研究者
研究点 (50)
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