A Phase II, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Proof of Concept Study With an Interim Futility Analysis of Epelsiban in Patients With Adenomyosis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mean percent change from baseline in monthly menstrual blood loss (MBL) to menstrual Cycle 3
研究概览
简要总结
The primary objective of the study is to assess the efficacy, safety, and tolerability of epelsiban compared with placebo in treatment of women with adenomyosis.
This is a 12-week, randomized, double-blind, placebo-controlled, parallel group study with an interim futility analysis. Subjects will be randomized 1:1:1 to receive 75 milligrams (mg) of epelsiban three times daily (TID), 200 mg of epelsiban TID, or placebo TID. The study will be composed of three periods: screening, treatment, and follow-up and the total time a subject will be in the study will be approximately 6 months.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eighteen to 55 years of age, inclusive
- •Pre-menopausal with a history of regular menstrual cycles every 21-35 days and without intermenstrual bleeding heavier than spotting and staining.
- •Females with adenomyosis confirmed on magnetic resonance imaging (MRI), - Females with heavy menstrual bleeding .
- •Willing and able to collect all menstrual cycle by-products for each cycle from screening to follow up.
- •Not pregnant as confirmed by a negative serum human chorionic gonadotropin
排除标准
- •A female subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •Abnormal gynecological examination other than adenomyosis and/or breast examination requiring intervention within six months of study start
- •Abnormal endometrial biopsy within six months of starting study treatment.
- •History of an endometrial ablation within 12 months of starting study treatment.
- •Uterine artery embolization within six months of starting study treatment.
- •Prior major uterine procedures or any other significant uterine abnormalities on MRI (previous caesarean section, dilation and curettage, and diagnostic hysteroscopy are permitted).
- •Confirmed rectovaginal endometriosis in women who have undergone a prior laparoscopy.
- •Active pelvic infection or current use of an intrauterine device within three months of screening.
- •Women with a history of transfusion for heavy menstrual bleeding within the past 2 years or history of postpartum hemorrhage.
- •Any uterine dimension >20 centimeter (cm).
- •Other major causes of heavy menstrual bleeding -
- •Use within 3 months or anticipated use of medications that modify reproductive function
- •Use or anticipated use of the following drugs: anticoagulants aminocaproic acid ,or any other medications that affect menstrual bleeding such as tranexamic acid.
- •Use of daily opioid pain medications other than with menses.
- •Hemoglobin <8 grams (g)/deciliter.
- •History of bleeding disorder or known presence of acquired or inherited thrombophilia, (sickle cell trait individuals are not excluded).
研究组 & 干预措施
Epelsiban 75 mg
Approximately 24 subjects will receive 75 mg of epelsiban three times a day (TID) via oral administration
干预措施: Epelsiban (Drug)
Epelsiban 200 mg
Approximately 24 subjects will receive 200 mg of epelsiban TID via oral administration
干预措施: Epelsiban (Drug)
Placebo
Approximately 24 subjects will receive a matching placebo TID via oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Mean percent change from baseline in monthly menstrual blood loss (MBL) to menstrual Cycle 3
时间窗: Baseline and end of menses Cycle 3 (approximately 12 weeks)
MBL will be measured from blood collected from menstrual cycle by-products and recovered by alkaline hematin method during each menstrual cycle
Number of subjects with adverse events (AE)
时间窗: Up to 3 months
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; safety and tolerability as assessed by incidence of adverse events
次要结局
- Average daily dysmenorrhea score from Day -1 to Day 2 in each cycle(Up to 3 months)
- Change from baseline in monthly menstrual blood loss (MBL) at menstrual Cycle 1, 2, and 3(Baseline, and end of menses Cycle 1, 2, and 3 (approximately 12 weeks))