A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center, Exploratory Dose-response Study to Assess the Efficacy and Safety of Different Oral Doses of BAY1128688 in Women With Symptomatic Endometriosis Over a 12-week Treatment Period
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 121
- 试验地点
- 67
- 主要终点
- Absolute change in mean pain of the 7 days with worst EAPP comparing the 28-day baseline cycle (baseline period of daily pain recordings) to the 28-day end of treatment cycle (daily pain recordings during the last 28 days of the treatment period)
研究概览
简要总结
Purpose of the study is to test whether study drug BAY1128688 brings relief for pain to women with endometriosis and if so to get a first impression which dose(s) work best.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of at least 18 years of age at the time of signing of informed consent
- •Women with endometriosis confirmed by at least one of the two criteria:
- •surgery within the last 10 years
- •imaging within the last 12 months
- •moderate to severe pelvic pain which will be assessed over a period of 28 days
- •Willingness to use only ibuprofen as rescue pain medication for endometriosis-associated pelvic pain
- •Willingness to use non-hormonal barrier method for contraception (here spermicide-coated condoms) from screening visit until the end of the study (unless adequate contraception is achieved by vasectomy of the partner or use of copper intrauterine device [IUD] or commitment to abstinence) and refrain from using hormonal contraception
排除标准
- •Pregnancy or lactation (more than three months since delivery, abortion, or lactation before start of treatment) AND no wish for pregnancy during the study
- •Altered bilirubin metabolism and liver function at Visit 1
- •Requirement to use pain medications for reasons other than endometriosis
- •Contraindications to using ibuprofen
- •Signs of hyperandrogenism
- •Absence of menstrual cycles and/or abnormal vaginal/genital bleeding
- •History of hysterectomy, tubal-ligation or bilateral ovariectomy
- •Uncontrolled thyroid disorder
研究组 & 干预措施
BAY1128688 (dose 5)
One BAY1128688 tablet (highest dose) in the morning and one in the evening
干预措施: BAY1128688 (Drug)
Placebo
One placebo tablet in the morning and one in the evening
干预措施: Placebo (Drug)
BAY1128688 (dose 3)
One BAY1128688 tablet (second intermediate dose) in the morning, one placebo tablet in the evening
干预措施: Placebo (Drug)
BAY1128688 (dose 4)
One BAY1128688 tablet (second intermediate dose) in the morning and one in the evening
干预措施: BAY1128688 (Drug)
BAY1128688 (dose 1)
One BAY1128688 tablet (lowest dose) in the morning, one placebo tablet in the evening
干预措施: BAY1128688 (Drug)
BAY1128688 (dose 1)
One BAY1128688 tablet (lowest dose) in the morning, one placebo tablet in the evening
干预措施: Placebo (Drug)
BAY1128688 (dose 2)
One BAY1128688 tablet (first intermediate dose) in the morning, one placebo tablet in the evening
干预措施: BAY1128688 (Drug)
BAY1128688 (dose 2)
One BAY1128688 tablet (first intermediate dose) in the morning, one placebo tablet in the evening
干预措施: Placebo (Drug)
BAY1128688 (dose 3)
One BAY1128688 tablet (second intermediate dose) in the morning, one placebo tablet in the evening
干预措施: BAY1128688 (Drug)
结局指标
主要结局
Absolute change in mean pain of the 7 days with worst EAPP comparing the 28-day baseline cycle (baseline period of daily pain recordings) to the 28-day end of treatment cycle (daily pain recordings during the last 28 days of the treatment period)
时间窗: 12 weeks
EAPP: endometriosis-associated pelvic pain, measured on the NRS (Numerical Rating Scale) by item 1 of the ESD (Endometriosis Symptom Diary)
次要结局
- Incidence of treatment-emergent adverse events(18 weeks)