EUCTR2017-000244-18-CZ进行中（未招募）1 期
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 BAY 1128688 in women with symptomatic endometriosis over a 12-week treatment period - Akrendo 1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 121
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Women of at least 18 years of age at the time of signing of informed consent
- •- Diagnosis of endometriosis confirmed by at least one of the two criteria:
- •-- visually-confirmed (by surgery or clinical inspection) within the last 10 years
- •-- imaging-confirmed within the last 12 months
- •- Symptoms of moderate to severe pelvic pain which will be assessed over a period of 28 days
- •- Good general health
- •- 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pregnancy or lactation (less 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 and/or contraindications to using the study drug
- •- Signs of hyperandrogenism
- •- Absence of menstrual cycles and/or abnormal vaginal/genital bleeding
- •- History of hysterectomy, tubal-ligation or bilateral ovariectomy
- •- Any diseases, conditions or medications/treatments that might intefere with the conduct of the study or the interpretation of the results
研究者
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