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 - AKRENDO1

Bayer0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

Trial ended prematurely

•- 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 to refrain from using hormonal contraception.

•- 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

发起方