Single arm study of the therapeutic efficacy and side effects of a half dose (every other day) of 40 mg of Relugolix in endometriosis or uterine fibroids

Izumi Gentaro0 个研究点目标入组 30 人开始时间: 2023年3月16日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Those who have menstruation
•2. Those diagnosed with endometriosis or uterine fibroids
•3. Those with symptoms associated with menstruation (dysmenorrhea, pelvic pain, or excessive menstruation) that are considered indications for the use of GnRH agonist preparations
•4. Women 18 years and older and under 48 years of age at the time consent is obtained
•5. Those who have received a full explanation of the study and have given written consent of their own free will based on a full understanding of the study
•6. Those who can make outpatient visits in accordance with the research implementation schedule

•1. Postmenopausal women
•2. Pregnant women or those who may be pregnant
•3. Those who are breastfeeding
•4. Those with submucosal myoma
•5. Those with undiagnosed abnormal genital bleeding (in the presence of possible malignant disease)
•6. Those with a history of hypersensitivity to the ingredients of Lergolix
•7. Those using GnRH analogs during the 3 months immediately prior to the start of the study medication
•8. Those Patients using sex hormone-based pharmacotherapy for endometriosis or uterine fibroids other than levonorgestrel-releasing intrauterine system (Mirena) during the month immediately preceding the start of the study drug
•9. Those unable to cooperate with non-hormonal contraception during the treatment period
•10. Those deemed by the principal investigator or subinvestigator to be inappropriate to participate in this study

发起方

Izumi Gentaro