Single arm study to evaluate the efficacy and safety of Relugolix in women with symptomatic adenomyosis

Hirota Yasushi0 个研究点目标入组 20 人开始时间: 2023年3月3日最近更新: 2023年10月17日

试验速览

暂无简介。

•1. Those who have menstruation
•2. Those diagnosed with adenomyosis by MRI
•3. Those with menstrual symptoms (excessive menstruation or pelvic pain)
•4. Women over 18 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 any of the ingredients of relugolix.
•7. Those who have used relugolix during the 12 weeks prior to the consent date
•8. Those who have used GnRH analogues during the 12 weeks prior to the consent date
•9. If taking sex hormones, those who cannot agree to discontinue oral administration by the day before the start of oral administration of the study medication
•10. Those who are unable to interrupt the use of erythromycin and rifampicin during the study treatment period
•11. Those with type 1 diabetes or type 2 diabetes with inadequate glycemic control
•12. Those who cannot agree to use non-hormonal contraception while using relugolix
•13. Those who are judged inappropriate for participation in this study by the principal investigator or co-investigator

发起方

Hirota Yasushi