The clinical trial of alternative Relugolix administration for uterine myoma prior to surgical treatment: a study protocol for Non-Adverse Relugolix Administration study (NARA study)

未提供0 个研究点目标入组 140 人开始时间: 2023年10月25日最近更新: 2025年1月8日

适应症

试验速览

暂无简介。

•Diagnosed with uterine leiomyoma
•Scheduled for or considering abdominal or laparoscopic hysterectomy or myomectomy
•Pre-menopausal female
•Age at the time of consent is between 20 and 51 years old (under 51).
•The patient has the capacity to consent and is able to give written consent of her own will.
•ECOG-PS1 or lower (within 1).
•(ECOG-PS1 means that the patient is limited in strenuous activities, but can walk and perform light or sedentary work.)

•Complicated uterine adenomyosis
•Use of GnRH products within 4 weeks prior to obtaining consent
•Use of sex hormones other than those listed above at the time consent was obtained
•Previous treatment with uterine artery embolization or focused ultrasound therapy
•Diagnosed with a malignant tumor
•Diagnosed with a disease with abnormal blood coagulation
•Undertreatment of an anticoagulant
•Pregnant or susceptible to pregnancy, or in lactation
•Abnormal genital bleeding without a diagnosis
•Allergy history to relugolix or synthetic luteinizing hormone-releasing hormone (LH-RH) or LH-RH derivatives
•Continuously taking erythromycin or rifampicin
•Patients who are deemed unsuitable for this study by the principal investigator or collaborator

change rate of leiomyoma volume

The change rate of leiomyoma volume before and after the administration of Relugolix

Change in uterine volume(24 weeks post-treatment)
Change in total Kupperman Index score(24 weeks post-treatment)
Change in bone mineral density (BMD)(24 weeks post-treatment)
Change in bone metabolism markers (BAP)(24 weeks after study drug administration)

发起方

未提供