A Multicenter, Randomized, Parallel-Group, Controlled Trial of the Utility of Preoperative Administration of Relugolix in Laparoscopic myomectomy - MyLacRstudy

Kitade Mari0 个研究点目标入组 80 人开始时间: 2022年1月19日最近更新: 2024年5月27日

适应症

试验速览

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•1)Patients with a diagnosis of uterine fibroids
•2)Patients scheduled for laparoscopic myomectomy
•3)Patients with =<5 uterine fibroids >=2 cm in greatest dimension
•4)Patients with a maximum uterine fibroid diameter of 4 cm or more and 12 cm or less
•5)Premenopausal women
•6)Patients aged 20 years or older at the time of informed consent
•7)Patients who have the ability to give informed consent and are able to obtain written informed consent based on their own free will

•1)Patients with previous pelvic surgery
•2)Patients with ovarian cyst or endometriosis on diagnostic imaging
•3)Patients with concomitant uterine adenomyosis
•4)Patients taking sex hormones within 4 weeks prior to obtaining consent
•5)Patients using sustained-release GnRH agonist formulations within 19 weeks prior to obtaining informed consent, patients using other GnRH analog formulations within 15 weeks prior to obtaining informed consent.
•6)Patients with contraindications to laparoscopic surgery
•7)Patients with malignancies
•8)Patients with coagulation abnormalities
•9)Patients taking anticoagulants
•10)Pregnant or possibly pregnant patients and breastfeeding patients
•11)Patients with undiagnosed abnormal genital bleeding
•12) Patients with a history of hypersensitivity to Relugolix or ingredients of leuprorelin acetate, synthetic LH-RH, LH-RH derivatives of leuprorelin acetate
•13)Patients for whom the principal investigator or the sub investigator judges it unsuitable for the case in this study

发起方

Kitade Mari