A Multicenter, Randomized, Parallel-Group, Controlled Trial of the Utility of Preoperative Administration of Relugolix in Laparoscopic myomectomy (MyLacRstudy)
MyLacRstudy (MyLacRstudy)
Kitade Mari
Juntendo University Hospital
3-1-3 Hongo,Bunkyo-ku,Tokyo,113-8431,Japan
+81-3-3813-3111
kitade@juntendo.ac.jp
Murakami Keisuke
Juntendo University Hospital
3-1-3 Hongo,Bunkyo-ku,Tokyo,113-8431,Japan
+81-3-5802-1100
kmuraka@juntendo.ac.jp
Not Recruiting
Jan. 19, 2022
July. 28, 2022
80
Interventional
randomized controlled trial
open(masking not used)
active control
parallel assignment
treatment purpose
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
20age old over
No limit
Female
Uterine fibroids
Relugolix Tablet Group:
Relugolix 40 mg po once/day for 12 wk (up to the day before surgery) is given before meals. The first dose should be administered on days 1-5 of the menstrual cycle.
Leuprorelin acetate-treated group:
Leuprorelin acetate 1.88 mg is administered subcutaneously once every 4 weeks for a total of three doses. However, 3.75 mg is given to heavier patients and those with severe uterine enlargement. The first dose should be administered on days 1-5 of the menstrual cycle.
Intraoperative blood loss
1)Surgical outcomes
Operative time
Isolated myoma weight, Number of removed fibroids
Presence or absence of blood transfusion
Whether the procedure is changed
Volume of drain drainage
Postoperative hospital stay
2)Percent change from baseline in uterine fibroid size at completion of treatment
3)Percent change from baseline in uterine size
4)Change from baseline in hemoglobin
5)Change from baseline in menopausal-like symptoms
6)Change from baseline in disease-specific quality of life
