Uterine fibroids
Conditions
Interventions
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.
Leuproreli
Sponsors
Kitade Mari
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Patients with a diagnosis of uterine fibroids 2)Patients scheduled for laparoscopic myomectomy 3)Patients with ==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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative blood loss | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactKeisuke Murakami
Juntendo University Hospital
Outcome results
None listed