MyLacRstudy

JRCT ID: jRCTs031210564

Registered date:19/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Uterine fibroids
• Date of first enrollment: 28/07/2022
• Target sample size: 80
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Intraoperative blood loss

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

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

Exclude 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

Related Information

• Primary Sponsor: Kitade Mari
• Source(s) of Monetary Support: ASKA Pharmaceutical Co., Ltd.
• Secondary ID(s): Nil known