The effectiveness of relugolix compared with leuprorelin for preoperative therapy before laparoscopic myomectomy: a...

To evaluate the preoperative oral relugolix treatment of patients undergoing laparoscopic myomectomy and to test the noninferiority of preoperative treatment with relugolix vs. leuprorelin on intraoperative blood loss.

Multicenter, randomized, open-label, active-controlled, parallel group trial in Japan.

Premenopausal women ≥20 years old diagnosed with uterine fibroids.

Relugolix oral tablet was taken once daily for 12 weeks preoperatively by patients in the relugolix group (N = 32), and leuprorelin subcutaneous injection was administered at 1.88 mg or 3.75 mg, three times over 12 weeks to patients in the leuprorelin group (N = 35); the last injection was administered 4 weeks preoperatively.

The primary outcome was intraoperative blood loss, measured in mL. Other key perioperative outcome measures were operative time and the number and weight of fibroids. Key efficacy outcome measures were uterine volume reduction rate, uterine fibroid volume reduction rate, hemoglobin levels, and uterine fibroid symptom health-related quality of life score. Other key measures were menstrual-like bleeding episodes, endocrine clinical laboratory values, and bone mineral density assessments.

Intraoperative blood loss was 72.7 ± 74.4 mL (95% confidence interval [CI], 45.9-99.5) in the relugolix group and 84.4 ± 87.5 mL (95% CI, 54.3-114.4) in the leuprorelin group. The between-group difference in intraoperative blood loss was -11.7 mL (95% CI, -51.5-28.1), demonstrating the noninferiority of relugolix compared with leuprorelin. There were no statistically significant between-group differences in other outcomes. However, postoperative estradiol levels rose earlier in the relugolix group than in the leuprorelin group.

Patients will benefit from preoperative therapy with the gonadotropin-releasing hormone agonist leuprorelin or the gonadotropin-releasing hormone antagonist relugolix in reducing blood loss. However, relugolix was associated with a more rapid recovery from the postoperative hypoestrogenic state than was leuprorelin.