Relugolix and Dienogest for Endometriosis: Randomized Controlled Study

INTERVENTION: Subject is assigned in 1:1 ratio to either the Relugoli Xgroup or the Dienogest group. Relugoli Xgroup: Relugoli Xtablet 40 mg is orally administered once a day before meals for 16 weeks. Starting the day after the last dose of Relugolix, Dienogest tablet 1 mg is orally administered twice a day for 24 weeks. Dienogest group: Dienogest tablet 1 mg orally administered twice a day for 24 weeks. CONDITION: endometriosis PRIMARY OUTCOME: The amount of change from baseline in maximum VAS score for endometriotic pelvic pain during the primary evaluation period SECONDARY OUTCOME: 1) The amount of change from baseline in the mean of VAS score of endometriotic pelvic pain during the primary evaluation period.; 2) The maximum VAS score for endometriotic pelvic pain every 28 days after administration and each amount of change from baseline.; 3) The mean of VAS score for endometriotic pelvic pain every 28 days after administration and each amount of change from baseline.; 4) The maximum VAS score for menstrual pain every 28 days after administration and each amount of change from baseline.; 5) The mean of VAS score for menstrual pain every 28 days after administration and each amount of change from baseline.; 6) The maximum VAS score for endometriotic pelvic pain of out of the menstrual period every 28 days after administration and each amount of change from baseline.; 7) The mean of VAS score for endometriotic pelvic pain of out of the menstrual period every 28 days after administration and each amount of change from baseline.; 8) The VAS score of dyspareunia and each amount of change from baseline.; 9) The B&B score for dysmenorrhea, B&B score for pelvic pain (out of the menstrual period), B&B score for dyspareunia and each amount of change from baseline.; 10) Severity of Douglas cavity induration, restricted uterine mobility, and pelvic tenderness and the amount of change from baseline.; 11) Disease‐specific QOL (the 30‐item Endometriosis Health Profile: EHP‐30) score; 12) Health‐related QOL (EQ‐5D) score; 13) Work Productivity (WHO‐HPQ) score; 14) Number of days and rate of analgesic medications taken every 28 days after administration, and the amount of change from baseline.; 15) Ovarian endometrioma diameter and the amount of change from baseline. INCLUSION CRITERIA: 1)Premenopausal Japanese women aged 18 years or older at the time of informed consent. 2)Patients with endometriosis. However, the diagnosis must be made by one of the following methods. In the case of recurrence after surgical treatment of endometriosis, those diagnosed again with one of the following. ‐Those diagnosed with endometriosis by laparotomy or laparoscopy performed within 5 years prior to VISIT1 ‐Those are shown an ovarian endometrioma by performed that MRI within 1 year prior to VISIT 1 or ultrasound (transvaginal, transabdominal or ransrectal) from VISIT 1 to VISIT 2 ‐Those who have been diagnosed with clinical endometriosis and have either Douglas cavity induration, restricted uterine mobility, or pelvic tenderness by internal or rectal examination performed from VISIT 1 to VISIT 2 3)Those with a maximum VAS score of >30 for endometriotic pelvic pain during the screening period, including more than one menstrual period. 4)Those who h