Non-inferiority study of comparing the efficacy of Relugolix with Dienogest for endometriosis-associated pain and the usefulness study of administering Relugolix prior to Dienogest administration (READY-study)

未提供0 个研究点目标入组 100 人开始时间: 2023年11月17日最近更新: 2024年9月3日

适应症

试验速览

暂无简介。

•Premenopausal Japanese women aged 18 years or older at the time of informed consent.
•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
•Those with a maximum VAS score of >30 for endometriotic pelvic pain during the screening period, including more than one menstrual period.
•Those who has dysmenorrhea or pelvic pain of moderate severity or greater on the B&B scale of VISIT 2
•Those who have cyclic menstruation.
•Those who agree on appropriate contraception on a daily basis from the time of informed consent throughout of the study.

•Those who used sex hormones within 4 weeks prior to obtaining consent.
•Those who used GnRH analogs within 12 weeks prior to obtaining consent.
•Those who with ovarian endometrioma larger than 10 cm and age 40 years or older at the time of conducted image inspection.
•Those who with a history of total hysterectomy or bilateral oophorectomy.
•Those who with complications of undiagnosed abnormal genital bleeding.
•Those who with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis.
•Those who with complications of pelvic infection.
•Those who with malignant tumors.
•Those who with a history or complications of severe hypersensitivity or severe adverse reactions to Relugolix or Dienogest.
•Those who is pregnant, lactating, planning to become pregnant between the time of informed consent and one month after the completion of the study, or planning to donate eggs during this period.
•Those deemed by the principal investigator or subinvestigator to be inappropriate to participate in this study.

maximum VAS score for endometriotic pelvic pain

时间窗: during the primary evaluation period

The amount of change from baseline

VAS score of endometriotic pelvic pain(primary evaluation period)
Maximum VAS score for endometriotic pelvic pain(every 28 days after administration)
Mean VAS score for endometriotic pelvic pain(every 28 days after administration)
Maximum VAS score for endometriotic pelvic pain (out of menstrual period)(every 28 days after administration)
Maximum VAS score for menstrual pain(every 28 days after administration)
Mean VAS score for menstrual pain(every 28 days after administration)
Mean VAS score for endometriotic pelvic pain (out of menstrual period)(every 28 days after administration)
VAS score of dyspareunia
B&B score
Severity of pelvic findings
EHP-30 score
EQ-5D score
WHO-HPQ score
Analgesic medications usage(every 28 days after administration)
Ovarian endometrioma diameter

发起方

未提供