Relugolix and Dienogest for Endometriosis: Randomized Controlled Study

JRCT ID: jRCTs061230064

Registered date:29/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: endometriosis
• Date of first enrollment: 17/11/2023
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Subject is assigned in 1:1 ratio to either the Relugolix group or the Dienogest group.
Relugolix group: Relugolix tablet 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.

Outcome(s)

• 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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include 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 has dysmenorrhea or pelvic pain of moderate severity or greater on the B&B scale of VISIT 2
5)Those who have cyclic menstruation.
6)Those who agree on appropriate contraception on a daily basis from the time of informed consent throughout of the study.

Exclude criteria

1) Those who used sex hormones within 4 weeks prior to obtaining consent.
2) Those who used GnRH analogs within 12 weeks prior to obtaining consent.
3) Those who with ovarian endometrioma larger than 10 cm and age 40 years or older at the time of conducted image inspection.
4) Those who with a history of total hysterectomy or bilateral oophorectomy.
5) Those who with complications of undiagnosed abnormal genital bleeding.
6) Those who with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis.
7) Those who with complications of pelvic infection.
8) Those who with malignant tumors.
9) Those who with a history or complications of severe hypersensitivity or severe adverse reactions to Relugolix or Dienogest.
10) 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.
11) Those deemed by the principal investigator or subinvestigator to be inappropriate to participate in this study.

Related Information

• Primary Sponsor: Taniguchi Fuminori
• Secondary Sponsor: ASKA Pharmaceutical Co., Ltd.