Single arm study to evaluate the efficacy and safety of Relugolix in adenomyosis

JRCT ID: jRCTs031220684

Registered date:03/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Aadenomyosis
• Date of first enrollment: 03/03/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Relugolix 40 mg is started for 12 weeks on days 1 to 5 of the first menstrual cycle after enrollment when sex hormones are not used, and at any time when sex hormones are used.

Outcome(s)

• Primary Outcome: Percent change in uterine volume after 12 weeks from baseline

Secondary Outcome

Evaluate changes in the following from baseline to 12 weeks:
1. Uterine volume
2. Blood Hb level
3. Blood CA125 level
4. MMAS (Menorrhagia Multi-Attribute Scale), a health-related QOL index specializing in menstrual symptoms
5. VAS, an index of pelvic pain
6. Length of endometriotic ovarian cyst, if present
7. If uterine fibroids are present, the three largest diameters from the largest volume

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 48age old
• Gender: Female

Include criteria

1. Those who have menstruation
2. Those diagnosed with adenomyosis by MRI
3. Those with menstrual symptoms (excessive menstruation or pelvic pain)
4. Women over 18 and under 48 years of age at the time consent is obtained
5. Those who have received a full explanation of the study and have given written consent of their own free will based on a full understanding of the study
6. Those who can make outpatient visits in accordance with the research implementation schedule

Exclude criteria

1. Postmenopausal women
2. Pregnant women or those who may be pregnant
3. Those who are breastfeeding
4. Those with submucosal myoma
5. Those with undiagnosed abnormal genital bleeding (in the presence of possible malignant disease)
6. Those with a history of hypersensitivity to any of the ingredients of relugolix.
7. Those who have used relugolix during the 12 weeks prior to the consent date
8. Those who have used GnRH analogues during the 12 weeks prior to the consent date
9. If taking sex hormones, those who cannot agree to discontinue oral administration by the day before the start of oral administration of the study medication
10. Those who are unable to interrupt the use of erythromycin and rifampicin during the study treatment period
11. Those with type 1 diabetes or type 2 diabetes with inadequate glycemic control
12. Those who cannot agree to use non-hormonal contraception while using relugolix
13. Those who are judged inappropriate for participation in this study by the principal investigator or co-investigator

Related Information

• Primary Sponsor: Hirota Yasushi