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

Recruiting

• Conditions: Aadenomyosis

• Registration Number: jRCTs031220684

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-03
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 20

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
-		Percent change in uterine volume after 12 weeks from baseline

Secondary Outcome Measures

Name	Time	Method
MMAS	from baseline to 12 weeks	Menorrhagia Multi-Attribute Scale, a health-related QOL index specializing in menstrual symptoms
VAS	from baseline to 12 weeks	an index of pelvic pain
Length of endometriotic ovarian cyst	from baseline to 12 weeks	if present
Uterine fibroids	from baseline to 12 weeks	if present, the three largest diameters from the largest volume