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Clinical Trials/JPRN-jRCTs031220684
JPRN-jRCTs031220684RecruitingPhase 2

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

Hirota Yasushi0 sites20 target enrollmentStarted: March 3, 2023Last updated:
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Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
20
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 18age old to < 48age old (—)
Sex
Female

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

Investigators

Sponsor
Hirota Yasushi

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