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Clinical Trials/JPRN-jRCTs031220684
JPRN-jRCTs031220684
Recruiting
Phase 2

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

Hirota Yasushi0 sites20 target enrollmentMarch 3, 2023
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Hirota Yasushi
Enrollment
20
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 3, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Hirota Yasushi

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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