ARA study

Not Applicable

Recruiting

• Conditions: eiomyoma; Leiomyoma, pre-surgical treatment, Relgolix, Every other day administration, Everyday administration

• Registration Number: JPRN-jRCTs051230078
• Lead Sponsor: Kawahara Naoki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-26
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

1) Diagnosed with uterine leiomyoma
2) Scheduled for an abdominal or laparoscopic hysterectomy or myomectomy
3) Pre-menopausal female
4) Age at the time of consent is between 20 and 51 years old (under 51).
5) The patient has the capacity to consent and is able to give written consent of her own will.
6) ECOG-PS1 or lower (within 1).
(ECOG-PS1 means that the patient is limited in strenuous activities, but can walk and perform light or sedentary work.)

Exclusion Criteria

1) Complicated uterine adenomyosis
2) Use of sex hormones within 4 weeks prior to obtaining consent
3) Previous treatment with uterine artery embolization or focused ultrasound therapy
4) Diagnosed with a malignant tumor
5) Diagnosed with a disease with abnormal blood coagulation
6) Undertreatment of an anticoagulant
7) Pregnant or susceptible to pregnancy, or in lactation
8) Abnormal genital bleeding without a diagnosis
9) Allergy history to relugolix or synthetic luteinizing hormone-releasing hormone (LH-RH) or LH-RH derivatives
10) Continuously taking erythromycin or rifampicin
11) Patients who are deemed unsuitable for this study by the principal investigator or collaborator

Study & Design

• Study Type: Interventional
• Study Design: Not specified