NARA study

JRCT ID: jRCTs051230078

Registered date:26/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Leiomyoma
• Date of first enrollment: 26/07/2023
• Target sample size: 140
• Study type: Interventional
• Intervention(s): The administration of relugolix every other day

Outcome(s)

• Primary Outcome: The primary endpoint will be the change rate of leiomyoma volume before and after the administration of Relugolix.

Secondary Outcome

1) Change in uterine volume from pre-treatment at 24 weeks post-treatment (%)
2) Change in total Kupperman Index score at 24 weeks post-treatment from pre-treatment (points)
3) Change in bone mineral density (BMD) from baseline at 24 weeks post-treatment (%)
4) Change in bone metabolism markers (BAP) from baseline at 24 weeks after study drug administration (%)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 51age old
• Gender: Female

Include 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.)

Exclude 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

Related Information

• Primary Sponsor: Kawahara Naoki
• Source(s) of Monetary Support: ASKA Pharmaceutical Co., Ltd.,Nara Medical University