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The clinical trial of alternative Relugolix administration for uterine myoma prior to surgical treatment: a study protocol for Non-Adverse Relugolix Administration study (NARA study)

NARA study

Kawahara Naoki

Nara Medical University Hospital

840 Shijo-cho, Kashihara, Nara, Japan

naoki35@naramed-u.ac.jp

Yamanaka Shoichiro

Nara Medical University Hospital

840 Shijo-cho, Kashihara, Nara, Japan

+81-744-29-8877

shoichiroyamanaka@naramed-u.ac.jp

Recruiting

July. 26, 2023

Interventional

randomized controlled trial

open(masking not used)

dose comparison control

parallel assignment

treatment purpose

1) Diagnosed with uterine leiomyoma
2) Scheduled for or considering 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.)

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

Female

Leiomyoma

The administration of relugolix every other day

Leiomyoma, pre-surgical treatment, Relgolix, Every other day administration, Everyday administration

Every other day administration, Everyday administration

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

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 (%)

+81-744-29-8835

July. 21, 2023

No

none