Myomectomy vs Uterine Artery Embolization vs GnRh Antagonist for AUB-L

This is a prospective cohort study comparing the novel FDA-approved oral GnRH antagonist ORIAHNN (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) to uterine artery embolization (UAE) or myomectomy (abdominal, laparoscopic, or hysteroscopic) for treatment of heavy menstrual bleeding due to leiomyomas. Uterine leiomyomas, also called fibroids, are hormone-dependent growths in the uterine muscle that are common in reproductive-age women (1). Leiomyomas can often lead to heavy menstrual bleeding. Definitive treatment for abnormal uterine bleeding due to leiomyomas is hysterectomy, but for patients who desire uterine conservation, a variety of treatment options exist. Regulation of menses with combined oral contraceptives or progestin only oral formulations are generally considered first line treatment but are not curative or effective for many patients. Another treatment option is a myomectomy, which is the surgical resection or removal of myomas. Myomectomy can be performed via hysteroscopy or laparoscopy, or by a vaginal or an abdominal approach. The route of removal depends on myoma location and patient symptoms. Another treatment option is Uterine fibroid or uterine artery embolization (UFE/UAE). UAE is a minimally invasive procedure where permanent particles are delivered to and block/embolize the blood supply to the myoma via a fluoroscopy directed arterial catheter. This typically leads to a decrease in fibroid size and associated bleeding (2). ORIAHNN, an oral GnRH antagonist that was FDA-approved in 2020, has demonstrated significant decrease in myoma-associated heavy menstrual bleeding compared to placebo (1) but has not been compared to other standard of care interventions. The primary objective of this study is to compare this novel medication to the common AUB-L treatments UAE and Myomectomy.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

Patients with heavy menstrual bleeding and uterine fibroids documented on imaging who are seeking treatment, and after completing standard counseling, chose either ORIAHNN, UAE, or myomectomy. If the patient has used hormonal treatments for fibroids in the past, a wash-out period of at least 3 months duration must be performed prior to study participation. If the patient has had a myomectomy of any type in the past, a period of at least 6 months must have passed since the surgery prior to study participation.

Exclusion Criteria:

pregnancy, presence of persistent (defined as present on 2 or more consecutive ultrasounds) or complex ovarian cyst, active cancer, history of osteoporosis, current pelvic inflammatory disease, history of liver or renal failure, presence of coagulopathy that is unable to be corrected, or untreated thyroid disease, and having previously been treated with UAE, GnRH antagonist, or myomectomy within the past 6 months.

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