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

NCT04856306 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2022-05-05

No results posted yet for this study

Summary

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.

Conditions

  • Heavy Menstrual Bleeding
  • Fibroid Uterus

Interventions

OTHER

Groups 1 and 2 myomectomy and uterine artery embolization, respectively, are surgical/procedure

See previous descriptions

DRUG

Elagolix Oral Product

See group 3 description

Sponsors & Collaborators

  • Medstar Health Research Institute

    lead OTHER

Principal Investigators

  • Nicholas Hazen, MD · MedStar Health

  • James Robinson, MD · MedStar Health

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-12
Primary Completion
2025-06-30
Completion
2025-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04856306 on ClinicalTrials.gov