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

NCT04856306 | Unknown FDA Drug

• 1 other identifier: STUDY00002872
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

fibroids

Outcome Measures

Primary Outcomes (1)

• Change in Menstrual blood loss

  Raw values and quantitative change in menstrual blood loss per month from patient's baseline

  12 months

Secondary Outcomes (3)

• UFS-QOL Score

  12 months

• Menopausal symptoms

  12 months

• Hemoglobin value

  12 months

Study Arms (3)

Myomectomy

After routine patient counseling on fibroid treatments, this group chooses surgical myomectomy of any type (abdominal/laparoscopic/hysteroscopic)

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

Uterine artery embolization

After routine patient counseling on fibroid treatments, this group chooses uterine artery embolization procedure.

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

Elagolix

After routine patient counseling on fibroid treatments, this group chooses the following medication: every morning (AM), 300mg elagolix, 1mg estradiol, and 0.5mg norethindrone acetate capsules taken in one combined capsule and every evening (PM), 300mg elagolix capsule. In our study, this medication will be administered for 12 months unless the subject withdraws from the study. It is FDA-approved for continuous use of up to 24 months.

Drug: Elagolix Oral Product

Interventions

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

See previous descriptions

Myomectomy; Uterine artery embolization

Elagolix Oral Product DRUG

See group 3 description

Also known as: Oriahnn

Elagolix

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women being treated for heavy menstrual bleeding due to fibroids at a MedStar facility.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (10)

• Schirf BE, Vogelzang RL, Chrisman HB. Complications of uterine fibroid embolization. Semin Intervent Radiol. 2006 Jun;23(2):143-9. doi: 10.1055/s-2006-941444.

  PMID: 21326757 BACKGROUND

• De La Cruz MS, Buchanan EM. Uterine Fibroids: Diagnosis and Treatment. Am Fam Physician. 2017 Jan 15;95(2):100-107.

  PMID: 28084714 BACKGROUND

• Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002 Feb;99(2):290-300. doi: 10.1016/s0029-7844(01)01702-1.

  PMID: 11814511 BACKGROUND

• Gupta JK, Sinha A, Lumsden MA, Hickey M. Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database Syst Rev. 2014 Dec 26;2014(12):CD005073. doi: 10.1002/14651858.CD005073.pub4.

  PMID: 25541260 BACKGROUND

• Goodwin SC, Bradley LD, Lipman JC, Stewart EA, Nosher JL, Sterling KM, Barth MH, Siskin GP, Shlansky-Goldberg RD; UAE versus Myomectomy Study Group. Uterine artery embolization versus myomectomy: a multicenter comparative study. Fertil Steril. 2006 Jan;85(1):14-21. doi: 10.1016/j.fertnstert.2005.05.074.

  PMID: 16412720 BACKGROUND

• Wyatt KM, Dimmock PW, Walker TJ, O'Brien PM. Determination of total menstrual blood loss. Fertil Steril. 2001 Jul;76(1):125-31. doi: 10.1016/s0015-0282(01)01847-7.

  PMID: 11438330 BACKGROUND

• Magnay JL, Nevatte TM, O'Brien S, Gerlinger C, Seitz C. Validation of a new menstrual pictogram (superabsorbent polymer-c version) for use with ultraslim towels that contain superabsorbent polymers. Fertil Steril. 2014 Feb;101(2):515-22. doi: 10.1016/j.fertnstert.2013.10.051. Epub 2013 Dec 12.

  PMID: 24331833 BACKGROUND

• Larsen L, Coyne K, Chwalisz K. Validation of the menstrual pictogram in women with leiomyomata associated with heavy menstrual bleeding. Reprod Sci. 2013 Jun;20(6):680-7. doi: 10.1177/1933719112463252. Epub 2012 Nov 27.

  PMID: 23188490 BACKGROUND

• Schlaff WD, Ackerman RT, Al-Hendy A, Archer DF, Barnhart KT, Bradley LD, Carr BR, Feinberg EC, Hurtado SM, Kim J, Liu R, Mabey RG Jr, Owens CD, Poindexter A, Puscheck EE, Rodriguez-Ginorio H, Simon JA, Soliman AM, Stewart EA, Watts NB, Muneyyirci-Delale O. Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids. N Engl J Med. 2020 Jan 23;382(4):328-340. doi: 10.1056/NEJMoa1904351.

  PMID: 31971678 RESULT

• Broder MS, Goodwin S, Chen G, Tang LJ, Costantino MM, Nguyen MH, Yegul TN, Erberich H. Comparison of long-term outcomes of myomectomy and uterine artery embolization. Obstet Gynecol. 2002 Nov;100(5 Pt 1):864-8. doi: 10.1016/s0029-7844(02)02182-8.

  PMID: 12423842 RESULT

Related Links

• 1\. FDA Approves the First Oral Medication for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women AbbVie Press Release. May 29, 2020.

MeSH Terms

Conditions

Menorrhagia; Leiomyoma

Interventions

Uterine Artery Embolization

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Embolization, Therapeutic; Hemostatic Techniques; Therapeutics; Therapeutic Occlusion; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Nicholas Hazen, MD

  MedStar Health

  STUDY DIRECTOR

• James Robinson, MD

  MedStar Health

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 23, 2021
• Study Start: April 12, 2021
• Primary Completion: June 30, 2025
• Study Completion: August 30, 2025
• Last Updated: May 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)