Myomectomy vs Uterine Artery Embolization vs GnRh Antagonist for AUB-L (Magical)

April 29, 2022 updated by: Medstar Health Research Institute
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Uterine fibroids, or leiomyomas, are common benign tumors in reproductive-age women. While many women with fibroids are asymptomatic, 20-50% of women may have bulk symptoms, such as pelvic pressure, urinary or gastrointestinal symptoms, and/or heavy menstrual bleeding (3-4). Heavy menstrual bleeding can lead to severe anemia requiring treatment, which has negative health and economic consequences (4). Fibroids are also associated with infertility and recurrent pregnancy loss (3). Symptom character and severity depend on fibroid size and location, and they can have a significant effect on women's quality of life.

Fibroid growth is dependent on estrogen and progesterone, thus common medical management of symptoms uses hormonal agents, such as oral contraceptives, selective progesterone receptor modulators, GnRH agonists, and intrauterine devices (3). Nonhormonal medical methods include tranexamic acid, an antifibrinolytic agent that reduces menstrual blood loss, and nonsteroidal anti-inflammatory drugs, which reduce blood loss and improve pain relief (3). Medical management is generally the first treatment strategy for symptomatic fibroids, but definitive treatment is via a hysterectomy. A hysterectomy is the most common surgical treatment of fibroids, but for women who desire to preserve the uterus, other surgical options are available (4, 5). A myomectomy removes fibroids employing either hysteroscopic, laparoscopic, abdominal approaches, or a combination of these methods. Another option for fibroid management is uterine fibroid or uterine artery embolization (UFE/UAE). This minimally invasive procedure uses a catheter to inject permanent particles inside uterine arteries to occlude the blood supply to the fibroid(s). Both myomectomy and UAE have high patient satisfaction rates. Both modalities also carry the risk of necessitating future interventions if symptoms are not controlled or if fibroids recur (5). Patients who undergo UAE have a slightly higher risk of further interventions compared to myomectomy (5).

For women who do not desire any type of surgical intervention or the UAE procedure, a new type of medical treatment has become available. Oriahnn, produced by AbbVie, is a combination of elagolix, an oral nonpeptide GnRH antagonist, and add-back therapy with estradiol and norethindrone (1, 4). It is administered at a total daily dose of 600mg: 300mg elagolix with add-back therapy in the morning and 300mg elagolix alone at night (4). Elagolix results in rapid, reversible suppression of gonadotrophin and ovarian sex hormones, and was first approved for treatment of endometriosis-associated pain (4). The side effects of elagolix are related to the creation of the hypoestrogenic state and are mitigated with add-back therapy (4). The dose and formula in Oriahnn showed a significant decrease in menstrual blood loss compared to placebo with a favorable safety profile but has never been compared to any other treatment for fibroids (4). It is FDA-approved for a treatment duration of 24 months (1).

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
See previous descriptions
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
See previous descriptions
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
See group 3 description
Other Names:
  • Oriahnn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Menstrual blood loss
Time Frame: 12 months
Raw values and quantitative change in menstrual blood loss per month from patient's baseline
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UFS-QOL Score
Time Frame: 12 months
Raw score and change in overall health-related quality of life score from UFS-QOL from patient's baseline at 3, 6, and 12-month intervals
12 months
Menopausal symptoms
Time Frame: 12 months
Raw score and change in overall menopausal symptoms score based on Menopausal Symptoms questionnaire from patient's baseline at 3, 6, and 12-month intervals
12 months
Hemoglobin value
Time Frame: 12 months
Hemoglobin laboratory values collected prior to treatment initiation and at 3-, 6-, 9-, and 12-month intervals.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Investigators

  • Study Director: Nicholas Hazen, MD, Medstar
  • Study Director: James Robinson, MD, Medstar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Anticipated)

June 30, 2025

Study Completion (Anticipated)

August 30, 2025

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (Actual)

April 23, 2021

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002872

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

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