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

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ClinicalTrials.gov Identifier: NCT04856306
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Vadim Morozov, Medstar Health Research Institute

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.

Condition or disease Intervention/treatment
Heavy Menstrual Bleeding Fibroid Uterus Other: Groups 1 and 2 myomectomy and uterine artery embolization, respectively, are surgical/procedure Drug: Elagolix Oral Product

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).

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Myomectomy vs Uterine Artery Embolization vs GnRh Antagonist for AUB-L
Actual Study Start Date : April 12, 2021
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : August 30, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Elagolix

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 Name: Oriahnn




Primary Outcome Measures :
  1. Change in Menstrual blood loss [ Time Frame: 12 months ]
    Raw values and quantitative change in menstrual blood loss per month from patient's baseline


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Hemoglobin value [ Time Frame: 12 months ]
    Hemoglobin laboratory values collected prior to treatment initiation and at 3-, 6-, 9-, and 12-month intervals.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women being treated for heavy menstrual bleeding due to fibroids at a MedStar facility.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04856306


Contacts
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Contact: Anna Zelivianskaia, MD 2028776526 Anna.S.Zelivianskaia@medstar.net

Locations
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United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Anna Zelivianskaia, MD    202-877-6526    Anna.S.Zelivianskaia@medstar.net   
Principal Investigator: Vadim Morozov, MD         
Sponsors and Collaborators
Medstar Health Research Institute
Investigators
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Study Director: Nicholas Hazen, MD Medstar
Study Director: James Robinson, MD Medstar
Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Vadim Morozov, Associate Professor of Obstetrics and Gynecology, Director of Fellowship in Minimally Invasive Gynecology, Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT04856306    
Other Study ID Numbers: STUDY00002872
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Vadim Morozov, Medstar Health Research Institute:
fibroids
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Menorrhagia
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Hemorrhage
Uterine Diseases
Hemorrhage
Pathologic Processes
Menstruation Disturbances