Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT04856306
Study type Observational
Source Medstar Health Research Institute
Contact Anna Zelivianskaia, MD
Phone 2028776526
Email [email protected]
Status Recruiting
Start date April 12, 2021
Completion date August 30, 2025

See also
  Status Clinical Trial Phase
Completed NCT02934789 - Effectiveness of Truclear on Patient Quality of Life N/A
Completed NCT02925494 - An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Active, not recruiting NCT04778072 - A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects N/A
Terminated NCT04132349 - Ulipristal Acetate in Symptomatic Uterine Fibroid Phase 4
Completed NCT00386308 - Efficacy and Safety Study of XP12B in Women With Menorrhagia Phase 3
Completed NCT03412890 - LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Not yet recruiting NCT04477837 - Prospective Comparison of Incidence of Heavy Menstrual Bleeding in Women Treated With Direct Oral Anticoagulants
Recruiting NCT02943655 - Treatment of Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause Phase 3
Completed NCT01431326 - Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Completed NCT00401193 - Efficacy and Safety of XP12B in Women With Menorrhagia Phase 3
Completed NCT03317795 - Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids Phase 4
Completed NCT03070951 - Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Active, not recruiting NCT02449304 - Evaluation of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device Phase 4
Terminated NCT02001324 - HMB- Data Collection Methods N/A
Completed NCT00113568 - Safety Study of XP12B in Women With Menorrhagia Phase 3
Completed NCT03103087 - LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Recruiting NCT03186586 - Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena Phase 4
Recruiting NCT04425577 - Ultrasound Evaluation Versus Direct Measurement of Uterine Cavity Length N/A
Active, not recruiting NCT03271489 - Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women Phase 3
Not yet recruiting NCT04205266 - IV Iron vs Oral Iron for Treatment of Anemia in Women With Abnormal Uterine Bleeding Phase 4