Last reviewed · How we verify
NCT04856306: Magical
Myomectomy vs Uterine Artery Embolization vs GnRh Antagonist for AUB-L
trial testing Groups 1 and 2 myomectomy and uterine artery embolization, respectively, are surgical/procedure in Heavy Menstrual Bleeding in 300 participants. Status unknown.
30 June 2025
Quick facts
| Lead sponsor | Medstar Health Research Institute |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 12 April 2021 |
| Primary completion | 30 June 2025 |
| Estimated completion | 30 August 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Groups 1 and 2 myomectomy and uterine artery embolization, respectively, are surgical/procedure
- Elagolix Oral Product — full drug profile →
Conditions studied
- Heavy Menstrual Bleeding — all drugs for Heavy Menstrual Bleeding →
- Fibroid Uterus — all drugs for Fibroid Uterus →
Sponsor
Medstar Health Research Institute
Who can join
18 and older, female only, with Heavy Menstrual Bleeding or Fibroid Uterus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04856306
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Heavy Menstrual Bleeding
Currently open trials in the same condition.
- NCT07326722 — Delivering tAN to Reduce HMB: The LUNA Study · NA · recruiting
- NCT06634719 — Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB) · NA · recruiting
- NCT06671548 — Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids · Phase 3 · recruiting
- NCT05922657 — A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device · recruiting
- NCT06921629 — Menstrual Complaints in Adolescents and Adults · active not recruiting
Other Medstar Health Research Institute trials
Trials by the same sponsor.
- NCT07445932 — Palliative Care Intervention to Improve Health Related Quality of Life for Patients on Long-Term LVAD Support · NA · not yet recruiting
- NCT07318545 — Intervention for Chronic Insufficient Sleep in Young Adult Cancer Patients and Survivors · NA · not yet recruiting
- NCT07337642 — Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty · NA · recruiting
- NCT07228377 — Digital Intervention for Symptom Management in Cancer and Opioid Sparing Using Virtual Reality (DISCOVR) Study · NA · recruiting
- NCT07223489 — Diagnostic Journey, Patient Experience, and Disparities in the Treatment of Spinal Muscular Atrophy (SMA) in the MedStar · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04856306 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medstar Health Research Institute
- Last refreshed: 5 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04856306.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing