Status:
UNKNOWN
Myomectomy vs Uterine Artery Embolization vs GnRh Antagonist for AUB-L
Lead Sponsor:
Medstar Health Research Institute
Conditions:
Heavy Menstrual Bleeding
Fibroid Uterus
Eligibility:
FEMALE
18+ years
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 emboliza...
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, u...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 30 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04856306
Start Date
April 12 2021
End Date
August 30 2025
Last Update
May 5 2022
Active Locations (1)
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1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010