Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT05538689
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Myfembree Oral Product — DRUG
    The study drug Myfembree will be taken orally with water, once daily, at approximately the same time, with or without food. Each tablet of Myfembree contains Relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5 mg.

Study Details

In this project, the proposition is that the use of daily dosed Myfembree ( a combination of relugolix with estradiol and norethindrone acetate), FDA-approved medication to treat heavy menses fibroid-related symptoms, has the potential to delay the recurrence of fibroid symptoms, prolong the improved quality of life and delay the need for re-intervention after uterine sparing surgery versus the routine standard of care.

Key Dates

Start date
Nov 20, 2022
Status verified
Sep 2025
Primary completion
Oct 24, 2024
Completion
Oct 24, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study drug Myfembree
    Participants will be asked to take a once-daily tablet of Myfembree ( relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for 24 months.
  • No Intervention: Standard of Care
    The standard of care will depend on the participant's type of surgery, health history, and clinical symptoms. It often includes pain management, bleeding management, physical exams, pelvic ultrasound, birth control, and Surgical reintervention.
  • Other: Parallel group for participants who opt not to be randomized
    patients who do not consent to randomization or opt to be in a specific group will be included in a parallel observational study and be administered their preferred treatment.

Primary Outcome Measure

Fibroid recurrence on ultrasound after myomectomy. [ Time Frame: 36 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of Chicago DCAMChicagoIllinois60637-
University of Chicago River EastChicagoIllinois60611-
University of Chicago South LoopChicagoIllinois60607-
University of Chicago FlossmoorFlossmoorIllinois60422-
University of Chicago Orland ParkOrland ParkIllinois60462-
University of Chicago ScherervilleScherervilleIndiana46375-

Find similar trials in Chicago, IL

By research site
University of Chicago DCAM· Chicago, ILUniversity of Chicago River East· Chicago, ILUniversity of Chicago South Loop· Chicago, ILUniversity of Chicago Flossmoor· Flossmoor, ILUniversity of Chicago Orland Park· Orland Park, ILUniversity of Chicago Schererville· Schererville, IN

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