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Hormone Therapy

Myfembree for Fibroids (SOUL Trial)

Phase 4
Led By Obianuju Sandra Madueke Laveaux, MD MPH
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has at least one or more of the following symptoms: Heavy menses defined as PBAC (Pictorial Bleeding Assessment Chart) score ≥ 120, Pelvic pain during menses measured on NRS (Numeric Pain Rating Scale) ≥ 4 at baseline, Moderately severe fibroid-related symptoms (a score ≥ 25 on the Uterine Fibroid UF quality of life symptoms severity subscale)
Has an endometrial (aspiration) biopsy, if clinically indicated, performed during the screening period, with results showing no clinically significant endometrial pathology (hyperplasia, endometritis, or endometrial cancer)
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

SOUL Trial Summary

This trial will compare the use of Myfembree to the standard of care in order to see if it can help improve quality of life and delay the need for fibroid surgery.

Who is the study for?
This trial is for premenopausal women aged 18 or older with uterine fibroids confirmed by ultrasound, experiencing heavy menstrual bleeding or pelvic pain. Participants must not be pregnant, have certain medical conditions like osteoporosis or significant cardiovascular disease, and agree to use non-hormonal contraception if sexually active.Check my eligibility
What is being tested?
The SOUL trial is testing whether taking Myfembree orally after surgical myomectomy can delay the return of fibroid symptoms compared to standard care. Myfembree combines relugolix with estradiol and norethindrone acetate and aims to prolong improved quality of life.See study design
What are the potential side effects?
Myfembree may cause side effects such as headaches, hot flashes, increased sweating, muscle pains, tiredness, hair loss, decreased sex drive and acne. It might also affect bone density over time.

SOUL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I experience heavy periods, pelvic pain during periods, or severe symptoms from fibroids.
My recent endometrial biopsy showed no significant issues.
I am a premenopausal woman aged 18 or older.
My uterine fibroids were confirmed by a recent pelvic ultrasound.

SOUL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fibroid recurrence on ultrasound after myomectomy.
Secondary outcome measures
Female Sexual Function Impairment assessed by Female Sexual Function Index Questionnaire.
Heavy menses recurrence after myomectomy with score ≥ 120 on Pictorial Bleeding Assessment Chart (PBAC).
Participants' quality of life assessed by the Quality of Life Questionnaire.
+3 more

SOUL Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Study drug MyfembreeExperimental Treatment1 Intervention
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.
Group II: Parallel group for participants who opt not to be randomizedExperimental Treatment1 Intervention
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.
Group III: Standard of CareActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,011 Previous Clinical Trials
733,849 Total Patients Enrolled
Myovant Sciences GmbHIndustry Sponsor
22 Previous Clinical Trials
12,354 Total Patients Enrolled
Obianuju Sandra Madueke Laveaux, MD MPHPrincipal InvestigatorUniversity of Chicago

Media Library

Myfembree Oral Product (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05538689 — Phase 4
Fibroid Research Study Groups: Parallel group for participants who opt not to be randomized, Standard of Care, Study drug Myfembree
Fibroid Clinical Trial 2023: Myfembree Oral Product Highlights & Side Effects. Trial Name: NCT05538689 — Phase 4
Myfembree Oral Product (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05538689 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare facilities are involved in conducting this trial?

"Patients can register for this study at 6 different locations, including University of Chicago DCAM in Schererville, University of Chicago Schererville in Orland Park and Univeristy of Chicago Orland Park in Flossmoor. Additionally there are 3 more venues to choose from."

Answered by AI

Are there any vacancies remaining for those interested in participating in this experiment?

"According to the clinicaltrials.gov database, this investigation is no longer actively recruiting patients. Having been posted on October 1st 2022 and last updated September 21st 2022, it has ceased its search for participants; however, there are still 99 other trials that will enroll new individuals at present."

Answered by AI

Has the FDA granted approval for Myfembree Oral Product?

"As this is a Phase 4 clinical trial, Myfembree Oral Product received an assessment of 3 on our safety scale. This indicates that the treatment has been approved for widespread public use."

Answered by AI
~64 spots leftby Oct 2025