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Hormone Therapy
Myfembree for Fibroids (SOUL Trial)
Phase 4
Recruiting
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)
Timeline
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 belowSelect...
I experience heavy periods, pelvic pain during periods, or severe symptoms from fibroids.
Select...
My recent endometrial biopsy showed no significant issues.
Select...
I am a premenopausal woman aged 18 or older.
Select...
My uterine fibroids were confirmed by a recent pelvic ultrasound.
SOUL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
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 moreSOUL Trial Design
2Treatment 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: 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.
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Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,641 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a procedure for fibroids or abnormal bleeding in the last 6 months.My endometriosis was confirmed by surgery within the last 10 years.I experience heavy periods, pelvic pain during periods, or severe symptoms from fibroids.I have a serious cervical condition but not the most common types if my HPV tests are negative.I expect to use more than 5 mg of oral steroids every other day during the study.You have liver or gallbladder problems indicated by specific blood test results. Additionally, your kidney function is below a certain level.My recent endometrial biopsy showed no significant issues.I have or had bone health issues but my bone density is now normal.I have serious heart problems or very high or low blood pressure.I agree to use two non-hormonal birth control methods or meet the exceptions.I experience unexplained vaginal bleeding outside of my regular periods.My ultrasound showed no other causes for heavy periods besides fibroids.I have jaundice or an active liver disease, including hepatitis.I am a premenopausal woman aged 18 or older.You need to have a negative pregnancy test before starting the study and at certain clinic visits.My uterine fibroids were confirmed by a recent pelvic ultrasound.I have taken medication other than calcium and vitamin D for bone density loss.I have a digestive condition that affects how my body absorbs food or how my stomach and intestines move.I do not have a history or current diagnosis of breast cancer, hormone-dependent tumors, or a high risk of blood clots.Criterion: You have had a severe allergic reaction or swelling to estradiol or norethindrone acetate.I am over 40 and had a normal mammogram in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Study drug Myfembree
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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