What side effects are associated with this type of intervention?

Common treatments for fibroids, such as the combination of Relugolix (a GnRH receptor antagonist), Estradiol (an estrogen), and Norethindrone Acetate (a progestin), can have several side effects. Relugolix may cause hot flashes, headaches, and decreased bone mineral density. Estradiol can lead to nausea, breast tenderness, and an increased risk of blood clots. Norethindrone Acetate may result in weight gain, mood changes, and breakthrough bleeding. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for fibroids that are similar to Myfembree. Relugolix, a GnRH receptor antagonist, has been studied and shown to be effective in reducing menstrual blood loss in women with uterine fibroids. Estradiol and Norethindrone Acetate, components of hormone therapy, are also used to manage symptoms associated with fibroids. Myfembree, which combines these three components, is FDA-approved for treating heavy menstrual bleeding associated with uterine fibroids, offering a comprehensive approach to managing fibroid symptoms.

What other types of research exist?

Promising alternatives to Myfembree for fibroid patients include: 1) Relugolix monotherapy, which has shown efficacy in reducing fibroid symptoms. 2) Elagolix, another GnRH receptor antagonist, which has been effective in managing fibroid-related symptoms. 3) Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS), a non-invasive procedure that targets and reduces fibroid size. 4) Uterine artery embolization (UAE), a minimally invasive procedure that reduces blood flow to fibroids, causing them to shrink. These alternatives offer various approaches to managing fibroid symptoms and may be available or in advanced stages of clinical trials by 2024.

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Hormone Therapy

Myfembree for Fibroids (SOUL Trial)

Q: What is the mechanism of action of this treatment?

Relugolix, a GnRH receptor antagonist, reduces estrogen and progesterone production by inhibiting gonadotropin release, leading to decreased fibroid size and symptoms. Estradiol, an estrogen, mitigates menopausal symptoms caused by reduced hormone levels, while Norethindrone Acetate, a progestin, provides hormonal balance and prevents endometrial hyperplasia. These treatments are important for fibroid patients as they offer effective symptom management, fibroid size reduction, and improved quality of life without surgery.

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)

Must not have

Has any of the following clinical laboratory abnormalities indicating hepatic or gallbladder impairment: Alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 x ULN on clinical laboratory testing at either the Screening 1 or Screening 2 visit (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome), Estimated glomerular filtration rate < 60 mL/min/m2 using the Modification of Diet in Renal Disease method

Has clinically significant cardiovascular disease including: Prior history of myocardial infarction, History of angina, History of congestive heart failure, History of clinically significant ventricular arrhythmias such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes, or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place or untreated supraventricular tachycardia (heart rate ≥ 120 beats per minute), QT interval by the Fridericia correction formula (QTcF) of > 470 msec, Hypotension, as indicated by systolic blood pressure < 84 millimeters of mercury (mmHg) on 2 repeat measures at least 15 minutes apart or treated ongoing symptomatic orthostatic hypotension with > 20 mmHg decrease in systolic blood pressure one minute or more after assuming an upright position, Uncontrolled hypertension, as indicated by systolic blood pressure > 160 mmHg on 2 repeat measures at least 15 minutes apart or diastolic blood pressure > 100 mmHg at any screening visit or the Baseline Day 1 visit, Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening electrocardiogram

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing Myfembree, a pill that combines three medications, to help women who have had surgery for fibroids. The goal is to delay the return of fibroid symptoms and improve their quality of life. Myfembree works by lowering certain hormone levels and balancing others to reduce heavy menstrual bleeding and other symptoms.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience heavy periods, pelvic pain during periods, or severe symptoms from fibroids.

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My recent endometrial biopsy showed no significant issues.

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I am a premenopausal woman aged 18 or older.

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My uterine fibroids were confirmed by a recent pelvic ultrasound.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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You have liver or gallbladder problems indicated by specific blood test results. Additionally, your kidney function is below a certain level.

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I have serious heart problems or very high or low blood pressure.

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I experience unexplained vaginal bleeding outside of my regular periods.

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I have jaundice or an active liver disease, including hepatitis.

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I have taken medication other than calcium and vitamin D for bone density loss.

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I have a digestive condition that affects how my body absorbs food or how my stomach and intestines move.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fibroid recurrence on ultrasound after myomectomy.

Secondary study objectives

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

Awards & Highlights

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.

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.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Relugolix, a GnRH receptor antagonist, reduces estrogen and progesterone production by inhibiting gonadotropin release, leading to decreased fibroid size and symptoms. Estradiol, an estrogen, mitigates menopausal symptoms caused by reduced hormone levels, while Norethindrone Acetate, a progestin, provides hormonal balance and prevents endometrial hyperplasia. These treatments are important for fibroid patients as they offer effective symptom management, fibroid size reduction, and improved quality of life without surgery.

Relugolix for oral treatment of uterine leiomyomas: a dose-finding, randomized, controlled trial.Uterine fibroid shrinkage after short-term use of selective progesterone receptor modulator or gonadotropin-releasing hormone agonist.