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Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL) | Clinical Trials | Clareo Health

WITHDRAWNPHASE4

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

Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial.

NCT05538689•University of Chicago

Summary

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Has voluntarily signed and dated the informed consent form prior to initiation of any screening or study-specific procedures
•2. Premenopausal female aged 18 years and older on the day of signing of the informed consent form
•3. Has a diagnosis of uterine fibroids that is confirmed by a pelvic ultrasound (transvaginal and/or transabdominal) performed during the screening period.
•4. Has at least one or more of the following symptoms:
•1. Heavy menses defined as PBAC (Pictorial Bleeding Assessment Chart) score ≥ 120
•2. Pelvic pain during menses measured on NRS (Numeric Pain Rating Scale) ≥ 4 at baseline
•3. Moderately severe fibroid-related symptoms (a score ≥ 25 on the Uterine Fibroid UF quality of life symptoms severity subscale)
•5. Has a negative urine pregnancy test at the Screening, Baseline and interval clinic visits
•6. Agrees to not be pregnant for at least 12 months. Participant may use any form of non-hormonal contraception consistently during the screening period . These may include: Diaphragm, cervical cap, spermicides, male and female condoms, copper IUD ( intra uterine device) and sponge. Each one will be explained in detail for the participants. However, the patient is not required to use dual contraception if she:
•1. Has a sexual partner(s) who was vasectomized at least 6 months prior to the screening period.
+4 more criteria

Exclusion Criteria

•1. Has transvaginal and/or transabdominal ultrasound during the screening period demonstrating pathology other than uterine fibroids that could be responsible for or contributing to the patient's heavy menstrual bleeding, such as uterine or cervical polyps \> 2.0 cm, or any other clinically significant gynecological disorder determined by the investigator to require further evaluation and/or treatment.
•Note: Saline or gel contrast is not routinely required. Use of such contrast is required only when the endometrium cannot be evaluated or when there are ambiguous and potentially exclusionary findings on the transvaginal and/or transabdominal ultrasound (e.g., suspected intrauterine masses, equivocal endometrial findings, etc.)
•2. Has unexplained vaginal bleeding outside of the patient's regular menstrual cycle
•3. Has undergone ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, as well as endometrial ablation for abnormal uterine bleeding within 6 months prior to the Screening visit
•4. Has a history of or currently has osteoporosis, or other metabolic bone disease, hyperparathyroidism, hyperprolactinemia, hyperthyroidism, anorexia nervosa, or low traumatic (from the standing position) or atraumatic fracture (toe, finger, skull, face, and ankle fractures are allowed). A history of successfully treated hyperparathyroidism, hyperprolactinemia, or hyperthyroidism is allowed if the patient's bone mineral density is within normal limits
•5. Has a history of the use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, denosumab, or any medication other than calcium and vitamin D preparations to treat bone mineral density loss
•6. Anticipated use of systemic glucocorticoids at an oral prednisone-equivalent dose of more than 5 mg every other day during the study. Note: topical, inhaled, intranasal, optic, ophthalmic, intraarticular, or intralesional subcutaneous are permitted without restriction
•7. Gastrointestinal disorder affecting absorption or gastrointestinal motility
•8. Has any additional contraindication to treatment with low-dose estradiol and norethindrone acetate, including:
•1. Current, known, suspected, or history of breast cancer
+28 more criteria

Locations (6)

University of Chicago South Loop

Chicago, Illinois, United States

University of Chicago River East

Chicago, Illinois, United States

University of Chicago DCAM

Chicago, Illinois, United States

University of Chicago Flossmoor

Flossmoor, Illinois, United States

University of Chicago Orland Park

Orland Park, Illinois, United States

University of Chicago Schererville

Schererville, Indiana, United States

Key Dates

Start Date

November 20, 2022

Primary Completion Date

October 24, 2024

Completion Date

October 24, 2024

Last Updated

September 29, 2025

Conditions

MetrorrhagiaPelvic PainMenorrhagiaLeiomyoma

Interventions

Myfembree Oral Product

DRUG

Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices

NCT06168058

Chronic Pelvic Pain SyndromePelvic Pain+3 more

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RECRUITINGPHASE2

Glycemic Regulation as Endometriosis Adjunct Treatment

NCT06611501

Pelvic PainEndometriosis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices

Glycemic Regulation as Endometriosis Adjunct Treatment

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