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

NCT05538689 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2025-09-29

No results posted yet for this study

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.

Conditions

  • Metrorrhagia
  • Pelvic Pain
  • Menorrhagia
  • Leiomyoma

Interventions

DRUG

Myfembree Oral Product

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.

Sponsors & Collaborators

  • Myovant Sciences GmbH

    collaborator INDUSTRY

  • University of Chicago

    lead OTHER

Principal Investigators

  • Obianuju Sandra Madueke Laveaux, MD MPH · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-20
Primary Completion
2024-10-24
Completion
2024-10-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05538689 on ClinicalTrials.gov