NCT05538689

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-11-20
• Primary completion: 2024-10-24
• Completion: 2024-10-24
• First posted: 2022-09-14
• Last updated: 2025-09-29

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study