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

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.

Timeline

Start

2022-11-20

Primary completion

2024-10-24

Completion

2024-10-24

Publications

• Alkhrait S, Al-Hendy A, Alkelani H, Karrison T, Laveaux OSM. Surgical myomectomy followed by oral Myfembree vs standard of care (SOUL trial): Study protocol for a randomized control trial. PLoS One. 2024 Jul 2;19(7):e0306053. doi: 10.1371/journal.pone.0306053. eCollection 2024.

Drugs

Indications