@article{TEXTUAL,
      recid = {12954},
      author = {Alkhrait, Samar and Al-Hendy, Ayman and Alkelani, Hiba and  Karrison, Theodore and Madueke Laveaux, Obianuju Sandra},
      title = {Surgical myomectomy followed by oral Myfembree vs standard  of care (SOUL trial): Study protocol for a randomized  control trial},
      journal = {PLOS ONE},
      address = {2024-07-02},
      number = {TEXTUAL},
      abstract = {&lt;p&gt;Background: Uterine leiomyomas (often referred to as  fibroids or myomas) are common benign, hormone-dependent  tumors that grow in the uterus and occur in approximately  25% of reproductive age women, depending on selected  population. Treatment recommendation is typically based on  fibroid size, location, the patient’s age, reproductive  plans, and obstetrical history. Despite the range of  treatment options available for uterine fibroids and their  symptoms, including hysterectomy, myomectomy, endometrial  ablation, endometrial uterine artery embolization, and  magnetic resonance-guided focused-ultrasound surgery,  myomectomy remains the gold standard treatment for patients  who desire fertility-preserving surgery for their uterine  fibroids. Myomectomy, while a prevalent surgical option for  the removal of fibroids, carries known risks such as  fibroid recurrence, symptom recurrence, and the subsequent  need for reintervention. Despite ongoing research and  advances in medical treatments for fibroids, there  currently are no universally recommended therapeutic  interventions proven to effectively delay the recurrence of  fibroids or the return of symptoms following this  procedure. This situation underscores a significant area of  unmet medical need and highlights the importance of  continued investigation into preventive strategies and  long-term management options for patients undergoing  fibroid removal with uterine preservation. We designed a  study to assess the efficacy of the new FDA-approved GnRH  antagonist, Myfembree in delaying the return of fibroids  and their associated symptoms.&lt;/p&gt; &lt;p&gt;Methods: A  randomized, prospective, open-label clinical trial. The  participants (n = 136) will be randomly distributed into  two groups. The Control Group (Standard of care) will  receive treatment with standard of care (SoC) after  surgical myomectomy and the treatment group will receive  Relugolix combination therapy (Myfembree®) after surgical  myomectomy. The study protocol was approved by the  University of Chicago’s Institutional Review Board  (IRB#22–0282), ensuring that all participants would provide  written informed consent before their inclusion.&lt;/p&gt;  &lt;p&gt;Discussion: In this project, we propose the use of daily  dosed Relugolix combination therapy (Relugolix with  estradiol and norethindrone acetate), which is approved for  uterine fibroids treatment, has the potential to delay the  recurrence of fibroid symptoms, prolong the improved  quality of life and delay need for re-intervention after  uterine sparing surgery.&lt;/p&gt; &lt;p&gt;Trial registration: The  study protocol was approved by the Institutional Review  Board of the University of Chicago on 9/16/2022 and was  registered at ClinicalTrials.gov with number &lt;a  href="https://clinicaltrials.gov/ct2/show/NCT05538689"&gt;NCT05538689&lt;/a&gt;  on Sep 7, 2022. All subjects will provide informed consent  to participate.&lt;/p&gt;},
      url = {http://knowledge.uchicago.edu/record/12954},
}