PDF(Pubmed)
Abstract：
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.
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.
CONCLUSIONS: 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.
BACKGROUND: 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 NCT05538689 on Sep 7, 2022. All subjects will provide informed consent to participate.
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.
CONCLUSIONS: 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.
BACKGROUND: 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 NCT05538689 on Sep 7, 2022. All subjects will provide informed consent to participate.
摘要：
背景：子宫平滑肌瘤（通常称为肌瘤或肌瘤）是常见的良性，在子宫中生长的激素依赖性肿瘤，发生在大约25％的育龄妇女中，取决于选定的人口。治疗建议通常基于肌瘤大小，location,病人的年龄,生殖计划,和产科历史。尽管子宫肌瘤及其症状的治疗选择范围广泛，包括子宫切除术,子宫肌瘤切除术,子宫内膜消融,子宫内膜子宫动脉栓塞术,磁共振引导的聚焦超声手术，子宫肌瘤切除术仍然是希望进行子宫肌瘤保留生育能力手术的患者的金标准治疗方法。子宫肌瘤切除术,虽然是切除肌瘤的普遍手术选择，具有已知的风险，如肌瘤复发，症状复发，以及随后重新干预的需要。尽管在肌瘤的医学治疗方面正在进行研究和进步，目前尚无普遍推荐的治疗性干预措施被证明能有效延缓子宫肌瘤的复发或手术后症状的复发.这种情况强调了未满足的医疗需求的重要领域，并强调了继续调查子宫肌瘤切除术患者的预防策略和长期管理选择的重要性。我们设计了一项研究来评估新的FDA批准的GnRH拮抗剂的疗效，Myfembree延迟肌瘤及其相关症状的复发。
方法：随机，prospective,开放标签临床试验。参与者（n=136）将随机分为两组。对照组（护理标准）将在手术子宫肌瘤切除术后接受标准护理（SoC）治疗，治疗组将在手术子宫肌瘤切除术后接受Relugolix联合治疗（Myfembree®）。研究方案得到芝加哥大学机构审查委员会(IRB#22-0282)的批准。确保所有参与者在加入前提供书面知情同意书。
结论：在这个项目中，我们建议使用每日剂量的Relugolix联合治疗（Relugolix与雌二醇和醋酸炔诺酮），被批准用于子宫肌瘤治疗，有可能延迟纤维瘤症状的复发，延长保留子宫手术后的生活质量和延迟再干预的需要。
背景：研究方案于2022年9月16日获得芝加哥大学机构审查委员会的批准，并于2022年9月7日在ClinicalTrials.gov注册，编号NCT05538689。所有受试者将提供参与的知情同意书。
方法：随机，prospective,开放标签临床试验。参与者（n=136）将随机分为两组。对照组（护理标准）将在手术子宫肌瘤切除术后接受标准护理（SoC）治疗，治疗组将在手术子宫肌瘤切除术后接受Relugolix联合治疗（Myfembree®）。研究方案得到芝加哥大学机构审查委员会(IRB#22-0282)的批准。确保所有参与者在加入前提供书面知情同意书。
结论：在这个项目中，我们建议使用每日剂量的Relugolix联合治疗（Relugolix与雌二醇和醋酸炔诺酮），被批准用于子宫肌瘤治疗，有可能延迟纤维瘤症状的复发，延长保留子宫手术后的生活质量和延迟再干预的需要。
背景：研究方案于2022年9月16日获得芝加哥大学机构审查委员会的批准，并于2022年9月7日在ClinicalTrials.gov注册，编号NCT05538689。所有受试者将提供参与的知情同意书。
