Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL) (NCT05538689) | Clinical Trial Compass
WithdrawnPhase 4
Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)
Stopped: Data not collected and analyzed; withdrawn due to lack of bandwidth.
United States0Started 2022-11-20
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Has voluntarily signed and dated the informed consent form prior to initiation of any screening or study-specific procedures
✓. Premenopausal female aged 18 years and older on the day of signing of the informed consent form
✓. Has a diagnosis of uterine fibroids that is confirmed by a pelvic ultrasound (transvaginal and/or transabdominal) performed during the screening period.
✓. Has at least one or more of the following symptoms:
✓. Heavy menses defined as PBAC (Pictorial Bleeding Assessment Chart) score ≥ 120
✓. Pelvic pain during menses measured on NRS (Numeric Pain Rating Scale) ≥ 4 at baseline
✓. Moderately severe fibroid-related symptoms (a score ≥ 25 on the Uterine Fibroid UF quality of life symptoms severity subscale)
✓. Has a negative urine pregnancy test at the Screening, Baseline and interval clinic visits
Exclusion criteria
✕. Has transvaginal and/or transabdominal ultrasound during the screening period demonstrating pathology other than uterine fibroids that could be responsible for or contributing to the patient's heavy menstrual bleeding, such as uterine or cervical polyps \> 2.0 cm, or any other clinically significant gynecological disorder determined by the investigator to require further evaluation and/or treatment.
✕. Has unexplained vaginal bleeding outside of the patient's regular menstrual cycle
What they're measuring
1
Fibroid recurrence on ultrasound after myomectomy.
. Has undergone ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, as well as endometrial ablation for abnormal uterine bleeding within 6 months prior to the Screening visit
✕. Has a history of or currently has osteoporosis, or other metabolic bone disease, hyperparathyroidism, hyperprolactinemia, hyperthyroidism, anorexia nervosa, or low traumatic (from the standing position) or atraumatic fracture (toe, finger, skull, face, and ankle fractures are allowed). A history of successfully treated hyperparathyroidism, hyperprolactinemia, or hyperthyroidism is allowed if the patient's bone mineral density is within normal limits
✕. Has a history of the use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, denosumab, or any medication other than calcium and vitamin D preparations to treat bone mineral density loss
✕. Anticipated use of systemic glucocorticoids at an oral prednisone-equivalent dose of more than 5 mg every other day during the study. Note: topical, inhaled, intranasal, optic, ophthalmic, intraarticular, or intralesional subcutaneous are permitted without restriction
✕. Gastrointestinal disorder affecting absorption or gastrointestinal motility
✕. Has any additional contraindication to treatment with low-dose estradiol and norethindrone acetate, including: