Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Leiomyoma

Myofibroma

Pain

Pelvic Pain

Menorrhagia

Metrorrhagia

Neurologic Manifestations

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Hemorrhage

Uterine Hemorrhage

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Menstruation Disturbances

All Drugs and Chemicals

Reproductive Control Agents

Relugolix

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Norethindrone

Norethindrone Acetate

Participants will be asked to take a once-daily tablet of Myfembree ( relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for 24 months.

The standard of care will depend on the participant's type of surgery, health history, and clinical symptoms. It often includes pain management, bleeding management, physical exams, pelvic ultrasound, birth control, and Surgical reintervention.

patients who do not consent to randomization or opt to be in a specific group will be included in a parallel observational study and be administered their preferred treatment.

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.

Myfembree Oral Product

Obianuju Sandra Madueke Laveaux, MD MPH

Samar Alkhrait, MD

Obianuju Sandra Madueke Laveaux, MD,MPH

Obianuju Sandra madueke Laveaux, MD,MPH

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.

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

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

Fibroid recurrence when compared to the post-myomectomy baseline pelvic ultrasound (transvaginal and/or transabdominal), defined as a new fibroid identified on ultrasound with a volume \>1 cm3.

The Quality of life questionnaire: UFS-QOL ( Uterine Fibroid symptoms \& Health Related-Quality of Life) is a self-reported questionnaire used to measure symptoms and health-related quality of life in women with uterine fibroids. The questionnaire contains 8 items concerning uterine fibroid symptoms and 29 items concerning health-related quality of life. Each item has a score (1-5), and the scores are summed so that a higher score indicates a higher quality of life.

The Work Productivity and Activity Impairment Questionnaire( WPAI: SHP) is a self-reported questionnaire assessing the effects of a participant's problem on her ability to work and perform activities on a scale from 0 (problem had no effect on daily activities) to 10 ( problem completely prevent doing daily activities).

The Female Sexual Function Index (FSFI) is a self-reported questionnaire that assesses different domains of sexual function in addition to providing an overall score regarding sexual function. The possible total score ranges from 2 to 36.

The Pictorial Bleeding Assessment Chart is a visual scoring system where the participant can directly record the number of her used feminine items (tampons and pads) and the degree to which they are bloodstained.

The Numerical Rating Scale is a subjective measure in which participants rate their pain on an eleven-point. Possible scores range from 0(no pain) to 10 (worst possible pain).

This will be measured based on the participant's reported symptoms and response to treatment. The re-intervention may include repeat myomectomy, uterine fibroid embolization, radiofrequency ablation, or hysterectomy.

Spots Global Cancer Trial Database for Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial