Leiomyoma, Menorrhagia, Metrorrhagia, Pelvic Pain
Conditions
Brief 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.
Interventions
DRUGMyfembree Oral Product
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.
Sponsors
University of Chicago
Myovant Sciences GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Inclusion Criteria (all inclusion criteria must have been met prior to randomization unless otherwise specified): 1. Has voluntarily signed and dated the informed consent form prior to initiation of any screening or study-specific procedures 2. Premenopausal female aged 18 years and older on the day of signing of the informed consent form 3. Has a diagnosis of uterine fibroids that is confirmed by a pelvic ultrasound (transvaginal and/or transabdominal) performed during the screening period. 4. Has at least one or more of the following symptoms: 1. Heavy menses defined as PBAC (Pictorial Bleeding Assessment Chart) score ≥ 120 2. Pelvic pain during menses measured on NRS (Numeric Pain Rating Scale) ≥ 4 at baseline 3. Moderately severe fibroid-related symptoms (a score ≥ 25 on the Uterine Fibroid UF quality of life symptoms severity subscale) 5. Has a negative urine pregnancy test at the Screening, Baseline and interval clinic visits 6. Agrees to not be pregnant for at least 12 months. Participant may use any form of non-hormonal contraception consistently during the screening period . These may include: Diaphragm, cervical cap, spermicides, male and female condoms, copper IUD ( intra uterine device) and sponge. Each one will be explained in detail for the participants. However, the patient is not required to use dual contraception if she: 1. Has a sexual partner(s) who was vasectomized at least 6 months prior to the screening period. 2. Had a bilateral tubal occlusion (including ligation and blockage methods such as Essure™), at least 4 months prior to the first screening visit (patients with Essure™ must have prior confirmation of tubal occlusion by hysterosalpingogram); 3. Is not sexually active with men; periodic sexual relationship(s) with men requires the use of dual non-hormonal contraception as noted above; or 4. Practices total abstinence from sexual intercourse as her preferred lifestyle; periodic abstinence is not acceptable. 7. Has an endometrial (aspiration) biopsy, if clinically indicated, performed during the screening period, with results showing no clinically significant endometrial pathology (hyperplasia, endometritis, or endometrial cancer).
Exclusion criteria
Participants who choose not to undergo randomization and instead opt for the parallel group, selecting the standard of care (SOC) arm, are exempted from meeting the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fibroid recurrence on ultrasound after myomectomy. | 36 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants' quality of life assessed by the Quality of Life Questionnaire. | 36 months | 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. |
| Work Productivity and Activity Impairment assessed by Work Productivity and Activity Impairment Questionnaire. | 36 months | 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). |
| Female Sexual Function Impairment assessed by Female Sexual Function Index Questionnaire. | 36 months | 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. |
| Heavy menses recurrence after myomectomy with score ≥ 120 on Pictorial Bleeding Assessment Chart (PBAC). | 36 months | 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. |
| Pelvic pain recurrence after myomectomy with Numerical Rating Scale (NRS) ≥ 4 at baseline. | 36 months | 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). |
| The need for surgical/non-surgical reintervention for recurrent symptoms after myomectomy reported by the participant and based on her provider's decision. | 36 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORObianuju Sandra Madueke Laveaux, MD MPH
University of Chicago
Outcome results
None listed