Study drug Myfembree for Leiomyoma

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of Chicago South Loop, Chicago, IL
Leiomyoma+3 More
Myfembree Oral Product - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Leiomyoma
  • Metrorrhagia
  • Menorrhagia
  • Pelvic Pain

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Leiomyoma

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 36 months

36 months
Female Sexual Function Impairment assessed by Female Sexual Function Index Questionnaire.
Fibroid recurrence on ultrasound after myomectomy.
Heavy menses recurrence after myomectomy with score ≥ 120 on Pictorial Bleeding Assessment Chart (PBAC).
Participants' quality of life assessed by the Quality of Life Questionnaire.
Pelvic pain recurrence after myomectomy with Numerical Rating Scale (NRS) ≥ 4 at baseline.
The need for surgical/non-surgical reintervention for recurrent symptoms after myomectomy reported by the participant and based on her provider's decision.
Work Productivity and Activity Impairment assessed by Work Productivity and Activity Impairment Questionnaire.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Leiomyoma

Trial Design

2 Treatment Groups

Standard of Care
1 of 2
Study drug Myfembree
1 of 2
Active Control
Experimental Treatment

136 Total Participants · 2 Treatment Groups

Primary Treatment: Study drug Myfembree · No Placebo Group · Phase 4

Study drug Myfembree
Drug
Experimental Group · 1 Intervention: Myfembree Oral Product · Intervention Types: Drug
Standard of CareNoIntervention Group · 1 Intervention: Standard of Care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months
Closest Location: University of Chicago South Loop · Chicago, IL
Photo of Chicago  1Photo of Chicago  2Photo of Chicago  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Leiomyoma
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have voluntarily signed and dated the informed consent form prior to initiation of any screening or study-specific procedures.
You are female and aged 18 years and older.\n
Pain during menses is measured on NRS (Numeric Pain Rating Scale) ≥ 4 at baseline.
You have moderate to severe fibroid-related symptoms.
You have not had a positive urine pregnancy test at the Screening, Baseline and interval clinic visits.
You are not sexually active with men; periodic sexual relationship(s) with men requires the use of dual non-hormonal contraception as noted above; or Practices total abstinence from sexual intercourse as her preferred lifestyle; periodic abstinence is not acceptable.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.