Status:
COMPLETED
Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Lead Sponsor:
Myovant Sciences GmbH
Conditions:
Uterine Leiomyoma
Uterine Fibroids
Eligibility:
FEMALE
18-51 years
Phase:
PHASE3
Brief Summary
The objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for u...
Detailed Description
This randomized withdrawal study is an international phase 3 double-blind, placebo-controlled study that will enroll eligible patients with uterine fibroids who have completed the 24-week treatment pe...
Eligibility Criteria
Inclusion
- Completed the open-label extension study (MVT-601-3003).
- Is a responder: Has a menstrual blood loss of \< 80 mL AND at least a 50% reduction from the parent study Baseline based on the results of the alkaline hematin testing performed on the feminine products returned at the Week 48 visit of the extension study.
- Is not expected to undergo gynecological surgery or ablation procedures for uterine fibroids within the study period
Exclusion
- Has undergone myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance guided focused ultrasound for fibroids, or endometrial ablation for abnormal uterine bleeding at any time during the Parent study or extension study.
- Has a weight that exceeds the weight limit of the dual-energy x-ray absorptiometry (DXA) scanner
- Has developed any contraindication to treatment with estradiol or norethindrone acetate
- Is currently pregnant or lactating, or intends to become pregnant during the study period
- Met a withdrawal criterion in the open-label extension (OLE) study.
Key Trial Info
Start Date :
October 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2021
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT03751124
Start Date
October 16 2018
End Date
October 20 2021
Last Update
June 25 2024
Active Locations (104)
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1
Birmingham
Birmingham, Alabama, United States, 35205
2
Mesa
Mesa, Arizona, United States, 85209
3
Tucson
Tucson, Arizona, United States, 85712
4
Canoga Park
Canoga Park, California, United States, 91303