Status:
COMPLETED
LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Lead Sponsor:
Myovant Sciences GmbH
Conditions:
Heavy Menstrual Bleeding
Uterine Fibroid
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with estradiol (E2) and norethindrone acetate (NETA) for 28 week...
Detailed Description
This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that enrolled eligible participants who have completed their participation in one of the ph...
Eligibility Criteria
Inclusion
- Key
- 1\. Completed 24 weeks of study drug treatment and study participation in either pivotal study, MVT-601-3001 or MVT-601-3002
- Key
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 pivotal study (MVT-601-3001 or MVT-601-3002)
- Met a withdrawal criterion in the pivotal study (MVT-601-3001 or MVT-601-3002).
Key Trial Info
Start Date :
October 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2021
Estimated Enrollment :
477 Patients enrolled
Trial Details
Trial ID
NCT03412890
Start Date
October 19 2017
End Date
January 13 2021
Last Update
May 9 2024
Active Locations (150)
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Andalusia
Andalusia, Alabama, United States, 36420
2
Birmingham
Birmingham, Alabama, United States, 35205
3
Mobile
Mobile, Alabama, United States, 36608
4
Mesa
Mesa, Arizona, United States, 85209