At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered With Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
In Brief
A Phase 3 clinical trial evaluating Relugolix and Estradiol/norethindrone acetate for Heavy Menstrual Bleeding and Uterine Fibroid. Completed, enrolled 477 participants across 150 sites in 9 countries.
Detailed 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 weeks on heavy menstrual bleeding associated with uterine fibroids in participants who previously completed a 24-week treatment period in one of the pivotal studies (MVT-601-3001 or MVT-601-3002).
Study Details
Timeline
Interventions
Relugolix 40-mg tablet administered orally once daily
Capsule containing co-formulated tablet of E2 (1 mg) and NETA (0.5 mg) administered orally once daily