At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An International Phase 3 Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
In Brief
A Phase 3 clinical trial evaluating Relugolix, Estradiol/norethindrone acetate, and 2 other interventions for Uterine Leiomyoma and Uterine Fibroids. Completed, enrolled 229 participants across 104 sites in 8 countries.
Detailed 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 up to 104 weeks in patients with uterine fibroids who have completed a total of 52 weeks of treatment, including a 24-week treatment period in a parent study (study MVT-601-3001 or MVT-601-3002) and a 28-week treatment period in the open-label extension study (MVT-601-3003), and who meet the definition of responder, defined as a patient who demonstrates a menstrual blood loss of \< 80 mL and at least a 50% reduction from parent study baseline menstrual blood loss volume on the alkaline hematin analysis of the feminine products returned at Week 48 in the extension study.
Study Details
Timeline
Interventions
Relugolix 40 mg tablet administered orally once daily
Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily
Placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor
Placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor