LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Condition: Heavy Menstrual Bleeding; Uterine Fibroid
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the long-term efficacy and safety of relugolix 40
      milligrams (mg) once daily co-administered with low-dose 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 parent studies
      (MVT-601-3001 or MVT-601-3002).
    

Detailed description: 
      This study is an international phase 3 open-label, single-arm, long-term efficacy and safety
      extension study that will enroll eligible participants who have completed their participation
      in one of the phase 3 randomized, double-blind, placebo-controlled parent studies,
      MVT-601-3001 (LIBERTY 1 - NCT03049735) or MVT-601-3002 (LIBERTY 2 - NCT 03103087). All
      participants will receive relugolix 40 mg orally once daily co-administered with low-dose E2
      (1.0 mg) and NETA (0.5 mg) for 28 weeks.

      Approximately 600 women with heavy menstrual bleeding associated with uterine fibroids will
      be enrolled, after having completed a 24-week treatment period in one of the parent studies.
      The objectives of the study are to evaluate long-term efficacy and safety through up to 52
      weeks of treatment (including treatment during the parent study) of relugolix co-administered
      with low-dose E2/NETA.

      Screening and baseline procedures will be done at the same visit for this extension study
      (referred to as the "Week 24/Baseline Visit"), which coincides with the Week 24 Visit from
      the parent study, and will be defined as the date of completion of the last Week 24 procedure
      in the parent study. Participants will have received their last dose of study drug in the
      parent study on the day prior to the Week 24/Baseline Visit and will receive their first dose
      of study drug for this extension study in the clinic after the participant is determined to
      be eligible for this extension study and has provided informed consent to participate. The
      administration of the first dose of study drug for MVT-601-3003 will define enrollment into
      this study. Study participants will then take the open-label study treatment orally once
      daily for 28 weeks.
    

Intervention name(s): Relugolix; Estradiol/norethindrone acetate
Intervention type(s): Drug; Drug
Intervention description(s): Relugolix 40-mg tablet administered orally once daily; Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily
Other intervention name(s): MVT-601; TAK-385; E2/NETA; Low-dose hormonal add-back
Intervention MeSH terms: Norethindrone; Norethindrone Acetate; Estradiol; Relugolix
Intervention model: Single Group Assignment
Intervention model description: Open-Label Extension
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uterine Fibroid; Heavy Menstrual Bleeding; Menstrual Blood Volume