LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

This study is an international phase 3 open-label, single-arm, long-term efficacy and safety
extension study that will enroll eligible patients 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 patients will
receive relugolix 40 mg once daily co-administered with low-dose estradiol (1.0 mg) and
norethindrone acetate (0.5 mg) for up to 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 estradiol/norethindrone acetate.

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. Patients 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 patient 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.

Key Inclusion Criteria:

1. Completed 24 weeks of study drug treatment and study participation in either
MVT‑601‑3001 or MVT‑601‑3002

Key Exclusion Criteria:

1. 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 (MVT‑601‑3001 or MVT‑601‑3002)

2. Met a withdrawal criterion in the parent study (MVT‑601‑3001 or MVT‑601‑3002).