LIBERTY EXTENSION
Research type
Research Study
Full title
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
IRAS ID
236547
Contact name
Nicholas Raine-Fenning
Contact email
Sponsor organisation
Myovant Sciences GmbH
Eudract number
2017-003310-74
Clinicaltrials.gov Identifier
131161, IND number
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Fibroids are non-cancerous growths that develop in or around the womb (uterus). Around 1 in 3 women develop them at some point in their life. They most often occur in women aged 30-50. Approximately 25% of women with fibroids develop symptoms requiring treatment. The most problematic symptom for women with uterine fibroids is heavy menstrual bleeding (heavy periods). The exact cause of these fibroids is unknown. Few medical options are available for patients; the current mainstay of treatment being surgery.
Relugolix is being developed as a treatment of heavy menstrual bleeding associated with uterine fibroids. Relugolix blocks certain receptors in the pituitary gland (a pea-sized gland, located at the bottom of the brain, involved in hormone control) leading to suppression of oestrogen which has been shown to improve symptoms of uterine fibroids.
The LIBERTY EXTENSION study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that will enrol eligible patients who have completed their participation in one of the phase 3 randomised, double-blind, placebo-controlled parent studies (MVT-601-3001 or MVT-601-3002). All patients will receive oral relugolix 40 mg once daily co-administered with low-dose oestradiol 1.0 mg and norethindrone acetate 0.5 mg for up to 28 weeks. Approximately 600 women (aged 18 to 51) with heavy menstrual bleeding associated with uterine fibroids will be enrolled at approximately 240 sites globally. 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) with relugolix co-administered with low-dose oestradiol/norethindrone acetate. Eligible patients will have completed participation in one of the parent studies and consented to participate in this extension study.
Participants will also be required to collect their used sanitary products during the study so that menstrual blood loss can be measured.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
18/EM/0007
Date of REC Opinion
21 Mar 2018
REC opinion
Further Information Favourable Opinion