LIBERTY 1
Research type
Research Study
Full title
An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co-Administered with and without Low-Dose Estradiol and Norethindrone Acetate in Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids
IRAS ID
222140
Contact name
Nicholas Raine-Fenning
Contact email
Sponsor organisation
Myovant Sciences, GmbH
Eudract number
2016-003727-27
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
131161, IND number
Duration of Study in the UK
1 years, 1 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.
Up to 390 female patients, aged between 18-50 years old, will be recruited to this study at approximately 120 sites globally. Eligible participants will be randomised equally to 1 of 3 groups. The first group will receive a daily 40 mg tablet of relugolix plus a daily capsule of low-dose oestradiol and norethindrone (a combination medicine used to treat menopause symptoms and to prevent bone loss) for 24 weeks. The second group will receive a daily 40 mg relugolix tablet plus a daily placebo capsule for 12 weeks followed by daily 40 mg relugolix tablet plus a daily low-dose oestradiol and norethindrone capsule for the next 12 weeks. The final group will receive a daily placebo tablet and capsule for 24 weeks.
Participants will undergo various tests and procedures including blood samples, urine samples, electrocardiograms, physical examinations and eDiary/questionnaire completion. 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
17/EM/0157
Date of REC Opinion
12 Jun 2017
REC opinion
Further Information Favourable Opinion