At a glance
ClinicalIndex Comparison Record- ✓Premenopausal female aged 18–50 years
- ✓Regular menstrual cycles 21–38 days, ≤14 days duration, for ≥3 months before screening
- ✓Confirmed diagnosis of uterine fibroids on transvaginal and/or transabdominal ultrasound
- ✓Heavy menstrual bleeding ≥160 mL in 1 cycle or ≥80 mL per cycle for 2 cycles (alkaline hematin method)
- ✕Ultrasound pathology other than uterine fibroids contributing to heavy menstrual bleeding
- ✕Rapidly enlarging uterine fibroids per investigator assessment
- ✕Weight exceeds DXA scanner limit or inadequate lumbar spine/proximal femur measurement
- ✕History of or current osteoporosis, metabolic bone disease, hyperparathyroidism, hyperprolactinemia, hyperthyroidism, anorexia nervosa, or low-trauma fracture (except toe, finger, skull, face, ankle)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
LIBERTY 2: 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
In Brief
A Phase 3 clinical trial evaluating Relugolix, Estradiol/norethindrone acetate, and 2 other interventions for Heavy Menstrual Bleeding and Uterine Fibroid. Completed, enrolled 382 participants across 127 sites in 8 countries.
Detailed Summary
The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.
Study Details
Timeline
Interventions
Relugolix (40 mg) tablet administered orally once daily.
E2 (1.0 mg)/NETA (0.5 mg) co-formulated capsule administered orally once daily.
Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the capsule containing E2/NETA in size, shape, color, and odor.