Treatment of Uterine Fibroid Symptoms with Relugolix Combination Therapy

Uterine fibroids are a common cause of heavy menstrual bleeding and pain. This study evaluated the efficacy and safety of once daily relugolix combination therapy (40 mg relugolix, 1 mg estradiol, and 0.5 mg norethindrone acetate) in women with fibroid-associated heavy menstrual bleeding. Two replicate international, double blind, phase 3 trials (LIBERTY 1 and LIBERTY 2) were conducted, involving 770 participants randomized to receive placebo, relugolix combination therapy, or delayed relugolix combination therapy. The primary efficacy endpoint was the percentage of participants achieving a response (menstrual blood loss <80 mL and ≥50% reduction from baseline). Results showed that 73% and 71% of participants in the relugolix combination therapy groups met the primary endpoint, compared to 19% and 15% in the placebo groups (P<0.001). Key secondary endpoints, including amenorrhea, pain reduction, and improved hemoglobin levels, were also significantly better with relugolix therapy. Bone mineral density was preserved, and adverse events were similar to placebo. The study concludes that relugolix combination therapy is effective and safe for managing fibroid symptoms.

Uterine fibroids are a common cause of heavy menstrual bleeding and pain. This study evaluated the efficacy and safety of once daily relugolix combination therapy (40 mg relugolix, 1 mg estradiol, and 0.5 mg norethindrone acetate) in women with fibroid-associated heavy menstrual bleeding. Two replicate international, double blind, phase 3 trials (LIBERTY 1 and LIBERTY 2) were conducted, involving 770 participants randomized to receive placebo, relugolix combination therapy, or delayed relugolix combination therapy. The primary efficacy endpoint was the percentage of participants achieving a response (menstrual blood loss <80 mL and ≥50% reduction from baseline). Results showed that 73% and 71% of participants in the relugolix combination therapy groups met the primary endpoint, compared to 19% and 15% in the placebo groups (P<0.001). Key secondary endpoints, including amenorrhea, pain reduction, and improved hemoglobin levels, were also significantly better with relugolix therapy. Bone mineral density was preserved, and adverse events were similar to placebo. The study concludes that relugolix combination therapy is effective and safe for managing fibroid symptoms.