Phase 3 Trials Set to Evaluate Uterine Fibroid Drug

Elagolix is an oral gonadotropin releasing hormone antagonist.

Two phase 3 clinical trials will test the safety and efficiency of Elagolix monotherapy or in combination with add-back therapy compared with placebo in patients with uterine fibroids.

Elagolix is an oral gonadotropin releasing hormone (GnRH) antagonist. Thus far, the drug has been studied in more than 40 trials with including more than 3000 patients.

AbbVie, who manufactured the drug in collaboration with Neurocrine Biosciences, will make a $15 million payment to Neurocrine upon the first patient’s enrollment into the trial.

"There are limited, nonsurgical treatment options for women suffering from heavy menstrual bleeding associated with uterine fibroids,” said Michael Severino, MD, executive vice president of research and development and chief scientific officer for AbbVie.

The studies will use the alkaline hematin method to determine changes in menstrual blood loss at baseline compared with month six of treatment. The study secondary efficacy endpoints will examine changes in fibroid volume, monthly blood loss, hemoglobin levels and bone mineral density.

Uterine fibroids are noncancerous muscle tissue tumors located in the uterus. These tumors can vary in size with the larger ones distorting the uterus.

The condition can be asymptomatic for some women. Although fibroids can form at any age, it most commonly occurs in women between the ages of 30 and 40 years.

The 2 randomized, parallel, double-blind, and placebo controlled clinical trials will enroll approximately 400 patients, who will receive an initial 6 month placebo controlled dose. At this point, eligible patients will continue for an additional 6 months in a safety and efficiency extension study.