AbbVie begins enrolment for new uterine fibroid drug trial

AbbVie has commenced enrolment for the first of two planned phase III trials assessing its drug Elagolix in the treatment of uterine fibroids.

Conducted in cooperation with Neurocrine Biosciences, the studies will evaluate the safety and efficacy of Elagolix alone or in combination with add-back therapy compared to placebo.

The aim will be to assess changes in menstrual blood loss utilising the alkaline haematin method, comparing baseline to results after six months of treatment. Additional secondary efficacy endpoints include changes in fibroid volume, monthly blood loss and haemoglobin levels.

Uterine fibroids are noncancerous muscle tissue tumors of the uterus that can cause symptoms such as heavier menstrual bleeding, pain, difficulty urinating, frequent urination, constipation or rectal pain.

Dr Michael Severino, executive vice-president for research and development and chief scientific officer at AbbVie, said: "There are limited non-surgical treatment options for women suffering from heavy menstrual bleeding associated with uterine fibroids. AbbVie is eager to further explore Elagolix's potential to address this unmet need."

This comes after the firm commenced enrolment for six phase III clinical trials assessing a new pan-genotypic hepatitis C regimen earlier this month.