Pharmaceutical research company AbbVie, in partnership with Neurocrine Biosciences, Inc., recently concluded Phase 2b of a clinical trial evaluating the safety and effectiveness of elagolix, a drug used to treat uterine fibroids, alone or in combination with add-back therapy compared to placebo.
Trial participants were women who suffered from heavy menstrual bleeding as a result of uterine fibroids. Preliminary study results showed elagolix, with or without add-back therapy, reduced heavy menstrual bleeding as compared to placebo.
Uterine fibroids are benign muscle tissue tumors in the uterus. They are most common in women age 30-40, but are found in women of all ages. They vary greatly in size and can be asymptomatic; however, some women with uterine fibroids suffer from heavy, painful periods, vaginal bleeding outside of menstruation, abdominal or lower back pain, difficulty urinating, frequent urination, painful intercourse, constipation or rectal pain.
"The positive results from this trial represent an important milestone in the development of elagolix as a potential new treatment option for women suffering from heavy menstrual bleeding associated with uterine fibroids," Michael Severino, executive vice president of research and development and chief scientific officer for AbbVie, said. "Our clinical research with elagolix for the treatment of uterine fibroids complements ongoing Phase 3 endometriosis research. These two development programs demonstrate AbbVie's continued commitment to therapeutic advances in women's health care."
Some adverse reactions to elagolix were reported. These include hot flush, headache, nausea, and vomiting.
The Phase 3 program for elagolix is slated to start in the first quarter of 2016.
Additionally, Elagolix Uterine Fibroid Phase 2a data have been accepted for presentation at the 2015 Annual Meeting of the American Society of Reproductive Medicine, which will take place in Baltimore in October.
Research on medication used to treat uterine fibroids moving forward