A recent phase III clinical trial found that a drug previously approved to treat endometriosis, called Elagolix, was effective in reducing heavy menstrual bleeding in women with uterine fibroids.
The study, published in the New England Journal of Medicine, was co-authored by Eve Feinberg, MD, ’04 GME, associate professor of Obstetrics and Gynecology in the Division of Reproductive Endocrinology and Infertility.
“Right now, the tools that we have for fibroids are either medical treatment, which historically has not worked very well, versus surgery and this drug may be an alternative to surgery that may offer true relief from the disease,” Feinberg said, who served on the Data Safety Monitoring Board and as a consultant to AbbVie for the clinical trial.
Uterine fibroids, also called leiomyomas or myomas, are typically noncancerous growths that often appear in a woman’s uterus during reproductive years, typically in her 20s to 40s. Although a majority of uterine fibroids are not malignant and not associated with an increased risk of uterine cancer, they can cause severe pelvic pain and menstrual bleeding.
The current study consisted of a multi-institution, randomized six-month phase three clinical trial. A group of 412 women with fibroid-associated bleeding were given a dose of 300 milligrams twice daily with hormonal therapy, or in this case add-back therapy, while another group of 378 women with the same condition were given a placebo.
Overall, the scientists found the drug coupled with add-back therapy to be very effective in reducing heavy menstrual bleeding. The mechanisms of the drug specifically block a hormone produced by the brain’s hypothalamus known as GnRH, which slow the body’s ability to secrete GnRH with the downstream effects of inhibiting ovulation and the production of estrogen, ultimately reducing the likelihood fibroids formation and menstrual bleeding, according to Feinberg.
“The degree of success we saw with the drug was remarkable. The findings were not even borderline significant, they were really significant in terms of how much this drug helped reduce menstrual bleeding,” Feinberg said.
Feinberg noted that the drug used long-term can reduce a woman’s estrogen levels, which can cause a reduction in bone mineral density. The drug is recommended to be used in conjunction with add-back therapy, in the form of low dose estrogen therapy, to prevent bone density loss.
When taken properly, the drug also reduces a woman’s chances of getting pregnant, though it is not recommended to be used as a contraceptive, according to Feinberg, adding that the length of time a patient takes the drug is dependent on how close she is to menopause, the severity of her fibroids and personal treatment goals. Women must use contraception when taking the drug, according to Feinberg.
As for next steps, Feinberg said she looks forward to testing the drug in other applications, such as helping to reduce the number of injections for patients undergoing in vitro fertilization. The drug was also recently tested in another clinical trial, also co-authored by Feinberg, in patients diagnosed with endometriosis.
This work was supported by AbbVie. Feinberg was also a consultant for AbbVie on a phase I trial for the drug.