MedicalResearch.com Interview with:
Dr. James A. Simon, MD CCD, NCMP, FACOG
Clinical professor of obstetrics and gynecology
George Washington University, and
Medical director, Women’s Health & Research Consultants®
MedicalResearch.com: What is the background for this study?
Response: The Phase 2b uterine fibroids study was a 24-week, multicenter, double-blind, randomized, placebo-controlled, parallel group clinical trial that evaluated the efficacy and safety of elagolix alone or in combination with add-back therapy (estradiol/norethindrone acetate) in women with heavy uterine bleeding associated with uterine fibroids. Elagolix is currently being investigated in diseases that are mediated by sex hormones, such as uterine fibroids and endometriosis.
The study was conducted in 567 premenopausal women, age 18 to 51, at 100 sites in the United States, Canada, Puerto Rico, Chile and the United Kingdom. The two cohort design study evaluated the safety and efficacy of two elagolix treatment regimens (300mg BID and 600mg QD) alone and in combination with two different strengths of add-back therapy (estradiol/norethindrone acetate). The data presented were results from the 300mg cohort. Results from the 600mg cohort were similar and will be reported in a future publication.
Current non-surgical treatments indicated for uterine fibroids are limited, and women suffering from heavy menstrual bleeding associated with uterine fibroids need more options.
MedicalResearch.com: What are the main findings?
Response: The data demonstrated that elagolix, with and without add-back therapy, met the primary efficacy endpoint of reduced heavy menstrual bleeding as compared to placebo (p<0.001).
The effects of elagolix on heavy menstrual bleeding were rapid as evidenced by a significant reduction in the number of heavy bleeding days based on assessment at month six compared to placebo. Women treated with elagolix had significant increases in hemoglobin concentration from baseline to month six compared to placebo. Uninterrupted treatment with elagolix was associated with decreased symptom severity and improved quality of life as assessed by the Uterine Fibroid Symptom and QoL (UFS-QoL) questionnaire.
The most common adverse events reported were hot flushes, headache and insomnia, which occurred more frequently in the elagolix treatment groups compared to placebo. Add-back therapy reduced the incidence of hot flushes in a dose-dependent manner. All elagolix treatment groups had a decrease in mean endometrial thickness from baseline to month six compared to placebo and there were no adverse endometrial findings from the endometrial biopsies at baseline or month six. Reduction in bone mineral density associated with elagolix alone was attenuated when elagolix was co-administered with add-back therapy, with marginal effects on efficacy.
MedicalResearch.com: What should readers take away from your report?
Response: The results demonstrate that elagolix was well tolerated and has the potential to be an important treatment option for women suffering from heavy menstrual bleeding associated with uterine fibroids.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: These results support the Phase 3 elagolix uterine fibroids program, which includes two replicate, pivotal, six-month efficacy and safety studies followed by a six-month safety and efficacy extension study. The primary endpoint in Phase 3 studies will assess the reduction in heavy menstrual bleeding compared to placebo as measured by the alkaline hematin method.
MedicalResearch.com: Is there anything else you would like to add?
Response: I receive research support from AbbVie Inc., Allergan, Plc, Agile Therapeutics, Bayer Healthcare, New England Research Institute, Palatin Technologies, Symbio Research and TherapeuticsMD; served a speaker for Novo Nordisk, Shionogi Inc. and Valeant Pharmaceuticals; served as an advisor and/or consultant for AbbVie, Inc., Allergan, Plc, AMAG Pharmaceuticals, Inc., Ascend Therapeutics , Azure Biotech, Inc., Millendo Therapeutics, Inc., Nuelle, Inc., Radius Health, Inc., Regeneron Pharmaceuticals, Inc., Roivant Sciences, Inc., Sanofi S.A., Sebela Pharmaceuticals, Inc., Sermonix Pharmaceuticals, Inc., Shionogi Inc., Symbiotec Pharmalab, TherapeuticsMD and Valeant Pharmaceuticals and is a stockholder in Sermonix Pharmaceuticals.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Note: Content is Not inteed as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
More Medical Research Interviews on MedicalResearch.com