Increased rates of mild or moderate hot flushes but <1% and 3% discontinuation in the lower-dose and higher-dose groups respectively
Higher levels of serum lipids (<20%)
Decreased bone mineral density z scores (lumbar spine) ≤ −1.5 or less after 6 months was 1.1% in the lower-dose and 3.3% in the higher-dose compared to 0.4% in the placebo group in the EM-I study and similar findings were noted in EM-II
No adverse endometrial findings were reported
Pregnancies were reported with no abnormal outcomes however sample size too small to draw conclusions
High and low doses of elagolix effectively improved dysmenorrhea and nonmenstrual pelvic pain in women with endometriosis-associated pain and results were sustained at 6 months
Analysis of data beyond 6 months as well as outcomes following multiple courses are still required for longer term use and safety profiling
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