Long-Term Safety of Elagolix With Hormonal Add-Back Therapy in Women With Endometriosis-Associated Pain: 24-Month Results [A86]
Bibliographic record
Abstract
INTRODUCTION: Elagolix is an oral GnRH antagonist approved for the treatment of moderate to severe endometriosis-associated pain (EAP) in the US, Canada, and Israel. Hormonal add-back therapy (1 mg estradiol/0.5 mg norethindrone acetate QD) may alleviate the hypoestrogenic effects (including bone mineral density [BMD] loss) associated with elagolix. The long-term safety of elagolix 200mg BID+add-back are currently under investigation in an ongoing phase 3, 48-month (M) study for EAP; this report focuses on open label safety results to 24M. METHODS: Premenopausal women with moderate-to-severe EAP were initially randomized 4:1:2 to receive elagolix 200 mg BID+add-back, elagolix 200 mg BID, or placebo for 12M, followed by open-label elagolix 200 mg BID+add-back for 36M. This 24M analysis assessed long-term safety including BMD. RESULTS: BMD measurements remained stable during the open label treatment period. At 24M, mean percent change from baseline in BMD for patients who initially received elagolix 200 mg BID+add-back (n=123), elagolix 200 mg BID (n=29), or placebo (n=60) was −0.85%, −1.21%, and −0.43% (spine); −0.23%, −0.58%, and −0.20%, (total hip); and −1.05%, −0.98%, and 0.14% (femoral neck). During the open-label period, safety profiles were generally similar across all three original treatment groups at 24M; rates of serious adverse events were generally low (less than 5%) and balanced across groups. CONCLUSION: Elagolix 200 mg BID+add-back therapy for 24M continues to have a favorable safety profile with minimal long-term impact on BMD. Combined with previously reported improvements in dysmenorrhea and non-menstrual pelvic pain, these safety data suggest elagolix 200 mg BID+add-back may provide a longer-term therapeutic option for women with EAP.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".