Baseline endometriosis-associated pain burden: Data from 1600+ women enrolled in elagolix clinical trials
Bibliographic record
Abstract
Background: The daily pain burden experienced by women with endometriosis has not been well studied. Objective: To characterize baseline pain among women with moderate-to-severe endometriosis-associated pain enrolled in phase 3 studies of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist. Study design: Data were pooled from the screening phase of two randomized, double-blind, placebo-controlled clinical trials. After cessation of endometriosis medications, patients entered the screening phase during which symptoms (dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia) and rescue medication use were recorded daily in electronic diaries. Endometriosis-associated pain was also scored using the Numeric Rating Scale (range 0–10). Baseline was defined as the last 35 days during the screening period. Results: Endometriosis-associated pain was reported by the 1686 study participants on most days during the baseline interval. Pain was often moderate or severe, with a mean Numeric Rating Scale score of 5.6 ± 1.7. Women reported dysmenorrhea an average of 8.1 ± 3.0 days (97.9% ± 7.0% of menstruating days), nonmenstrual pelvic pain on 20.5 ± 5.4 days (90.3% ± 15.8% of nonmenstruating days), and dyspareunia on 8.7 ± 8.0 days (81.7% ± 29.7% of sexually active days). When they occurred, dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia were frequently moderate or severe in intensity. Women were free of pelvic pain for an average of 2.4 ± 3.9 days during the 35-day evaluation interval. Conclusion: Among women with untreated moderate-to-severe endometriosis pain, the daily burden of pain was extensive, both during menstruation and on nonmenstruating days.
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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 | 0.011 | 0.013 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 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".