CHAMGAP
VERIFIEDPassed the Codex final verification and publication gate. Evidence-verification cutoff: 2026-07-24. AI was used for research and drafting; the existence of all 2 cited sources was verified at the original page, followed by blind grading, adversarial audit, and build validation. Methodology v1.0.
Verdict No. 1816 · Search date 2026-07-24 · Methodology v1.0

Elagolix,
does it really help with Response in endometriosis-associated dysmenorrhea and nonmenstrual pelvic pain?

30-Second Summary
C
Evidence Grade C · 54 · Safety caution
Pain responses were large in two phase 3 trials, but independent replication is absent
Hot flushes and lipid increases are common, and bone mineral density can fall with dose and duration. Pregnancy potential, osteoporosis risk, liver disease, and interacting medicines require clinician review.
What the
research shows
Elagolix is rated C for endometriosis-associated pain. The actual modified intention-to-treat primary analyses included 865 of 872 randomized participants in EM-I and 799 of 817 in EM-II. Both trials met the month-3 coprimary responder endpoints for dysmenorrhea and nonmenstrual pelvic pain. Response required a reduction on the 0-to-3 pain scale meeting a prespecified ROC-derived threshold without increased rescue analgesic use. All decisive evidence belongs to the AbbVie development program, so the I0 ceiling limits the grade to C.
What the
ads claim
The supported fact is increased pain response over three to six months. Claims of permanent cure or lesion removal go beyond the evidence.
*

Useful facts when choosing a product

  • A responder met a trial-specific prespecified ROC-derived reduction on the 0-to-3 pain diary and did not increase rescue analgesic use.
  • verdict 653, which is B with 66 points, concerns dienogest in the same indication. Verdict 1626, which is B with 75 points, concerns linzagolix in uterine fibroids, a different indication, so its evidence was not transferred.
ID

Chamgap Semantic Classification Code

Candidate index · review held

M.elagolix.MULTI.response-in-endometriosis-associated-dysmenorrhea-and-nonmenstrual-pelvic-pain.assess.placebo

Medicinal interventions > Elagolix > Multiple: primary unresolved > Response in endometriosis-associated dysmenorrhea and nonmenstrual pelvic pain > Association or change assessment > Placebo

An automated migration candidate, not an issued permanent code; exact claim scope remains under review. This machine-generated migration candidate helps retrieval but is not a permanent assignment. The original verdict ID and URL remain authoritative.

Download semantic index (JSON) · Codebook v1

Gap Measurement · Verdict 1816 · C 54
What advertising claims
What independent, higher-quality research supports
△ GAP
01

What the research actually shows

Taylor and colleagues randomized 872 women in EM-I and analyzed 865 by modified intention to treat; EM-II randomized 817 and analyzed 799. The month-3 coprimary endpoints combined a clinically meaningful pain reduction with decreased or stable rescue-analgesic use. Prespecified ROC-derived thresholds were -0.81 for dysmenorrhea and -0.36 for nonmenstrual pain in EM-I, and -0.85 and -0.43 in EM-II. High-dose dysmenorrhea response was 75.8% and 72.4% versus 19.6% and 22.7%; nonmenstrual pain response was 54.5% and 57.8% versus 36.5% in both placebo groups. AbbVie sponsored, designed, and analyzed both trials, so they are not independent replication.

02

Why this is classified as C (54)

The profile is P, R1, I0, E+, and B0. The same AbbVie development program is not independent replication, and manufacturer-only evidence caps the result at C with 54 points.

Counterpoint. Choice against dienogest and other therapies should separately weigh contraindications, cost, pregnancy plans, and hypoestrogenic effects.

Rejudgment record. Cross-check applied — Accepted two positive phase 3 trials while rating the same AbbVie development program as R1 and I0

Stored scoring profile
EndpointPSymptom or function itself is the target - including patient reports and performance tests
ReplicationR1Single confirmatory trial
IndependenceI0Evidence comes only from manufacturer studies
Effect sizeE+Meets the clinically important threshold

Stored derived and displayed grades match; this is not a current recalculation or validity check (C).

Sub-claim grades by effect

This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.

Effect (sub-claim)GradeBasis
Response in endometriosis-associated dysmenorrheaCA large clinical response was replicated in two phase 3 trials, but evidence is manufacturer-only.
Response in endometriosis-associated nonmenstrual pelvic painCThe coprimary endpoint succeeded in both trials, but the I0 ceiling applies.
Maintenance of endometriosis pain improvement through three to six monthsCResponse persisted through six months within the same manufacturer program.

Cross-check — AI research and Codex final gate

AI was used for research and drafting. Blind grading, adversarial audit, and the methodology boundary rules were then reapplied before Codex performed the final evidence, grade, copy, and build checks. If a grade cannot be narrowed, both evidence positions and their reasons are published.
03

Evidence Table

StudyDesignSampleFundingEndpointResultWeight
Taylor HS et al. 2017 ELARIS EM-IPhase 3 double-blind randomized placebo-controlled trial872 randomized; actual modified intention-to-treat primary analysis 865Manufacturer funding, design, and analysis by AbbVieCoprimary month-3 dysmenorrhea and nonmenstrual pelvic-pain responseBoth doses met both coprimary endpoints; high dose was 75.8% and 54.5% versus 19.6% and 36.5% with placebo.Pivotal manufacturer confirmatory trial
Taylor HS et al. 2017 ELARIS EM-IIPhase 3 double-blind randomized placebo-controlled trial817 randomized; actual modified intention-to-treat primary analysis 799Manufacturer funding, design, and analysis by AbbVieCoprimary month-3 dysmenorrhea and nonmenstrual pelvic-pain responseBoth doses met both coprimary endpoints; high dose was 72.4% and 57.8% versus 22.7% and 36.5% with placebo.Replication within the same manufacturer program
§

Receipt — 2 References

All 2 cited sources were verified for existence at the original page (as of 2026-07-24).

Taylor HS, Giudice LC, Lessey BA, et al. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017;377(1):28-40. PMID: 28525302. DOI: 10.1056/NEJMoa1700089.
checked
Diamond MP, Carr B, Dmowski WP, et al. Elagolix treatment for endometriosis-associated pain: results from a phase 2, randomized, double-blind, placebo-controlled study. Reprod Sci. 2014;21(3):363-371. PMID: 23885105. DOI: 10.1177/1933719113497292.
checked
Research and draft: AI used · Cross-check: blind grading and adversarial audit
Final verification and publication gate: Codex · Evidence date: 2026-07-24 · Corrections: none

Cite this verdict

Elagolix x reduced endometriosis-associated pain Evidence Grade C card
[Chamgap] Elagolix x reduced endometriosis-associated pain — Evidence Grade C·54. 2 cited sources checked. Source: https://chamgap.com/en/verdicts/womens/elagolix-endometriosis-dysmenorrhea-pelvic-pain/ · CC BY 4.0

CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.

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What this document does and does not do

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