Early onset, maintenance of effect, and day-/night-time findings following fezolinetant treatment for moderate to severe vasomotor symptoms associated with menopause: A pooled phase 3 analysis
Bibliographic record
Abstract
OBJECTIVES: To evaluate onset of action, maintenance of effect, day-/night-time efficacy, and treatment response with fezolinetant for the treatment of vasomotor symptoms (VMS) using phase 3 data. STUDY DESIGN: SKYLIGHT 1 and 2 enrolled individuals (≥40-≤65 years) assigned female at birth who were seeking treatment/relief from moderate to severe VMS. Participants were randomised to placebo, or fezolinetant 30 or 45 mg for 12 weeks. Subsequently, fezolinetant-treated participants continued their dose and placebo participants were re-randomised to fezolinetant 30 or 45 mg for 40 weeks. MAIN OUTCOME MEASURES: Daily frequency and severity of VMS during week 1, up to week 12, over 52 weeks, during the day and night; and proportion of responders. RESULTS: Improvements in VMS frequency and severity with fezolinetant versus placebo were observed from day 1 (1022 participants). At weeks 1 and 12, least squares mean (95 % confidence interval [CI]) reductions in VMS frequency for fezolinetant 45 mg versus placebo were - 1.46 (-2.01, -0.92) and - 2.51 (-3.20, -1.82). VMS frequency and severity improvements were maintained throughout 52 weeks and for both the day- and night-time assessments. A greater proportion of fezolinetant-treated participants had a reduction of ≥50 % in VMS frequency from baseline to week 12 versus placebo (58.7 % versus 36.0 %, odds ratio [95 % CI]: 2.542 [1.868-3.472]). Similar trends were noted with 30 mg. CONCLUSIONS: The onset of action for fezolinetant was observed from day 1 for VMS frequency and severity and was maintained for 52 weeks. Fezolinetant can provide rapid and prolonged relief from VMS. CLINICAL TRIAL REGISTRATION: SKYLIGHT 1 ClinicalTrials.gov: NCT04003155 (https://clinicaltrials.gov/ct2/show/NCT04003155). SKYLIGHT 2 ClinicalTrials.gov: NCT04003142 (https://clinicaltrials.gov/ct2/show/NCT04003142).
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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 | 0.011 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.015 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
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".