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 distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".