Effect of fezolinetant on patient-reported quality-of-life outcomes: Data from a phase 3b study (DAYLIGHT) of the treatment of moderate to severe vasomotor symptoms associated with menopause in women considered unsuitable for hormone therapy
Bibliographic record
Abstract
OBJECTIVE: To report patient-reported quality-of-life (QOL) outcomes in the DAYLIGHT study. STUDY DESIGN: DAYLIGHT was a phase 3b, randomized, double-blind, 24-week, placebo-controlled study. Participants were women aged ≥40 to ≤65 years with moderate to severe vasomotor symptoms (VMS) considered unsuitable for hormone therapy (HT) (contraindications, caution, stoppers, or averse) randomized 1:1 to placebo or fezolinetant 45 mg once daily. MAIN OUTCOME MEASURES: Primary endpoint: mean change in daily VMS frequency of moderate to severe episodes from baseline to week 24. Secondary: patient-reported sleep disturbance (PROMIS SD SF 8b). Exploratory: patient-reported sleep disturbance (Patient Global Impression of Severity/Change in Sleep Disturbance [PGI-S/PGI-C SD]), menopause and VMS-related QOL (Female Sexual Function Index [FSFI], Menopause-Specific Quality of Life [MENQOL], Patient Global Impression of Change in Vasomotor Symptoms [PGI-C VMS], Work Productivity and Activity Impairment questionnaire specific to VMS [WPAI-VMS]), and general QOL (European Quality of Life 5 Dimensions 5 Level Version [EQ-5D-5L], Patient Health Questionnaire for Anxiety and Depression [PHQ-4]). RESULTS: Overall, 452 women received at least one dose of study drug (placebo n = 226; fezolinetant n = 226): HT contraindicated (50; 11 %), caution (165; 37 %), stoppers (69; 15 %), and averse (168; 37 %). DAYLIGHT results showed statistically significant reductions in VMS frequency/severity in the fezolinetant group versus placebo at week 24. Week 24 improvements were seen in the fezolinetant group versus placebo in: PROMIS SD SF 8b total score (least squares [LS] mean difference: -2.5; 95 % CI: -3.9, -1.1; p < 0.001), MENQOL total score (LS mean difference: -0.44; 95 % CI: -0.69, -0.18; p < 0.001), and WPAI-VMS (activity impairment [p < 0.001], overall work productivity loss [p = 0.036], and presenteeism [p = 0.002] domains). A higher proportion of participants in the fezolinetant group reported positive changes in sleep disturbance (PGI-C SD, p < 0.001), sleep disturbance severity (PGI-S SD, p = 0.042), and VMS (PGI-C VMS, p < 0.001) versus placebo. CONCLUSIONS: Patient-reported outcomes demonstrate that reductions in VMS frequency with fezolinetant treatment were associated with improvements in QOL.
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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 | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| 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".