Fezolinetant treatment for hot flashes associated with menopause: a plain language summary of the SKYLIGHT 1 and SKYLIGHT 2 studies
Bibliographic record
Abstract
Plain Language SummaryWhat is this summary about?This summary includes information from the SKYLIGHT 1 and SKYLIGHT 2 studies. Both studies took place in Europe and North America between 2019 and 2021 with identical study designs. The studies looked at the effect of fezolinetant treatment on hot flashes/flushes and night sweats (also known as vasomotor symptoms) associated with menopause. Hot flashes are common, bothersome, and often continue for many years during menopause. All study participants took either a fezolinetant pill or a placebo pill. The placebo pill looked like the fezolinetant pill, but did not have medicine in it. Researchers wanted to find out how many hot flashes were reported, and how severe the hot flashes were. They also looked at side effects, sleep problems, and quality of life.What were the results?Compared with placebo, fezolinetant reduced the number and severity of hot flashes reported each day. By 3 months in SKYLIGHT 1, the number of hot flashes were cut in half for 57% who took 45 mg fezolinetant, 45% who took 30 mg fezolinetant, and 30% who took placebo. By 3 months in SKYLIGHT 2, the number of hot flashes were cut in half for 61% who took 45 mg fezolinetant, 51% who took 30 mg fezolinetant, and 43% who took placebo. Safety was similar for participants who took fezolinetant or placebo in these studies.What do the results mean?The results of the SKYLIGHT 1 and SKYLIGHT 2 studies showed that fezolinetant reduced the number and severity of hot flashes associated with menopause. Fezolinetant is now approved as a treatment option for moderate to severe hot flashes in many regions, including the United States, Europe, and Australia, at a dose of 45 mg once daily.How to say (download PDF and double click sound icon to play sound)…Fezolinetant: FEZ-oh-LIN-e-tantHormone: HOR-mownMenopause: MEH-nuh-pawzNeurokinin: NOOR-oh-KY-ninPlacebo: pluh-SEE-bohVasomotor: VAY-zoh-MOH-terThis is an abstract of the Plain Language Summary of Publication article.View the full Plain Language Summary PDF of this article to read the full-textLink to original article here
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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 | 0.007 | 0.017 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.006 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.019 | 0.002 |
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".