A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause (NCT06112756), a randomized phase 2 study. The primary outcome is Change From Baseline in Wakefulness After Sleep Onset (WASO) at Week 4 as Measured by Polysomnography (PSG).

2. Clinical Question

The study was a Phase 2 pilot trial with a planned treatment period of 12 weeks. Its stated main purpose was to examine sleep disturbances using polysomnography, a sleep test. The primary endpoint was the change in WASO at week 4. The registry also describes assessment of WASO at week 12 and sleep efficiency at both week 4 and week 12, as well as participant-reported sleep disturbance and insomnia measures.

The clinical question is comparative: it concerns the difference in changes between the assigned groups, not simply whether participants in either group changed from their own baseline. The posted primary comparison estimates a larger reduction in WASO in the elinzanetant group than in the placebo group. The interpretation of that comparison depends on the uncertainty around the estimate and on the analysis details available in the record. Detailed eligibility criteria, baseline sleep characteristics and the full analysis plan are not reported in the registry record.

3. Trial Design

This was a randomized, parallel-group, Phase 2 pilot study sponsored by Bayer. The registry lists an enrollment of 110 and a completed status. The study began on 2023-11-08, and primary completion was recorded as 2024-08-22. Participants were assigned to elinzanetant or placebo and were intended to take the assigned treatment for 12 weeks.

The official title describes the trial as double-blind, while the registry design fields list quadruple masking. These descriptions do not establish which people involved in the trial were masked; those roles are not reported in the registry record. The record identifies the comparator as a matching placebo. It does not describe allocation concealment, the randomization sequence, treatment adherence, or the handling of treatment discontinuation.

The primary outcome was change from baseline in WASO at week 4 measured by polysomnography. The posted primary arm summaries include 47 participants in each group. These outcome counts should not be treated as a replacement for the enrollment figure: enrollment describes the trial record, while the outcome summaries describe the participants represented in those results. The registry also reports safety information for 55 participants at risk in each group.

Other planned or posted outcomes include WASO at week 12; sleep efficiency at week 4 and week 12; and scores from the PROMIS Sleep Disturbance Short Form and Insomnia Severity Index at week 4 and week 12. The record lists eight outcome measures and seven posted secondary outcomes, but results are available for only some secondary measures. Participant flow, the number randomized to each group, and reasons for any differences in outcome counts are not reported in the registry record. Nor is the trial’s original sample-size justification reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Out of the 338 screened participants, 110 were randomized and received treatment, and 103 participants completed the study. Among the 228 participants who did not proceed to randomization, screening failure was the primary reason (223 participants).

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline in Wakefulness After Sleep Onset (WASO) at Week 4 as Measured by Polysomnography (PSG), measured over From baseline until week 4.

The primary endpoint is change from baseline in wakefulness after sleep onset, or WASO, at week 4, measured by polysomnography and expressed in minutes. The registry defines WASO as the total time spent awake from the onset of persistent sleep until lights on. Persistent sleep is defined in the record as 20 consecutive epochs, or 10 min, of non-wakefulness. Smaller WASO values indicate shorter periods of wakefulness after sleep onset.

Change from baseline expresses how a measure differs from its starting value over the specified follow-up. Here, a negative change indicates a decrease in WASO relative to baseline. The comparative result asks whether the average change differs between the elinzanetant and placebo groups. That comparison is more informative about the contrast between assigned groups than reading either group’s change in isolation, although it does not by itself establish why the observed difference arose.

Polysomnography is an objective sleep test, and WASO focuses on waking that occurs after sleep has begun. It therefore addresses a different aspect of sleep from total time asleep or a participant’s own report of sleep disturbance. The registry also identifies sleep efficiency, PROMIS sleep disturbance and insomnia severity as outcomes, giving a broader set of measures of sleep. Those measures do not replace the primary endpoint: the principal posted question is specifically about the between-group difference in change in WASO at week 4.

The record does not report the full measurement protocol, baseline values, or details of how missing or unusable sleep-test observations were handled. Those omissions limit what can be established about endpoint collection and analysis beyond the definitions and results posted in the registry.

7. Results Posted in the Registry

• Elinzanetant: mean -23.50 versus -1.01 on control; difference -22.49 (95% CI -35.39 to -9.59), standardized effect d = -0.70; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Change From Baseline in WASO at Week 12 as Measured by PSG

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • Elinzanetant: mean -16.48 versus -15.54 on control; difference -0.94 (95% CI -13.97 to 12.09), standardized effect d = -0.03; z-test p = 0.888.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Elinzanetant and the control. The interval gives the range of effects that remain compatible with the data.

Change From Baseline in Sleep Efficiency (SE) at Week 4 as Measured by PSG

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Elinzanetant: mean 6.85 versus 1.13 on control; difference 5.72 (95% CI 2.18 to 9.26), standardized effect d = 0.62; z-test p = 0.002.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Elinzanetant than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change From Baseline in SE at Week 12 as Measured by PSG

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Elinzanetant: mean 5.15 versus 4.67 on control; difference 0.48 (95% CI -2.96 to 3.92), standardized effect d = 0.05; z-test p = 0.785.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Elinzanetant and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes broaden the picture beyond the primary week 4 WASO measure. They include a later WASO assessment, sleep efficiency at two follow-up times, and participant-reported sleep disturbance and insomnia measures. The record lists seven secondary outcomes, but only some have posted results in the data. Results for the participant-reported measures are not reported in the registry record.

Across the posted secondary results, the week 4 sleep-efficiency comparison is the clearest additional separation between groups. The week 12 comparisons for WASO and sleep efficiency are less decisive: their intervals include no difference. This means the pattern is not uniformly strong across the posted measures and follow-up times. The primary result remains the week 4 WASO comparison; secondary measures offer context but do not serve as independent confirmation of the same endpoint.

Each secondary measure captures a different feature of sleep, and follow-up time matters. Sleep efficiency is not the same outcome as time awake after sleep onset, while participant-reported scores reflect a different type of measurement from polysomnography. Differences among results can therefore reflect the distinct constructs and timing as well as statistical uncertainty. The registry record does not provide enough detail to assess whether these secondary outcomes were specified in a formal testing sequence.

Unadjusted secondary results carry less weight when several outcomes are examined because each additional comparison creates another opportunity for an apparently notable result to arise by chance. In general, multiplicity procedures can address this issue, but the registry does not report whether any were used. The secondary pattern is best treated as descriptive evidence that complements, rather than overrides, the primary result. It cannot establish a consistent effect across all sleep outcomes from the results posted.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Change From Baseline in WASO at Week 12 as Measured by PSG
• Change From Baseline in Sleep Efficiency (SE) at Week 4 as Measured by PSG
• Change From Baseline in SE at Week 12 as Measured by PSG
• Change From Baseline in Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score at Week 4
• Change From Baseline inPatient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score at Week 12
• Change From Baseline in Insomnia Severity Index (ISI) Total Score at Week 4
• Change From Baseline in ISI Total Score at Week 12

9. Statistical Interpretation

10. Statistical Methods Explained

The results involve continuous outcomes: measurements such as WASO in minutes and sleep efficiency expressed as a percentage. A group mean summarizes the average value or average change among the participants represented in that group. It does not show the full spread of individual observations, and similar averages can arise from different patterns across participants.

What does a change from baseline represent?

A change score compares a participant’s follow-up measurement with their baseline measurement. The posted arm values summarize those changes. For WASO, the registry defines lower values as shorter periods of wakefulness after sleep onset. A negative average change therefore represents a decrease from baseline. A comparison between groups then estimates how far apart the group summaries are, rather than treating a change in one group as proof of a difference between treatments.

What is a least-squares mean?

The primary outcome is labeled as a least-squares mean, with a standard error as its dispersion measure. In general, a least-squares mean is a model-based group estimate, often adjusted for terms in a statistical model. The registry record does not report the model terms or the analysis specification for this outcome, so it is not possible to determine which adjustments, if any, produced these estimates. The standard error describes uncertainty in an estimated mean; it is not the same quantity as the variation among individual participants.

The posted primary arm summaries list standard errors of 4.63 for elinzanetant and 4.68 for placebo. The comparison also reports a pooled standard deviation of 31.91 and a standardized difference of -0.705. The record indicates that the standard deviation used for this comparison is approximate. These summaries offer different views of scale and variability, but they do not replace the original participant-level data or explain how the model was fitted.

How should the mean difference be read?

The posted primary mean difference is -22.49 minutes. It represents the elinzanetant group estimate compared with the placebo group estimate for change in WASO. A negative value points toward a larger decrease in WASO in the elinzanetant group. The confidence interval, from -35.39 to -9.587, expresses uncertainty about the size of that difference. It is not a range containing a known proportion of individual participant outcomes.

The reported p-value is unadjusted. In general, a p-value describes how compatible the observed data are with a specified null model of no group difference, under the analysis assumptions. It is not the probability that the null hypothesis is true, nor a measure of the size or importance of a result. Here, p < 0.001 is the posted unadjusted value. The registry record does not report whether or how this result was adjusted for the other outcomes or any other analysis decisions.

Why do the secondary outcomes use different summaries?

The sleep-efficiency outcomes are reported as means with standard deviations, rather than least-squares means with standard errors. A standard deviation describes the spread of individual observations around a group mean. A standard error describes uncertainty in an estimated mean. They answer different questions and should not be compared as though they were the same measure of variability.

For sleep efficiency at week 4, the posted comparison has a mean difference of 5.72 percentage points and a 95% confidence interval from 2.182 to 9.258. At week 12, the posted mean difference is 0.48 percentage points, with an interval from -2.964 to 3.924. The week 12 WASO comparison is reported as a least-squares mean comparison with a standard error. Its confidence interval ranges from -13.97 to 12.09. The different endpoint definitions and summary approaches matter when interpreting or comparing these results.

Why can over-dispersion matter?

General statistical explanation: some count outcomes vary more across participants than a simple model expects. This is called over-dispersion, and it can make standard errors and confidence intervals too narrow if it is ignored. The posted outcomes in this record are continuous measures, not count outcomes, and no over-dispersion analysis is described. This concept is included only as a general distinction; the registry record does not identify it as a method used in this trial.

The record lists zero reported analyses in the analysis summary and does not provide a detailed statistical analysis plan. It also does not report how missing observations, deviations from treatment, or multiple comparisons were handled. General explanations of confidence intervals, standard errors and p-values do not fill those gaps. They help explain the posted summaries, but cannot reconstruct an analysis that the registry record does not describe.

11. Confidence Intervals and Precision

The primary comparison is estimated as a mean difference of -22.49 minutes. Its 95% confidence interval runs from -35.39 to -9.587. In general, a confidence interval represents a range of estimates compatible with the data and the method used, under its assumptions. It communicates uncertainty about the group contrast; it does not mean that individual participant results fall within that range.

For the primary outcome, the interval lies below no difference. This supports a distinction between the estimated direction and the uncertainty about magnitude: the posted estimate favors a greater reduction in WASO in the elinzanetant group, while the interval shows that the exact size of that difference is not known precisely. The interval does not address unreported sources of uncertainty such as analysis choices or missing outcome data.

The posted secondary intervals illustrate why point estimates alone are insufficient. The week 4 sleep-efficiency interval, 2.182 to 9.258 percentage points, lies above no difference. In contrast, the week 12 sleep-efficiency interval, -2.964 to 3.924 percentage points, includes no difference; the week 12 WASO interval, -13.97 to 12.09 minutes, also includes no difference. These ranges describe uncertainty for separate measures and time points, not a single overall effect.

The registry reports standard errors for the primary arm summaries and standard deviations for the sleep-efficiency summaries. Those quantities describe different aspects of uncertainty and variation. The posted comparisons are based on the available summary results, and the record does not provide participant-level data or detailed model specifications for independently assessing the intervals. Their precision should therefore be understood in the context of what is posted, not as a guarantee that all relevant sources of uncertainty have been captured.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size section is a planning illustration based on the observed effect, not the trial’s original design calculation. For these continuous outcomes, the figures are participants per arm, not a total across both arms and not a total number of events. The assumptions stated for the illustration are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect set as the stated fraction of the observed effect. The original trial’s own sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the illustrated number of participants per arm under the stated assumptions for an analysis to have an 80% chance of detecting the chosen effect if that effect is real and the assumptions hold. The 90% column gives the corresponding planning figure for 90% power. These are prospective planning quantities; they do not measure the chance that the posted result is true or whether this completed trial had enough power after the fact. This is not observed power.

The rows show planning for 100%, 75% and 50% of the observed effect. The smaller the effect a future study aims to detect, the more participants it generally needs, because a smaller group difference is harder to distinguish from random variation. The displayed values should be read as illustrations tied to the effect estimate from this trial, not as a recommended sample size. In particular, an observed effect from a pilot study may not be a stable estimate for planning another study. The accompanying table and curve show how the planning figures change across the stated effect assumptions.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -22.490; pooled standard deviation σ = 31.914.
2. n = 2 × (1.96 + 0.842)² × 31.914² / -22.490² = 31.6, rounded up to 32 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -22.49                      # observed difference in means
sigma <- 31.9135323961482                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(6112756)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 32 (80% power), 43 (90% power)
 75% of observed effect: n per arm = 57 (80% power), 76 (90% power)
 50% of observed effect: n per arm = 127 (80% power), 170 (90% power)
power.t.test: 32.6 
Simulated power at n = 32 per arm: 0.791 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The record lists a primary outcome and several secondary outcomes assessed at different follow-up times. This creates a multiplicity question: when multiple outcomes or comparisons are examined, the chance of at least one result appearing notable by chance can increase. In general, a prespecified testing hierarchy or an adjustment for multiple comparisons can help control that risk. The registry record does not report a multiplicity strategy, a testing hierarchy, or whether the posted p-values were adjusted. The primary p-value is explicitly unadjusted in the posted comparison.

The registry also does not report a detailed statistical analysis plan. In particular, it does not describe the analysis population, the handling of participants who stopped treatment, the treatment of missing measurements, or any imputation method. These details matter because the number of participants represented in a result can differ from the number enrolled, and choices about incomplete observations can affect estimates and uncertainty. The reason the primary outcome summaries show 47 participants in each group while safety summaries show 55 at risk in each group is not reported in the registry record.

The registry labels the primary outcome summaries as least-squares means but does not report the model specification or covariates. It is therefore not possible to determine from the record whether the comparison was adjusted for baseline values or other variables, or to reproduce the analysis. The randomized parallel-group design supports a comparative question, but a description of the design does not replace the analysis details needed to assess how the reported estimate was obtained.

Detailed participant flow, protocol deviations, and the composition of the analysis sets are also not reported in the registry record. These omissions do not invalidate the posted numbers, but they limit independent assessment of their robustness and of how closely the analysis followed the intended trial procedures. Interpretations of the results should distinguish what is directly posted from what would require a protocol, analysis plan, or fuller clinical study report.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: diverticulitis (1.8%), basal cell carcinoma (1.8%).

The registry reports serious adverse events among 55 participants at risk in each group. There were 0 serious adverse events in the elinzanetant group and 2 in the placebo group. It also reports 24 participants with other adverse events in the elinzanetant group and 25 in the placebo group. No deaths were reported in either group.

The record lists diverticulitis and basal cell carcinoma among the top serious adverse event terms, each at 1.8%. These figures describe the safety events reported in the registry; they do not establish that a treatment caused or prevented an event. Serious adverse events and other adverse events are separate categories in the posted summary, so the counts should not be added or treated as directly interchangeable.

These are descriptive figures from a trial with the reported at-risk counts. The record does not provide event timing, individual clinical details, exposure-adjusted rates, or a detailed method for judging causality. The difference in reported counts should therefore be interpreted cautiously and not as a definitive comparison of safety. Safety information is limited to what the registry summary reports.

16. What the Result Does, and Does Not, Mean

The posted primary result describes a between-group difference in change in WASO at week 4. The estimate is -22.49 minutes, with a 95% confidence interval from -35.39 to -9.587 and an unadjusted p < 0.001. In the trial results, the elinzanetant group’s average WASO decrease was greater than the placebo group’s. This is a description of the posted comparison, not medical advice or a conclusion about what an individual should do.

The finding does not by itself establish that the same difference would occur in other groups of women, settings, or treatment periods. The study is identified as a Phase 2 pilot, and the registry record does not report detailed participant characteristics or a full analysis plan. The confidence interval conveys statistical uncertainty under the method used; it does not account for every possible limitation in design, measurement, analysis, or reporting.

The result also does not show that all aspects of sleep changed in the same way. The secondary pattern varies by measure and follow-up time, and the registry does not report results for all listed secondary outcomes in the information. The primary polysomnography measure is distinct from sleep efficiency and participant-reported outcomes. Nor do the posted results alone establish the clinical importance of the estimated difference: the registry does not report a threshold for a meaningful change in WASO.

The safety summary records serious and other adverse events, but the counts are descriptive and do not establish causation. More complete interpretation would require details not reported in the registry record, including participant flow, analysis populations, missing-data handling, multiplicity procedures and the prespecified analysis. The posted data support a statistical reading of the reported outcomes, but not broader claims beyond those observations.

17. Why This Trial Matters Statistically

This trial is statistically informative because it compares a sleep-test outcome between randomized treatment groups rather than relying only on within-group changes. Its primary endpoint is a continuous measure with a stated interpretation: lower WASO indicates shorter periods awake after sleep onset. That makes the direction of the reported contrast interpretable, while the confidence interval helps show the uncertainty in its size.

The record also provides a useful example of why multiple summaries must be read together. The primary outcome is reported as a least-squares mean with standard errors, while sleep-efficiency outcomes are reported as means with standard deviations. Group estimates, dispersion measures, comparative differences and confidence intervals each answer different questions. Treating them as interchangeable would obscure rather than clarify the evidence.

The pattern across follow-up times also illustrates the importance of separating a primary endpoint from secondary outcomes. The posted week 4 WASO contrast is clearer than the later WASO and sleep-efficiency comparisons. Several outcomes can enrich interpretation, but without a reported multiplicity plan and complete analysis details, secondary findings should remain supporting context rather than a set of equally strong confirmatory conclusions.

Finally, the registry offers a compact account of results but leaves important analysis details unreported. That makes transparency about uncertainty especially important. Readers can describe the posted estimates and their intervals, while recognizing that the record alone does not show how missing data, model choices, or multiple testing were handled. This distinction between a reported result and the evidence needed to fully assess it is central to sound statistical interpretation.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry record identifies the study as a pilot but does not report the original sample-size justification. The displayed planning illustrations are based on the observed effect and should not be mistaken for the trial’s design calculation. The primary result represents 47 participants per group in the posted summaries, while the record lists enrollment of 110. A participant-flow account explaining the difference is not reported in the registry record.

There is also a difference between the posted outcome counts and the safety at-risk counts, which are 55 per group. The record does not explain the denominators or describe the analysis populations. Without this information, readers cannot establish from the registry summary which participants were included in each analysis or why counts differ across outcomes.

The registry does not report the statistical model, covariates, missing-data procedures, handling of treatment discontinuation, or multiplicity approach. It also does not provide baseline values or detailed participant characteristics in the results. These omissions limit assessment of comparability, precision and robustness beyond the displayed summaries.

The study’s masking descriptions differ: the official title says double-blind, while the design fields say quadruple. The record does not specify which trial roles were masked. The posted outcome information is also incomplete relative to the listed secondary measures; results for the participant-reported sleep and insomnia scales are not reported in the registry record. Together, these reporting gaps mean the registry provides a useful but partial account of the trial.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause — NCT06112756.
• Registry record last updated 2025-11-10; status last verified 2025-10.
• Results first posted 2025-11-10.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

22. Record Summary

NCT06112756 is a completed, randomized, parallel-group Phase 2 pilot study sponsored by Bayer. It compared elinzanetant with matching placebo for sleep disturbances associated with menopause, with treatment intended to continue for 12 weeks. The primary outcome was change from baseline in polysomnography-measured WASO at week 4.

The posted primary comparison estimates a mean difference of -22.49 minutes, with a 95% confidence interval from -35.39 to -9.587 and an unadjusted p < 0.001. Secondary results show a less uniform pattern across outcomes and follow-up times. Safety summaries report 0 serious adverse events in the elinzanetant group and 2 in the placebo group, with no deaths reported.

The registry does not report the original sample-size justification, detailed analysis plan, missing-data methods, multiplicity approach, or participant-flow details. The results should be read as the posted statistical summaries, with those limits in view.