This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (NCT05042362), a randomized phase 3 study. The primary outcome is Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD])..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05042362 |
| Phase | Phase 3 |
| Condition | Vasomotor Symptoms Associated With Menopause, Hot Flashes |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 396 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Bayer |
| Results posted | Yes |
2. Clinical Question
Population
Postmenopausal women with moderate to severe vasomotor symptoms, described in the registry as hot flashes. The primary outcome population is participants in the full analysis set with evaluable data. The registry record does not give further eligibility details in the information available for this analysis.
Intervention
Elinzanetant, identified as BAY3427080, at 120 mg orally once daily. The study arm description specifies treatment for 26 weeks.
Comparator
Matching placebo orally once daily for 12 weeks, followed by elinzanetant 120 mg for 14 weeks. The primary outcome is specified as change from baseline to Week 4, within the period described as placebo-controlled.
Primary question
What is the mean change in the frequency of moderate to severe hot flashes from baseline to Week 4, assessed by the Hot Flash Daily Diary, in each study group? The registry record does not report the primary outcome results or a between-group estimate, so it does not establish the size or precision of a group difference.
The trial asks whether the frequency of moderate to severe hot flashes changes over the short-term assessment period in participants assigned to elinzanetant compared with participants assigned to placebo. The diary-based endpoint captures symptoms recorded by participants rather than a laboratory measure. The trial also lists outcomes concerning hot-flash frequency over time, sleep disturbance, menopause-specific quality of life, and depressive symptoms.
This is a question about the recorded outcomes under the trial's assigned regimens. It is not, by itself, a question about every postmenopausal woman, other doses, or treatment beyond the study period. The registry record identifies a randomized, double-blind, placebo-controlled phase 3 study, but does not report the primary outcome estimates, confidence intervals, or significance tests. Consequently, the clinical question can be described, but the posted results do not permit an assessment of the observed primary comparison.
3. Trial Design
The registry identifies NCT05042362 as a phase 3, randomized, quadruple-masked, parallel-group study sponsored by Bayer. The trial was completed, with enrollment of 396. The registry lists the start date as 2021-08-27 and the primary completion date as 2023-07-25. These record details describe the study, but do not establish how many participants contributed evaluable data to the primary analysis.
The active-treatment arm received elinzanetant 120 mg orally once daily for 26 weeks. The comparator arm received matching placebo orally once daily for 12 weeks, followed by elinzanetant 120 mg for 14 weeks. Thus, the comparator group was not assigned to placebo throughout the full study period. The primary outcome is assessed at Week 4, during the initial placebo-controlled period.
Random allocation is intended to make the groups comparable, on average, at the start of a trial. Masking is intended to reduce the influence of treatment knowledge on participant reporting, clinical care, and outcome assessment. The registry labels the study quadruple-masked but does not specify in the information reported which roles were masked. A parallel-group design assigns participants to a study arm and follows those groups over time, rather than having each participant receive both initial assignments.
The primary measure is the mean change in moderate to severe hot-flash frequency from baseline to Week 4, using the Hot Flash Daily Diary. Other listed outcomes include frequency at Week 1 and over time, sleep disturbance, menopause-specific quality of life, and depressive-symptom measures. The registry record does not report the detailed allocation procedure, protocol deviations, or statistical analysis plan. It also does not report the primary outcome estimates needed to quantify the Week 4 comparison.
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: A total of 1535 participants were screened; 1139 participants were not randomized. Most common reason for not being randomized was not meeting the eligibility criteria (1087 participants). 396 participants were randomized to treatment. A total of 197 participants were randomized to placebo - elinzanetant 120 mg arm and 199 participants to elinzanetant 120 mg arm.
Overall Study
| Stage | Elinzanetant 120 mg | Placebo - Elinzanetant 120 mg |
|---|---|---|
| STARTED | 199 | 197 |
| COMPLETED | 154 | 155 |
| NOT COMPLETED | 45 | 42 |
Reasons for not completing this period:
| Reason | Elinzanetant 120 mg | Placebo - Elinzanetant 120 mg |
|---|---|---|
| Adverse Event | 7 | 9 |
| Lack of Efficacy | 0 | 2 |
| Lost to Follow-up | 7 | 4 |
| Missing | 4 | 2 |
| Withdrawal by Subject | 5 | 9 |
| Randomized by Mistake | 1 | 2 |
| Physician Decision | 3 | 0 |
| Other | 0 | 1 |
| Non-Compliance with Study Drug | 2 | 3 |
| incompleted treatment; finished follow-up | 16 | 10 |
Analysis population for the primary outcome, as defined in the registry: Participants in full analysis set (FAS) with evaluable data.
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.
Population: Full analysis set (FAS) was analyzed. FAS: all randomized subjects were included. Subjects in the full analysis set were analyzed according to the randomized intervention (intention-to-treat).
| Characteristic | Unit | Elinzanetant 120 mg | Placebo - Elinzanetant 120 mg | Total |
|---|---|---|---|---|
| Participants analysed | 199 | 197 | 396 | |
| Age, Continuous | years | 54.6 (SD 4.9) | 54.5 (SD 4.9) | 54.6 (SD 4.9) |
| Sex: Female, Male: Female | Participants | 199 | 197 | 396 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 17 | 14 | 31 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 180 | 179 | 359 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 | 4 | 6 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Asian | Participants | 2 | 1 | 3 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 38 | 38 | 76 |
| Race (NIH/OMB): White | Participants | 151 | 154 | 305 |
| Race (NIH/OMB): More than one race | Participants | 3 | 0 | 3 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 4 | 3 | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD])., measured over From baseline to Week 4.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Hot Flashes per day |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is mean change from baseline to Week 4 in the frequency of moderate to severe hot flashes, measured in hot flashes per day with the Hot Flash Daily Diary. For Week 4, the registry specifies that Days 22-28 are used, with Day 1 corresponding to the start of treatment. The weekly mean daily frequency is calculated from the total moderate to severe hot flashes recorded and the number of days with available diary data for that week.
This endpoint is used to quantify symptom frequency over a defined period using participants' daily records. A change from baseline expresses the Week 4 measurement relative to the participant's starting level; comparing the groups can help distinguish changes associated with assignment to the study regimens from changes also seen under placebo. This is a general explanation of the role of a baseline-change endpoint, not a claim about the result in this trial.
The primary population is described as participants in the full analysis set with evaluable data. The registry record does not report the numerical mean changes, their variability, the difference between groups, a confidence interval, or a p-value for this endpoint. It therefore does not report the magnitude or precision of the primary comparison. The measure also concerns frequency during the specified assessment week; it should not be treated as a direct measure of symptom severity, overall quality of life, or outcomes beyond the recorded study period.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a defined primary outcome and assessment window, but does not report the primary outcome results. In particular, it does not give the mean change in hot-flash frequency for either group, the estimated between-group contrast, a confidence interval, or a p-value. The posted results therefore do not provide a basis for describing the direction, size, or statistical precision of the primary comparison.
For a continuous endpoint such as hot flashes per day, a group mean describes the average observed change among the participants included in that analysis. A between-group estimate would describe how the groups' average changes differ. The confidence interval around such an estimate would indicate the range of values compatible with the data and the analysis assumptions. These are general statistical interpretations; the corresponding primary estimates are not reported in the registry record for this trial.
The endpoint is based on diary entries over Days 22-28 for the Week 4 assessment, and the registry states that the weekly mean daily frequency uses days with available data. That definition helps clarify what the outcome represents. It does not reveal how much diary data were missing, whether missingness differed between groups, or what rules governed the analysis beyond the described available-day calculation. Those details are not reported in the registry record.
The trial enrolled 396 participants overall, but enrollment is not the same as the number contributing evaluable data to the primary outcome. The registry describes the primary population as the full analysis set with evaluable data; the number included in that analysis is not reported in the registry record. Without the group-specific results and analysis population counts, the observed data cannot be independently assessed for precision or completeness.
Safety counts are reported for several treatment periods and groups. They are descriptive counts, not substitutes for the missing primary efficacy estimate. The periods and treatment histories differ across these groups, so raw counts across them do not provide a straightforward randomized comparison of risk. The registry records 0 deaths in each listed group. Interpretation of the serious adverse event counts is addressed separately, with care not to treat unlike exposure periods as equivalent.
No conclusion about whether the observed primary outcome difference is statistically distinguishable from no difference can be drawn from the registry information reported. Likewise, statistical uncertainty cannot be characterized without an estimate and its interval. This interpretation is limited to the posted record and should not be extended into a claim about treatment effect.
9. Statistical Methods Explained
The following describes general statistical concepts relevant to this trial and separates them from methods explicitly described in the registry record. The record specifies the endpoint, its assessment week, the analysis population in broad terms, and a planning-illustration framework. It does not report a full statistical analysis plan or the primary outcome estimates.
What does a mean change represent?
The primary endpoint is continuous: each participant's outcome is a frequency expressed as hot flashes per day, and the analysis concerns mean change from baseline to Week 4. In general, a mean summarizes the average of participant-level values. A mean change is calculated by comparing follow-up with baseline for each relevant participant and summarizing those changes. The registry specifies the target measure as mean change, but the numeric group means and group contrast are not reported in the registry record.
A group mean is not a description of every participant. Individual experiences can vary around the mean, and a mean alone does not show the shape of the outcome distribution. Standard deviation is a measure of spread among observations; the registry identifies standard deviation as the dispersion measure for the primary outcome, but does not report the primary result values or standard deviations.
How should a confidence interval be read?
In general, a confidence interval expresses the uncertainty around an estimated quantity under the analysis assumptions. For a between-group difference, it indicates a range of effect values compatible with the observed data and method. A narrower interval indicates greater precision than a wider interval, though precision is not the same as clinical importance. The registry record does not report a confidence interval for the primary comparison, so its precision cannot be evaluated from the posted primary results.
A p-value, when reported, assesses how compatible the data are with a specified null hypothesis under a statistical model. It does not measure the probability that the null hypothesis is true, and it does not convey the size or importance of an effect. No primary p-value is reported in the registry record. It would therefore be inappropriate to infer statistical significance from the endpoint description or enrollment alone.
What does randomization contribute?
As a general design principle, random assignment can reduce systematic differences between groups at baseline, including differences that are not measured, when allocation is implemented as intended. Masking can reduce certain forms of influence from knowledge of assigned treatment. Neither feature guarantees that every measured characteristic will be balanced in a particular trial, nor does design alone supply an estimate of treatment effect. The registry identifies randomization and quadruple masking but does not provide further implementation details in the information reported.
Why does the diary calculation matter?
The registry defines the Week 4 frequency using Days 22-28 and calculates mean daily frequency by dividing the number of moderate to severe hot flashes recorded during that week by the number of days with available data. This makes the outcome a daily rate based on observed diary days rather than simply a total across all assigned days. In general, using available days can retain information from participants who have incomplete diary records, but it does not by itself resolve possible bias if missing diary days are related to symptoms or treatment. The record does not report the amount or pattern of missing diary data or additional missing-data methods.
What do the planning illustrations mean?
The registry describes a sample-size planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. Such illustrations are hypothetical planning calculations. They are not observed power, do not change the trial's observed results, and should not be read as evidence that the study had a particular probability of detecting an effect. The numerical planning illustrations and the observed effect needed to interpret them are not reported in the registry information available for this analysis.
In general, a planning calculation asks how many participants might be needed under stated assumptions to detect a chosen effect with a chosen level of statistical power. Its answer depends on assumptions, including the outcome variability and the effect targeted. It is not a substitute for the trial's estimated effect and confidence interval. The record does not report the trial's own design-stage sample-size justification, so the planning illustration should not be represented as the protocol's rationale.
Why can over-dispersion matter?
As a general concept, over-dispersion occurs when observed variability is greater than a statistical model assumes. If a model underestimates variability, its uncertainty estimates may be too small and its intervals too narrow. This is especially relevant in some count-data models, where observations may vary more than a simple model allows. The primary endpoint in this record is summarized as a mean with standard deviation, and no model for the primary comparison is reported. No claim about over-dispersion or its handling can therefore be made for this analysis.
Overall, the registry provides useful definitions of the endpoint and some design features, but not enough detail to reconstruct the primary statistical analysis. The specific model, covariate adjustment, handling of protocol deviations, and other analysis procedures are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 10 outcome measures and 7 analyses. It does not report how the analyses relate to each outcome, which tests were considered confirmatory, or whether any multiplicity adjustment was planned or used. When several outcomes or repeated comparisons are tested, the chance of obtaining at least one nominally unusual result can increase. Statistical approaches can control that issue, but the appropriate approach depends on the prespecified testing strategy. No particular strategy should be attributed to this trial because it is not reported in the registry record.
The primary endpoint is specified as change from baseline to Week 4. Other listed outcomes include hot-flash frequency at Week 1 and over time, sleep disturbance at Week 12, menopause-specific quality of life at Week 12, and depressive-symptom measures at Week 12 and Week 26. The presence of multiple outcomes makes it important to know which analyses were intended to support confirmatory conclusions and how they were ordered or adjusted. Those details are not reported in the registry record.
The primary analysis population is described as participants in the full analysis set with evaluable data. The number of participants in that population, the group counts contributing to the endpoint, and the definition of evaluable data beyond the endpoint description are not reported in the registry record. Although the endpoint calculation uses the number of available diary days, the record does not describe how missing baseline or follow-up data were handled in the overall analysis, whether imputation was used, or how sensitivity analyses addressed missingness.
These gaps limit assessment of both the analysis population and the robustness of results. They do not demonstrate that the analysis was inappropriate; rather, the necessary details are not reported in the registry record. Without those details and the primary estimates, the posted information cannot support a full evaluation of multiplicity control, missing-data assumptions, or sensitivity to analysis choices.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Elinzanetant 120 mg Week 1-12 | 4 | 199 | 2.0% |
| Placebo Week 1-12 | 2 | 194 | 1.0% |
| Elinzanetant 120 mg Week 13-26 | 0 | 171 | 0.0% |
| Placebo - Elinzanetant 120 mg Week 13-26 | 9 | 168 | 5.4% |
| Elinzanetant 120 mg Week 1-26 | 13 | 367 | 3.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Elinzanetant 120 mg Week 1-12 | 0 of 199 |
| Placebo Week 1-12 | 0 of 194 |
| Elinzanetant 120 mg Week 13-26 | 0 of 171 |
| Placebo - Elinzanetant 120 mg Week 13-26 | 0 of 168 |
| Elinzanetant 120 mg Week 1-26 | 0 of 367 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Elinzanetant 120 mg Week 1-12 | 38 of 199 |
| Placebo Week 1-12 | 28 of 194 |
| Elinzanetant 120 mg Week 13-26 | 6 of 171 |
| Placebo - Elinzanetant 120 mg Week 13-26 | 9 of 168 |
| Elinzanetant 120 mg Week 1-26 | 51 of 367 |
Most frequent serious adverse event terms
| Event term | Organ system | Elinzanetant 120 mg Week 1-12 | Placebo Week 1-12 | Elinzanetant 120 mg Week 13-26 | Placebo - Elinzanetant 120 mg Week 13-26 | Elinzanetant 120 mg Week 1-26 |
|---|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | 0 of 199 | 1 of 194 | 0 of 171 | 2 of 168 | 2 of 367 |
| Abdominal pain | Gastrointestinal disorders | 0 of 199 | 0 of 194 | 0 of 171 | 1 of 168 | 1 of 367 |
| Diverticulitis | Infections and infestations | 1 of 199 | 0 of 194 | 0 of 171 | 0 of 168 | 1 of 367 |
| Otitis externa | Infections and infestations | 0 of 199 | 0 of 194 | 0 of 171 | 1 of 168 | 1 of 367 |
| Pneumonia | Infections and infestations | 1 of 199 | 0 of 194 | 0 of 171 | 0 of 168 | 1 of 367 |
| Pyelonephritis | Infections and infestations | 0 of 199 | 0 of 194 | 0 of 171 | 1 of 168 | 1 of 367 |
| Accident | Injury, poisoning and procedural complications | 0 of 199 | 0 of 194 | 0 of 171 | 1 of 168 | 1 of 367 |
| Tibia fracture | Injury, poisoning and procedural complications | 0 of 199 | 0 of 194 | 0 of 171 | 1 of 168 | 1 of 367 |
| Syncope | Nervous system disorders | 1 of 199 | 0 of 194 | 0 of 171 | 0 of 168 | 1 of 367 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 1 of 199 | 0 of 194 | 0 of 171 | 0 of 168 | 1 of 367 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Elinzanetant 120 mg Week 1-12 | Placebo Week 1-12 | Elinzanetant 120 mg Week 13-26 | Placebo - Elinzanetant 120 mg Week 13-26 | Elinzanetant 120 mg Week 1-26 |
|---|---|---|---|---|---|---|
| Headache | Nervous system disorders | 14 of 199 | 5 of 194 | 4 of 171 | 6 of 168 | 24 of 367 |
| Depression rating scale score increased | Investigations | 12 of 199 | 11 of 194 | 1 of 171 | 2 of 168 | 14 of 367 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 10 of 199 | 10 of 194 | 1 of 171 | 1 of 168 | 12 of 367 |
| Fatigue | General disorders | 14 of 199 | 3 of 194 | 0 of 171 | 1 of 168 | 15 of 367 |
Serious events with the highest arm-level rate: cholelithiasis (1.2%), abdominal pain (0.6%), otitis externa (0.6%), pyelonephritis (0.6%), accident (0.6%).
The registry reports serious adverse event counts and other adverse event counts for listed treatment groups and periods. For elinzanetant 120 mg during Week 1-12, 4 of 199 participants are recorded with a serious adverse event, and 38 of 199 with other adverse events. For placebo during Week 1-12, the corresponding counts are 2 of 194 and 28 of 194. These are counts within the registry's stated groups; they do not by themselves establish that a treatment caused an event.
For Week 13-26, the registry records 0 of 171 participants with a serious adverse event and 6 of 171 with other adverse events for elinzanetant 120 mg. For the placebo-then-elinzanetant group during Week 13-26, it records 9 of 168 for serious adverse events and 9 of 168 for other adverse events. For elinzanetant 120 mg during Week 1-26, it records 13 of 367 for serious adverse events and 51 of 367 for other adverse events. The registry records 0 deaths in each listed group.
These periods are not all directly comparable: treatment exposure and follow-up differ, and the Week 1-26 group is reported separately from the shorter-period groups. Counts should therefore be read in the context of each stated group and period, not ranked as if they came from identical comparisons. The registry also lists serious-event terms with percentages, including cholelithiasis at 1.2% and abdominal pain, otitis externa, pyelonephritis, accident, and tibia fracture at 0.6% each. Event-term percentages and group counts are descriptive; causal interpretation and a balanced comparison require more information than these counts alone provide.
12. What the Result Does, and Does Not, Mean
The trial's design and primary endpoint define a randomized comparison of elinzanetant with placebo for moderate to severe menopausal hot flashes. Its primary measure is mean change in daily hot-flash frequency from baseline to Week 4, calculated from diary data recorded on Days 22-28. The registry also describes a longer treatment period and additional outcomes. These details clarify what the study set out to assess.
What the posted results do not report is equally important. The primary group means, between-group estimate, uncertainty interval, and p-value are not reported in the registry record. Thus, the record does not show the observed magnitude or precision of the primary comparison. Enrollment of 396 participants and completion status do not supply those missing estimates and cannot replace an analysis of the endpoint.
Even if a group difference were reported, a statistical difference would not automatically establish that its size is important to participants. Conversely, an imprecise estimate would not demonstrate that no effect exists. Those judgments require estimates and uncertainty, along with an appropriate clinical context. This is a general explanation; the registry record does not report the primary result needed to make such an assessment for this trial.
The safety counts describe events recorded in groups with different treatment periods and histories. They should not be interpreted as a standalone causal comparison. A count of events does not, by itself, show whether an event was caused by study treatment, and the registry's zero deaths in the listed groups does not answer all questions about safety.
The record therefore supports an account of the trial design, endpoint definition, and reported adverse-event counts, but not a conclusion about the size or certainty of the primary outcome difference. It also does not allow conclusions about effects beyond the study period or in populations not described by the trial. Any interpretation should remain within the information that the registry record reports.
13. Why This Trial Matters Statistically
This trial illustrates why a clear endpoint definition is essential to interpreting clinical research. “Hot flashes per day” is made more specific by identifying moderate to severe symptoms, the diary instrument, the change-from-baseline measure, and the Week 4 window of Days 22-28. Defining how available diary days enter the weekly average makes the target quantity more understandable and helps readers distinguish it from a simple weekly total.
The design also demonstrates the importance of following treatment history across time. The comparator arm receives placebo for 12 weeks and then elinzanetant for 14 weeks, while the active arm is described as receiving elinzanetant for 26 weeks. A comparison at Week 4 occurs in the initial placebo-controlled period; later-period safety counts reflect different exposure histories. Clear attention to timing prevents unlike periods from being treated as a single interchangeable comparison.
At the same time, a well-defined question is not the same as a fully interpretable result. The registry reports enrollment and several design features, but does not report the primary outcome estimates or their uncertainty. Without these, readers cannot judge the size or precision of the Week 4 comparison. The gap demonstrates why effect estimates and confidence intervals are central to statistical interpretation, rather than relying on trial phase, enrollment, or outcome descriptions.
The record also makes the distinction between observed analysis and planning illustration relevant. Planning calculations use assumptions to explore sample-size requirements; they are not measures of observed power and do not show what the trial found. Overall, the trial is statistically informative as an example of how endpoint specification, masking, randomization, analysis populations, multiplicity, missing data, and reporting all shape interpretation. The limits of the registry information are part of that interpretation.
14. 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 primary limitation for interpreting the main research question is that the primary outcome results are not reported in the registry record. No group-specific mean changes, between-group estimate, confidence interval, or p-value is available in the posted information. The analysis therefore cannot describe the observed direction, magnitude, or precision of the primary comparison.
The registry states that the primary population consists of participants in the full analysis set with evaluable data, but does not report how many participants were included in that analysis. The endpoint calculation uses available diary days, yet the record does not quantify missing diary data or report how missingness was addressed beyond that calculation. The amount of missing information and its possible effect on the estimate cannot be assessed.
The detailed statistical plan is not reported in the registry record. This includes the specific model for the primary comparison, any covariate adjustments, the handling of protocol deviations, the confirmatory status of secondary outcomes, and any strategy for controlling multiplicity. These omissions prevent independent reconstruction of the analysis; they do not establish that the trial used a particular method or that a method was deficient.
Safety interpretation is also constrained by the different treatment periods and histories represented in the reported groups. The counts are descriptive, and the record does not provide enough detail in the information reported to treat them as directly comparable causal estimates. Finally, the registry describes a study in postmenopausal women with vasomotor symptoms; the record does not establish how results would apply to other populations or settings. These limitations reflect what is not reported, not evidence that an unreported analysis was or was not performed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause — NCT05042362.
- Registry record last updated 2026-02-12; status last verified 2026-01.
- Results first posted 2026-02-12.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT05042362 is a completed phase 3, randomized, quadruple-masked, parallel-group study sponsored by Bayer, with enrollment of 396. The registry lists a start date of 2021-08-27 and a primary completion date of 2023-07-25. The active regimen was elinzanetant 120 mg orally once daily; the comparator regimen was placebo for 12 weeks followed by elinzanetant 120 mg for 14 weeks.
The primary outcome is mean change from baseline to Week 4 in moderate to severe hot-flash frequency, assessed by the Hot Flash Daily Diary and expressed as hot flashes per day. The primary population is participants in the full analysis set with evaluable data. The registry record does not report the primary outcome estimates or the detailed statistical analysis plan. It does report adverse-event counts by group and period, including 0 deaths in each listed group. Those counts require cautious interpretation because treatment periods and histories differ.