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 Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer (NCT05587296), a randomized phase 3 study. The primary outcome is Mean Change in Frequency of Moderate to Severe Hot Flashes (HF) From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD]).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05587296 |
| Phase | Phase 3 |
| Condition | Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer, Hot Flashes |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 474 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Bayer |
| Results posted | Yes |
2. Clinical Question
Population
Women with, or at high risk for developing, hormone-receptor positive breast cancer who have vasomotor symptoms caused by adjuvant endocrine therapy. The primary outcome population is labeled FAS; the registry record does not report its definition.
Intervention
Elinzanetant (BAY3427080), taken orally once daily at 120 mg. The study is intended to assess symptom frequency and safety during treatment.
Comparator
Matching placebo taken orally once daily for 12 weeks, followed by 120 mg elinzanetant once daily. The placebo comparison therefore applies to the initial treatment period described in the arm information.
Primary question
Does mean daily frequency of moderate to severe hot flashes change from baseline to Week 4 among participants receiving elinzanetant, in comparison with placebo? The registry record identifies this endpoint, but the corresponding treatment-effect estimate and uncertainty are not reported in the registry record.
3. Trial Design
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group study sponsored by Bayer. The registry record lists an enrollment of 474. It describes an initial placebo-controlled treatment period and longer follow-up: placebo recipients are scheduled to switch to elinzanetant after Week 12, while the official title describes assessment over 52 weeks and an optional additional period of up to 3.5 years.
The study concerns vasomotor symptoms, including hot flashes, associated with adjuvant endocrine therapy in women with hormone-receptor positive breast cancer or at high risk for developing it. The intervention is elinzanetant 120 mg orally once daily. The comparator arm receives matching placebo orally once daily for 12 weeks, followed by elinzanetant at the same stated dose.
The registry record gives a start date of 2022-10-14 and a primary completion date of 2024-01-29. Its status is active, not recruiting. These administrative details do not establish that every planned outcome has been reported. In particular, the primary endpoint is described, but its efficacy results are not reported in the registry record.
Randomization is intended to make treatment groups comparable on average, while double masking is intended to limit differences in expectations or assessment related to treatment knowledge. These are general design principles; the registry record does not report the specific randomization procedures or masking details. It also does not report the protocol’s sample-size justification, allocation ratio, or detailed statistical analysis plan.
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 758 screened participants, 474 were randomized.
Overall Study
| Stage | Elinzanetant (BAY3427080) | Placebo - Elinzanetant (BAY3427080) |
|---|---|---|
| STARTED | 316 | 158 |
| COMPLETED | 262 | 133 |
| NOT COMPLETED | 54 | 25 |
Reasons for not completing this period:
| Reason | Elinzanetant (BAY3427080) | Placebo - Elinzanetant (BAY3427080) |
|---|---|---|
| Adverse Event | 15 | 7 |
| Lack of Efficacy | 2 | 0 |
| Lost to Follow-up | 1 | 0 |
| Withdrawal by Subject | 14 | 4 |
| miscellaneous | 3 | 6 |
| Did not complete study treatment but completed post-treatment phase/follow-up | 19 | 8 |
Analysis population for the primary outcome, as defined in the registry: FAS
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.
| Characteristic | Unit | Elinzanetant (BAY3427080) | Placebo - Elinzanetant (BAY3427080) | Total |
|---|---|---|---|---|
| Participants analysed | 316 | 158 | 474 | |
| Age, Continuous | years | 50.8 (SD 7.5) | 51.5 (SD 6.7) | 51.0 (SD 7.3) |
| Sex: Female, Male: Female | Participants | 316 | 158 | 474 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 7 | 5 | 12 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 289 | 143 | 432 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 20 | 10 | 30 |
6. Primary Endpoint
The registry lists the primary outcome as Mean Change in Frequency of Moderate to Severe Hot Flashes (HF) From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD]), measured over 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 in frequency of moderate to severe hot flashes from baseline to Week 4, assessed with the Hot Flash Daily Diary. The measure is expressed as hot flashes per day. Participants recorded hot flashes electronically in morning and evening diary entries. The diary distinguished mild, moderate, and severe episodes; the primary endpoint includes moderate and severe episodes rather than all reported hot flashes.
The registry record defines mean daily frequency for a week as the total number of moderate to severe hot flashes during that week divided by the number of available diary days with data during that week. Change from baseline describes how this average differs at the assessment time from the baseline value. A mean is useful for expressing the group’s average symptom frequency, while participant-level values can vary around that average.
This endpoint is relevant to the stated study question because it quantifies symptom frequency during treatment. The diary’s definitions distinguish severity by the experience of sweating and whether activity can continue. The record identifies Week 4 as the primary assessment, but does not report the baseline or Week 4 group means, the estimated treatment contrast, or its uncertainty. The registry record therefore does not establish the size or precision of any observed change.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record gives a clearly specified primary outcome: mean change in moderate to severe hot-flash frequency from baseline to Week 4, measured using the Hot Flash Daily Diary. However, it does not report a numerical primary efficacy result. There is no posted group mean change, treatment contrast, confidence interval, standard error, or p-value for that endpoint in the record. Consequently, the magnitude and precision of the primary comparison cannot be characterized from the registry record.
This absence of an efficacy estimate is not evidence that the treatments had the same effect, nor is it evidence that one treatment performed better. It means that the registry record does not provide the result needed to make that statistical comparison. The endpoint description and trial design explain what investigators intended to measure, not what the comparison found.
The safety information is numerical but answers a different question. During Week 1-12, the registry lists serious adverse events affecting 8 of 315 participants at risk in the elinzanetant group and 1 of 158 at risk in the placebo group. For other adverse events, it lists 145 of 315 and 61 of 158, respectively. These are recorded counts within the stated groups and periods. They do not by themselves establish a treatment effect on safety: interpretation would require attention to event definitions, observation time, participant-level exposure, and the analysis approach, which are not fully described in the registry record.
Later safety entries concern different treatment periods, including periods after placebo recipients switched to elinzanetant. For example, the record lists 8 serious adverse events among 294 at risk during elinzanetant Week 13-26, and 4 among 150 at risk during placebo-to-elinzanetant Week 13-26. Those groups and periods should be read as distinct registry entries, not as a direct randomized comparison of ongoing placebo with elinzanetant throughout that interval.
The registry also lists zero deaths for each reported safety group. This describes the recorded groups and periods; it does not supply an estimate of comparative mortality. Several serious-event terms are listed with percentages, including COVID-19, concussion, hypokalaemia, and recurrent breast cancer. The record does not give enough context in this information to infer a causal relationship between treatment and any individual event term.
9. Statistical Methods Explained
What does a mean change describe?
For a continuous measure, a mean is the arithmetic average across participants with values included in the analysis. Mean change compares an average at a follow-up assessment with an average at baseline, or averages each participant’s change, depending on the specified analysis. Those approaches can differ when participant data are incomplete or when the analysis adjusts for other variables. The registry record names mean change as the endpoint but does not report the detailed estimator used for the treatment comparison.
In this study, the diary-based frequency is defined by the registry as the total number of moderate to severe hot flashes during a week divided by the number of days with available diary data during that week. The resulting measure is a daily average. A change in that measure is expressed in hot flashes per day. Without the group-level baseline and follow-up values, or a treatment contrast, the direction and size of the observed change cannot be determined from the record.
What does the standard deviation represent?
The primary outcome is described using a mean and standard deviation. A standard deviation describes how dispersed individual observations are around their mean. It is not the same as the standard error, and it is not a confidence interval for a treatment effect. A group can have a small standard deviation while the estimated difference between groups remains uncertain, or vice versa; uncertainty in a comparison depends on the analysis and the amount of available information.
A confidence interval, as a general statistical concept, gives a range of values compatible with an estimate under the model and procedure used. Its width reflects precision, among other things. The registry record does not report a confidence interval for the primary comparison, so its precision cannot be assessed from a treatment-effect interval. A p-value, if reported, would address compatibility with a specified null hypothesis under an analysis model; it would not describe the size or clinical importance of an effect. No primary endpoint p-value is reported in the registry record.
Why does the diary’s available-day denominator matter?
The daily frequency uses the days with diary data rather than assuming every day has an entry. This definition makes the denominator explicit, but does not by itself explain how missing diary days are handled in the baseline-to-Week 4 analysis. Different missing-data methods can target different quantities and can rely on different assumptions. The registry record does not report its missing-data strategy, rules for minimum diary completion, or sensitivity analyses. Thus, the endpoint definition should not be mistaken for a complete description of how incomplete records entered the analysis.
Diary entries are collected in the morning and evening, and the endpoint concerns episodes during the day and night. Repeated reporting can provide a record of symptoms over time, but it also creates the possibility of incomplete entries and variation in reporting. The record does not describe procedures for checking diary quality or handling inconsistent entries.
What can randomization and masking contribute?
In general, random allocation can reduce systematic differences between groups at the start of a trial, while masking can reduce influence from expectations on participant reporting, care, or outcome assessment. These design features support a fair comparison, but they do not guarantee that groups remain identical in every respect or that the outcome estimate is precise. The registry record labels the study randomized and double-blind. Specific details about sequence generation, concealment, and the success of masking are not reported in the registry record.
The parallel-group design assigns participants to treatment groups for comparison, while the placebo group is scheduled to receive elinzanetant after 12 weeks. This treatment change matters when interpreting later-period safety information: later entries do not represent the same placebo-controlled contrast as the initial period. The primary endpoint is at Week 4, within the described initial placebo-controlled period.
What does a planning illustration mean?
Sample-size calculations are planning exercises that use assumptions about the target effect, variability, significance level, allocation, and analysis. A planning illustration based on a fraction of an observed effect is conditional on that assumed effect; it is not observed power and does not show how likely the trial was to find a result. The stated illustration assumptions include a two-sided significance level of 0.05, equal allocation, and a normal approximation. The record does not report the trial’s own design justification or explain whether these illustrative assumptions match its original planning.
Because the primary efficacy estimate is not reported in the registry record, a reader cannot use the endpoint description alone to judge the observed effect or its precision. Nor can an illustrative sample size substitute for the actual result. The primary analysis model, covariate adjustment, treatment of repeated measures, and any confirmatory testing procedure are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 8 outcome measures and 4 analyses. The primary outcome is the change in moderate to severe hot-flash frequency from baseline to Week 4. Listed secondary outcomes include changes in hot-flash severity at Week 4 and Week 12, frequency at Week 1 and over time, sleep disturbance, and menopause-specific quality of life. These multiple outcomes and assessment times create a general multiplicity issue: when many hypotheses are tested, the chance of at least one apparently unusual result can increase unless testing is planned and interpreted accordingly.
The registry record does not report a multiplicity adjustment, a hierarchy of confirmatory endpoints, or the statistical plan specifying how the listed outcomes and analyses were tested. The primary efficacy estimate and its inferential statistics are not reported in the registry record, so the record does not support a conclusion about whether any multiplicity procedure was applied.
The primary outcome population is labeled FAS, but the registry record does not report the definition of that population, its size, or how participants were included in the analysis. Missing-data methods are also not reported in the registry record. This is relevant because diary completion determines the available-day denominator for the weekly frequency measure, while the analysis of change over time may require additional rules for incomplete participant records.
The record does not describe imputation, assumptions about why data are missing, sensitivity analyses, or handling of participants who discontinue treatment. These omissions limit assessment of how robust a future or separately reported efficacy estimate would be to missing data. They do not demonstrate that any particular method was or was not used outside the registry record.
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 120mg Week 1-12 | 8 | 315 | 2.5% |
| Placebo Week 1-12 | 1 | 158 | 0.6% |
| Elinzanetant 120mg Week 13-26 | 8 | 294 | 2.7% |
| Placebo - Elinzanetant 120mg Week 13-26 | 4 | 150 | 2.7% |
| Elinzanetant 120mg Week 1-26 | 18 | 465 | 3.9% |
| Elinzanetant 120mg Week 27-52 | 18 | 409 | 4.4% |
| Elinzanetant 120mg Week 1-52 | 33 | 465 | 7.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Elinzanetant 120mg Week 1-12 | 0 of 315 |
| Placebo Week 1-12 | 0 of 158 |
| Elinzanetant 120mg Week 13-26 | 0 of 294 |
| Placebo - Elinzanetant 120mg Week 13-26 | 0 of 150 |
| Elinzanetant 120mg Week 1-26 | 0 of 465 |
| Elinzanetant 120mg Week 27-52 | 0 of 409 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0.05% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Elinzanetant 120mg Week 1-12 | 145 of 315 |
| Placebo Week 1-12 | 61 of 158 |
| Elinzanetant 120mg Week 13-26 | 72 of 294 |
| Placebo - Elinzanetant 120mg Week 13-26 | 38 of 150 |
| Elinzanetant 120mg Week 1-26 | 211 of 465 |
| Elinzanetant 120mg Week 27-52 | 73 of 409 |
Most frequent serious adverse event terms
| Event term | Organ system | Elinzanetant 120mg Week 1-12 | Placebo Week 1-12 | Elinzanetant 120mg Week 13-26 | Placebo - Elinzanetant 120mg Week 13-26 | Elinzanetant 120mg Week 1-26 | Elinzanetant 120mg Week 27-52 |
|---|---|---|---|---|---|---|---|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 315 | 0 of 158 | 1 of 294 | 0 of 150 | 2 of 465 | 0 of 409 |
| Cataract | Eye disorders | 0 of 315 | 0 of 158 | 1 of 294 | 0 of 150 | 1 of 465 | 1 of 409 |
| Tremor | Nervous system disorders | 1 of 315 | 0 of 158 | 1 of 294 | 0 of 150 | 1 of 465 | 0 of 409 |
| Breast reconstruction | Surgical and medical procedures | 1 of 315 | 0 of 158 | 0 of 294 | 0 of 150 | 1 of 465 | 1 of 409 |
| Atrial fibrillation | Cardiac disorders | 1 of 315 | 0 of 158 | 0 of 294 | 0 of 150 | 1 of 465 | 0 of 409 |
| Intestinal obstruction | Gastrointestinal disorders | 1 of 315 | 0 of 158 | 0 of 294 | 0 of 150 | 1 of 465 | 0 of 409 |
| Bile duct stone | Hepatobiliary disorders | 0 of 315 | 0 of 158 | 1 of 294 | 0 of 150 | 1 of 465 | 0 of 409 |
| COVID-19 | Infections and infestations | 0 of 315 | 0 of 158 | 0 of 294 | 1 of 150 | 1 of 465 | 0 of 409 |
| Infection | Infections and infestations | 1 of 315 | 0 of 158 | 0 of 294 | 0 of 150 | 1 of 465 | 0 of 409 |
| Post procedural sepsis | Infections and infestations | 0 of 315 | 0 of 158 | 1 of 294 | 0 of 150 | 1 of 465 | 0 of 409 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Elinzanetant 120mg Week 1-12 | Placebo Week 1-12 | Elinzanetant 120mg Week 13-26 | Placebo - Elinzanetant 120mg Week 13-26 | Elinzanetant 120mg Week 1-26 | Elinzanetant 120mg Week 27-52 |
|---|---|---|---|---|---|---|---|
| Headache | Nervous system disorders | 30 of 315 | 20 of 158 | 13 of 294 | 7 of 150 | 48 of 465 | 11 of 409 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 20 of 315 | 10 of 158 | 19 of 294 | 6 of 150 | 42 of 465 | 15 of 409 |
| Fatigue | General disorders | 30 of 315 | 8 of 158 | 7 of 294 | 5 of 150 | 41 of 465 | 3 of 409 |
| Somnolence | Nervous system disorders | 34 of 315 | 6 of 158 | 4 of 294 | 5 of 150 | 42 of 465 | 1 of 409 |
| Nausea | Gastrointestinal disorders | 19 of 315 | 10 of 158 | 6 of 294 | 5 of 150 | 28 of 465 | 3 of 409 |
| Nasopharyngitis | Infections and infestations | 12 of 315 | 5 of 158 | 9 of 294 | 8 of 150 | 28 of 465 | 9 of 409 |
| Diarrhoea | Gastrointestinal disorders | 16 of 315 | 3 of 158 | 6 of 294 | 4 of 150 | 25 of 465 | 7 of 409 |
| Depression rating scale score increased | Investigations | 21 of 315 | 13 of 158 | 1 of 294 | 0 of 150 | 22 of 465 | 2 of 409 |
| Back pain | Musculoskeletal and connective tissue disorders | 10 of 315 | 7 of 158 | 5 of 294 | 2 of 150 | 16 of 465 | 14 of 409 |
| Asthenia | General disorders | 13 of 315 | 2 of 158 | 7 of 294 | 3 of 150 | 22 of 465 | 5 of 409 |
Serious events with the highest arm-level rate: covid-19 (0.7%), concussion (0.7%), hypokalaemia (0.7%), breast cancer recurrent (0.7%), ligament operation (0.6%).
For Week 1-12, the registry lists 8 participants with serious adverse events among 315 at risk in the elinzanetant group, and 1 among 158 at risk in the placebo group. It lists other adverse events affecting 145 of 315 and 61 of 158, respectively. These are counts and denominators for the stated period, not adjusted comparisons or estimates of a causal effect.
The record also lists safety information across later intervals. Elinzanetant Week 13-26 has 8 serious events among 294 at risk, and the placebo-to-elinzanetant group for Week 13-26 has 4 among 150 at risk. Elinzanetant Week 1-26 lists 18 among 465 at risk; Week 27-52 lists 18 among 409; and Week 1-52 lists 33 among 465. These entries cover different time periods and groups, so their counts should not be added together as if they were independent participants or nonoverlapping observations.
The registry lists zero deaths in each reported group. It also lists serious-event terms with percentages, such as COVID-19 at 0.7% and concussion at 0.7%. These figures describe entries in the safety record; they do not establish that a treatment caused an event. Definitions, exposure-adjusted analyses, and formal between-group safety comparisons are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes the clinical question and the measurement plan: compare change in mean moderate to severe hot-flash frequency from baseline to Week 4, using a daily diary, in a randomized, double-blind comparison of elinzanetant with placebo. It also gives the treatment schedules and reports safety counts for several groups and periods. These details make the intended outcome and the scope of the recorded safety information understandable.
It does not report the primary efficacy result. There is no treatment-effect estimate or interval from which to judge the direction, magnitude, or precision of the primary comparison. The absence of that result must not be interpreted as evidence of no effect, as proof of benefit, or as proof that the comparison was inconclusive. It means that the registry record does not report the information required to make those judgments.
Safety counts provide descriptive information about recorded events among participants at risk in the specified groups and periods. They do not alone determine whether risks differ between treatments, particularly because later periods include participants who switched from placebo to elinzanetant. A count also does not describe the severity, duration, or clinical context of every event. Those details and a complete comparative safety analysis are not reported in the registry record.
More generally, a statistically precise estimate would still need to be interpreted alongside the outcome definition, analysis population, missing-data approach, and clinical context. Those details are not all available in the registry record. The record supports a description of the planned primary endpoint and selected safety observations, but not a conclusion about treatment efficacy.
13. Why This Trial Matters Statistically
This trial raises a statistical question about measuring a frequent, variable symptom with repeated diary records. Its primary endpoint converts recorded moderate to severe hot flashes into a mean daily frequency using days with available data. That gives the outcome a clear unit and makes the intended comparison interpretable, while also making diary completeness and missing-data handling important parts of the analysis.
The randomized, double-blind, placebo-controlled design is suited to a comparative question. The Week 4 primary assessment occurs during the initial placebo-controlled period, whereas later follow-up includes a scheduled switch from placebo to elinzanetant. Keeping those periods distinct is important: a later safety count after switching is not the same kind of comparison as a concurrent randomized contrast.
The record also illustrates why describing an endpoint is not the same as reporting its result. A reader needs an effect estimate and a measure of uncertainty to assess both magnitude and precision. The registry record specifies the endpoint but does not report its efficacy estimate. The available safety counts can be described, but they do not fill that gap or provide a complete treatment comparison.
Finally, multiple listed outcomes and assessment times make the analysis plan relevant to interpretation. Without a reported testing strategy, missing-data approach, or primary comparison estimate, the registry information is not enough to evaluate confirmatory evidence. These limitations concern what can be concluded from the registry record; they do not establish what analyses may appear in other records.
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 central limitation is that the registry record describes the primary endpoint without reporting its efficacy results. Group values, a treatment contrast, and an uncertainty measure for the Week 4 comparison are not reported in the registry record. This prevents assessment of the observed effect’s direction, magnitude, and precision.
The record labels the primary analysis population FAS but does not define it or report its size. It does not describe missing-data handling, diary-completion thresholds, the primary statistical model, covariate adjustment, or sensitivity analyses. These omissions are especially pertinent to a diary-based endpoint whose weekly average uses days with available data.
The record lists multiple outcomes and analyses but does not report a multiplicity strategy or testing hierarchy. It also does not provide the protocol’s sample-size justification or enough detail to assess whether the planning assumptions described for illustrative calculations were part of the original trial design.
Safety counts cover groups and periods that include the placebo-to-elinzanetant switch and overlapping elinzanetant intervals. The registry record does not provide exposure-adjusted comparisons or detailed event definitions in this information. Consequently, descriptive counts and listed percentages should not be treated as a complete comparative safety analysis. The registry status is active, not recruiting; this status alone does not indicate whether additional results will be posted.
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 Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer — NCT05587296.
- Registry record last updated 2026-07-09; status last verified 2026-06.
- Results first posted 2025-10-29.
- 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.
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18. Record Summary
NCT05587296 is a Phase 3 randomized, double-blind, parallel-group study sponsored by Bayer. It evaluates oral elinzanetant 120 mg once daily against matching placebo for 12 weeks, followed by elinzanetant in the placebo group. The registry lists enrollment of 474 and a primary completion date of 2024-01-29.
The primary endpoint is mean change in moderate to severe hot-flash frequency from baseline to Week 4, measured using the Hot Flash Daily Diary. The primary efficacy result is not reported in the registry record. The record includes serious and other adverse-event counts across several groups and follow-up periods, but does not report a complete comparative safety analysis or detailed statistical methods for efficacy.