Trial · NCT05042362
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, Phase 3, Completed, Bayer; results first posted 2026-02-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT05042362. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05042362
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT05042362
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 396 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Vasomotor Symptoms Associated With Menopause, Hot Flashes
- Interventions
- Elinzanetant (BAY3427080), Placebo
- First posted
- 2021-09-13
- Last updated
- 2026-02-12
- Other registries' IDs
- eudract:2020-004908-33
- Results first posted
- 2026-02-12
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD]). | From baseline to Week 4 | The frequency of moderate to severe HF for each week during the treatment period was calculated using the available data during that particular week. Specifically for Week 4, Days 22-28 were used (Day 1 corresponds to start of treatment). Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week |
| Primary | Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD). | From baseline to Week 12 | The frequency of moderate to severe HF for each week during the treatment period was calculated using the available data during that particular week. Specifically for Week 12, Days 78-84 were used (Day 1 corresponds to start of treatment). Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week |
| Primary | Mean Change in Severity of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD). | From baseline to Week 4 | In the HFDD, hot flash (HF) severity is scored as 1=mild, 2=moderate, and 3=severe; a decrease indicates improvement. The diary records the number of mild, moderate, and severe HFs during day and night. Mild HFs are a "sensation of heat without sweating"; moderate are "heat with sweating but able to continue activity"; severe are "heat with sweating that stops activity." Baseline mean daily severity is calculated as: (2×moderateHFs+3×severeHFs)÷(totalmoderate+severeHFs).(2 × moderate HFs + 3 × severe HFs) ÷ (total moderate + severe HFs).(2×moderateHFs+3×severeHFs)÷(totalmoderate+severeHFs). If none occur, severity=0. Weekly severity during treatment is based on available days (Week 4: Days 22-28; Week 12: Days 78-84; Day 1=start of treatment), averaging the mean daily severity for that week. If more than 2 days are missing, the weekly value is set to missing. |
| Primary | Mean Change in Severity of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD). | From baseline to Week 12 | In the HFDD, hot flash (HF) severity is categorized as 1=mild, 2=moderate, 3=severe; thus, a decrease indicates improvement. The HFDD records the number of mild, moderate, and severe HFs during day and night. Mild HFs are a "sensation of heat without sweating"; moderate involve "heat with sweating but able to continue activity"; severe involve "heat with sweating that stops activity." Mean daily severity at baseline is calculated as: (2 × moderate HFs) + (3 × severe HFs)\\\] ÷ (total moderate + severe HFs). If none occur, severity is set to 0. Weekly severity during treatment is based on available days (Week 4: Days 22-28; Week 12: Days 78-84; Day 1=start of treatment), averaging mean daily severity across that week. If more than 2 days are missing, the week is set to missing. |
| Secondary | Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 1 (Assessed by HFDD). | From baseline to Week 1 | The frequency of moderate to severe HF for each week during the treatment period was calculated using the available data during that particular week. Specifically for Week 1, Days 2-8 were used (Day 1 corresponds to start of treatment). Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week |
| Secondary | Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time. | From baseline to Week 30 | The frequency of moderate to severe HF for each week during the treatment period was calculated using the available data during that particular week. Specifically, for Week 1 Days 2-8 were used instead of 1-7, because the intake started on Day 1 only before going to bed, for Week 4 Days 22-28 were used and for Week 12 Days 78-84 were used (Day 1 corresponds to start of treatment). These data were aggregated to a mean daily frequency as (total number of moderate to severe HF during that week) / (total number of available days with data during that week). In case data was not available for more than 2 days within a week, the value for that particular week was set to missing. |
| Secondary | Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline to Week 12. | From baseline to Week 12 | In controversy of what you have been proposing above here you are just explaining the PROMIS SD SF 8b scores, not the secondary endpoint which is the change in the T-scores from BL to week 12 The PROMIS Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) measures sleep disturbance over the past 7 days using 8 items assessing sleep quality, depth, restorative sleep, difficulty falling or staying asleep, and perceptions of sleep adequacy and satisfaction. Items use 5-point response options that vary by item (e.g., Not at all → Very much; Never → Always; Very poor → Very good). Item scores sum to a raw score of 8-40, which is converted to a T-score (mean 50, SD 10; range 28.9-76.5). Higher scores reflect greater sleep disturbance. PROMIS cut points classify T-scores of 55-59 as mild, 60-69 as moderate, and ≥70 as severe disturbance. |
| Secondary | Mean Menopause Specific Quality of Life Scale (MENQOL) Total Score From Baseline to Week 12. | From baseline to Week 12 | The MENQOL questionnaire was comprised of 29 items assessing the presence of menopausal symptoms and the impact of menopause on health-related quality of life over the past week. The items assessed four domains of symptoms and functioning: VMS, psychosocial functioning, physical functioning, and sexual functioning. For each item, the participant indicated if they had experienced the symptom (yes/no). If participants selected yes, participants rated how bothered they were by the symptom using a six-point verbal descriptor scale, with response options ranging from 0 'not at all bothered' to 6 'extremely bothered'. Based on the individual responses, item scores, domain scores, and a total MENQOL score were calculated. Each score ranged from 1-8, higher scores indicated greater bother. |
| Secondary | Mean Beck Depression Inventory (BDI-II) Total Score From Baseline to Week 12. | From baseline to Week 12 | The BDI-II was a 21-item questionnaire assessed the intensity of depressive symptoms over the past 2 weeks. Each item was a list of four statements arranged in increasing levels of severity about a particular symptom of depression. Items used a 4-point verbal response scale ranging from 0 (not at all) to 3 (extreme form of each symptom); specific response options were tailored to the aspect of depression being measured in each item. A total score ranging from 0 to 63 was calculated with scores of 0-13 indicating mild minimal range, 14 - 19 mild depression, 20 - 28 indicating moderate and 29 - 63 severe depression (higher score = greater depression). |
| Secondary | Mean Change in BDI-II Total Score From Baseline to Week 26. | From baseline to Week 26 | The BDI-II was a 21-item questionnaire assessing the intensity of depressive symptoms over the past 2 weeks. Each item was a list of four statements arranged in increasing levels of severity about a particular symptom of depression. Items used a 4-point verbal response scale ranging from 0 (not at all) to 3 (extreme form of each symptom); specific response options were tailored to the aspect of depression being measured in each item. A total score ranging from 0 to 63 was calculated with scores of 0-13 indicating mild minimal range, 14 - 19 mild depression, 20 - 28 indicating moderate and 29 - 63 severe depression (higher score = greater depression). |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD]). | From baseline to Week 4 | Participants in full analysis set (FAS) with evaluable data. | Hot Flashes per day | MEAN |
| PRIMARY | Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD). | From baseline to Week 12 | Participants in full analysis set (FAS) with evaluable data. | Hot Flashes per day | MEAN |
| PRIMARY | Mean Change in Severity of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD). | From baseline to Week 4 | Participants in full analysis set (FAS) with evaluable data. | Units on a scale | MEAN |
| PRIMARY | Mean Change in Severity of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD). | From baseline to Week 12 | Participants in full analysis set (FAS) with evaluable data. | Units on a scale | MEAN |
| SECONDARY | Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 1 (Assessed by HFDD). | From baseline to Week 1 | Participants in full analysis set (FAS) with evaluable data. | Hot Flashes per day | MEAN |
| SECONDARY | Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time. | From baseline to Week 30 | Participants in full analysis set (FAS) with evaluable data. | Hot Flashes per day | MEAN |
| SECONDARY | Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline to Week 12. | From baseline to Week 12 | Participants in full analysis set (FAS) with evaluable data. | T-score | MEAN |
| SECONDARY | Mean Menopause Specific Quality of Life Scale (MENQOL) Total Score From Baseline to Week 12. | From baseline to Week 12 | Participants in full analysis set (FAS) with evaluable data. | Scores on scale | MEAN |
| SECONDARY | Mean Beck Depression Inventory (BDI-II) Total Score From Baseline to Week 12. | From baseline to Week 12 | Participants in full analysis set (FAS) with evaluable data. | Scores on scale | MEAN |
| SECONDARY | Mean Change in BDI-II Total Score From Baseline to Week 26. | From baseline to Week 26 | Participants in full analysis set (FAS) with evaluable data. | Scores on scale | MEAN |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD]). | Elinzanetant 120 mg | Baseline | 13.38 | Standard Deviation 6.57 | Hot Flashes per day |
| Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD]). | Placebo - Elinzanetant 120 mg | Baseline | 14.26 | Standard Deviation 13.94 | Hot Flashes per day |
| Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD]). | Elinzanetant 120 mg | Week 4: Change from baseline | -7.48 | Standard Deviation 5.80 | Hot Flashes per day |
| Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD]). | Placebo - Elinzanetant 120 mg | Week 4: Change from baseline | -4.37 | Standard Deviation 6.73 | Hot Flashes per day |
| Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD). | Elinzanetant 120 mg | Baseline | 13.38 | Standard Deviation 6.57 | Hot Flashes per day |
| Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD). | Placebo - Elinzanetant 120 mg | Baseline | 14.26 | Standard Deviation 13.94 | Hot Flashes per day |
| Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD). | Elinzanetant 120 mg | Week 12: Change from baseline | -8.74 | Standard Deviation 6.70 | Hot Flashes per day |
| Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD). | Placebo - Elinzanetant 120 mg | Week 12: Change from baseline | -5.53 | Standard Deviation 10.16 | Hot Flashes per day |
| Mean Change in Severity of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD). | Elinzanetant 120 mg | Baseline | 2.56 | Standard Deviation 0.22 | Units on a scale |
| Mean Change in Severity of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD). | Placebo - Elinzanetant 120 mg | Baseline | 2.53 | Standard Deviation 0.23 | Units on a scale |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Elinzanetant 120 mg | 199 | |
| Overall Study | STARTED | Placebo - Elinzanetant 120 mg | 197 | |
| Overall Study | COMPLETED | Elinzanetant 120 mg | 154 | |
| Overall Study | COMPLETED | Placebo - Elinzanetant 120 mg | 155 | |
| Overall Study | NOT COMPLETED | Elinzanetant 120 mg | 45 | |
| Overall Study | NOT COMPLETED | Placebo - Elinzanetant 120 mg | 42 |
Source ClinicalTrials.gov
Adverse events90
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Elinzanetant 120 mg Week 1-12 | 14 | 199 | 14 |
| other | Fatigue | General disorders | Placebo Week 1-12 | 3 | 194 | 3 |
| other | Fatigue | General disorders | Elinzanetant 120 mg Week 13-26 | 0 | 171 | 0 |
| other | Fatigue | General disorders | Placebo - Elinzanetant 120 mg Week 13-26 | 1 | 168 | 1 |
| other | Fatigue | General disorders | Elinzanetant 120 mg Week 1-26 | 15 | 367 | 15 |
| other | Depression rating scale score increased | Investigations | Elinzanetant 120 mg Week 1-12 | 12 | 199 | 13 |
| other | Depression rating scale score increased | Investigations | Placebo Week 1-12 | 11 | 194 | 12 |
| other | Depression rating scale score increased | Investigations | Elinzanetant 120 mg Week 13-26 | 1 | 171 | 1 |
| other | Depression rating scale score increased | Investigations | Placebo - Elinzanetant 120 mg Week 13-26 | 2 | 168 | 2 |
| other | Depression rating scale score increased | Investigations | Elinzanetant 120 mg Week 1-26 | 14 | 367 | 16 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Elinzanetant 120 mg Week 1-12 | 0 | 199 |
| Total, all-cause mortality | Placebo Week 1-12 | 0 | 194 |
| Total, all-cause mortality | Elinzanetant 120 mg Week 13-26 | 0 | 171 |
| Total, all-cause mortality | Placebo - Elinzanetant 120 mg Week 13-26 | 0 | 168 |
| Total, all-cause mortality | Elinzanetant 120 mg Week 1-26 | 0 | 367 |
| Total, other adverse events | Elinzanetant 120 mg Week 1-12 | 38 | 199 |
| Total, other adverse events | Placebo Week 1-12 | 28 | 194 |
| Total, other adverse events | Elinzanetant 120 mg Week 13-26 | 6 | 171 |
| Total, other adverse events | Placebo - Elinzanetant 120 mg Week 13-26 | 9 | 168 |
| Total, other adverse events | Elinzanetant 120 mg Week 1-26 | 51 | 367 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39172446 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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