Trial · NCT06112756
A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause
NCT06112756, Phase 2, Completed, Bayer; results first posted 2025-11-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause. Trials, record NCT06112756. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06112756
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause
- NCT number
- NCT06112756
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 110 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Sleep Disturbances Associated With Menopause
- Interventions
- Elinzanetant, Placebo
- First posted
- 2023-11-01
- Last updated
- 2025-11-10
- Results first posted
- 2025-11-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Wakefulness After Sleep Onset (WASO) at Week 4 as Measured by Polysomnography (PSG) | From baseline until week 4 | WASO is defined as total time (min) spent awake from onset of persistent sleep to lights on. Persistent sleep is defined as 20 consecutive epochs (10 min) of non wakefulness. Smaller WASO values indicate shorter periods of wakefulness after sleep onset. |
| Secondary | Change From Baseline in WASO at Week 12 as Measured by PSG | From baseline until week 12 | WASO is defined as total time (min) spent awake from onset of persistent sleep to lights on. Persistent sleep is defined as 20 consecutive epochs (10 min) of non wakefulness. Smaller WASO values indicate shorter periods of wakefulness after sleep onset. |
| Secondary | Change From Baseline in Sleep Efficiency (SE) at Week 4 as Measured by PSG | From baseline to Week 4 | Sleep efficiency is defined as the percentage of time spent asleep while in bed. (Total sleep time / time in bed) x 100. Higher sleep efficiency values indicate more time spent asleep. |
| Secondary | Change From Baseline in SE at Week 12 as Measured by PSG | From baseline to week 12 | Sleep efficiency is defined as the percentage of time spent asleep while in bed. (Total sleep time / time in bed) x 100. Higher sleep efficiency values indicate more time spent asleep. |
| Secondary | 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 | From baseline until week 4 | Participants' responses to the 8 items of the instrument are scored on a 1-5 numeric rating scale and will be aggregated to derive total raw scores ranging from 8-40 with higher scores indicating greater severity of sleep disturbance. These total raw scores will be converted into T-scores for comparison with population norms (United States general population). T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. |
| Secondary | Change From Baseline inPatient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score at Week 12 | From baseline until week 12 | Participants' responses to the 8 items of the instrument are scored on a 1-5 numeric rating scale and will be aggregated to derive total raw scores ranging from 8-40 with higher scores indicating greater severity of sleep disturbance. These total raw scores will be converted into T-scores for comparison with population norms (United States general population). T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. |
| Secondary | Change From Baseline in Insomnia Severity Index (ISI) Total Score at Week 4 | From baseline until week 4 | Insomnia Severity Index (ISI): The ISI is a 7-item tool that measures insomnia severity over the past two weeks (Bastien et al., 2001). It evaluates sleep onset, maintenance issues, early morning awakenings, satisfaction with sleep, noticeability of problems, distress caused, and daytime interference. Scoring: The ISI uses a 5-point Likert scale (0 to 4). Item scores are summed to yield a total score ranging from 0 to 28. Severity Categories: 0-7: No clinically significant insomnia (better outcome) 8-14: Subthreshold insomnia (moderate outcome) 15-21: Clinical insomnia (moderate severity) (worse outcome) 22-28: Clinical insomnia (severe) (worse outcome) Interpretation: Higher total scores indicate worse insomnia severity, while lower scores indicate better sleep quality. The total score is the sum of individual item scores. |
| Secondary | Change From Baseline in ISI Total Score at Week 12 | From baseline until week 12 | Insomnia Severity Index (ISI): The ISI is a 7-item tool that measures insomnia severity over the past two weeks (Bastien et al., 2001). It evaluates sleep onset, maintenance issues, early morning awakenings, satisfaction with sleep, noticeability of problems, distress caused, and daytime interference. Scoring: The ISI uses a 5-point Likert scale (0 to 4). Item scores are summed to yield a total score ranging from 0 to 28. Severity Categories: 0-7: No clinically significant insomnia (better outcome) 8-14: Subthreshold insomnia (moderate outcome) 15-21: Clinical insomnia (moderate severity) (worse outcome) 22-28: Clinical insomnia (severe) (worse outcome) Interpretation: Higher total scores indicate worse insomnia severity, while lower scores indicate better sleep quality. The total score is the sum of individual item scores. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Wakefulness After Sleep Onset (WASO) at Week 4 as Measured by Polysomnography (PSG) | From baseline until week 4 | Minutes | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline in WASO at Week 12 as Measured by PSG | From baseline until week 12 | Minutes | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline in Sleep Efficiency (SE) at Week 4 as Measured by PSG | From baseline to Week 4 | Percentage | MEAN | |
| SECONDARY | Change From Baseline in SE at Week 12 as Measured by PSG | From baseline to week 12 | Percentage | MEAN | |
| SECONDARY | 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 | From baseline until week 4 | T-Score | MEAN | |
| SECONDARY | Change From Baseline inPatient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score at Week 12 | From baseline until week 12 | T-Score | MEAN | |
| SECONDARY | Change From Baseline in Insomnia Severity Index (ISI) Total Score at Week 4 | From baseline until week 4 | Scores on a scale | MEAN | |
| SECONDARY | Change From Baseline in ISI Total Score at Week 12 | From baseline until week 12 | ISI total score | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Wakefulness After Sleep Onset (WASO) at Week 4 as Measured by Polysomnography (PSG) | Elinzanetant | -23.50 | Standard Error 4.63 | Minutes | |
| Change From Baseline in Wakefulness After Sleep Onset (WASO) at Week 4 as Measured by Polysomnography (PSG) | Placebo | -1.01 | Standard Error 4.68 | Minutes | |
| Change From Baseline in WASO at Week 12 as Measured by PSG | Elinzanetant | -16.48 | Standard Error 4.64 | Minutes | |
| Change From Baseline in WASO at Week 12 as Measured by PSG | Placebo | -15.54 | Standard Error 4.76 | Minutes | |
| Change From Baseline in Sleep Efficiency (SE) at Week 4 as Measured by PSG | Elinzanetant | 6.85 | Standard Deviation 8.07 | Percentage | |
| Change From Baseline in Sleep Efficiency (SE) at Week 4 as Measured by PSG | Placebo | 1.13 | Standard Deviation 10.31 | Percentage | |
| Change From Baseline in SE at Week 12 as Measured by PSG | Elinzanetant | 5.15 | Standard Deviation 9.68 | Percentage | |
| Change From Baseline in SE at Week 12 as Measured by PSG | Placebo | 4.67 | Standard Deviation 8.10 | Percentage | |
| 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 | Elinzanetant | -11.17 | Standard Deviation 8.04 | T-Score | |
| 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 | Placebo | -6.59 | Standard Deviation 6.76 | T-Score |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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 | 55 | |
| Overall Study | STARTED | Placebo | 55 | |
| Overall Study | COMPLETED | Elinzanetant | 52 | |
| Overall Study | COMPLETED | Placebo | 51 | |
| Overall Study | NOT COMPLETED | Elinzanetant | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events106
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 | Anaemia | Blood and lymphatic system disorders | BAY 3427080 / Elinzanetant | 0 | 55 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 55 | 1 |
| other | Thrombocytosis | Blood and lymphatic system disorders | BAY 3427080 / Elinzanetant | 1 | 55 | 1 |
| other | Thrombocytosis | Blood and lymphatic system disorders | Placebo | 0 | 55 | 0 |
| other | Vertigo | Ear and labyrinth disorders | BAY 3427080 / Elinzanetant | 0 | 55 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 1 | 55 | 1 |
| other | Abdominal discomfort | Gastrointestinal disorders | BAY 3427080 / Elinzanetant | 1 | 55 | 1 |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 0 | 55 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | BAY 3427080 / Elinzanetant | 0 | 55 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 55 | 1 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BAY 3427080 / Elinzanetant | 0 | 55 |
| Total, all-cause mortality | Placebo | 0 | 55 |
| Total, other adverse events | BAY 3427080 / Elinzanetant | 24 | 55 |
| Total, other adverse events | Placebo | 25 | 55 |
| Total, serious adverse events | BAY 3427080 / Elinzanetant | 0 | 55 |
| Total, serious adverse events | Placebo | 2 | 55 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BAY 3427080 / Elinzanetant vs Placebo: deaths from any cause | Trial comparisons |
| BAY 3427080 / Elinzanetant vs Placebo: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06112756
GET https://conductscience.org/api/trials/v1/NCT06112756/events?page=2