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    Clinical Trial Results:
    A double-blind, randomized, placebo-controlled multicenter study to investigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms over 52 weeks in postmenopausal women

    Summary
    EudraCT number
    		 2021-000059-38
    Trial protocol
    		 BE   ES   FI   DK   BG   PL  
    Global end of trial date
    12 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Feb 2025
    First version publication date
    13 Feb 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY3427080/21810
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05030584
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser Wilhelm Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Feb 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of elinzanetant for the treatment of VMS associated with the menopause
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects (or their legally authorized representative according to local legislation). Participating subjects (or their legally authorized representative according to local legislation) signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Aug 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 44
    Country: Number of subjects enrolled
    Bulgaria: 70
    Country: Number of subjects enrolled
    Canada: 32
    Country: Number of subjects enrolled
    Denmark: 24
    Country: Number of subjects enrolled
    Finland: 32
    Country: Number of subjects enrolled
    Poland: 91
    Country: Number of subjects enrolled
    Spain: 50
    Country: Number of subjects enrolled
    United Kingdom: 40
    Country: Number of subjects enrolled
    United States: 245
    Worldwide total number of subjects
    628
    EEA total number of subjects
    311
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    628
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 75 study centers in North America and in several countries in Europe, between 27-Aug-2021 (first participant first visit) and 12-Feb-2024 (last participant last visit).

    Pre-assignment
    Screening details
    		 A total of 1524 patients were screened, of whom 628 were randomized.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Elinzanetant (BAY3427080)
    Arm description
    		 Subjects received 120 mg elinzanetant orally once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elinzanetant
    Investigational medicinal product code
    BAY3427080
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    120 mg elinzanetant orally once daily.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received matching placebo orally once daily.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo orally once daily.

    Number of subjects in period 1
    		Elinzanetant (BAY3427080) Placebo
    Started
    313
    315
    Received treatment
    312
    315
    Completed
    222
    231
    Not completed
    91
    84
         Physician decision
    1
    4
         Consent withdrawn by subject
    21
    28
         Randomized by Mistake
    -
    2
         Non-Compliance with Study Drug
    2
    3
         Adverse event, non-fatal
    17
    2
         Technical Problems
    -
    1
         non specified
    4
    3
         Lost to follow-up
    5
    2
         Completed post-treatment/FU visits
    41
    31
         Lack of efficacy
    -
    6
         Protocol deviation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Elinzanetant (BAY3427080)
    Reporting group description
    		 Subjects received 120 mg elinzanetant orally once daily.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo orally once daily.

    Reporting group values
    		 Elinzanetant (BAY3427080) Placebo Total
    Number of subjects
    		 313 315 628
    Age Categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.6 ( 4.7 ) 54.9 ( 5.0 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 313 315 628
        Male
    		 0 0 0
    Race
    Units: Subjects
        Asian
    		 2 2 4
        Native Hawaiian or Other Pacific Islander
    		 1 0 1
        Black or African American
    		 51 44 95
        White
    		 240 253 493
        More than one race
    		 0 1 1
        Unknown or Not Reported
    		 19 15 34
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 34 34 68
        Not Hispanic or Latino
    		 266 273 539
        Unknown or Not Reported
    		 13 8 21

    End points

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    End points reporting groups
    Reporting group title
    Elinzanetant (BAY3427080)
    Reporting group description
    		 Subjects received 120 mg elinzanetant orally once daily.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo orally once daily.

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized subjects.

    Subject analysis set title
    Safety Analysis Set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least one dose of study intervention.

    Primary: Mean change in frequency of moderate to severe hot flashes (HFs) from baseline to Week 12 (assessed by hot flash daily diary [HFDD])

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    End point title
    		 Mean change in frequency of moderate to severe hot flashes (HFs) from baseline to Week 12 (assessed by hot flash daily diary [HFDD])
    End point description
    The HFDD items assess the number of mild, moderate, and severe HF experienced during the day and during the night. In addition, the number of awakenings during the night and disturbance of sleep due to HF will be documented in the morning diary. Mild HF are defined as a “sensation of heat without sweating”, moderate HF are defined as a “sensation of heat with sweating, but able to continue activity”, and severe HF are defined as a “sensation of heat with sweating, causing cessation (stopping) of activity”. 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, Day 78-84 were used (Day 1 corresponds to start of treatment).
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Elinzanetant (BAY3427080) Placebo
    Number of subjects analysed
    313 [1]
    315 [2]
    Units: Number of HF per day
    arithmetic mean (standard deviation)
        Baseline (n=312,315)
    6.71 ( 7.15 )
    6.81 ( 6.15 )
        Change from Baseline (n=258,278)
    -5.40 ( 7.29 )
    -3.50 ( 4.96 )
    Notes
    [1] - FAS
    [2] - FAS
    Statistical analysis title
    		 MMRM analysis
    Statistical analysis description
    For category "Change from baseline". The number of subjects in the statistical analysis is 555.
    Comparison groups
    Elinzanetant (BAY3427080) v Placebo
    Number of subjects included in analysis
    628
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [3]
    Method
    		 Mixed model repeated measures (MMRM)
    Parameter type
    		 Difference in LS-means
    Point estimate
    -1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.04
         upper limit
    		 -1.05
    Notes
    [3] - The type I error rate was controlled at a one-sided α=0.025 level.

    Secondary: Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total T-score from baseline over time

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    End point title
    		 Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total T-score from baseline over time
    End point description
    The PROMIS SD SF 8b includes 8 items assessing sleep disturbance over the past 7 days. Items assess sleep quality, sleep depth and restoration associated with sleep, perceived difficulties with getting to sleep or staying asleep and perceptions of the adequacy of and satisfaction with sleep. Participants respond to the items on a 5-point scale from not at all, never or very poor to very much, always or very good. Four of the items are scored reversely. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance. The total raw scores were converted to total T-scores for analysis of this endpoint (range 28.9–76.5).
    End point type
    Secondary
    End point timeframe
    Baseline to Week 56
    End point values
    		 Elinzanetant (BAY3427080) Placebo
    Number of subjects analysed
    313
    315
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Baseline (n=270,274)
    57.35 ( 6.66 )
    57.96 ( 7.63 )
        Change from baseline to Week 1 (n=265,270)
    -5.19 ( 7.17 )
    -1.60 ( 5.39 )
        Change from baseline to Week 2 (n=262,265)
    -6.78 ( 7.96 )
    -2.89 ( 6.78 )
        Change from baseline to Week 3 (n=258,265)
    -7.67 ( 8.24 )
    -3.34 ( 6.88 )
        Change from baseline to Week 4 (n=249,263)
    -7.70 ( 8.27 )
    -3.81 ( 6.98 )
        Change from baseline to Week 8 (n=241,253)
    -7.98 ( 8.58 )
    -4.36 ( 7.64 )
        Change from baseline to Week 12 (n=228,246)
    -7.97 ( 8.04 )
    -5.26 ( 8.02 )
        Change from baseline to Week 18 (n=188,192)
    -8.83 ( 9.05 )
    -5.77 ( 7.82 )
        Change from baseline to Week 24 (n=178,195)
    -9.77 ( 9.00 )
    -5.85 ( 7.79 )
        Change from baseline to Week 36 (n=186,190)
    -9.20 ( 8.74 )
    -5.88 ( 8.38 )
        Change from baseline to Week 52 (n=151,159)
    -9.36 ( 8.41 )
    -5.73 ( 7.91 )
        Change at Week 56 (Follow-up) (n=184,177)
    -5.83 ( 8.71 )
    -5.38 ( 7.50 )
    No statistical analyses for this end point

    Secondary: Mean change in menopause specific quality of life scale (MENQOL) total score from baseline over time

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    End point title
    		 Mean change in menopause specific quality of life scale (MENQOL) total score from baseline over time
    End point description
    The MENQOL questionnaire is 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 assess four domains of symptoms and functioning: Vasomotor functioning, psychosocial functioning, physical functioning, and sexual functioning. For each item, the participant indicates if they have experienced the symptom (yes/no). If they select yes, they rate 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 are calculated. Each score ranges from 1-8, higher scores indicate greater bother.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 56
    End point values
    		 Elinzanetant (BAY3427080) Placebo
    Number of subjects analysed
    313
    315
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Baseline (n=262,264)
    4.10 ( 1.21 )
    4.41 ( 1.37 )
        Change from baseline to Week 4 (n=235,250)
    -0.94 ( 1.22 )
    -0.67 ( 1.21 )
        Change from baseline to Week 8 (n=233,243)
    -1.07 ( 1.24 )
    -0.86 ( 1.18 )
        Change from baseline to Week 12 (n=220,235)
    -1.10 ( 1.25 )
    -0.95 ( 1.32 )
        Change from baseline to Week 18 (n=183,185)
    -1.30 ( 1.32 )
    -1.11 ( 1.40 )
        Change from baseline to Week 24 (n=173,185)
    -1.25 ( 1.17 )
    -1.15 ( 1.37 )
        Change from baseline to Week 36 (n=179,182)
    -1.18 ( 1.21 )
    -1.02 ( 1.42 )
        Change from baseline to Week 52 (n=147,154)
    -1.30 ( 1.33 )
    -1.11 ( 1.35 )
        Change at Week 56 (Follow-up) (n=178,172)
    -0.82 ( 1.25 )
    -1.04 ( 1.59 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events tables: up to 14 days from the last drug intake. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 56 weeks.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Elinzanetant (BAY3427080)
    Reporting group description
    		 Subjects received 120 mg elinzanetant orally once daily.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo orally once daily.

    Serious adverse events
    		 Elinzanetant (BAY3427080) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 313 (4.15%)
    6 / 314 (1.91%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Blood glucose increased
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 314 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 314 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Injury
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 314 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 314 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 314 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 314 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Encephalitis toxic
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 314 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparaesthesia
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 314 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 314 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 314 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 314 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 314 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis chronic
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 314 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 313 (0.32%)
    1 / 314 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 314 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Epiglottitis
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 314 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected bite
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 314 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis meningococcal
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 314 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fusobacterium infection
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 314 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Elinzanetant (BAY3427080) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    85 / 313 (27.16%)
    73 / 314 (23.25%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    16 / 313 (5.11%)
    4 / 314 (1.27%)
         occurrences all number
    18
    4
    Headache
         subjects affected / exposed
    30 / 313 (9.58%)
    22 / 314 (7.01%)
         occurrences all number
    51
    51
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    21 / 313 (6.71%)
    9 / 314 (2.87%)
         occurrences all number
    23
    9
    Infections and infestations
    COVID-19
         subjects affected / exposed
    22 / 313 (7.03%)
    32 / 314 (10.19%)
         occurrences all number
    22
    32
    Nasopharyngitis
         subjects affected / exposed
    15 / 313 (4.79%)
    21 / 314 (6.69%)
         occurrences all number
    16
    23

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Feb 2022
    1. Exclusion criteria were modified. 2. Instructions regarding drugs that are sensitive substrates of OATP1B1/1B3, P-gp or BCRP during co-administration of elinzanetant were updated to allow administration of BCRP and/or OATP1B1/1B3 together with elinzanetant without restrictions. 3. Discontinuation of study intervention and Participant discontinuation/withdrawal from the study sections were updated. 4. Mammogram should be done either prior to COVID-vaccinations, or it should be delayed for a certain period after a vaccination, according to local guidelines. 5. Adverse events of special interest and Close observation of participants with liver function test findings sections were updated. 6. The primary endpoints will be analyzed using a mixed model with repeated measures (MMRM) on the change from baseline scores at different Weeks including also Week 8. 7. Liver safety - related monitoring and discontinuation criteria was updated. 8. Appendix 6: Prohibited concomitant medications was updated.
    22 Jun 2022
    1. Demography and baseline characteristics were updated to include educational level, and gynecological and reproductive history including numbers of pregnancy and birth. 2. Inclusion criterion 6: A new sub-bullet was added: HPV testing in participants with “absence of endocervical/transformation zone component” will be used as an adjunctive test automatically. Participants can be included if they are negative for high-risk HPV strains. 3. Exclusion Criteria: Re-test is allowed once in case of an abnormal INR value. 4. All vaginal hormonal products are prohibited from 4 weeks prior to Baseline, and not only those with systemic exposure.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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