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    Clinical Trial Results:
    Double-blind trial investigating the efficacy of different doses of Progesterone compared with Placebo for treatment of vasomotor symptoms

    Summary
    EudraCT number
    		 2016-004386-12
    Trial protocol
    		 DE   AT  
    Global end of trial date
    06 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jun 2021
    First version publication date
    03 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BHR-401-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Besins Healthcare Ltd.
    Sponsor organisation address
    16 Pembroke Street Upper, Dublin 2, Ireland,
    Public contact
    Global Clinical Development, Besins Healthcare Ltd., moconnell@besins-healthcare.com
    Scientific contact
    Global Clinical Development, Besins Healthcare Ltd., moconnell@besins-healthcare.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
    05 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Dec 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the clinical trial is to demonstrate superiority of BHR401 (oral micronized progesterone) versus placebo as a monotherapy for moderate to severe VMS in postmenopausal women.
    Protection of trial subjects
    Micronized Progesterone preparations (like BHR-401) are licensed for endometrial protection in the context of menopausal hormone therapy at doses of 200 mg and 300 mg, two of the doses were used in the present study. The safety profile of micronized progesterone at these doses is favorable, with headache, drowsiness and dizziness being the most frequently reported side effects. These are most likely due to the sedating effects of progesterone and its metabolites. Therefore, study medication should be taken in the evening, before bed time, to avoid a burden to the subjects by these otherwise non-serious side effects. The 400 mg dose used in the present study is not licensed in Germany yet; however, oral doses of up to 400 mg/d are licensed for the treatment of secondary amenorrhea in the USA. Furthermore, based on pharmacokinetic evaluations where even higher doses of progesterone are given (and consequently higher plasma levels of progesterone are achieved), no significant safety concerns, other than those also described for the 200 mg and 300 mg doses, can be currently associated with an oral intake of this dose. Regardless of the dose, allergic reactions to micronized progesterone have been observed, mainly towards the excipients (e.g. soy lecithin). Therefore, subjects with a soy allergy were excluded from participation in this study. The risk to subjects was minimized by compliance with eligibility criteria and study procedures as well as close clinical monitoring. Participating subjects benefit from careful monitoring and follow-up during the entire study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Switzerland: 4
    Country: Number of subjects enrolled
    Germany: 70
    Worldwide total number of subjects
    74
    EEA total number of subjects
    70
    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)
    63
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 74
    Number of subjects completed
    		 55

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Missing: 1
    Reason: Number of subjects
    		 Insufficient VMS frequency: 14
    Reason: Number of subjects
    		 no actuell mammographie: 1
    Reason: Number of subjects
    		 Smoker: 1
    Reason: Number of subjects
    		 Screening period exited: 1
    Reason: Number of subjects
    		 mammography suspect: 1
    Period 1
    Period 1 title
    Treatment Phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BHR-401 200 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    BHR-401 200mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3 capsules per day: 1 capsule 200 mg BHR-401, 1 capsule 200mg Placebo, 1 capsule 300 mg Placebo

    Arm title
    		 BHR-401 300 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    BHR-401 300mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3 capsules per day: 1 capsule 300 mg BHR-401, 2 capsules 200mg Placebo

    Arm title
    		 BHR-401 400 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    BHR-401 400mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3 capsules per day: 2 capsules 200 mg BHR-401, 1 capsule 300 mg Placebo

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3 capsules per day: 2 capsules 200 mg Placebo, 1 capsule 300mg Placebo

    Number of subjects in period 1 [1]
    		BHR-401 200 mg BHR-401 300 mg BHR-401 400 mg Placebo
    Started
    13
    16
    12
    14
    Completed
    11
    13
    8
    11
    Not completed
    2
    3
    4
    3
         hollidays
    -
    -
    -
    1
         Consent withdrawn by subject
    -
    2
    -
    -
         Adverse event, non-fatal
    -
    -
    1
    1
         injury of inclusion criteria
    1
    -
    -
    -
         SAE
    -
    -
    1
    -
         end of study
    -
    -
    -
    1
         Lack of efficacy
    1
    1
    2
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 19 subject did not finalize the screening period. I.e., 74 subjects were screened and 55 subjects finally were analyzed.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BHR-401 200 mg
    Reporting group description
    		 -

    Reporting group title
    BHR-401 300 mg
    Reporting group description
    		 -

    Reporting group title
    BHR-401 400 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 BHR-401 200 mg BHR-401 300 mg BHR-401 400 mg Placebo Total
    Number of subjects
    		 13 16 12 14 55
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.6 ( 2.57 ) 57.2 ( 6.79 ) 57.4 ( 6.74 ) 56.6 ( 5.84 ) -
    Gender categorical
    Units: Subjects
        Female
    		 13 16 12 14 55
        Male
    		 0 0 0 0 0
    Age at menarche
    Units: years
        arithmetic mean (standard deviation)
    		 13.3 ( 1.18 ) 13.1 ( 1.65 ) 13.5 ( 1.75 ) 12.9 ( 0.73 ) -
    Number of pregnancies
    Units: number
        arithmetic mean (standard deviation)
    		 1.8 ( 1.14 ) 1.7 ( 0.79 ) 2.3 ( 1.19 ) 1.9 ( 1.00 ) -
    Number of live births
    Units: number
        arithmetic mean (standard deviation)
    		 1.6 ( 0.67 ) 1.6 ( 0.81 ) 1.8 ( 0.75 ) 1.6 ( 0.51 ) -
    Time since beginning of menopause
    Units: years
        arithmetic mean (standard deviation)
    		 5.4 ( 4.13 ) 6.7 ( 8.69 ) 6.8 ( 6.67 ) 7.4 ( 10.35 ) -
    Time since first VMS
    Units: years
        arithmetic mean (standard deviation)
    		 4.1 ( 2.82 ) 4.3 ( 4.54 ) 5.6 ( 6.24 ) 5.0 ( 6.00 ) -

    End points

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    End points reporting groups
    Reporting group title
    BHR-401 200 mg
    Reporting group description
    		 -

    Reporting group title
    BHR-401 300 mg
    Reporting group description
    		 -

    Reporting group title
    BHR-401 400 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    SAF
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety data set (SAF) comprises all randomized subjects who were administered the study medication at least once.

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full analysis data set (FAS) includes all subjects of the SAF who provided any post-baseline data related to efficacy.

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol (PP) data set includes all subjects from the FAS who did not exhibit a major protocol deviation, e.g. protocol deviations that might have an influence on the outcome of the study.

    Primary: Absolute change in the frequency of moderate or severe VMS per day between baseline and week 12

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    End point title
    		 Absolute change in the frequency of moderate or severe VMS per day between baseline and week 12
    End point description
    End point type
    Primary
    End point timeframe
    Change from Baseline to Week 12 (Treatment Phase)
    End point values
    		 BHR-401 200 mg BHR-401 300 mg BHR-401 400 mg Placebo
    Number of subjects analysed
    12 [1]
    16
    10 [2]
    13 [3]
    Units: number
        arithmetic mean (standard deviation)
    -7.70 ( 4.913 )
    -8.29 ( 7.725 )
    -9.00 ( 4.046 )
    -7.40 ( 3.579 )
    Notes
    [1] - Data from one patient missing
    [2] - 11 patients in the FAS, data from 1 patient missing
    [3] - Data from 1 patient missing
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    BHR-401 200 mg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8798
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    BHR-401 300 mg v Placebo
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7457
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    BHR-401 400 mg v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1397
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Absolute change of VMS severity between baseline and week 12

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    End point title
    		 Absolute change of VMS severity between baseline and week 12
    End point description
    End point type
    Secondary
    End point timeframe
    Change from between baseline to week 12 (Treatment Phase)
    End point values
    		 BHR-401 200 mg BHR-401 300 mg BHR-401 400 mg Placebo
    Number of subjects analysed
    11 [4]
    15 [5]
    9 [6]
    11 [7]
    Units: scoring
        arithmetic mean (standard deviation)
    -0.58 ( 0.600 )
    -0.49 ( 0.658 )
    -0.69 ( 0.809 )
    -0.44 ( 0.597 )
    Notes
    [4] - data from 2 patients missing
    [5] - data from 1 patient missing
    [6] - 11 patietns in FAS, data from 2 patients missing
    [7] - data from 3 patients missing
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    BHR-401 200 mg v Placebo
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3744
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    BHR-401 300 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9534
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    BHR-401 400 mg v Placebo
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8808
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Absolute change in the frequency of moderate or severe VMS per day between baseline and week 4

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    End point title
    		 Absolute change in the frequency of moderate or severe VMS per day between baseline and week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Change from Baseline to Week 4 (Treatment Phase)
    End point values
    		 BHR-401 200 mg BHR-401 300 mg BHR-401 400 mg Placebo
    Number of subjects analysed
    12
    15
    10
    11
    Units: number
        arithmetic mean (standard deviation)
    -6.40 ( 3.441 )
    -7.04 ( 6.167 )
    -6.54 ( 2.184 )
    -6.75 ( 3.880 )
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    BHR-401 200 mg v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6978
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    BHR-401 300 mg v Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.785
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    BHR-401 400 mg v Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4611
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Absolute change of VMS severity between baseline and week 4

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    End point title
    		 Absolute change of VMS severity between baseline and week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 4 (Treatment Phase)
    End point values
    		 BHR-401 200 mg BHR-401 300 mg BHR-401 400 mg Placebo
    Number of subjects analysed
    12
    13
    10
    11
    Units: scoring
        arithmetic mean (standard deviation)
    -0.36 ( 0.412 )
    -0.37 ( 0.253 )
    0.00 ( 0.263 )
    -0.28 ( 0.499 )
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    BHR-401 200 mg v Placebo
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9122
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    BHR-401 300 mg v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.98
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    BHR-401 400 mg v Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4272
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent AEs (TEAEs) are defined as any event with a start date occurring on or after baseline or, if pre-existing, worsening after baseline, and occurring within the period of treatment with the trial drug, i.e. until visit 5.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    BHR-401 200mg
    Reporting group description
    		 -

    Reporting group title
    BHR-401 300mg
    Reporting group description
    		 -

    Reporting group title
    BHR-401 400mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 BHR-401 200mg BHR-401 300mg BHR-401 400mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 16 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 16 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1.8%
    Non-serious adverse events
    		 BHR-401 200mg BHR-401 300mg BHR-401 400mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 13 (30.77%)
    6 / 16 (37.50%)
    3 / 12 (25.00%)
    5 / 14 (35.71%)
    Injury, poisoning and procedural complications
    Muscle strain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 16 (6.25%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 16 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Tachycardia paroxysmal
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 16 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Surgical and medical procedures
    Dental care
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 16 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 16 (6.25%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Malaise
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 16 (6.25%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 16 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 16 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 16 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 16 (0.00%)
    1 / 12 (8.33%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    1
    Endometrial thickening
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 16 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ovarian cyst
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 16 (0.00%)
    1 / 12 (8.33%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 16 (6.25%)
    2 / 12 (16.67%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    2
    1
    Psychiatric disorders
    Nervousness
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 16 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Restlessness
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 16 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 16 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Back pain
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 16 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 16 (6.25%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cystitis
         subjects affected / exposed
    2 / 13 (15.38%)
    2 / 16 (12.50%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 16 (0.00%)
    0 / 12 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 16 (6.25%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    No conclusion can be drawn from the study results due to the premature termination of the study. This decision was not based on a safety concern, but due to insufficient subject accrual rate.
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    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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