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    Clinical Trial Results:
    A Phase IIa, Double-Blind, Placebo-Controlled, Study of ESN364 Administered for 12 Weeks to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Women Presenting With Uterine Fibroids.

    Summary
    EudraCT number
    		 2014-004425-41
    Trial protocol
    		 BE   DE   AT  
    Global end of trial date
    04 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Dec 2017
    First version publication date
    28 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ESN364-UF-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ogeda S.A.
    Sponsor organisation address
    47 Rue Adrienne Bolland, Gosselies, Belgium, 6047
    Public contact
    Clinical Trial Disclosure, Ogeda S.A, astellas.resultsdisclosure@astellas.com
    Scientific contact
    Clinical Trial Disclosure, Ogeda S.A, astellas.resultsdisclosure@astellas.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
    27 Mar 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jan 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate efficacy of two doses of ESN364 versus placebo when administered for 12 weeks to reduce excessive uterine bleeding (assessed by Pictorial Blood Loss Assessment Chart [PBAC]).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization (ICH) Note for Guidance on Good Clinical Practice (GCP) (CPMP/ICH/135/95) and with applicable local requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Apr 2015
    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
    Belgium: 16
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 5
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    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)
    23
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 31 subjects were screened. 23 subjects were randomized and all 23 subjects completed the study. Pre-menopausal women between 18 and 55 yrs diagnosed with UF and no surgical intervention for myoma within the last 5 yrs.

    Period 1
    Period 1 title
    Overall trial (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
    Blinding implementation details
    Blinding was achieved by the double-dummy method with placebo identical in smell, taste and appearance

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ESN364 60 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ESN364
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received an oral dose of ESN364 60 mg once daily up to 12 weeks

    Arm title
    		 ESN364 180 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ESN364
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received an oral dose of ESN364 180 mg once daily up to 12 weeks

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received an oral dose of Placebo once daily up to 12 weeks

    Number of subjects in period 1
    		ESN364 60 mg ESN364 180 mg Placebo
    Started
    10
    6
    7
    Completed
    10
    6
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ESN364 60 mg
    Reporting group description
    		 -

    Reporting group title
    ESN364 180 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 ESN364 60 mg ESN364 180 mg Placebo Total
    Number of subjects
    		 10 6 7 23
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 10 6 7 23
    Gender categorical
    Units: Subjects
        Female
    		 10 6 7 23

    End points

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    End points reporting groups
    Reporting group title
    ESN364 60 mg
    Reporting group description
    		 -

    Reporting group title
    ESN364 180 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Change from Baseline in Decreased Uterine Bleeding as Assessed by Pictorial Blood Loss Assessment Chart (PBAC) at Week 12

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    End point title
    		 Change from Baseline in Decreased Uterine Bleeding as Assessed by Pictorial Blood Loss Assessment Chart (PBAC) at Week 12 [1]
    End point description
    Uterine bleeding was assessed with the use of PBAC, validated self reporting method to estimate menstrual blood loss. Subjects recorded daily use of tampons and towels and the degree to which they were soiled with blood. Scores ranged from 0 to more than 500 with higher numbers indicating more bleeding. Analysis population was Intent-to-treat (ITT) and it consisted of all randomized subjects who received at least one dose of study drug and who had post-baseline efficacy data.
    End point type
    Primary
    End point timeframe
    From baseline to week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The study was terminated early due to a low recruitment rate resulting in a lower number of subjects in the analysis. Therefore, the efficacy analysis was limited to descriptive statistics and listings for the primary endpoint.
    End point values
    		 ESN364 60 mg ESN364 180 mg Placebo
    Number of subjects analysed
    10
    6
    7
    Units: PBAC score
        arithmetic mean (standard deviation)
    -114.34 ± 223.59
    -90.57 ± 206.96
    20.77 ± 95.09
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Decreased PBAC Score of >30% and >50% from Baseline to Week 12

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    End point title
    		 Percentage of Subjects with Decreased PBAC Score of >30% and >50% from Baseline to Week 12 [2]
    End point description
    Percentage of subjects with decreased PBAC score of >30% and >50% per treatment arm. Analysis population was Intent-to-treat (ITT)
    End point type
    Primary
    End point timeframe
    At week 12
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The study was terminated early due to a low recruitment rate resulting in a lower number of subjects in the analysis. Therefore, the efficacy analysis was limited to descriptive statistics and listings for the primary endpoint.
    End point values
    		 ESN364 60 mg ESN364 180 mg Placebo
    Number of subjects analysed
    10
    6
    7
    Units: Percentage of Decrease in PBAC score
    number (not applicable)
        >30%
    50.0
    33.3
    28.6
        >50%
    40.0
    16.7
    14.3
    No statistical analyses for this end point

    Primary: Percentage of Subjects with PBAC Score <75 from Baseline to Week 12

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    End point title
    		 Percentage of Subjects with PBAC Score <75 from Baseline to Week 12 [3]
    End point description
    This primary efficacy analysis represents a descriptive statistic of the proportion of patients, per treatment arm, with PBAC scores <75 at week 12, in percentages. Analysis population was Intent-to-treat (ITT)
    End point type
    Primary
    End point timeframe
    At week 12
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The study was terminated early due to a low recruitment rate resulting in a lower number of subjects in the analysis. Therefore, the efficacy analysis was limited to descriptive statistics and listings for the primary endpoint.
    End point values
    		 ESN364 60 mg ESN364 180 mg Placebo
    Number of subjects analysed
    10
    6
    7
    Units: PBAC Score in percentages
    number (not applicable)
        PBAC score <75
    30.0
    0.0
    14.3
    No statistical analyses for this end point

    Other pre-specified: Pharmacodynamics: Changes from baseline in Hormone Concentrations at week 12

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    End point title
    		 Pharmacodynamics: Changes from baseline in Hormone Concentrations at week 12
    End point description
    Changes from baseline in mean hormone concentrations per timepoint during treatment
    End point type
    Other pre-specified
    End point timeframe
    At week 12
    End point values
    		 ESN364 60 mg ESN364 180 mg Placebo
    Number of subjects analysed
    10
    6
    7
    Units: Hormone
    arithmetic mean (standard deviation)
        LH (mIU/mL)
    -2.16 ± 3.10
    8.52 ± 15.58
    -0.63 ± 4.87
        Progesterone (ng/mL)
    1.49 ± 2.96
    -0.03 ± 0.41
    3.93 ± 6.51
        SHBG (nmol/L)
    -5.67 ± 13.25
    -5.35 ± 8.32
    10.70 ± 8.91
        Estradiol (nmol/L)
    -0.07 ± 0.21
    -0.08 ± 0.37
    0.32 ± 0.28
        FSH (IU/L)
    0.10 ± 6.88
    19.03 ± 37.43
    -5.69 ± 11.70
        Cortisol (nmol/L)
    33.20 ± 85.19
    59.80 ± 63.64
    -11.70 ± 129.16
        Androstenedione (nmol/L)
    -0.84 ± 2.23
    0.07 ± 1.17
    -0.51 ± 2.53
        Aldosterone (pmol/L)
    -459.00 ± 1313.60
    -42.30 ± 239.55
    118.10 ± 269.11
        DHEA-S (ug/dL)
    11.30 ± 41.56
    6.70 ± 31.26
    11.00 ± 14.21
        ACTH (pmol/L)
    0.54 ± 1.29
    0.48 ± 0.80
    -0.33 ± 0.80
        Prolactin (ng/mL)
    -4.96 ± 6.64
    -2.85 ± 5.29
    -1.41 ± 3.46
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    TEAEs during treatment period. From first treatment administration date time to last treatment administration date + 6 days with 23:59 added as time part.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    ESN364 60 mg
    Reporting group description
    		 Subjects received an oral dose of ESN364 60 mg once daily up to 12 weeks.

    Reporting group title
    ESN364 180 mg
    Reporting group description
    		 Subjects received an oral dosa of ESN364 180 mg once daily up to 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received an oral dose of Placebo once daily up to 12 weeks.

    Serious adverse events
    		 ESN364 60 mg ESN364 180 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ESN364 60 mg ESN364 180 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 10 (80.00%)
    6 / 6 (100.00%)
    6 / 7 (85.71%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 10 (0.00%)
    4 / 6 (66.67%)
    1 / 7 (14.29%)
         occurrences all number
    0
    6
    1
    Influenza like illness
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    1
    Pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Breast tenderness
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Dysmenorrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 6 (50.00%)
    2 / 7 (28.57%)
         occurrences all number
    0
    5
    5
    Menopausal symptoms
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    1
    Metrorrhagia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Pelvic pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Cough
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    1
    1
    0
    Electrocardiogram T wave abnormal
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Electrocardiogram T wave inversion
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural pain
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 6 (33.33%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    Cardiac disorders
    Left atrial dilatation
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Sinus arrhythmia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 10 (0.00%)
    4 / 6 (66.67%)
    2 / 7 (28.57%)
         occurrences all number
    0
    6
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    1
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    4
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    Vomiting
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Nausea
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Back pain
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 6 (33.33%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Hordeolum
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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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.
    The study was terminated early due to a low recruitment rate resulting in a lower number of subjects in the analysis. Therefore, the efficacy analysis was limited to descriptive statistics and listings for the primary endpoint.
    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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