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    Clinical Trial Results:
    Characterisation of ovulation inhibition and effects on metabolic parameters and haemostatic system of multiple administrations of a fixed-dose combination product containing 0.02 mg ethinylestradiol and 2 mg dienogest (24+4) in a multiple administration, comparative parallel-group trial vs. a marketed product containing 0.02 mg ethinylestradiol and 0.10 mg levonorgestrel with healthy females of childbearing potential

    Summary
    EudraCT number
    		 2012-000041-12
    Trial protocol
    		 NL  
    Global end of trial date
    05 Mar 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Aug 2016
    First version publication date
    05 Aug 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    49/11/EDG/TP2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 CRO SocraTec R&D study No.: 1259ed11ct
    Sponsors
    Sponsor organisation name
    Zentiva k.s.
    Sponsor organisation address
    U Kabelovny 130, Prague 10 Dolní Měcholupy, Czech Republic, 10237
    Public contact
    Tomáš Hauser, M.D., Zentiva k.s., 00420 267 243 451, tomas.hauser@sanofi.com
    Scientific contact
    Tomáš Hauser, M.D., Zentiva k.s., 00420 267 243 451, tomas.hauser@sanofi.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
    31 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Mar 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Mar 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aims of this clinical trial are: • descriptive characterisation of the influence of Test or Reference on ovarian activity determined by means of maximum follicular diameter and Hoogland score • descriptive characterisation of the effect of Test or Reference on endometrial thickness, cervical mucus as well as on the pituitary and ovarian hormones the latter determined via follicle stimulating hormone (FSH), luteinising hormone (LH), estradiol (E2) and progesterone (P) • descriptive characterisation of effect of Test or Reference on sex hormone binding globulin (SHBG) and corticosteroid binding globulin (CBG) levels, C-reactive protein, lipid profile as well as haemostatic and carbohydrate parameters • descriptive characterisation of bleeding pattern • descriptive characterisation of return of ovulation • descriptive characterisation of overall safety and tolerability in the study population
    Protection of trial subjects
    Subjects we advised to use barrier contraceptive methods.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Mar 2012
    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
    Netherlands: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    60
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 date of first enrolment: 2012-04-16 Clinical site: dinox b.v. Hanzeplein 1, entrance 53 9713 GZ Groningen, The Netherlands Tel.: +31-50-361099-9 Fax: +31-50-361090-9

    Pre-assignment
    Screening details
    		 demographic data medical, gynaecological and obstetric history (prior and concomitant medication,concomitant diseases) physical examination gynaecological and breast examination (incl. TVUS) vital signs,BMI clinical laboratory: blood analysis incl. haematology and serum chemistry urine pregnancy test PAP smear

    Period 1
    Period 1 title
    Treatment phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was performed in an open design.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TEST
    Arm description
    		 Included subjects that entered the treatment phase and received Test treatment, stratified by time point of ovulation observed in the pre-treatment cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BONADEA PLUS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily administration of one tablet of Test containing 0.02 mg EE and 2 mg DNG over 24 days followed by 4 treatment-free days per cycle. Each treatment was administered over three treatment cycles of 28 days each.

    Arm title
    		 REFERENCE
    Arm description
    		 Included subjects who entered the treatment phase and received Reference treatment stratified by time point of ovulation observed in the pre-treatment cycle.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Miranova®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily administration of one tablet of Reference containing 0.02 mg EE and 0.1 mg LNG over 21 days followed by 7 treatment-free days per cycle. Each treatment was administered over three treatment cycles of 28 days each.

    Number of subjects in period 1 [1]
    		TEST REFERENCE
    Started
    29
    30
    Completed
    27
    26
    Not completed
    2
    4
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    1
    1
         Protocol deviation
    -
    1
    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: 1 subject not receiving medication: Reason: drop out due to withdrawal of consent

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment phase
    Reporting group description
    		 -

    Reporting group values
    		 Treatment phase Total
    Number of subjects
    		 59 59
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 59 59
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 24.63 ± 3.9 -
    Gender categorical
    Units: Subjects
        Female
    		 59 59
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS was defined as all subjects of the SAS, who after randomisation, completed at least one treatment cycle of 28 days, or in whom ovulation and/or a Hoogland score >4 were observed in any cycle during randomised treatment.

    Subject analysis set title
    Per protocol set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects: • who completely passed the pre-defined treatment regimen and • whose relevant trial variables were available in all periods, and • who finished the clinical trial without major protocol deviations.

    Subject analysis sets values
    		 Full analysis set Per protocol set
    Number of subjects
    57
    53
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    57
    53
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    24.4 ± 3.7
    24.34 ± 3.7
    Gender categorical
    Units: Subjects
        Female
    57
    53
        Male
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    TEST
    Reporting group description
    		 Included subjects that entered the treatment phase and received Test treatment, stratified by time point of ovulation observed in the pre-treatment cycle.

    Reporting group title
    REFERENCE
    Reporting group description
    		 Included subjects who entered the treatment phase and received Reference treatment stratified by time point of ovulation observed in the pre-treatment cycle.

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS was defined as all subjects of the SAS, who after randomisation, completed at least one treatment cycle of 28 days, or in whom ovulation and/or a Hoogland score >4 were observed in any cycle during randomised treatment.

    Subject analysis set title
    Per protocol set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects: • who completely passed the pre-defined treatment regimen and • whose relevant trial variables were available in all periods, and • who finished the clinical trial without major protocol deviations.

    Primary: Maximum follicular diameter - Treatment cycle 1 (FAS)

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    End point title
    		 Maximum follicular diameter - Treatment cycle 1 (FAS)
    End point description
    End point type
    Primary
    End point timeframe
    Tretament cycle 1, 28 days
    End point values
    		 TEST REFERENCE
    Number of subjects analysed
    28
    29
    Units: mm
        arithmetic mean (standard deviation)
    7.14 ± 2.9
    6.92 ± 1.5
    Statistical analysis title
    		 Max.follicular diameter-treatment comparison (FAS)
    Statistical analysis description
    The treatment groups were compared per treatment cycle (treatment cycles 1 and 3, only) using a 2-way analysis of variance models, in this case a linear mixed model with repeated measures, including the factors "treatment group", and "time (treatment cycle)" as well as an interaction factor between these two factors. The factor "treatment group" had two levels: Test and Reference. The factor "time" had two levels: treatment cycles 1 and 3.
    Comparison groups
    TEST v REFERENCE
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.9732
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8419
         upper limit
    		 1.1249
    Notes
    [1] - Several mixed models with different structures of the covariance matrix were calculated to find the best model. The model with best (=smallest) Akaike Information Criteria was to be taken. If more than one Akaike Information Criteria was smallest, the easiest structure of covariance matrix was to be taken; Easiest was compound symmetry, followed by unstructured, autoregressive and autoregressive moving average 1.1.

    Primary: Maximum follicular diameter - Treatment cycle 3 (FAS)

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    End point title
    		 Maximum follicular diameter - Treatment cycle 3 (FAS)
    End point description
    End point type
    Primary
    End point timeframe
    Treatment cycle 3, 28 days
    End point values
    		 TEST REFERENCE
    Number of subjects analysed
    27
    26
    Units: mm
        arithmetic mean (standard deviation)
    7 ± 2.44
    9.1 ± 4.96
    Statistical analysis title
    		 Max.follicular diameter-treatment comparison (FAS)
    Statistical analysis description
    The treatment groups were compared per treatment cycle (treatment cycles 1 and 3, only) using a 2-way analysis of variance models, in this case a linear mixed model with repeated measures, including the factors "treatment group", and "time (treatment cycle)" as well as an interaction factor between these two factors. The factor "treatment group" had two levels: Test and Reference. The factor "time" had two levels: treatment cycles 1 and 3.
    Comparison groups
    TEST v REFERENCE
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.7479
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6023
         upper limit
    		 0.9287
    Notes
    [2] - Several mixed models with different structures of the covariance matrix were calculated to find the best model. The model with best (=smallest) Akaike Information Criteria was to be taken. If more than one Akaike Information Criteria was smallest, the easiest structure of covariance matrix was to be taken; Easiest was compound symmetry, followed by unstructured, autoregressive and autoregressive moving average 1.1.

    Primary: Hoogland and Skouby score - Treatment cycle 1 (FAS)

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    End point title
    		 Hoogland and Skouby score - Treatment cycle 1 (FAS)
    End point description
    End point type
    Primary
    End point timeframe
    Treatment cycle 1, 28 days
    End point values
    		 TEST REFERENCE
    Number of subjects analysed
    28
    29
    Units: cumulative count
    39
    34
    Statistical analysis title
    		 Hoogland/Skouby score-treatment comparison (FAS)
    Statistical analysis description
    For the maximum Hoogland and Skouby score, the treatment groups will be compared per treatment cycle (treatment cycle 1 and 3) using the two-sided Mann-Whitney-U Test.
    Comparison groups
    REFERENCE v TEST
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Hoogland and Skouby score - Treatment cycle 3 (FAS)

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    End point title
    		 Hoogland and Skouby score - Treatment cycle 3 (FAS)
    End point description
    End point type
    Primary
    End point timeframe
    Treatment cycle 3, 28 days
    End point values
    		 TEST REFERENCE
    Number of subjects analysed
    27
    26
    Units: cumulative count
    38
    49
    Statistical analysis title
    		 Hoogland/Skouby score-Treatment comparison (FAS)
    Statistical analysis description
    For the maximum Hoogland and Skouby score, the treatment groups will be compared per treatment cycle (treatment cycle 1 and 3) using the two-sided Mann-Whitney-U Test.
    Comparison groups
    TEST v REFERENCE
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    125 study days - Treatment phase (3 Treatment cycles of 28 days) + Follow up phase
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    TEST
    Reporting group description
    		 Adverse events reported by subjects that received the Test treatment

    Reporting group title
    REFERENCE
    Reporting group description
    		 Adverse events reported by subjects that received the Reference treatment

    Serious adverse events
    		 TEST REFERENCE
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 TEST REFERENCE
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 29 (96.55%)
    29 / 30 (96.67%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    Malaise
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Hangover
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 30 (3.33%)
         occurrences all number
    4
    1
    Irritability
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    2
    Reproductive system and breast disorders
    Breast tenderness
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    Dysmenorrhoea
         subjects affected / exposed
    5 / 29 (17.24%)
    8 / 30 (26.67%)
         occurrences all number
    9
    12
    Breast pain
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 30 (3.33%)
         occurrences all number
    3
    1
    Vaginal discharge
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Vulvovaginal pruritus
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Coital bleeding
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    Cough
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Libido decreased
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Affect lability
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Depressed mood
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Traumatic haematoma
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Procedural pain
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Contusion
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    Concussion
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Eye injury
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 29 (41.38%)
    17 / 30 (56.67%)
         occurrences all number
    28
    24
    Migraine
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Amnesia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Migraine with aura
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 30 (0.00%)
         occurrences all number
    3
    0
    Abdominal pain lower
         subjects affected / exposed
    7 / 29 (24.14%)
    5 / 30 (16.67%)
         occurrences all number
    8
    7
    Nausea
         subjects affected / exposed
    5 / 29 (17.24%)
    3 / 30 (10.00%)
         occurrences all number
    6
    3
    Abdominal pain upper
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Abdominal distension
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 30 (6.67%)
         occurrences all number
    2
    3
    Diarrhoea
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Abdominal discomfort
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Anorectal discomfort
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Lip swelling
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Dental discomfort
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Acne
         subjects affected / exposed
    2 / 29 (6.90%)
    4 / 30 (13.33%)
         occurrences all number
    2
    4
    Eczema
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 30 (0.00%)
         occurrences all number
    3
    0
    Arthralgia
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 29 (34.48%)
    15 / 30 (50.00%)
         occurrences all number
    10
    19
    Gastroenteritis
         subjects affected / exposed
    8 / 29 (27.59%)
    2 / 30 (6.67%)
         occurrences all number
    8
    2
    Oral herpes
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    Influenza
         subjects affected / exposed
    2 / 29 (6.90%)
    5 / 30 (16.67%)
         occurrences all number
    2
    5
    Cystitis
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    Furuncle
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Carbuncle
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences all number
    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.
    None reported
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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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