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    Clinical Trial Results:
    Phase II trial to evaluate the maintenance of ovulation inhibition with LF111 (drospirenone 4.0 mg 24/4 regimen) after scheduled 24-hour delays in pill intake.

    Summary
    EudraCT number
    		 2013-001513-33
    Trial protocol
    		 DE  
    Global end of trial date
    17 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 May 2020
    First version publication date
    29 May 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CF111/204
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Laboratorios Leon Farma, S.A.
    Sponsor organisation address
    La Vallina s/n, Polígono Industrial de Navatejera, León, Spain, 28004
    Public contact
    Directeur du Dèveloppement, CHEMO France, 0033 149662226, dominique.drouin@chemofrance.com
    Scientific contact
    Directeur du Dèveloppement, CHEMO France, 0033 149662226, dominique.drouin@chemofrance.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
    02 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that ovulation inhibition with LF111 (drospirenone 4.0 mg 24/4 regimen) is maintained in spite of scheduled 24-hour delays in pill intake.
    Protection of trial subjects
    N/A
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    21 May 2013
    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
    Germany: 130
    Worldwide total number of subjects
    130
    EEA total number of subjects
    130
    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)
    130
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy premenopausal females of any ethnic origin without regular intake of medicine, 18 to 35 years of age, inclusive. Smokers not older than 30 years, inclusive (up to 10 cigarettes daily). Subjects had to be in good physical and mental health as determined by vital signs, medical history, physical examination, gynaecological examination, etc.

    Pre-assignment
    Screening details
    		 Screening phase: During this period the information and informed consent procedure and screening examinations were performed: • Medical, surgical and gynaecological history including demographic data • Physical and gynaecological examinations including cervix smear and TVUS • Standard laboratory examinations of blood and urine for safety

    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Blinding was not applicable because this was an open-label trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Group A performed the following sequence: • Cycle 1: DRSP 4.0 mg 24/4 regimen (regular intake scheme) • Cycle 2: DRSP 4.0 mg 24/4 regimen (delayed intake scheme)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Drospirenone 4 mg
    Investigational medicinal product code
    LF111
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily. Drospirenone 4.0 mg was to be taken by all subjects enrolled in this trial for a duration of 2 x 28 days

    Arm title
    		 Group B
    Arm description
    		 Group B performed the following sequence: • Cycle 1: DRSP 4.0 mg 24/4 regimen (delayed intake scheme) • Cycle 2: DRSP 4.0 mg 24/4 regimen (regular intake scheme)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Drospirenone 4 mg
    Investigational medicinal product code
    LF111
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily. Drospirenone 4.0 mg was to be taken by all subjects enrolled in this trial for a duration of 2 x 28 days

    Number of subjects in period 1
    		Group A Group B
    Started
    65
    65
    Completed
    58
    63
    Not completed
    7
    2
         private reasons
    -
    1
         Consent withdrawn by subject
    2
    -
         Adverse event, non-fatal
    2
    1
         Pregnancy
    2
    -
         subject missed visit at Cycle 2 Day 27 and follow-
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Group A performed the following sequence: • Cycle 1: DRSP 4.0 mg 24/4 regimen (regular intake scheme) • Cycle 2: DRSP 4.0 mg 24/4 regimen (delayed intake scheme)

    Reporting group title
    Group B
    Reporting group description
    		 Group B performed the following sequence: • Cycle 1: DRSP 4.0 mg 24/4 regimen (delayed intake scheme) • Cycle 2: DRSP 4.0 mg 24/4 regimen (regular intake scheme)

    Reporting group values
    		 Group A Group B Total
    Number of subjects
    		 65 65 130
    Age categorical
    Units: Subjects
        Adults (18 to 35)
    		 65 65 130
    Gender categorical
    Units: Subjects
        Female
    		 65 65 130
    Subject analysis sets

    Subject analysis set title
    Safety Saet
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set consisted of all subjects who had been allocated to treatment and had at least one dose of IMP intake.

    Subject analysis set title
    Allocated to Treatment Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Allocated to Treatment Set consisted of all subjects who signed the informed consent and had been allocated to treatment

    Subject analysis set title
    Full Anaysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set consisted of all subjects who were included in the Safety Set and had at least one study observation.

    Subject analysis set title
    Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol Set consisted of all subjects who were included in the Full Analysis Set and had no major protocol violation

    Subject analysis sets values
    		 Safety Saet Allocated to Treatment Set Full Anaysis Set Per Protocol Set
    Number of subjects
    127
    130
    127
    127
    Age categorical
    Units: Subjects
        Adults (18 to 35)
    127
    130
    127
    127
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    127
    130
    127
    127

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Group A performed the following sequence: • Cycle 1: DRSP 4.0 mg 24/4 regimen (regular intake scheme) • Cycle 2: DRSP 4.0 mg 24/4 regimen (delayed intake scheme)

    Reporting group title
    Group B
    Reporting group description
    		 Group B performed the following sequence: • Cycle 1: DRSP 4.0 mg 24/4 regimen (delayed intake scheme) • Cycle 2: DRSP 4.0 mg 24/4 regimen (regular intake scheme)

    Subject analysis set title
    Safety Saet
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set consisted of all subjects who had been allocated to treatment and had at least one dose of IMP intake.

    Subject analysis set title
    Allocated to Treatment Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Allocated to Treatment Set consisted of all subjects who signed the informed consent and had been allocated to treatment

    Subject analysis set title
    Full Anaysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set consisted of all subjects who were included in the Safety Set and had at least one study observation.

    Subject analysis set title
    Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol Set consisted of all subjects who were included in the Full Analysis Set and had no major protocol violation

    Primary: Ovulation rate

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    End point title
    		 Ovulation rate [1]
    End point description
    An ovulation was to be assumed if both of the following conditions were fulfilled: • Ultrasound confirmation of a persisting or ruptured follicle > 13 mm • Progesterone level > 16 nmol/L for at least five consecutive days
    End point type
    Primary
    End point timeframe
    Cycle 1 and Cycle 2
    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: statistical analyses have not been performed
    End point values
    		 Group A Group B Full Anaysis Set
    Number of subjects analysed
    65
    65
    127
    Units: N/A
    65
    65
    127
    No statistical analyses for this end point

    Secondary: Adverse events

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    End point title
    		 Adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    All AEs, including SAEs, occurring within the period of observation for the clinical trial had to be recorded. The period of observation for the collection of AEs extended from the time when the subject gave informed consent until the date of final visit
    End point values
    		 Group A Group B Safety Saet
    Number of subjects analysed
    62
    65
    127
    Units: number of adverse events
    60
    64
    124
    No statistical analyses for this end point

    Secondary: bleeding pattern

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    End point title
    		 bleeding pattern
    End point description
    Bleeding pattern was summarised based on the following defined tolerability endpoints: • Number and rate of subjects with bleeding or spotting for each day of treatment, by cycle and by overall treatment period • Number of days with bleeding or spotting per cycle • Number of days with a certain spotting/bleeding intensity (spotting, slight, moderate, heavy) per cycle • Number and length of bleeding/spotting episodes
    End point type
    Secondary
    End point timeframe
    From Cycle 1 Day 1 (i.e. start of IMP intake) to final visit (or EDV), the subjects recorded daily any vaginal bleeding with bleeding intensity in their diary.
    End point values
    		 Group A Group B Safety Saet Full Anaysis Set
    Number of subjects analysed
    65
    65
    127
    127
    Units: n/m (%)
    62
    65
    127
    127
    No statistical analyses for this end point

    Secondary: clinical laboratory evaluation

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    End point title
    		 clinical laboratory evaluation
    End point description
    safety laboratory values (haematology, biochemistry, liver function, clotting status, virology and urinalysis results)
    End point type
    Secondary
    End point timeframe
    screening and final examination
    End point values
    		 Group A Group B Safety Saet
    Number of subjects analysed
    65
    65
    127
    Units: various units
    62
    65
    127
    No statistical analyses for this end point

    Secondary: Vital signs

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    End point title
    		 Vital signs
    End point description
    Blood pressure and pulse was measured in sitting position after the subject had rested for at least 5 minutes. The measurements were performed at screening visit, Cycle 1 Day 12 ±1, Cycle 2 Day 12 ±1 and final visit (or EDV). Height was measured at screening visit only. Body weight was measured at screening visit and at final visit (or EDV), lightly dressed and without shoes.
    End point type
    Secondary
    End point timeframe
    screening, cycle 1, cycle 2, Final visit
    End point values
    		 Group A Group B Safety Saet
    Number of subjects analysed
    65
    65
    127
    Units: various units
    62
    65
    127
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The period of observation for the collection of AEs extended from the time when the subject gave informed consent until the date of final visit.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 -

    Reporting group title
    Group B
    Reporting group description
    		 -

    Serious adverse events
    		 Group A Group B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 65 (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: 5%
    Non-serious adverse events
    		 Group A Group B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 62 (96.77%)
    64 / 65 (98.46%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 65 (1.54%)
         occurrences all number
    1
    1
    Surgical and medical procedures
    Mole excision
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Tooth extraction
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Tooth repair
         subjects affected / exposed
    1 / 62 (1.61%)
    3 / 65 (4.62%)
         occurrences all number
    1
    3
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    2 / 62 (3.23%)
    7 / 65 (10.77%)
         occurrences all number
    2
    7
    Injection site haematoma
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 65 (0.00%)
         occurrences all number
    2
    0
    Immune system disorders
    Mycotic allergy
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Social circumstances
    Tattoo
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Breast discomfort
         subjects affected / exposed
    1 / 62 (1.61%)
    3 / 65 (4.62%)
         occurrences all number
    1
    3
    Breast enlargement
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 65 (0.00%)
         occurrences all number
    2
    0
    Breast pain
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 65 (1.54%)
         occurrences all number
    1
    1
    Dysmenorrhoea
         subjects affected / exposed
    9 / 62 (14.52%)
    11 / 65 (16.92%)
         occurrences all number
    11
    11
    Hydrometra
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    menorrhagia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Ovarian cyst
         subjects affected / exposed
    3 / 62 (4.84%)
    3 / 65 (4.62%)
         occurrences all number
    3
    3
    Vaginal discharge
         subjects affected / exposed
    3 / 62 (4.84%)
    0 / 65 (0.00%)
         occurrences all number
    3
    0
    Vulvovaginal pruritus
         subjects affected / exposed
    2 / 62 (3.23%)
    2 / 65 (3.08%)
         occurrences all number
    2
    2
    Respiratory, thoracic and mediastinal disorders
    cough
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 65 (3.08%)
         occurrences all number
    1
    2
    Dysphonia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    4 / 62 (6.45%)
    1 / 65 (1.54%)
         occurrences all number
    5
    1
    Psychiatric disorders
    Affective disorder
         subjects affected / exposed
    3 / 62 (4.84%)
    2 / 65 (3.08%)
         occurrences all number
    3
    2
    Agitation
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Libido increased
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Loss of libido
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Mood altered
         subjects affected / exposed
    2 / 62 (3.23%)
    3 / 65 (4.62%)
         occurrences all number
    2
    3
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Blood bilirubin increased
         subjects affected / exposed
    2 / 62 (3.23%)
    2 / 65 (3.08%)
         occurrences all number
    2
    2
    Blood cholesterol increased
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Blood potassium decreased
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Body temperature increased
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Glucose urine
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Lymphocyte count increased
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Neutrophil count decreased
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Nitrite urine present
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Platelet count increased
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 65 (1.54%)
         occurrences all number
    1
    1
    Weight increased
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 65 (1.54%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Arthropod bite
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Contusion
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 65 (3.08%)
         occurrences all number
    1
    2
    Joint injection
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Limb injury
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 65 (1.54%)
         occurrences all number
    1
    1
    Radius fracture
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Rib fracture
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Thermal burn
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 65 (3.08%)
         occurrences all number
    0
    2
    Cardiac disorders
    Cardiovascular disorder
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Nervous system disorders
    Cervicogenic headache
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Disturbance in attention
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 65 (3.08%)
         occurrences all number
    0
    2
    Headache
         subjects affected / exposed
    26 / 62 (41.94%)
    32 / 65 (49.23%)
         occurrences all number
    45
    52
    Hypoaesthesia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Sciatica
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    leukopenia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Auricular swelling
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Vertigo
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 65 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 62 (4.84%)
    2 / 65 (3.08%)
         occurrences all number
    3
    2
    Abdominal pain lower
         subjects affected / exposed
    9 / 62 (14.52%)
    8 / 65 (12.31%)
         occurrences all number
    11
    10
    Abdominal pain upper
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 65 (1.54%)
         occurrences all number
    1
    1
    Stomatitis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 65 (1.54%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 65 (3.08%)
         occurrences all number
    1
    2
    Gastritis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Haematochezia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    4 / 62 (6.45%)
    7 / 65 (10.77%)
         occurrences all number
    4
    7
    Toothache
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 65 (1.54%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    2 / 62 (3.23%)
    4 / 65 (6.15%)
         occurrences all number
    2
    4
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    8 / 62 (12.90%)
    7 / 65 (10.77%)
         occurrences all number
    9
    7
    Alopecia
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 65 (1.54%)
         occurrences all number
    1
    1
    Dry skin
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 65 (1.54%)
         occurrences all number
    1
    1
    Paronychia
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Albuminuria
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 65 (3.08%)
         occurrences all number
    1
    2
    Bilirubinuria
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Haematuria
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 65 (1.54%)
         occurrences all number
    1
    1
    Leukocyturia
         subjects affected / exposed
    2 / 62 (3.23%)
    1 / 65 (1.54%)
         occurrences all number
    2
    1
    Pollakiuria
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Polyuria
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Proteinuria
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    5 / 62 (8.06%)
    1 / 65 (1.54%)
         occurrences all number
    5
    1
    Muscle spasms
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Spinal deformity
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Tenosynovitis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 65 (3.08%)
         occurrences all number
    0
    2
    Cystitis
         subjects affected / exposed
    1 / 62 (1.61%)
    5 / 65 (7.69%)
         occurrences all number
    1
    5
    Echinococciasis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Gastrointestinal infection
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 65 (1.54%)
         occurrences all number
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    27 / 62 (43.55%)
    34 / 65 (52.31%)
         occurrences all number
    31
    39
    Oral herpes
         subjects affected / exposed
    4 / 62 (6.45%)
    4 / 65 (6.15%)
         occurrences all number
    4
    4
    Otitis externa
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 65 (1.54%)
         occurrences all number
    0
    1
    Urethritis
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 65 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    3 / 62 (4.84%)
    1 / 65 (1.54%)
         occurrences all number
    3
    1

    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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    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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