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    Clinical Trial Results:
    Randomized, Open-Label Study to Evaluate the Influence on the Ovarian Activity, and the Cervix Score Over Two Treatment Cycles of 4.0 mg Drospirenone Daily for 24 Days as Compared to 0.075 mg Desogestrel Daily for 28 Days in 60 Healthy, Young Females

    Summary
    EudraCT number
    		 2010-024546-30
    Trial protocol
    		 DE  
    Global end of trial date
    24 Sep 2012

    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

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    Trial identification
    Sponsor protocol code
    CF111/202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Laboratorios León Farma S.A.
    Sponsor organisation address
    La Vallina s/n, Polígono Industrial de Navatejera, León, Spain, 24008
    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
    01 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Sep 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the ovulation inhibition potential as reflected by the ovarian activity (follicular growth, estradiol and progesterone serum concentrations) of Drospirenone (DRSP) in comparison to desogestrel, contained in the marketed progesterone only pill CERAZET®, in 60 healthy women
    Protection of trial subjects
    N/A
    Background therapy
    		 N/A
    Evidence for comparator
    		 The present study was designed as an investigation of the known progestogen DRSP with respect to its ability to be used as a POP. To describe the ovarian function, the European Medicines Agency guideline’s recommendation was to study at least two cycles in each woman. The ovulation inhibitory potential and the properties on the cervix score were assessed over two treatment cycles, which were completely monitored. The comparator in this parallel-group study was CERAZET®, a marketed product with similar features.
    Actual start date of recruitment
    01 Jan 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
    Germany: 64
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    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)
    64
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects had to meet of the inclusion criteria. Every subject had the right to refuse further participation in the study at any time and without providing reasons and without any personal disadvantage.

    Pre-assignment
    Screening details
    		 A total of 96 subjects were screened, of which 32 subjects were screening failures. Reasons for screening failure included withdrawal of consent: 5 subjects; persistent increase of blood pressure, headache with dizziness and vomiting, and intake of prohibited medication: 1 subject for each reason. The remaining 24 subjects had "other” reasons.

    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Test drug treatment group
    Arm description
    		 Each subject will receive 3 blisters (2 blisters for two treatment cycles plus 1 reserve blister) of 28 coated tablets with 24 active tablets containing 4.0 mg drospirenone and 4 placebo tablets, each.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Drospirenone (DRSP) 4.0 mg coated tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 film-coated tablet with 4.0 mg drospirenone per day to be taken as close as possible to a 24 hour schedule (± 3 hours) over 24 days, followed by four placebo tablets. Treatment starts on the 1st day or 2nd day of menstruation following randomization (only if bleeding starts in the evening and the subject wants to take the study medication in the morning). The total amount of drospirenone will be 192 mg per subject.

    Arm title
    		 Reference drug treatment group
    Arm description
    		 Subjects will receive 3 packages (2 packages for two treatment cycles plus 1 reserve package) with 28 tablets containing 0.075 mg desogestrel
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cerazet (0.075 mg desogestrel)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet with 0.075 mg desogestrel per day to be taken as close as possible to a 24 hour schedule (± 3 hours) over 28 days. Treatment starts on the 1st day or 2nd day of menstruation following randomization (only if bleeding starts in the evening and the subject wants to take the study medication in the morning). The total amount of desogestrel will be 4.2 mg per subject.

    Number of subjects in period 1
    		Test drug treatment group Reference drug treatment group
    Started
    32
    32
    Completed
    29
    29
    Not completed
    3
    3
         Consent withdrawn by subject
    1
    1
         Physician decision
    1
    -
         Not specified
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Test drug treatment group
    Reporting group description
    		 Each subject will receive 3 blisters (2 blisters for two treatment cycles plus 1 reserve blister) of 28 coated tablets with 24 active tablets containing 4.0 mg drospirenone and 4 placebo tablets, each.

    Reporting group title
    Reference drug treatment group
    Reporting group description
    		 Subjects will receive 3 packages (2 packages for two treatment cycles plus 1 reserve package) with 28 tablets containing 0.075 mg desogestrel

    Reporting group values
    		 Test drug treatment group Reference drug treatment group Total
    Number of subjects
    		 32 32 64
    Age categorical
    18 to 35 years of age
    Units: Subjects
        Adults (18-35 years)
    		 32 32 64
    Gender categorical
    Units: Subjects
        Female
    		 32 32 64
    Subject analysis sets

    Subject analysis set title
    Safety Set (SS)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    consists of all volunteers who have received at least one dose of study medication (test or reference)

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    consists of all subjects who received at least one dose of the study medication (test or reference), for whom CRF entries are available, and for whom at least one Hoogland-Score result is available after start of treatment, regardless of procotol deviations

    Subject analysis set title
    Per Protoco Set (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    consists of all subjects from the FAS excluding volunteers with major protocol deviations.

    Subject analysis sets values
    		 Safety Set (SS) Full Analysis Set (FAS) Per Protoco Set (PP)
    Number of subjects
    64
    63
    56
    Age categorical
    18 to 35 years of age
    Units: Subjects
        Adults (18-35 years)
    64
    63
    56
    Age continuous
    Units:
        
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    64
    63
    56

    End points

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    End points reporting groups
    Reporting group title
    Test drug treatment group
    Reporting group description
    		 Each subject will receive 3 blisters (2 blisters for two treatment cycles plus 1 reserve blister) of 28 coated tablets with 24 active tablets containing 4.0 mg drospirenone and 4 placebo tablets, each.

    Reporting group title
    Reference drug treatment group
    Reporting group description
    		 Subjects will receive 3 packages (2 packages for two treatment cycles plus 1 reserve package) with 28 tablets containing 0.075 mg desogestrel

    Subject analysis set title
    Safety Set (SS)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    consists of all volunteers who have received at least one dose of study medication (test or reference)

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    consists of all subjects who received at least one dose of the study medication (test or reference), for whom CRF entries are available, and for whom at least one Hoogland-Score result is available after start of treatment, regardless of procotol deviations

    Subject analysis set title
    Per Protoco Set (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    consists of all subjects from the FAS excluding volunteers with major protocol deviations.

    Primary: Hoogland Score

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    End point title
    		 Hoogland Score [1]
    End point description
    Multiple data of the leading follicle size and peripheral hormone levels of progesterone and estradiol were collected over two treatment cycles and condensed in a Hoogland-Score evaluation. In case of a suspected ovulation in any treatment cycle the Landgren Score was evaluated, in addition
    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: No statistical hypothesis tests for efficacy were performed in this exploratory study as the study was to generate first data
    End point values
    		 Test drug treatment group Reference drug treatment group Per Protoco Set (PP)
    Number of subjects analysed
    32
    32
    56
    Units: number
    27
    29
    56
    No statistical analyses for this end point

    Secondary: Follicle size

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    End point title
    		 Follicle size
    End point description
    End point type
    Secondary
    End point timeframe
    Follicle size was measured in the precycle every third day until ovulation, starting at Day 9 (±1) up to Day 27 (±1), as well as during both treatment cycles every third day starting at Day 3, and at final examination
    End point values
    		 Test drug treatment group Reference drug treatment group Per Protoco Set (PP)
    Number of subjects analysed
    32
    32
    56
    Units: mm
    27
    29
    56
    No statistical analyses for this end point

    Secondary: Serum progesterone levels

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    End point title
    		 Serum progesterone levels
    End point description
    End point type
    Secondary
    End point timeframe
    every third day during both treatment cycles, i.e. on Day 3, Day 6, Day 9 etc.
    End point values
    		 Test drug treatment group Reference drug treatment group Per Protoco Set (PP)
    Number of subjects analysed
    32
    32
    56
    Units: nml/L
    32
    32
    56
    No statistical analyses for this end point

    Secondary: Serum estradiol levels

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    End point title
    		 Serum estradiol levels
    End point description
    End point type
    Secondary
    End point timeframe
    Serum estradiol (pmol/L) levels were measured every third day during both treatment cycles, i.e. on Day 3, Day 6, Day 9 etc
    End point values
    		 Test drug treatment group Reference drug treatment group Per Protoco Set (PP)
    Number of subjects analysed
    32
    32
    56
    Units: pmol/L
    32
    32
    56
    No statistical analyses for this end point

    Secondary: Insler score

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    End point title
    		 Insler score
    End point description
    The cervix condition was evaluated by means of Insler Score in all cycles whenever the follicle size exceeded 13 mm. The Insler score reflects the cervical condition for a possible ascension of the sperms
    End point type
    Secondary
    End point timeframe
    precycle, cycle 1, cycle 2 and post-treatment cycle
    End point values
    		 Test drug treatment group Reference drug treatment group Per Protoco Set (PP)
    Number of subjects analysed
    32
    32
    56
    Units: points
    27
    29
    56
    No statistical analyses for this end point

    Secondary: Return of ovulation

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    End point title
    		 Return of ovulation
    End point description
    End point type
    Secondary
    End point timeframe
    post-treatment cycle
    End point values
    		 Test drug treatment group Reference drug treatment group Per Protoco Set (PP)
    Number of subjects analysed
    32
    32
    56
    Units: subjects
    27
    29
    56
    No statistical analyses for this end point

    Secondary: Serum LH levels

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    End point title
    		 Serum LH levels
    End point description
    End point type
    Secondary
    End point timeframe
    The subjects’ serum LH levels were determined every third day during both treatment cycles
    End point values
    		 Test drug treatment group Reference drug treatment group Per Protoco Set (PP)
    Number of subjects analysed
    32
    32
    56
    Units: U/L
    27
    29
    56
    No statistical analyses for this end point

    Secondary: Serum FSH levels

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    End point title
    		 Serum FSH levels
    End point description
    End point type
    Secondary
    End point timeframe
    The subjects’ serum FSH levels were determined every third day during both treatment cycles
    End point values
    		 Test drug treatment group Reference drug treatment group Per Protoco Set (PP)
    Number of subjects analysed
    32
    32
    56
    Units: U/L
    27
    29
    56
    No statistical analyses for this end point

    Secondary: Endometrial thickness

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    End point title
    		 Endometrial thickness
    End point description
    End point type
    Secondary
    End point timeframe
    all visits including precycle
    End point values
    		 Test drug treatment group Reference drug treatment group Per Protoco Set (PP)
    Number of subjects analysed
    32
    32
    56
    Units: mm
    27
    29
    56
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE reported spontaneously by the subject or observed by the clinical investigator was monitored during the clinical trial or registered at each visit
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Test
    Reporting group description
    		 -

    Reporting group title
    Reference
    Reporting group description
    		 -

    Serious adverse events
    		 Test Reference
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 32 (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
    		 Test Reference
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 32 (90.63%)
    31 / 32 (96.88%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 32 (25.00%)
    7 / 32 (21.88%)
         occurrences all number
    15
    9
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    4 / 32 (12.50%)
    3 / 32 (9.38%)
         occurrences all number
    5
    3
    toothache
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 32 (0.00%)
         occurrences all number
    4
    0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    2 / 32 (6.25%)
    4 / 32 (12.50%)
         occurrences all number
    2
    6
    Dysmenorrhoea
         subjects affected / exposed
    3 / 32 (9.38%)
    2 / 32 (6.25%)
         occurrences all number
    4
    4
    Breast discomfort
         subjects affected / exposed
    1 / 32 (3.13%)
    3 / 32 (9.38%)
         occurrences all number
    1
    4
    Galactorrhoea
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    3 / 32 (9.38%)
    4 / 32 (12.50%)
         occurrences all number
    3
    5
    Psychiatric disorders
    Affective disorder
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    0
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    14 / 32 (43.75%)
    14 / 32 (43.75%)
         occurrences all number
    15
    14
    Vulvovaginal candidiasis
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 32 (9.38%)
         occurrences all number
    2
    4
    Cystitis
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 32 (6.25%)
         occurrences all number
    1
    2
    Sinusitis
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    0
    2

    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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