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    Clinical Trial Results:
    A study to evaluate the effect on the endometrium of a new formulation containing 4 mg drospirenone (Drospirenone 4 mg film-coated tablet) administered over a period of 13 cycles. A monocentric, open, multiple dose trial in healthy female subjects at risk of pregnancy

    Summary
    EudraCT number
    		 2013-002300-13
    Trial protocol
    		 BG  
    Global end of trial date
    20 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jun 2020
    First version publication date
    19 Jun 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CCR13001,CF111/205
    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
    Chief Scientific Officer, Enrico Colli, +34 91 771 15 00, enrico.colli@exeltis.com
    Scientific contact
    Chief Scientific Officer, Enrico Colli, +34 91 771 15 00, enrico.colli@exeltis.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
    23 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the endometrial safety of an oral test preparation containing 4 mg drospirenone (Test IMP: Drospirenone 4 mg film-coated tablet) after multiple dose administration of 4 mg drospirenone for a total duration of 13 cycles of 28 days each: 24 days of active treatment followed by 4 days placebo treatment per treatment cycle.
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Nov 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
    Bulgaria: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy woman at risk of pregnancy, Age between 18 and 40 years, At least four menstrual cycles during the last six months before screening were regular, At least one regular menstrual cycle after the end of prev intake of oral contraceptive, Systolic blood pressure <140 mmHg, diastolic blood pressure <90 mmHg, in sitting position, after 5 min rest

    Pre-assignment
    Screening details
    		 Screening period of about 8 weeks. The subjects underwent a clinical, gynecological, and laboratory screening examination with the aim of evaluating their eligibility for the trial. As soon as all results were available, the eligible subjects started treatment with the test product on the first day of bleeding in the following menstrual cycle.

    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
    Not blinded study

    Arms
    Arm title
    		 Treatment Arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Drospirenone 4 mg film-coated tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4 mg drospirenone per film-coated tablet, 1 film-coated tablet (=4 mg drospirenone) as a multiple dose of one tablet per day for a total duration of 13 cycles of 28 days each: 24 days of active treatment followed by 4 days placebo treatment per cycle

    Number of subjects in period 1
    		Treatment Arm
    Started
    22
    Completed
    17
    Not completed
    5
         Consent withdrawn by subject
    2
         Adverse event, non-fatal
    1
         Loss of contact
    1
         Loss of contact after visit 2
    1

    Baseline characteristics

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

    Reporting group values
    		 Treatment Arm Total
    Number of subjects
    		 22 22
    Age categorical
    Units: Subjects
        Adults 18 - 40 years
    		 22 22
    Gender categorical
    Units: Subjects
        Female
    		 22 22
    Subject analysis sets

    Subject analysis set title
    Safety population set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    A total number of 21 healthy pre-menopausal female subjects were confirmed to have started the treatment with study medication

    Subject analysis sets values
    		 Safety population set
    Number of subjects
    21
    Age categorical
    Units: Subjects
        Adults 18 - 40 years
    21
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    21

    End points

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    End points reporting groups
    Reporting group title
    Treatment Arm
    Reporting group description
    		 -

    Subject analysis set title
    Safety population set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    A total number of 21 healthy pre-menopausal female subjects were confirmed to have started the treatment with study medication

    Primary: Rating of endometrial biopsy

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    End point title
    		 Rating of endometrial biopsy [1]
    End point description
    The endometrial biopsy was taken by means of Pipelle® Endometrial Suction Curette and evaluated by a local independent pathologist. The endometrial samples were examined microscopically and the histological result was documented in the CRF at visit 2. The endometrial biopsy result was classified in 6 categories (according to Lindgren et al., 19921): Inadequate, Atrophic, Proliferative, Secretory, Hyperplasia and Non-secretory.
    End point type
    Primary
    End point timeframe
    Visit 1 and Visit 7
    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: this is not a comparative study. Statistical analyses were not performed
    End point values
    		 Treatment Arm Safety population set
    Number of subjects analysed
    21
    21
    Units: category
        Inadequate
    4
    4
        Atrophic
    0
    0
        Proliferative
    12
    12
        Secretory
    3
    3
        Hyperplasia
    0
    0
        Non-secretory
    0
    0
    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
    The endometrial thickness was measured by means of transvaginal sonography during the gynecological examination at Visit 1 (pre-treatment) and at Visit 7 (post-treatment)
    End point values
    		 Treatment Arm Safety population set
    Number of subjects analysed
    22
    21
    Units: mm
    21
    21
    No statistical analyses for this end point

    Secondary: Incidence of adverse events and serious adverse events

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    End point title
    		 Incidence of adverse events and serious adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    during the treatment period
    End point values
    		 Safety population set
    Number of subjects analysed
    21
    Units: number of AEs
    21
    No statistical analyses for this end point

    Secondary: changes from baseline in the results of clinical examination and vital

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    End point title
    		 changes from baseline in the results of clinical examination and vital
    End point description
    End point type
    Secondary
    End point timeframe
    general state (visit 1 and visit 8), physical examination (visit 1 and visit 8), body temperature (visit 1), heart rate, systolic and diastolic blood pressure (visit 1 to visit 8)
    End point values
    		 Safety population set
    Number of subjects analysed
    21
    Units: various
    21
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    during treatment
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Safety Set
    Reporting group description
    		 -

    Serious adverse events
    		 Safety Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 21 (9.52%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hydroureter
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Calculus urethral
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pyelonephritis chronic
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Safety Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 21 (52.38%)
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Weight increased
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    Hand fracture
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Wrist fracture
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Uterine polyp
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Psychiatric disorders
    Alcoholic hangover
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Cystitis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Pyelonephritis chronic
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Vaginal infection
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Viral infection
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Dec 2013
    substantial Amendment 1.0 to the study protocol (Final Version 1.0 from 08-Jul-2013), related to corrections in the inclusion criteria, to additional exclusion/withdrawal criteria and additional information to the Subject Information and Informed Consent, was issued on 17-Oct-2013 on regulatory authority (Bulgarian Drug Agency) request

    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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