Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Open-Label, Randomized Study to Evaluate the Influence on the Hormonal and Ovarian Activity of Two Different Dosages of Drospirenone (either 4.0 mg for 24 Days or 2.8 mg Daily for 28 Days) Over Two Treatment Cycles in 50 Healthy, Young Females

    Summary
    EudraCT number
    		 2011-004085-15
    Trial protocol
    		 DE  
    Global end of trial date
    10 Apr 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

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CF111/203
    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, Chemo Research, 0034 917711500, enrico.colli@exeltis.com
    Scientific contact
    Chief Scientific Officer, Chemo Research, 0034 917711500, 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
    12 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Apr 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the ovulation inhibition potential reflected by the hormonal and ovarian activity of two different dosages and intake regimens of drospirenone (DRSP) in 50 healthy women. Subjects will be assigned to one of two treatment regimens after stratification for the ovulation day in the precycle.
    Protection of trial subjects
    N/A
    Background therapy
    		 N/A
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2011
    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: 53
    Worldwide total number of subjects
    53
    EEA total number of subjects
    53
    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)
    53
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Healthy premenopausal females of any ethnic origin (18 to 35 years of age), inclusive; (smokers not older than 30 years; smokers ≤ 30 years up to 10 cigarettes daily), BMI of 18-30 kg/m2, history of regular cycles, blood pressure after resting for 5 minutes between 90-140 mmHg (systolic) and 50-90 mmHg (diastolic), etc.

    Pre-assignment
    Screening details
    		 Screening was divided in two sections: The first section took place before the start of the precycle and the second part followed after an ovulation could be detected in the precycle.

    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 applicable, because this was an open-label trial.

    Arms
    Arm title
    		 Treatment Arm
    Arm description
    		 Fifty subjects were allocated either to Treatment 1 (4.0 mg DRSP for 24 days followed by 4 placebo tablets) or Treatment 2 (2.8 mg DRSP for 28 days) over two treatment cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Drospirenone 4.0 mg coated tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    28 coated tablets, oral, once daily,

    Investigational medicinal product name
    Drospirenone 2.8 mg coated tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    28 tablets, oral, once daily

    Number of subjects in period 1
    		Treatment Arm
    Started
    53
    Completed
    50
    Not completed
    3
         Consent withdrawn by subject
    1
         Intake of prohibited medication
    1
         Adverse event, non-fatal
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Treatment Arm
    Reporting group description
    		 Fifty subjects were allocated either to Treatment 1 (4.0 mg DRSP for 24 days followed by 4 placebo tablets) or Treatment 2 (2.8 mg DRSP for 28 days) over two treatment cycles.

    Reporting group values
    		 Treatment Arm Total
    Number of subjects
    		 53 53
    Age categorical
    Units: Subjects
        Adults (18 to 35 years)
    		 53 53
    Gender categorical
    Units: Subjects
        Female
    		 53 53
    Subject analysis sets

    Subject analysis set title
    Per Protoco Set (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Consisted of all subjects from the FAS, excluding volunteers with major protocol deviations

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) consisted of all subjects who had received at least one dose of the product (Treatment 1 or Treatment 2), for whom CRF entries were available, and for whom at least one Hoogland-Score result was available after start of treatment, regardless of protocol deviations

    Subject analysis set title
    Safety Analysis Set (SF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety analysis set (SF) consisted of all volunteers who had received at least one dose of investigational product

    Subject analysis sets values
    		 Per Protoco Set (PPS) Full Analysis Set (FAS) Safety Analysis Set (SF)
    Number of subjects
    49
    50
    52
    Age categorical
    Units: Subjects
        Adults (18 to 35 years)
    49
    50
    52
    Age continuous
    Units:
        
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    49
    50
    52

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Treatment Arm
    Reporting group description
    		 Fifty subjects were allocated either to Treatment 1 (4.0 mg DRSP for 24 days followed by 4 placebo tablets) or Treatment 2 (2.8 mg DRSP for 28 days) over two treatment cycles.

    Subject analysis set title
    Per Protoco Set (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Consisted of all subjects from the FAS, excluding volunteers with major protocol deviations

    Subject analysis set title
    Full Analysis Set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) consisted of all subjects who had received at least one dose of the product (Treatment 1 or Treatment 2), for whom CRF entries were available, and for whom at least one Hoogland-Score result was available after start of treatment, regardless of protocol deviations

    Subject analysis set title
    Safety Analysis Set (SF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety analysis set (SF) consisted of all volunteers who had received at least one dose of investigational product

    Primary: Hoogland score

    		 Close Top of page
    End point title
    		 Hoogland score [1]
    End point description
    The Hoogland Score is a composite parameter of follicle size as well as estradiol and progesterone levels
    End point type
    Primary
    End point timeframe
    1st cycle: day 3, 6, 9, 12, 15, 18, 21, 24, 27 2nd cycle: day 3, 6, 9, 12, 15, 18, 21, 24, 27
    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
    		 Treatment Arm Per Protoco Set (PPS) Full Analysis Set (FAS)
    Number of subjects analysed
    53
    49
    50
    Units: number
    53
    49
    50
    No statistical analyses for this end point

    Secondary: LH and FSH

    		 Close Top of page
    End point title
    		 LH and FSH
    End point description
    The pituitary hormones LH and FSH were determined to interpret the influence of the IMP on the central hormonal regulation and feedback
    End point type
    Secondary
    End point timeframe
    Follicle phase, ovulatory phase, luteal phase
    End point values
    		 Treatment Arm Per Protoco Set (PPS) Full Analysis Set (FAS)
    Number of subjects analysed
    53
    49
    50
    Units: U/L
    53
    49
    50
    No statistical analyses for this end point

    Secondary: Endometrial thickness

    		 Close Top of page
    End point title
    		 Endometrial thickness
    End point description
    Endometrial thickness was assessed in order to determine any changes in the endometrial bed which are inappropriate for nidation. Especially in case of any occurring ovulation under treatment the corresponding endometrium thickness was evaluated and compared to the ovulatory precycle. A thickness of < 6 mm was regarded as non-conceptional endometrium
    End point type
    Secondary
    End point timeframe
    It was measured at each visit
    End point values
    		 Treatment Arm Per Protoco Set (PPS) Full Analysis Set (FAS)
    Number of subjects analysed
    53
    49
    50
    Units: mm
    53
    49
    50
    No statistical analyses for this end point

    Secondary: bleeding pattern

    		 Close Top of page
    End point title
    		 bleeding pattern
    End point description
    Evaluation of bleeding intensities was based on the following classification, whereas the subjects were informed not to consider the change of any tampons or sanitary napkins for hygienic reasons or well-being:  Spotting: very mild bleeding  Slight: bleeding requiring the use of 1-2 tampons or sanitary napkins per day  Moderate: bleeding requiring the use of 3-4 tampons or sanitary napkins per day  Heavy: bleeding requiring the use of 5 or more tampons or sanitary napkins per day.
    End point type
    Secondary
    End point timeframe
    daily diary entries by the subjects
    End point values
    		 Treatment Arm Per Protoco Set (PPS) Full Analysis Set (FAS)
    Number of subjects analysed
    53
    49
    50
    Units: intensity
    53
    49
    50
    No statistical analyses for this end point

    Secondary: Adverse events

    		 Close Top of page
    End point title
    		 Adverse events
    End point description
    Adverse events (AE) were all disturbances to health and well-being, subjective and objective disease symptoms (including pathological, clinically relevant changes in laboratory values), intercurrent illnesses and accidents observed during the course of a clinical trial, independent of whether a causal relationship with the administration of the investigational drug was possible.
    End point type
    Secondary
    End point timeframe
    An AE which was reported spontaneously by the subject or which was observed by the clinical investigator was to be monitored during the clinical trial or registered at each visit and entered into the CRF adverse event page.
    End point values
    		 Treatment Arm Safety Analysis Set (SF)
    Number of subjects analysed
    53
    52
    Units: number of AEs
    53
    52
    No statistical analyses for this end point

    Secondary: Clinical Laboratory Evaluations

    		 Close Top of page
    End point title
    		 Clinical Laboratory Evaluations
    End point description
    Haematology: Leucocytes, erythrocytes, haemoglobin, haematocrit, mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), platelets, neutrophils, eosinophils, basophils, lymphocytes, monocytes Liver function: Glutamate pyruvate transaminase (ALAT/GPT), glutamate oxaloacetate transaminase (ASAT/GOT) Serum chemistry: Sodium, potassium, chloride, creatinine Virology: HbsAg, anti-HCV, anti-HIV Urinalysis: glucose, ß-hCG (at the trial site and home test)
    End point type
    Secondary
    End point timeframe
    virology only once at screening; Safety blood sampling was conducted under at least 4 hours fasting conditions. Subjects were requested to keep a fasting period prior to their visit (e.g. without breakfast).
    End point values
    		 Treatment Arm Safety Analysis Set (SF)
    Number of subjects analysed
    53
    52
    Units: N/A
    53
    52
    No statistical analyses for this end point

    Secondary: vital signs

    		 Close Top of page
    End point title
    		 vital signs
    End point description
    Vital signs parameters comprised systolic blood pressure, diastolic blood pressure, heart rate, and body mass index (BMI)
    End point type
    Secondary
    End point timeframe
    at screening and final examination
    End point values
    		 Treatment Arm Safety Analysis Set (SF)
    Number of subjects analysed
    53
    52
    Units: N/A
    53
    52
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    during the course of the clinical trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Treatment group DRSP 4 mg
    Reporting group description
    		 -

    Reporting group title
    Treatment group DRSP 2.8 mg
    Reporting group description
    		 subjects taking drospirenone 2.8 mg

    Serious adverse events
    		 Treatment group DRSP 4 mg Treatment group DRSP 2.8 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 25 (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
    		 Treatment group DRSP 4 mg Treatment group DRSP 2.8 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 27 (77.78%)
    24 / 25 (96.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 27 (18.52%)
    8 / 25 (32.00%)
         occurrences all number
    21
    16
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    3 / 27 (11.11%)
    4 / 25 (16.00%)
         occurrences all number
    7
    4
    Ovarian cyst
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 25 (8.00%)
         occurrences all number
    4
    3
    Breast discomfort
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 25 (8.00%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    4 / 27 (14.81%)
    1 / 25 (4.00%)
         occurrences all number
    5
    1
    Abdominal pain lower
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 25 (8.00%)
         occurrences all number
    4
    2
    Diarrhoea
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 25 (8.00%)
         occurrences all number
    1
    2
    Nausea
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 25 (8.00%)
         occurrences all number
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    4 / 27 (14.81%)
    2 / 25 (8.00%)
         occurrences all number
    6
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    5 / 27 (18.52%)
    0 / 25 (0.00%)
         occurrences all number
    5
    0
    Psychiatric disorders
    Affective disorder
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 25 (4.00%)
         occurrences all number
    2
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    11 / 27 (40.74%)
    17 / 25 (68.00%)
         occurrences all number
    13
    20
    Oral herpes
         subjects affected / exposed
    3 / 27 (11.11%)
    5 / 25 (20.00%)
         occurrences all number
    8
    5
    Cystitis
         subjects affected / exposed
    3 / 27 (11.11%)
    0 / 25 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal infection
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 25 (0.00%)
         occurrences all number
    3
    0

    More information

    		 Close Top of page

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 04 01:33:34 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA