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    Clinical Trial Results:
    Randomized Clinical Trial comparing the endometrial transformation with 25 mg/day of subcutaneous progesterone (Prolutex) versus 50 mg/day intramuscular progesterone (Prontogest)

    Summary
    EudraCT number
    		 2015-000290-12
    Trial protocol
    		 ES  
    Global end of trial date
    29 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Oct 2020
    First version publication date
    31 Oct 2020
    Other versions
    Summary report(s)
    		 1412-BCN-087-AB Results

    Trial information

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    Trial identification
    Sponsor protocol code
    1412-BCN-087-AB
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02567552
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IVI Barcelona
    Sponsor organisation address
    Ronda del General Mitre, 14, 08017 Barcelona, Barcelona, Spain,
    Public contact
    Medicina Reproductiva, Clínica IVI Barcelona, 0034 932 063 000, agustin.ballesteros@ivi.es
    Scientific contact
    Medicina Reproductiva, Clínica IVI Barcelona, 0034 932 063 000, agustin.ballesteros@ivi.es
    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
    14 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the predecidualización endometrial (ie, measuring the effects of progesterone in the endometrial glands and stroma in the luteal phase) and endometrial receptivity on Day 5 as gene expression, following daily administration of 25 mg / day of subcutaneous progesterone and 50 mg / day intramuscular progesterone, both for 5 days, to see if there are differences in the use of both progesterone.
    Protection of trial subjects
    Monitoring and Insurance
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Apr 2015
    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
    Spain: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 1 year

    Pre-assignment
    Screening details
    		 Female aged between 18 and 34 years • BMI between 18 and 28 kg/m2 • Endometrial thickness > 7 mm the day of progesterone treatment initiation (day of follicular puncture) • Follicular maturation with a single bolus of GnRH agonist • Egg donors who undergo a cycle of ovarian stimulation in the IVI Barcelona Centre • Egg donors selected in accor

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Masked samples for histological evaluation and assessment of gene expression

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prolutex
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prolutex
    Investigational medicinal product code
    Other name
    Subcutaneous progesterona
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    25 mg/day

    Arm title
    		 Prontogest
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prontogest
    Investigational medicinal product code
    Other name
    Intramuscular Progesterone
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    50 mg/day

    Number of subjects in period 1
    		Prolutex Prontogest
    Started
    12
    12
    Completed
    12
    11
    Not completed
    0
    1
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 24 24
    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)
    		 24 24
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 24 24
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Prolutex
    Reporting group description
    		 -

    Reporting group title
    Prontogest
    Reporting group description
    		 -

    Primary: Predecidual Transformation

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    End point title
    		 Predecidual Transformation
    End point description
    Histologic dating of the endometrium at day 5: early secretory phase, media secretory phase or late secretory phase
    End point type
    Primary
    End point timeframe
    5 days
    End point values
    		 Prolutex Prontogest
    Number of subjects analysed
    12
    11
    Units: %
        early secretory phase
    1
    2
        media secretory phase
    7
    8
        late secretory phase
    4
    1
    Statistical analysis title
    		 Statistical Analysis for Predecidual Transformat
    Comparison groups
    Prolutex v Prontogest
    Number of subjects included in analysis
    23
    Analysis specification
    Post-hoc
    Analysis type
    		 other [1]
    P-value
    		 = 0.3395
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [1] - Pilot study

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1 year
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Prolutex
    Reporting group description
    		 -

    Reporting group title
    Prontogest
    Reporting group description
    		 -

    Serious adverse events
    		 Prolutex Prontogest
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (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
    		 Prolutex Prontogest
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 12 (41.67%)
    4 / 12 (33.33%)
    General disorders and administration site conditions
    Discomfort in injection site
         subjects affected / exposed
    3 / 12 (25.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    Pain in injection site
         subjects affected / exposed
    0 / 12 (0.00%)
    4 / 12 (33.33%)
         occurrences all number
    0
    0
    Reproductive system and breast disorders
    Breast inflammation
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 12 (0.00%)
         occurrences all number
    0
    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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    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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