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    Clinical Trial Results:
    Uterine fibroids: Impact of ulipristal acetate 10 mg on ART results.

    Summary
    EudraCT number
    		 2014-000964-16
    Trial protocol
    		 ES  
    Global end of trial date
    31 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Oct 2020
    First version publication date
    30 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1311-BCN-138-DG
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IVI Valencia
    Sponsor organisation address
    Plaza Policia Local, Valencia, Spain,
    Public contact
    Daniela Galliano, IVI Valencia, +34 963050900, Daniela.Galliano@ivi.es
    Scientific contact
    Daniela Galliano, IVI Valencia, +34 963050900, Daniela.Galliano@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
    31 May 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Demonstrate an 15% increase in the rate of clinical pregnancy in women with inoperable intramural fibroids not distorting the uterine cavity within a program OVD, after administration of uPA in a dose of 10 mg orally daily for 12 weeks
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Mar 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: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    2
    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)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients> 18 and <50 years Patients who undergo a first / second cycle OVD Patients who present within 1-3 intramural myomas> 2 cm and <5 cm that do not distort the cavity, Type 3 and 4 of the FIGO classification (Figure 1). Miomas inoperable for medical judgment or patient desire, you want to avoid the post-surgical time waiting 6 months / 1 year

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Arm title
    		 ESMYA
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Acetate ulipristal
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pastille
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg/day

    Number of subjects in period 1
    		ESMYA
    Started
    2
    Completed
    2

    Baseline characteristics

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    End points

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

    Primary: clinical pregnancy rate

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    End point title
    		 clinical pregnancy rate [1]
    End point description
    End point type
    Primary
    End point timeframe
    1 year
    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: Premature cancellation. Results have not been analysed
    End point values
    		 ESMYA
    Number of subjects analysed
    0 [2]
    Units: %
    Notes
    [2] - Premature cancellation. Results have not been analysed
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    3 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 1%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Premature cancellation. Results have not been analysed

    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? Yes
    Date
    Interruption
    Restart date
    31 May 2016
    Lack of availibility of eligible subjects
    -

    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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