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    Clinical Trial Results:
    PREOPERATIVE LOCALLY APPLIED OESTROGEN IN POSTMENOPAUSAL WOMEN WITH PELVIC ORGAN PROLAPSE: CHANGES IN SUBJECTIVE AND OBJECTIVE OUTCOME: A PROSPECTIVE RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

    Summary
    EudraCT number
    		 2016-000410-30
    Trial protocol
    		 AT  
    Global end of trial date
    27 Aug 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Sep 2021
    First version publication date
    23 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EstrogenPOP2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Währinger Gürtel 18-20, Vienna, Austria,
    Public contact
    Urogynecological Department, Medical University of Vienna, Department of Obstetrics and Gynecology, 0043 140400 29620,
    Scientific contact
    Urogynecological Department, Medical University of Vienna, Department of Obstetrics and Gynecology, 0043 140400 29620,
    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 Feb 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Aug 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Aug 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective • To demonstrate treatment efficacy of preoperative vaginally administered oestrogen in postmenopausal women with symptomatic pelvic organ prolapse in comparison to placebo, measured by a subjective questionnaire
    Protection of trial subjects
    The study intervention of applying vaginal cream is not associated with pain or distress.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2016
    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
    Austria: 103
    Worldwide total number of subjects
    103
    EEA total number of subjects
    103
    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)
    63
    From 65 to 84 years
    38
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment took place over a 31-month period between January 2017 and August 2020 in two urogynaecology centers in east Austria (Medical University of Vienna and University Hospital Tulln). One hundred and twenty women were randomised to receive either vaginal estrogen cream (n =60) or placebo cream (n=60). Once the target sample size was reached,

    Pre-assignment
    Screening details
    		 All eligible patients were referred by a gynecologist and seen by an urogynecologist at the study centers. 176 women were assessed for eligibility.

    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
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Estrogen
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Linoladiol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Vaginal use
    Dosage and administration details
    The active ingredient of Linoladiol® Estradiol-Emulsion is 0.10mg estradiol in 1g cream and is chemically and biologically identical to endogenous human estradiol. Women were instructed to use the cream (estrogen as well as placebo) intravaginally with the enclosed applicator once daily for one week, every 48 hours for the following week, and then twice weekly for the remaining 4 weeks (=total treatment duration 6 weeks).

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Vaginal use
    Dosage and administration details
    The placebo cream contained cetyl alcohol, probylene glycol, triglycerides, hostacerin T3, polysorbate, almond oil, benzyl alcohol and purified water. Women were instructed to use the cream (estrogen as well as placebo) intravaginally with the enclosed applicator once daily for one week, every 48 hours for the following week, and then twice weekly for the remaining 4 weeks (=total treatment duration 6 weeks).

    Number of subjects in period 1
    		Estrogen Placebo
    Started
    51
    52
    Completed
    51
    52

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Estrogen
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Estrogen Placebo Total
    Number of subjects
    		 51 52 103
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Data are mean ± SD or n (%)
    Units: years
        arithmetic mean (standard deviation)
    		 64.3 ( 9.7 ) 61.8 ( 10.1 ) -
    Gender categorical
    not applicable - only female
    Units: Subjects
        Female
    		 51 52 103
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    estrogen in women with prolapse
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    103 of 120 (86%) women provided primary analysis data.

    Subject analysis sets values
    		 estrogen in women with prolapse
    Number of subjects
    103
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Data are mean ± SD or n (%)
    Units: years
        arithmetic mean (standard deviation)
    62.8 ( 10 )
    Gender categorical
    not applicable - only female
    Units: Subjects
        Female
    103
        Male
    0

    End points

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

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    estrogen in women with prolapse
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    103 of 120 (86%) women provided primary analysis data.

    Primary: Difference of prolapse domain score and other pelvic floor domain scores baseline minus 6 weeks of estrogen treatment

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    End point title
    		 Difference of prolapse domain score and other pelvic floor domain scores baseline minus 6 weeks of estrogen treatment
    End point description
    End point type
    Primary
    End point timeframe
    assessment from January 2017 and August 2020
    End point values
    		 Estrogen Placebo
    Number of subjects analysed
    51
    52
    Units: score
        number (not applicable)
    51
    52
    Attachments
    		 Untitled (Filename: Tables BJOG revised.docx)
    Statistical analysis title
    		 Difference of prolapse domain score and other pelv
    Comparison groups
    Estrogen v Placebo
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    January 2017 October 2020
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    subjects
    Reporting group description
    		 -

    Serious adverse events
    		 subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 103 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 103 (0.97%)
    Skin and subcutaneous tissue disorders
    skin intolerance
         subjects affected / exposed
    1 / 103 (0.97%)
         occurrences all number
    1

    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
    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.

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