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    Clinical Trial Results:
    A randomised controlled trial to compare the effect of micronized progesterone and Medroxyprogesterone Acetate on the vascular elasticity, lipid profile and coagulation cascade of women with premature ovarian failure.

    Summary
    EudraCT number
    		 2012-004511-30
    Trial protocol
    		 GB  
    Global end of trial date
    23 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2019
    First version publication date
    29 Jul 2019
    Other versions
    Summary report(s)
    		 FINAL STUDY REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    POF01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College Hospital NHS Foundation Trust
    Sponsor organisation address
    Denmark Hill, London, United Kingdom, SE5 9RS
    Public contact
    Haitham Hamoda, King's College Hospital NHS Foundation Trust, 0044 02032995390, haitham.hamoda@nhs.net
    Scientific contact
    Haitham Hamoda, King's College Hospital NHS Foundation Trust, 0044 02032995390, haitham.hamoda@nhs.net
    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 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective: To assess the effect of micronized progesterone and medroxy progesterone acetate on vascular elasticity. This will be assessed by examining the changes in pulse wave analysis in women with premature ovarian failure receiving combined oestrogen/progestogen HRT.
    Protection of trial subjects
    Prior to randomisation, the participants will be asked to stop their current treatment regimen for a total of 1 month, to ensure an adequate washout time period has been accounted for. This washout time frame has been based on other published trials. It accounts for the half life of the medication. It is necessary to ensure that previous treatments do not influence or impact on the trial results. There is no evidence to suggest any risk from stopping their current treatment regime for this short duration.
    Background therapy
    		 Combined HRT is the recommended treatment in women with POI until the natural age of the menopause. There are many different varieties. This study assessed two different progesterone preparations given in combination with transdermal oestrogen. If the subjects were previously prescribed HRT, then a wash out period of 4-6 weeks was advised prior to starting the new preparation. Each treatment arm was prescribed a type of HRT as treatment is recommended. No patient was given a placebo.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jan 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
    United Kingdom: 68
    Worldwide total number of subjects
    68
    EEA total number of subjects
    68
    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)
    68
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from King’s College London NHS Foundation Trust over a 30 month period between 2013 and 2016.

    Pre-assignment
    Screening details
    		 Prior to randomisation, the participants will be asked to stop their current treatment regimen for a total of 1 month, to ensure an adequate washout time period has been accounted for. There is no evidence to suggest any risk from stopping their current treatment regime for this short duration.

    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
    Open label trial

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A - Utrogestan
    Arm description
    		 Utrogestan, oral, 200 mg/24 hours from days 15-26 of a 28 days cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Utrogestan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Utrogestan, oral, 200 mg/24 hours from days 15-26 of a 28 days cycle.

    Arm title
    		 Group B - Provera
    Arm description
    		 Medroxyprogesterone Acetate, Provera, oral, 10 mg/24 hours from days 16-26/cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Provera
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Medroxyprogesterone Acetate, Provera, oral, 10 mg/24 hours from days 16-26/cycle.

    Number of subjects in period 1
    		Group A - Utrogestan Group B - Provera
    Started
    34
    34
    Completed
    28
    31
    Not completed
    6
    3
         Consent withdrawn by subject
    -
    1
         Patient choice
    1
    -
         Protocol deviation
    1
    1
         Lack of efficacy
    4
    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
    		 68 68
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 68 68
    Gender categorical
    Units: Subjects
        Female
    		 68 68
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Group A - Utrogestan
    Reporting group description
    		 Utrogestan, oral, 200 mg/24 hours from days 15-26 of a 28 days cycle.

    Reporting group title
    Group B - Provera
    Reporting group description
    		 Medroxyprogesterone Acetate, Provera, oral, 10 mg/24 hours from days 16-26/cycle.

    Primary: The mean changes in the vascular elasticity.

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    End point title
    		 The mean changes in the vascular elasticity. [1]
    End point description
    End point type
    Primary
    End point timeframe
    Changes in vascular elasticity between baseline and visit 5
    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: There was no statistical difference seen between the 2 treatment arms for the primary endpoint. Please see attached report for other endpoint analysis.
    End point values
    		 Group A - Utrogestan Group B - Provera
    Number of subjects analysed
    34
    34
    Units: Change in vascular elasticity
    34
    34
    Attachments
    		 FINAL STUDY REPORT
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From first dose of IMP until 30 days post last dose of IMP.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Group A - Utrogestan
    Reporting group description
    		 -

    Reporting group title
    Group B - Provera
    Reporting group description
    		 -

    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: As this was a low risk trial accepted through the notification scheme as being as no greater risk than standard of care, no AEs were recorded. Only symptoms were recorded patient completed questionnaires.
    Serious adverse events
    		 Group A - Utrogestan Group B - Provera
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 34 (5.88%)
    1 / 34 (2.94%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Shingles
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group A - Utrogestan Group B - Provera
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 34 (0.00%)

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24072634
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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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