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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   38002   clinical trials with a EudraCT protocol, of which   6235   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).
     
    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:
    PROgesterone Therapy for Endometrial Cancer prevention in obese women (PROTEC)

    Summary
    EudraCT number
    2014-005610-37
    Trial protocol
    GB  
    Global end of trial date
    01 Oct 2017

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

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    PROTEC1
    Additional study identifiers
    ISRCTN number
    ISRCTN40940943
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    REC reference: 15/EE/0063
    Sponsors
    Sponsor organisation name
    Manchester University NHS Foundation Trust
    Sponsor organisation address
    29 Grafton Street, Manchester, United Kingdom, M13 9WU
    Public contact
    Dr Lynne Webster, Head of the Research Office, Manchester University NHS Foundation Trust, +44 0161 276 4125, research.sponsor@mft.nhs.uk
    Scientific contact
    Dr Lynne Webster, Head of the Research Office, Manchester University NHS Foundation Trust, +44 0161 276 4125, research.sponsor@mft.nhs.uk
    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 Oct 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether the Mirena coil is effective at interrupting pathways in the womb associated with increased risk of developing cancer.
    Protection of trial subjects
    Taking part in the study involved a gift of time from the patients. Appointment times were made by telephone in advance for the most convenient time for the patient where possible and reasonable travel expenses were reimbursed. There was a discussion of personal information in the medical history, however the doctors involved in this study were practicing clinicans in the NHS and all information were handled and stored according to the Data Protection Act 1998. Having blood taken may be uncomfortable or cause bruising. The staff taking the samples were trained in phlebotomy. Endometrial biopsies and insertion of the Mirena IUS may be uncomfortable or embarassing for some women. There is a small risk of infection and rarely uterine perforation. Genital swabs were taken during the screening assessment to reduce the risk of infection. Senior clinicans with experience in these procedures performed these tasks in an suitable environment for internal examinations with a female chaparone available at request. Should any patient find the clinical procedures too painful they were to be abandoned. The patients were fully informed of the risks and the signs and symptoms of possible complications. In the event of any complications the study patients were to be referred to the on call gynaecology team at St Mary's if necessary. The Mirena IUS can cause irregular bleeding (spotting) in some women. If the participants found this unacceptable we would remove the Mirena IUS at any time on request. Some women may find it distressing to realise they are at increased risk of endometrial cancer because they have a high BMI. If we were unable to obtain a baseline endometrial sample to reassure a patient routine gynaecology practice advice was given on risk reducing behaviours and any concerning features of history were to be investigated outside the research study.
    Background therapy
    None
    Evidence for comparator
    There was no comparator used within this trial.
    Actual start date of recruitment
    17 Jun 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
    United Kingdom: 35
    Worldwide total number of subjects
    35
    EEA total number of subjects
    35
    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)
    35
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    The green light to begin recruitment to the study was issued by the sponsor on 17/06/2015. Participants were recruited from the Sleep Apnoea Clinic at Salford Royal Hospital which is a tertiary center that takes referrals from across the North West. Recruitment closed 31/07/2017.

    Pre-assignment
    Screening details
    Inclusion: 1) Women seen in the Sleep Apnoea Clinic at Salford Royal Hospital 2) BMI >40 3) Consent 4) Aged 18 or over 5) Normal up to date smear 6) Normal endometrial sample at screening Exclusion: 1) Previous hysterectomy 2) LNGIUS or IUD in situ or in previous 6 months 3) Pregnant or breast feeding 4) Progestin IUS contradicted

    Period 1
    Period 1 title
    Enrolment
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    There was no placebo or control group within this trial and so it was not blinded.

    Arms
    Arm title
    Mirena 20micrograms/24hours intrauterine delivery system
    Arm description
    Patients will undergo the following procedures: 1. Medical history, height, weight, blood pressure, waist and hip measurements 2. Telephone calls for menstrual history and adverse events 3. Questionnaire including MBL chart 4. Venepuncture 40mls blood for safety and trial bloods 5. Venepuncture 30mls blood for trialbloods 6. Mirena IUS insertion
    Arm type
    Experimental

    Investigational medicinal product name
    Levonorgestrel
    Investigational medicinal product code
    PL00010/0547
    Other name
    Mirena Intra Uterine System
    Pharmaceutical forms
    Vaginal delivery system
    Routes of administration
    Vaginal use
    Dosage and administration details
    20 micrograms to be administered daily via a intrauterine delivery system for a duration of 9 months.

    Number of subjects in period 1
    Mirena 20micrograms/24hours intrauterine delivery system
    Started
    35
    Completed
    25
    Not completed
    10
         Screen fail
    6
         Consent withdrawn by subject
    4
    Period 2
    Period 2 title
    Baseline
    Is this the baseline period?
    Yes [1]
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Mirena IUS
    Arm description
    -
    Arm type
    Observational

    Investigational medicinal product name
    Levonorgestrel
    Investigational medicinal product code
    PL00010/0547
    Other name
    Mirena Intra Uterine System
    Pharmaceutical forms
    Vaginal delivery system
    Routes of administration
    Vaginal use
    Dosage and administration details
    20 micrograms to be administered daily via a intrauterine delivery system for a duration of 9 months.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: There is an initial enrolment timepoint, when patients are identified and consented.
    Number of subjects in period 2 [2]
    Mirena IUS
    Started
    25
    Completed
    25
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 35 patients were enrolled into the study, but 6 were incorrectly enrolled and 4 withdraw their consent prior to collection of baseline data.
    Period 3
    Period 3 title
    Followup - Implementation
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Mirena IUS - Implementation
    Arm description
    -
    Arm type
    Observational

    Investigational medicinal product name
    Levonorgestrel
    Investigational medicinal product code
    PL00010/0547
    Other name
    Mirena Intra Uterine System
    Pharmaceutical forms
    Vaginal delivery system
    Routes of administration
    Vaginal use
    Dosage and administration details
    20 micrograms to be administered daily via a intrauterine delivery system for a duration of 9 months.

    Number of subjects in period 3
    Mirena IUS - Implementation
    Started
    25
    Completed
    25
    Period 4
    Period 4 title
    Followup - timepoint 2
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Mirena IUS - Timepoint 2
    Arm description
    -
    Arm type
    Observational

    Investigational medicinal product name
    Levonorgestrel
    Investigational medicinal product code
    PL00010/0547
    Other name
    Mirena Intra Uterine System
    Pharmaceutical forms
    Vaginal delivery system
    Routes of administration
    Vaginal use
    Dosage and administration details
    20 micrograms to be administered daily via a intrauterine delivery system for a duration of 9 months.

    Number of subjects in period 4
    Mirena IUS - Timepoint 2
    Started
    25
    Completed
    25

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    -

    Reporting group values
    Baseline Total
    Number of subjects
    25 25
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    25 25
    Age continuous
    At first biospy
    Units: years
        arithmetic mean (standard deviation)
    53.6 ± 5.02 -
    Gender categorical
    Units: Subjects
        Female
    25 25
    Ethnicity
    Units: Subjects
        Asian
    1 1
        White
    24 24
    Smoker
    Units: Subjects
        Ever
    4 4
        Never
    18 18
        Current
    3 3
    Menopausal
    Units: Subjects
        Post
    13 13
        Pre
    12 12
    Cycle
    Units: Subjects
        Unknown
    16 16
        Group I
    5 5
        Group R
    4 4
    Periods
    Units: Subjects
        Grp A
    5 5
        Grp H
    6 6
        Grp N
    2 2
        Grp P
    12 12
    IMB
    Units: Subjects
        Yes
    1 1
        No
    24 24
    PCB
    Units: Subjects
        Yes
    0 0
        No
    25 25
    PMB
    Units: Subjects
        Yes
    2 2
        No
    23 23
    HRT
    Units: Subjects
        Yes
    3 3
        No
    22 22
    Contraception/HRT
    Units: Subjects
        CC
    1 1
        Ellest Duet
    1 1
        Femiston
    1 1
        Norethisterone
    1 1
        Unknown
    21 21
    Overdue smear
    Units: Subjects
        Yes
    7 7
        No
    18 18
    Smear result
    Units: Subjects
        Unknown
    18 18
        No
    7 7
    Comorbidities: Diabetes
    Units: Subjects
        Yes
    10 10
        No
    15 15
    Comorbidities: Subfertility
    Units: Subjects
        Yes
    2 2
        No
    23 23
    Comorbidities: Asthma/COPD
    Units: Subjects
        Yes
    8 8
        No
    17 17
    Comorbidities: Osteoarthritis/backpain
    Units: Subjects
        Yes
    15 15
        No
    10 10
    Comorbidities: Gallbladder/liver disease
    Units: Subjects
        Yes
    5 5
        No
    20 20
    Comorbidities: Depression/anxiety
    Units: Subjects
        Yes
    8 8
        No
    17 17
    Comorbidities: Hypertension
    Units: Subjects
        Yes
    15 15
        No
    10 10
    Comorbidities: GORD
    Units: Subjects
        Yes
    4 4
        No
    21 21
    Comorbidities: Thyroid disease
    Units: Subjects
        Yes
    4 4
        No
    21 21
    Comorbidities: Thromboembolic
    Units: Subjects
        Yes
    3 3
        No
    22 22
    Comorbidities: Hyperchol
    Units: Subjects
        Yes
    5 5
        No
    20 20
    Comorbidities: Sleep Apnea
    Units: Subjects
        Yes
    9 9
        No
    16 16
    Comorbidities: Cardiac Disease
    Units: Subjects
        Yes
    2 2
        No
    23 23
    Other comorbidities: Bone Marrow Transplant
    Units: Subjects
        Yes
    1 1
        No
    24 24
    Other comorbidities: Cellulitis
    Units: Subjects
        Yes
    1 1
        No
    24 24
    Other comorbidities: Crohns
    Units: Subjects
        Yes
    1 1
        No
    24 24
    Other comorbidities: Irritable bladder
    Units: Subjects
        Yes
    1 1
        No
    24 24
    Other comorbidities: Kidney
    Units: Subjects
        Yes
    1 1
        No
    24 24
    Other comorbidities: Migraine
    Units: Subjects
        Yes
    2 2
        No
    23 23
    Other comorbidities: Ovarian 1b
    Units: Subjects
        Yes
    1 1
        No
    24 24
    Over comorbidities: Ovarian cyst
    Units: Subjects
        Yes
    1 1
        No
    24 24
    Other comorbidities: Peripheral Neuropathy
    Units: Subjects
        Yes
    1 1
        No
    24 24
    Other comorbidities: Psychosis
    Units: Subjects
        Yes
    1 1
        No
    24 24
    Other comorbidities: Restless leg
    Units: Subjects
        Yes
    1 1
        No
    24 24
    Other comorbidities: Rhinitis, bells palsy
    Units: Subjects
        Yes
    1 1
        No
    24 24
    Menstrual cycle
    Units: Subjects
        Stage A
    5 5
        Stage I
    3 3
        Stage R
    4 4
        Stage p
    13 13
    Biopsy result
    Units: Subjects
        Result E
    5 5
        Result N
    20 20
    Parity
    Units: Subjects
        Zero
    1 1
        One
    6 6
        Two
    10 10
        Three
    2 2
        Four
    3 3
        Five
    1 1
        Six
    0 0
        Seven
    1 1
        Eight
    1 1
    PCOS
    Units: Subjects
        Yes
    6 6
        No
    19 19
    Height
    Units: metres
        arithmetic mean (standard deviation)
    1.6 ± 0.05 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    129.1 ± 19.16 -
    BMI
    Units: ratio (kg/msquared)
        arithmetic mean (standard deviation)
    48.3 ± 6.27 -
    Waist circumference
    Units: cm
        arithmetic mean (standard deviation)
    131.3 ± 13.60 -
    Hip circumference
    Units: cm
        arithmetic mean (standard deviation)
    150.7 ± 13.96 -
    Waist Hip ratio
    Units: cm:cm
        arithmetic mean (standard deviation)
    0.9 ± 0.07 -
    Dress Size
    Units: UK measurements
        arithmetic mean (standard deviation)
    25.6 ± 4.37 -
    Dress size 10 years prior
    Units: UK dress size measurement
        arithmetic mean (standard deviation)
    21.5 ± 4.76 -
    Day of cycle at baseline
    Units: Day
        median (inter-quartile range (Q1-Q3))
    16 (11 to 37) -
    Duration of fast
    Units: Hours
        median (inter-quartile range (Q1-Q3))
    12 (4 to 12) -
    HOMA
    Units: Index
        arithmetic mean (standard deviation)
    12.5 ± 7.07 -
    Testosterone
    Units: nmol/L
        arithmetic mean (standard deviation)
    7.1 ± 3.63 -
    Oestradiol
    Units: pg/ml
        arithmetic mean (standard deviation)
    11.8 ± 6.55 -
    Progesterone
    Units: ng/mL
        median (inter-quartile range (Q1-Q3))
    1 (1 to 4) -
    CRP
    Units: mg/L
        arithmetic mean (standard deviation)
    9.0 ± 4.12 -
    Glucose
    Units: mmol/L
        arithmetic mean (standard deviation)
    5.5 ± 0.82 -
    Insulin
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    122 (61 to 163) -
    FSH
    Units: IU/mL
        median (inter-quartile range (Q1-Q3))
    21.7 (11.3 to 50.5) -
    LH
    Units: IU
        median (inter-quartile range (Q1-Q3))
    12.9 (8.7 to 25.7) -
    LHFSHratio
    Units: Ratio
        arithmetic mean (standard deviation)
    12.5 ± 7.07 -
    FAI
    Units: Index
        median (inter-quartile range (Q1-Q3))
    2.7 (1.2 to 4.2) -
    HBG
    Units: g/dL
        median (inter-quartile range (Q1-Q3))
    35 (29 to 51) -
    IGFBP
    Units: mg/L
        arithmetic mean (standard deviation)
    99.7 ± 39.10 -
    Leptin
    Units: ng/dL
        median (inter-quartile range (Q1-Q3))
    70.3 (56.4 to 90.7) -
    Adiponectin
    Units: μg/ml
        median (inter-quartile range (Q1-Q3))
    2.9 (1.9 to 4.0) -
    HbA1c
    Units: mmol/mol
        arithmetic mean (standard deviation)
    41.9 ± 8.20 -
    pAKTstrong
    Units: percentage
        median (inter-quartile range (Q1-Q3))
    0.0 (0.0 to 4.5) -
    pAKTmoderate
    Units: percentage
        median (inter-quartile range (Q1-Q3))
    3.0 (0.0 to 20.0) -
    pAKTweak
    Units: percentage
        median (inter-quartile range (Q1-Q3))
    75.0 (45.0 to 99.0) -
    pAKTnegative
    Units: percentage
        median (inter-quartile range (Q1-Q3))
    0.0 (0.0 to 35.0) -
    PRHScore
    Units: Score
        median (inter-quartile range (Q1-Q3))
    0.8 (0.7 to 0.9) -
    PTENStrong
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    0.0 (0.0 to 35.0) -
    PTENModerate
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    57.5 (35.0 to 90.0) -
    PTENWeak
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    7.5 (0.0 to 45.0) -
    ERgHScore
    Units: Score
        arithmetic mean (standard deviation)
    0.8 ± 0.1 -
    ERsHScore
    Units: Score
        arithmetic mean (standard deviation)
    0.7 ± 0.1 -
    Ki67 Total pos
    Units: Count
        median (inter-quartile range (Q1-Q3))
    321.5 (30 to 407) -
    Ki67 Total neg
    Units: Count
        median (inter-quartile range (Q1-Q3))
    745.5 (582 to 947) -
    Ki67 Pos Neg Ratio
    Units: Ratio
        median (inter-quartile range (Q1-Q3))
    0.335 (0.027 to 0.685) -
    Ki67 Percent Pos
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    25.1 (2.6 to 40.7) -

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Mirena 20micrograms/24hours intrauterine delivery system
    Reporting group description
    Patients will undergo the following procedures: 1. Medical history, height, weight, blood pressure, waist and hip measurements 2. Telephone calls for menstrual history and adverse events 3. Questionnaire including MBL chart 4. Venepuncture 40mls blood for safety and trial bloods 5. Venepuncture 30mls blood for trialbloods 6. Mirena IUS insertion
    Reporting group title
    Mirena IUS
    Reporting group description
    -
    Reporting group title
    Mirena IUS - Implementation
    Reporting group description
    -
    Reporting group title
    Mirena IUS - Timepoint 2
    Reporting group description
    -

    Primary: Ki67 Percentage Pos

    Close Top of page
    End point title
    Ki67 Percentage Pos [1]
    End point description
    End point type
    Primary
    End point timeframe
    Followup
    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: This is a single arm exploratory study with small numbers looking at change in ki67 between baseline, implementation, and follow-up. A mixed effects regression model showed a significant difference at follow-up of around 15%. Potential confounders were not found to effect the outcome.
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    24
    25
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    16.7 (10.8 to 30.9)
    8.5 (5.3 to 16.5)
    No statistical analyses for this end point

    Secondary: Ki67 Total pos

    Close Top of page
    End point title
    Ki67 Total pos
    End point description
    End point type
    Secondary
    End point timeframe
    Follow-up
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    24
    25
    Units: Count
        median (inter-quartile range (Q1-Q3))
    189.5 (91.5 to 395)
    79 (48 to 158)
    No statistical analyses for this end point

    Secondary: Ki67 Total neg

    Close Top of page
    End point title
    Ki67 Total neg
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    24
    25
    Units: Count
        median (inter-quartile range (Q1-Q3))
    880 (673 to 1063)
    945 (698 to 971)
    No statistical analyses for this end point

    Secondary: Ki67 Pos Neg Ratio

    Close Top of page
    End point title
    Ki67 Pos Neg Ratio
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    24
    25
    Units: Ratio
        median (inter-quartile range (Q1-Q3))
    0.201 (0.121 to 0.449)
    0.093 (0.056 to 0.198)
    No statistical analyses for this end point

    Secondary: Weight

    Close Top of page
    End point title
    Weight
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    25
    25
    Units: kg
        arithmetic mean (standard deviation)
    128.3 ± 19.4
    126.7 ± 19.2
    No statistical analyses for this end point

    Secondary: BMI

    Close Top of page
    End point title
    BMI
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    25
    25
    Units: ratio (kg/msquared)
        arithmetic mean (standard deviation)
    48.0 ± 6.4
    47.5 ± 6.7
    No statistical analyses for this end point

    Secondary: Waist circumference

    Close Top of page
    End point title
    Waist circumference
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    25
    24
    Units: cm
        arithmetic mean (standard deviation)
    130.8 ± 13.2
    128.1 ± 14.3
    No statistical analyses for this end point

    Secondary: Hip circumference

    Close Top of page
    End point title
    Hip circumference
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    25
    24
    Units: cm
        arithmetic mean (standard deviation)
    149.5 ± 13.7
    147.6 ± 14.2
    No statistical analyses for this end point

    Secondary: Waist hip ratio

    Close Top of page
    End point title
    Waist hip ratio
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    24
    24
    Units: Ratio
        arithmetic mean (standard deviation)
    0.88 ± 0.07
    0.87 ± 0.07
    No statistical analyses for this end point

    Secondary: HOMA

    Close Top of page
    End point title
    HOMA
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    21
    21
    Units: Index
        arithmetic mean (standard deviation)
    28.0 ± 24.3
    33.8 ± 34.9
    No statistical analyses for this end point

    Secondary: Testosterone

    Close Top of page
    End point title
    Testosterone
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    24
    25
    Units: nmol/L
        arithmetic mean (standard deviation)
    6.3 ± 3.4
    6.8 ± 3.7
    No statistical analyses for this end point

    Secondary: Oestradiol

    Close Top of page
    End point title
    Oestradiol
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    24
    25
    Units: pg/mL
        arithmetic mean (standard deviation)
    9.7 ± 5.5
    10.1 ± 6.0
    No statistical analyses for this end point

    Secondary: Progesterone

    Close Top of page
    End point title
    Progesterone
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    24
    25
    Units: ng/mL
        median (inter-quartile range (Q1-Q3))
    1.0 (1.0 to 6.5)
    1.0 (1.0 to 1.0)
    No statistical analyses for this end point

    Secondary: CRP

    Close Top of page
    End point title
    CRP
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    23
    25
    Units: mg/L
        arithmetic mean (standard deviation)
    6.2 ± 3.3
    7.3 ± 4.0
    No statistical analyses for this end point

    Secondary: Glucose

    Close Top of page
    End point title
    Glucose
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    22
    24
    Units: mmol/L
        arithmetic mean (standard deviation)
    5.5 ± 1.0
    5.5 ± 0.9
    No statistical analyses for this end point

    Secondary: Insulin

    Close Top of page
    End point title
    Insulin
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    24
    24
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    89.5 (76 to 156)
    79.5 (55.5 to 173)
    No statistical analyses for this end point

    Secondary: FSH

    Close Top of page
    End point title
    FSH
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    24
    25
    Units: IU/mL
        median (inter-quartile range (Q1-Q3))
    20.85 (8.8 to 43.6)
    23.7 (13.3 to 53.5)
    No statistical analyses for this end point

    Secondary: LH

    Close Top of page
    End point title
    LH
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    23
    24
    Units: IU
        median (inter-quartile range (Q1-Q3))
    11.8 (5.4 to 26.5)
    16.75 (9.95 to 38.45)
    No statistical analyses for this end point

    Secondary: LHFSHRatio

    Close Top of page
    End point title
    LHFSHRatio
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    22
    24
    Units: Ratio
        arithmetic mean (standard deviation)
    0.70 ± 0.27
    0.68 ± 0.17
    No statistical analyses for this end point

    Secondary: FAI

    Close Top of page
    End point title
    FAI
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    22
    24
    Units: Index
        median (inter-quartile range (Q1-Q3))
    1.75 (0.9 to 3.6)
    1.95 (1.25 to 3.85)
    No statistical analyses for this end point

    Secondary: HBG

    Close Top of page
    End point title
    HBG
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    24
    25
    Units: g/dL
        median (inter-quartile range (Q1-Q3))
    36 (27.5 to 61)
    30 (27 to 56)
    No statistical analyses for this end point

    Secondary: IGFBP

    Close Top of page
    End point title
    IGFBP
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    24
    16
    Units: mg/L
        arithmetic mean (standard deviation)
    98.3 ± 49.6
    100.8 ± 35.3
    No statistical analyses for this end point

    Secondary: Leptin

    Close Top of page
    End point title
    Leptin
    End point description
    End point type
    Secondary
    End point timeframe
    Secondary
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    24
    24
    Units: ncpa.cpl
        median (inter-quartile range (Q1-Q3))
    72.2 (54.8 to 96.4)
    76.2 (62.0 to 97.7)
    No statistical analyses for this end point

    Secondary: Adipoenectin

    Close Top of page
    End point title
    Adipoenectin
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    24
    24
    Units: μg/ml
        median (inter-quartile range (Q1-Q3))
    2.8 (2.0 to 3.8)
    2.0 (1.6 to 3.3)
    No statistical analyses for this end point

    Secondary: HbA1c

    Close Top of page
    End point title
    HbA1c
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    22
    23
    Units: mmol/mol
        arithmetic mean (standard deviation)
    41.7 ± 9.3
    42.2 ± 9.5
    No statistical analyses for this end point

    Secondary: IGF1

    Close Top of page
    End point title
    IGF1
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    24
    24
    Units: ng/ml,
        arithmetic mean (standard deviation)
    10.0 ± 5.2
    10.3 ± 5.7
    No statistical analyses for this end point

    Secondary: pAKTstrong

    Close Top of page
    End point title
    pAKTstrong
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    18
    20
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    0 (0 to 1)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: pAKTmoderate

    Close Top of page
    End point title
    pAKTmoderate
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    21
    21
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    1 (0 to 9)
    0 (0 to 5)
    No statistical analyses for this end point

    Secondary: pAKTnegative

    Close Top of page
    End point title
    pAKTnegative
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    20
    22
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    7.5 (0.5 to 39)
    10 (4 to 40)
    No statistical analyses for this end point

    Secondary: pAKTweak

    Close Top of page
    End point title
    pAKTweak
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    22
    24
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    80 (52 to 98)
    80 (60 to 97.5)
    No statistical analyses for this end point

    Secondary: PRHScore

    Close Top of page
    End point title
    PRHScore
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    22
    23
    Units: Score
        median (inter-quartile range (Q1-Q3))
    0.8889 (0.7778 to 0.9444)
    0.4444 (0.3333 to 0.5556)
    No statistical analyses for this end point

    Secondary: PTENStrong

    Close Top of page
    End point title
    PTENStrong
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    23
    25
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    0 (0 to 30)
    0 (0 to 5)
    No statistical analyses for this end point

    Secondary: PTENModerate

    Close Top of page
    End point title
    PTENModerate
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    23
    25
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    60 (40 to 95)
    80 (50 to 100)
    No statistical analyses for this end point

    Secondary: PTENWeak

    Close Top of page
    End point title
    PTENWeak
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    23
    25
    Units: Percentage
        median (inter-quartile range (Q1-Q3))
    5 (0 to 35)
    10 (0 to 35)
    No statistical analyses for this end point

    Secondary: ERgHScore

    Close Top of page
    End point title
    ERgHScore
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    23
    22
    Units: Score
        arithmetic mean (standard deviation)
    0.9 ± 0.1
    0.8 ± 0.1
    No statistical analyses for this end point

    Secondary: ERsHScore

    Close Top of page
    End point title
    ERsHScore
    End point description
    End point type
    Secondary
    End point timeframe
    Followup
    End point values
    Mirena IUS - Implementation Mirena IUS - Timepoint 2
    Number of subjects analysed
    19
    21
    Units: Score
        arithmetic mean (standard deviation)
    0.7 ± 0.1
    0.7 ± 0.1
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    SAEs occuring within the duration of the study were collected and reported to the sponsor.
    Adverse event reporting additional description
    AEs are recorded on a template AE log which were made available for review at monitoring visits. Any SAE will be reported by the Principal Investigator (including a completed SAE form) within 24 hours of first knowledge to the Sponsor.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Mirena 20micrograms/24hours intrauterine delivery system
    Reporting group description
    -

    Serious adverse events
    Mirena 20micrograms/24hours intrauterine delivery system
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 35 (2.86%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Psychiatric disorders
    Patient swallowed (x60) co-codamo (500/30) tablets and went to bed. Woke the next morning, vomitted.
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Patient lay on the ground to die of dehydration for two nights
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Mirena 20micrograms/24hours intrauterine delivery system
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 35 (14.29%)
    Blood and lymphatic system disorders
    Vasculitis
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences all number
    1
    Pregnancy, puerperium and perinatal conditions
    Pelvic inflammatory disease
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences all number
    1
    General disorders and administration site conditions
    Sciatica
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences all number
    1
    Discomfort
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences all number
    1
    Infections and infestations
    Urinary Tract Infection
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences all number
    1

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Sep 2015
    Substantial amendment 2: 1) The protocol is amended to allow recruitment of patients through the Sleep Apnoea or other service at Salford Royal or any gynaecology clinic at St Mary's Hospital Manchester or any patient who approaches the research team directly after hearing of the trial through "word of mouth", CRUK or clinical trials.gov or other clinical research website or publication. Notification of the participants involvement to their GP will remain compulsory for all trial participants. 2) The use of an alternative (validated) questionnaire at the baseline/insertion of Mirena and follow up visits. After listening to the committee's original concerns regarding our questionnaire and feedback from our participants we wish to change the questionnaire to a more general health and wellbeing questionnaire and specific assessment on menstrual bleeding. 3) The protocol is amended to allow contact of participants by their clinical team 4) The protocol is amended to reflect that St Mary's Hospital is the only site where assessments will be performed 5) The patient information sheet is amended to reflect the new questionnaire 6) The consent form is amended to reflect the new version of the patient information sheet Received REC favourable opinion 20/10/2015.
    05 May 2016
    Substantial amendment 1: The protocol for this trial has been changed after ethics approval was granted at the request of the MHRA in their ‘notice of grounds for nonacceptance’ letter in response to our initial clinical trials application. The MHRA have requested that the protocol be amended to include the exclusion criteria of "postpartum endometritis, infected abortion during the past three months and recent trophoblastic disease while hCG levels remain elevated" before they approve the study. Received REC favourable opinion 22/05/2015.

    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
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA