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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:
    A Prospective, Multi-centre, Single-Arm, Open Label Study of the Long term Use of a LHRH Agonist (Decapeptyl® SR, 11.25 mg) in Combination with Livial® Add-back Therapy in the Management of Chronic Cyclical Pelvic Pain in Pre-Menopausal Women

    Summary
    EudraCT number
    		 2007-001159-20
    Trial protocol
    		 GB  
    Global end of trial date
    09 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Sep 2018
    First version publication date
    22 Sep 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    STH14404
    Additional study identifiers
    ISRCTN number
    		 ISRCTN19040577
    US NCT number
    		 NCT00735852
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sheffield Teaching Hospitals NHS Foundation Trust
    Sponsor organisation address
    8 Beech Hill Road, Sheffield, United Kingdom, S10 2SB
    Public contact
    Mr Mostafa Metwally, Sheffield Teaching Hospitals NHS Foundation Trust, 0114 2268092, mostafa.metwally@sth.nhs.uk
    Scientific contact
    Mr Mostafa Metwally, Sheffield Teaching Hospitals NHS Foundation Trust, 0114 2268092, mostafa.metwally@sth.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
    09 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    09 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the impact of treatment with Decapeptyl SR plus Tibolone on CCPP throughout the 24 month treatment period. Changes will be determined by comparison to Baseline. Pain will be assessed using the Chronic Pain Grade (CPG) Questionnaire
    Protection of trial subjects
    No specific measures were in place as these were not deemed necessary.
    Background therapy
    		 Livial was used an add back therapy to help prevent bone loss and to help to minimise the potential side effects of the decapeptyl (menopausal symptoms).
    Evidence for comparator
    		 No comparators were used.
    Actual start date of recruitment
    18 Dec 2008
    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: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    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)
    31
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Recruitment period December 2008- December 2013

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 31
    Number of subjects completed
    		 27

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Reason: Number of subjects
    		 Physician decision: 1
    Reason: Number of subjects
    		 screen fail: 1
    Reason: Number of subjects
    		 lost to follow up: 1
    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 treatment
    Arm description
    		 commenced unblinded open label treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Decapeptyl
    Investigational medicinal product code
    L02AE04
    Other name
    Triptorelin
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Decapeptyl 11.25 mg given IM 3 monthly for 2 years. Prepared by mixing powder with solution immediately prior to use

    Number of subjects in period 1 [1]
    		treatment
    Started
    27
    Completed
    27
    Notes
    [1] - 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: 4 patients left the study after being consented. One was a screen fail, one withdrew consent, one was physicians decision to withdraw the patient and one was lost to follow up.
    Period 2
    Period 2 title
    24 months
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 treatment
    Arm description
    		 Unblinded open label treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Decapeptyl
    Investigational medicinal product code
    L02AE04
    Other name
    Triptorelin
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Decapeptyl 11.25 mg given IM 3 monthly for 2 years. Prepared by mixing powder with solution immediately prior to use

    Number of subjects in period 2
    		treatment
    Started
    27
    Completed
    13
    Not completed
    14
         Consent withdrawn by subject
    4
         Adverse event, non-fatal
    4
         Lack of efficacy
    6
    Period 3
    Period 3 title
    30 Months
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Follow up
    Arm description
    		 Follow up
    Arm type
    		 Follow up

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Follow up
    Started
    13
    Completed
    13

    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
    		 27 27
    Age categorical
    women aged 18- 45 years inclusive
    Units: Subjects
        Adult women 18-45
    		 27 27
    Gender categorical
    Units: Subjects
        Female
    		 27 27

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    treatment
    Reporting group description
    		 commenced unblinded open label treatment
    Reporting group title
    treatment
    Reporting group description
    		 Unblinded open label treatment
    Reporting group title
    Follow up
    Reporting group description
    		 Follow up

    Primary: Pain score at 24 months of treatment compared to baseline

    		 Close Top of page
    End point title
    		 Pain score at 24 months of treatment compared to baseline [1]
    End point description
    Pain scores at 24 months were compared to pain scores at baseline using the CPG questionniare
    End point type
    Primary
    End point timeframe
    24 months
    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: No further statistical analyses are available from the study team
    End point values
    		 treatment treatment
    Number of subjects analysed
    27
    13
    Units: Pain score out of 100
        median (full range (min-max))
    66.7 (30 to 93)
    13.33 (0 to 36.3)
    No statistical analyses for this end point

    Secondary: Pain score at month 30 compared to month 24

    		 Close Top of page
    End point title
    		 Pain score at month 30 compared to month 24
    End point description
    Pain scores at 30 months were compared to scores at 24 months (i.e. 6 months following end of treatment)
    End point type
    Secondary
    End point timeframe
    30 months
    End point values
    		 treatment Follow up
    Number of subjects analysed
    13
    13
    Units: pain score
        median (full range (min-max))
    13.33 (0 to 36.3)
    56.66 (6 to 80)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    until 28 days after last administration of study drug
    Adverse event reporting additional description
    patients issued with study diary to record adverse events. In addition patients were asked at each study visit to report any adverse events.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Decapeptyl® SR, 11.25 mg
    Reporting group description
    		 All study participants received the same dose for the same time period.

    Serious adverse events
    		 Decapeptyl® SR, 11.25 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 27 (22.22%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Head injury
    Additional description: accident - banged head. due to presence of intracranial shunt was admitted overnight for observation
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Ventriculo-peritoneal shunt
    Additional description: Patient experienced multiple SAEs due to inpatient hospitalisation to insert and revise placement of intracranial shunt. This was due to pre existing raised intracranial pressure.
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    4 / 27 (14.81%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Post procedural complication
    Additional description: Umbilical wound infection post surgery for placement of intracranial stent.
         subjects affected / exposed
    1 / 27 (3.70%)
         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
    		 Decapeptyl® SR, 11.25 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 27 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pyogenic granuloma
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Vascular disorders
    Hot flush
         subjects affected / exposed
    9 / 27 (33.33%)
         occurrences all number
    10
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    2
    Lethargy
         subjects affected / exposed
    4 / 27 (14.81%)
         occurrences all number
    5
    Pyrexia
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    general malaise
         subjects affected / exposed
    3 / 27 (11.11%)
         occurrences all number
    3
    swelling of hands
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    swelling of feet
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Immune system disorders
    hayfever
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    3
    Reproductive system and breast disorders
    vaginal bleeding
         subjects affected / exposed
    13 / 27 (48.15%)
         occurrences all number
    23
    Dyspareunia
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    2
    endometrioma
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Ovarian cyst
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    Pelvic pain
         subjects affected / exposed
    11 / 27 (40.74%)
         occurrences all number
    24
    Breast tenderness
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    Dysmenorrhoea
         subjects affected / exposed
    4 / 27 (14.81%)
         occurrences all number
    5
    Vaginal discharge
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    sore throat
         subjects affected / exposed
    3 / 27 (11.11%)
         occurrences all number
    3
    dry cough
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    sinus pain
         subjects affected / exposed
    5 / 27 (18.52%)
         occurrences all number
    7
    nose bleed
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    6
    Insomnia
         subjects affected / exposed
    6 / 27 (22.22%)
         occurrences all number
    8
    Mood swings
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Loss of libido
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    Depression
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    low mood
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    3
    Investigations
    bone density decreased
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    lumbar puncture
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    2
    intracranial pressure monitoring
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    blood pressure raised
         subjects affected / exposed
    4 / 27 (14.81%)
         occurrences all number
    4
    weight gain
         subjects affected / exposed
    3 / 27 (11.11%)
         occurrences all number
    3
    Injury, poisoning and procedural complications
    wrist sprain
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    14 / 27 (51.85%)
         occurrences all number
    35
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Migraine
         subjects affected / exposed
    3 / 27 (11.11%)
         occurrences all number
    5
    trapped nerve
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    faint
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    pins and needles
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Ear and labyrinth disorders
    ear ache
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    perforated ear drum
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Eye disorders
    dry eyes
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 27 (18.52%)
         occurrences all number
    5
    Nausea
         subjects affected / exposed
    4 / 27 (14.81%)
         occurrences all number
    4
    upset stomach
         subjects affected / exposed
    3 / 27 (11.11%)
         occurrences all number
    8
    benign gastric polyp
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    abdominal bloating
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    5
    Constipation
         subjects affected / exposed
    3 / 27 (11.11%)
         occurrences all number
    3
    heartburn
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    indigestion
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    food poisoning
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    upper abdominal pain
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    rectal bleeding
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    itchy skin
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    3
    Acne
         subjects affected / exposed
    4 / 27 (14.81%)
         occurrences all number
    9
    Night sweats
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    skin rash
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    Swelling face
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Renal and urinary disorders
    frequency of micturition
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    kidney pain
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    aching joints
         subjects affected / exposed
    7 / 27 (25.93%)
         occurrences all number
    8
    axilliary lump
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    back pain
         subjects affected / exposed
    5 / 27 (18.52%)
         occurrences all number
    9
    leg pain
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    leg cramps
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Osteoarthritis
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Infections and infestations
    common cold
         subjects affected / exposed
    9 / 27 (33.33%)
         occurrences all number
    19
    flu symptoms
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    3
    viral infection
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    2
    infection urinary tract
         subjects affected / exposed
    3 / 27 (11.11%)
         occurrences all number
    5
    Skin infection
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    gum abscess
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    chest infection
         subjects affected / exposed
    5 / 27 (18.52%)
         occurrences all number
    5
    wound infection
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    vaginal infection
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    oral thrush
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    thrush vaginal
         subjects affected / exposed
    3 / 27 (11.11%)
         occurrences all number
    3
    Ear infection
         subjects affected / exposed
    3 / 27 (11.11%)
         occurrences all number
    3
    Influenza
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    cold sores
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    2
    throat infection
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    2
    post operataive wound infection
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    tonsilitis
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    hook worm
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1

    More information

    		 Close Top of page

    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.
    The current study has several limitations . The study had a significant drop out rate. This was not unexpected over a study of such long duration and may be a reflection of the fluctuation in impact of CCPP seen in this young group of patients.
    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.

    European Medicines Agency © 1995-Fri May 09 19:51:29 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA