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    The EU Clinical Trials Register currently displays   43866   clinical trials with a EudraCT protocol, of which   7287   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).

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    Summary
    EudraCT Number:2007-001159-20
    Sponsor's Protocol Code Number:STH14404
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-16
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2007-001159-20
    A.3Full title of the trial
    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
    A.3.2Name or abbreviated title of the trial where available
    HRT Add-back therapy in the management of CCPP using Decapeptyl
    A.4.1Sponsor's protocol code numberSTH14404
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSheffield Teaching Hospitals NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Decapeptyl SR 11.25mg
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIPTORELIN
    D.3.9.1CAS number 57773634
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11.25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic cyclical pelvic pain
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10064189
    E.1.2Term Chronic pelvic pain syndrome
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10014778
    E.1.2Term Endometriosis
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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
    E.2.2Secondary objectives of the trial
    In addition to the CPG Questionnaire assessment of pain and quality of life will be undertaken using the following questionnaires
    EHP-30
    R-WHG
    SF-12
    SF-MPG

    Safety Objectives
    As well as assessing the overall safety of the intervention the change in lumbar spine and hip Bone Marrow Density will be assessed using dual-energy X-ray absorptiometry (DEXA) scans

    Health Economics Objectives
    Assess the costs associated with treatment, and assess its outcomes in terms of quality adjusted life years.
    Assess the tentative incremental cost per quality adjusted life year for treatment by comparing cost and outcome on treatment to costs and outcomes in the year before treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •The patient must have given written (personally signed and dated) informed consent given before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of their normal medical care.
    •The patient must be aged between 18 and 45 years inclusive.
    •The patient must have a clinical diagnosis of Chronic Cyclical Pelvic Pain (CCPP) of at least 6 months duration (with or without evidence of endometriosis).
    •The patient must have had investigations for possible endometriosis within three years prior to the Screening visit.
    •The patient must have had a regular menstrual cycles (between 24 and 42 days) for the 3 months prior to screening.
    •Treatment with a LHRHa is indicated for the patient.
    •The patient must be able to understand, and willing to comply with the requirements of the protocol.
    E.4Principal exclusion criteria
    •The patient has been treated with any LHRHa within 6 months prior to screening.
    •The patient has been treated with Danazol, gestrinone or cyproterone acetate within the 6 months prior to screening or anticipated requirement during the study.
    •The patient has used cyclical progestogens or combined oral contraceptives within one full menstrual cycle (including a spontaneous bleed) prior to screening, or anticipated requirement for these treatments during the study period.
    •The patient is treated with any other medication for CCPP (other than analgesics) within three months prior to screening.
    •The patient has continuous or acyclic pelvic pain.
    •The patient has known metabolic bone disease.
    •The patient has an abnormal full blood count or liver or renal function at screening or within the 6 months prior to screening.
    •The patient has unexplained vaginal bleeding.
    •The patient has a bone mineral density age adjusted T-Score of -2 or below at the Screening visit.
    •The patient has any other medical condition or abnormality that in the opinion of the investigator would impact upon the safety or efficacy of the study treatment or any study assessments.
    •The patient is receiving concomitant treatment with coumarin or indanedione derivatives.
    •The patient has a known contraindication, allergy or hypersensitivity to any of the test compounds or materials (including both Decapeptyl SR and Livial).
    •The patient is pregnant or lactating. Female patients of child-bearing potential (i.e. who are not surgically sterile) must have a negative urine pregnancy test at the Baseline visit.
    •The patient is planning a pregnancy within 31 months of screening.
    •The patient is of child-bearing potential and is unwilling to use adequate barrier contraception for the duration of the study.
    •The patient has received any investigational drug therapy within 30 days prior to the study, or is scheduled to receive such a drug during the study period.
    •The patient has previously entered this study.
    E.5 End points
    E.5.1Primary end point(s)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-09
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    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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