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    Summary
    EudraCT Number:2012-002047-26
    Sponsor's Protocol Code Number:FDC116115
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-01
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-002047-26
    A.3Full title of the trial
    FDC116115: A prospective study of sexual function in sexually active men treated for BPH
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of sexual function in sexually active men treated for BPH
    A.4.1Sponsor's protocol code numberFDC116115
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research & Development Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGlaxoSmithKline research & Development Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClincial Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressStockley Park West, 1-3 Ironbridge Road,
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 IBU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442089904466
    B.5.5Fax number442089904466
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    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 Duodart
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.1Product nameDuodart
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTAMSULOSIN HYDROCHLORIDE
    D.3.9.1CAS number 106463-17-6
    D.3.9.4EV Substance CodeSUB04673MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDUTASTERIDE
    D.3.9.1CAS number 164656-23-9
    D.3.9.3Other descriptive nameDUTASTERIDE
    D.3.9.4EV Substance CodeSUB06430MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    BPH (Benign prostatic hyperplasia
    E.1.1.1Medical condition in easily understood language
    Enlarged prostate
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10004446
    E.1.2Term Benign prostatic hyperplasia
    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 change in sexual function from baseline in sexually active men with at least moderate BPH (international prostate symptom score - IPSS = or > 12) who are treated with DUODART, compared to men treated with placebo at 1 year. Change in sexual function will be assessed by change in total score from the full men’s sexual health questionnaire (MSHQ) which has domains for erectile dysfunction, ejaculatory function and libido.
    E.2.2Secondary objectives of the trial
    Changes in sexual function from baseline using the full Men’s Sexual Health Questionnaire (MSHQ).
    Assess percentage of subjects reaching various thresholds of change in total MSHQ at 12 months.
    Changes in erectile dysfunction (ED), ejaculatory dysfunction (EjD), and libido domains (of the MSHQ).
    Assess changes in BPH symptoms, quality of life, perception of treatment benefit/satisfaction with treatment and relationship of these changes to sexual function.
    Assess changes in MSHQ in subpopulations of men with good BPH symptomatic response that is subjects with IPSS improvement of ≥2 and ≥3 points from baseline and, separately to assess changes in MSHQ scores at 12 months in subpopulations of men with ≥25% improvement from baseline.
    EXPLORATORY OBJECTIVE: assess the persistence of sexual adverse events by following up those men with sexual adverse events who withdraw from the study or men with sexual adverse events present at the last visit of the treatment phase.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males aged ≥50 years.
    2. Men must be sexually active.
    3. A confirmed clinical diagnosis of BPH.
    4. International Prostate Symptom Score (IPSS) > or = 12 at Visit 1 (screening), with bother score 4 or less (score from the IPSS Quality of Life question 8).
    5. Prostate volume ≥30 cc (by transrectal ultrasonography; TRUS). Measurement should be available by the baseline visit and should have been made /arranged at the screening visit or within the previous 6 months.
    6. Total serum prostate specific antigen (PSA) ≥1.5 ng/mL (but see exclusion criteria 1) at Visit 1 (screening).
    7. Willing and able to give signed written informed consent and comply with study procedures, including the ability to participate in the study for the full 1 year (or 18 months if necessary because of a persistent sexual AE).
    8. Fluent and literate in local language with the ability to read, comprehend and record information on the MSHQ, IPSS, PPSM, BPH Impact Index (BII) and C-SSRS questionnaires.
    9. Able to swallow and retain oral medication.
    10. Men with a female partner of childbearing potential must either agree to use effective contraception or have had a prior vasectomy. Contraception must be used from 2 weeks prior to administration of the first dose of study treatment until at least 5 half-lives for the drug (45 days) plus 3 months (i.e. a total of 4.5 months) to allow clearance of any altered sperm after the last dose of study treatment.
    French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
    Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product or other study treatment that may impact subject eligibility is provided in the SmPC for DUODART.
    E.4Principal exclusion criteria
    1. Total serum PSA >10.0 ng/mL at Visit 1 (screening).
    2. History or evidence of prostate cancer. Subjects with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study.
    3. Current or prior use (within the periods given) of the following prohibited medications
    i. Any prior use of a 5α-reductase inhibitor (finasteride or dutasteride),
    ii. Anti-cholinergics (e.g. oxybutynin, propantheline, tolerodine, solifenacin or darifenacin) within 1 month prior to visit 2 (baseline)
    iii. An alpha-adrenoreceptor blocker (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 1 month prior to visit 2 (baseline)
    iv. Use of any drugs with anti-androgenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents) within the 6 months prior to visit 1 (screening).
    v. Use of any drugs noted for propensity to cause gynaecomastia, or which could affect prostate volume, within 6 months prior to Visit 1 (screening).
    vi. Use of any investigational or marketed study drug within 30 days or 5 half-lives of the drug in question, (whichever is longer), preceding visit 2 (baseline).
    4. Current use (at the baseline visit or within the prior 1month) of: PDE-5 inhibitors, Anabolic steroids, Drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin.
    5. Use of phytotherapy for BPH within 2 weeks prior to Visit 1 (screening) and/or predicted to need phytotherapy during the study.
    6. History of a known (immediate or delayed) hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to the study medication or excipients that, in the opinion of the Investigator or GSK, contraindicate their participation.
    7. Previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive or minimally invasive procedures to treat BPH.
    8. History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to Visit 1 (screening). Catheterisation (<10F) is acceptable with no time restriction.
    9. Presence of structural abnormalities in the LUT or sexual organs (e.g. urethral stricture, Peyronie's Disease etc) that may cause LUT symptoms or sexual dysfunction.
    10. History of AUR.
    11. Post-void residual volume >100 mL (suprapubic ultrasound) at Visit 1 (screening) or a recorded PVR above this level on any previous examination. Measurement should be available by the baseline visit and should have been made /arranged at the screening visit or within the previous 6 months.
    12. Any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections).
    13. History of ‘first dose’ hypotensive episode on initiation of alpha-1-adrenoreceptor antagonist therapy.
    14. History of postural hypotension, dizziness, vertigo or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury.
    15. History of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy.
    16. Prior history of malignancies (other than basal cell carcinoma or squamous cell carcinoma of the skin) within the past 5 years. Subjects with an earlier history of malignancy who have had no evidence of disease for at least the past 5 years are eligible.
    17. History of hepatic impairment or abnormal liver function tests at Visit 1 (screening) (defined as ALT, AST or alkaline phosphatase >2 times the ULN, or total bilirubin >1.5 times the ULN (unless associated with predominantly indirect bilirubin elevation or Gilbert's syndrome).
    18. History of renal insufficiency, or serum creatinine >1.5 times the upper limit of normal at Visit 1 (screening).
    19. Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to the Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
    20. History or current evidence of drug or alcohol abuse within the previous 12 months.
    21. History or presence of any serious and/or unstable pre-existing psychiatric disorder or other conditions that in the opinion of the Investigator or GSK Medical Monitor, could interfere with subject’s safety, obtaining informed consent, compliance to the study procedures, or confound the results of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change in sexual function will be assessed by change in total score from the full men’s sexual health questionnaire (MSHQ) which has domains for erectile dysfunction, ejaculatory function and libido.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    E.5.2Secondary end point(s)
    Changes in sexual function from baseline using the full Men’s Sexual Health Questionnaire (MSHQ).
    Assess percentage of subjects reaching various thresholds of change in total MSHQ at 12 months.
    Changes in erectile dysfunction (ED), ejaculatory dysfunction (EjD), and libido domains (of the MSHQ).
    Assess changes in BPH symptoms, quality of life, perception of treatment benefit/satisfaction with treatment and relationship of these changes to sexual function.
    Assess changes in MSHQ in subpopulations of men with good BPH symptomatic response that is subjects with IPSS improvement of ≥2 and ≥3 points from baseline and, separately to assess changes in MSHQ scores at 12 months in subpopulations of men with ≥25% improvement from baseline.
    EXPLORATORY OBJECTIVE: assess the persistence of sexual adverse events by following up those men with sexual adverse events who withdraw from the study or men with sexual adverse events present at the last visit of the treatment phase.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    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 No
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    France
    Germany
    Greece
    Hungary
    Italy
    Netherlands
    Spain
    E.8.7Trial has a data monitoring committee No
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state85
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 414
    F.4.2.2In the whole clinical trial 476
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None. Please refer to section 5.6 of the protocol. The investigator is responsible for ensuring that consideration has been given to the poststudy care of the patient’s medical condition whether or not GSK is providing specific post study treatment.
    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 Decision2012-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-05
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