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    Summary
    EudraCT Number:2010-020220-22
    Sponsor's Protocol Code Number:H6D-MC-LVIR
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-23
    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 ConcernedAustria - BASG
    A.2EudraCT number2010-020220-22
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effect of Tadalafil Once Daily for 8 Weeks on Prostatic Blood Flow and Perfusion Parameters in Men with Signs and Symptoms of Benign Prostatic Hyperplasia
    A.3.2Name or abbreviated title of the trial where available
    LVIR
    A.4.1Sponsor's protocol code numberH6D-MC-LVIR
    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 SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    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 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 CIALIS 5 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly and Nederlend B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTadalafil
    D.3.2Product code LY450190
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNTADALAFIL
    D.3.9.1CAS number 171596-29-5
    D.3.9.2Current sponsor codeLY450190
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 placeboFilm-coated tablet
    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
    Benign Prostatic Hyperplasia (BPH)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10004446
    E.1.2Term Benign prostatic hyperplasia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of Study LVIR is to evaluate the effect of tadalafil 5 mg once daily for 8 weeks compared with placebo on improving prostatic blood perfusion in men with signs and symptoms of BPH, also referred to as BPH-LUTS (lower urinary tract symptoms), as measured by arterial resistive index (RI) in the prostate transition zone.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are as follows:
    •To evaluate the effect of tadalafil 5 mg once daily for 8 weeks versus placebo on other regional blood flow and perfusion parameters in the prostate as measured by: Color Doppler ultrasound pixel intensity (color pixel intensity, CPI) in the prostate transition zone and arterial RI and CPI in prostate peripheral zone
    • To evaluate the effect of tadalafil 5 mg once daily for 8 weeks versus placebo on blood flow and perfusion parameters in the bladder neck as measured by arterial RI and CPI
    • To evaluate the effect of tadalafil 5 mg once daily for 4 weeks versus placebo on all of the above blood flow and perfusion parameters in the prostate and bladder neck
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects are eligible to be included in the study only if they meet all of the following criteria:
    [1] Present with benign prostatic hyperplasia (BPH; also referred to as BPH-LUTS [lower urinary tract symptoms]) based on the disease diagnostic criteria at screening.
    [2] Are men 45 years of age or older at screening.
    [3] Provide signed informed consent at screening.
    [4] Agree not to use any other approved or experimental pharmacologic BPH, overactive bladder (OAB), or erectile dysfunction (ED) treatments, including alpha blockers, 5-alpha reductase inhibitors (5-ARIs), antimuscarinics, phosphodiesterase type 5 (PDE5) inhibitors, or herbal preparations at any time during the study.
    [5] Have not taken the following treatments within the indicated duration:
    • Finasteride therapy for at least 3 months prior to the TRUS assessment period.
    • Dutasteride therapy for at least 6 months prior to the TRUS assessment period.
    • All other BPH therapy (including herbal preparations and vitamin preparations containing saw palmetto) for at least 4 weeks prior to the TRUS assessment period.
    • Overactive bladder therapy for at least 4 weeks prior to the TRUS assessment period.
    • ED therapy for at least 4 weeks prior to the TRUS assessment period.
    • Any other experimental or off-label BPH therapy, such as injectable therapies with a protracted effect, for at least 6 months prior to the TRUS assessment period.
    [6] Have LUTS with a total IPSS ≥13 under 1 of the following conditions:
    • At screening if the subject does not require wash-out of therapy for BPH-LUTS.
    • At the start of the TRUS assessment period if the subject requires wash-out (4 weeks) of BPH-LUTS therapy.
    [7] Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of ≥4 to ≤15 mL/second (from a prevoid total bladder volume [assessed by ultrasound] of ≥150 to ≤550 mL and a minimum voided volume of 125 mL) under 1 of the following conditions:
    • At screening if the subject does not require wash-out of therapy for BPH-LUTS.
    • At the start of the TRUS assessment period if the subject requires wash-out (4 weeks) of BPH-LUTS therapy.
    E.4Principal exclusion criteria
    [8] Prostate specific antigen (PSA) >10.0 ng/mL at screening
    [9] PSA ≥4.0 to ≤10.0 ng/mL at screening if prostate malignancy has not been ruled out to the satisfaction of a urologist
    [10] Bladder postvoid residual volume ≥ 300 mL by ultrasound determination at screening
    [11] History of any of the following pelvic conditions:
    • Pelvic surgery or any other pelvic procedure
    • Pelvic radiotherapy
    • Any pelvic surgical procedure of the urinary tract
    • Lower urinary tract malignancy or trauma
    [12] Lower urinary tract instrumentation within 30 days of screening
    [13] History of urinary retention or lower urinary tract stones within 6 months of screening
    [14] History of urethral obstruction due to stricture, valves, sclerosis, or tumor
    [15] Clinical evidence or medical history of any of the following bladder conditions:
    • Mullerian duct cysts
    • Atonic, decompensated or hypocontractile bladder
    • Detrusor-sphincter dyssynergia
    • Intravesical obstruction
    • Interstitial cystitis
    [16] Clinical evidence of any of the following urinary tract conditions at screening:
    • Urinary tract infection
    • Urinary tract inflammation
    • Current antibiotic therapy for urinary tract infection
    • Clinically significant microscopic hematuria
    [17] Clinical evidence of prostate cancer
    [18] History of prostate saturation biopsy
    [19] Any condition which may preclude or negatively influence tolerance to TRUS
    [20] Clinical evidence on TRUS of any of the following prostate conditions at the start of the TRUS assessment period or other findings related to prostate anatomy on screening TRUS that may interfere with measurement of ultrasound blood flow parameters
    • Prominent median or midline lobe
    • Multiple prostatic cystic changes or multiple calcifications
    • Scarring from previous prostate biopsies
    [21] Current neurologic disease or condition associated with neurogenic bladder
    [22] History of significant renal insufficiency
    [23] Clinical evidence of severe hepatic impairment at screening
    [24] History of any of the following cardiac conditions:
    • Angina requiring treatment with long-acting nitrates
    • Angina requiring treatment with short-acting nitrates within 90 days of screening
    • Unstable angina within 90 days of screening
    • Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention
    [25] History of any of the following coronary conditions within 90 days of screening:
    • Myocardial infarction
    • Coronary artery bypass graft surgery
    • Percutaneous coronary intervention
    [26] Any evidence of moderate to severe cardiac disease within 6 months of screening
    [27] Systolic blood pressure >160 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg at screening (if stress is suspected, retest under basal conditions) or malignant hypertension
    [28] Scheduled or planned surgery during the course of the study
    [29] History of drug, alcohol, or substance abuse within 6 months of screening
    [30] Any condition that would interfere with subject ability to provide informed consent or comply with study instructions, would place subject at increased risk, or might confound the interpretation of the study results
    [31] Current treatment with nitrates (as outlined in Exclusion Criterion 24), androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone agonists/antagonists, anabolic steroids, or non-prescription products containing estrogenic or androgenic supplements
    [32] Current systemic treatment with any of the following:
    • Potent cytochrome P450 3A4 inhibitors
    • CYP3A4 inducer rifampicin
    [33] Previously received pharmacological treatment for BPH-LUTS (alpha-blockers or 5-alpha reductase inhibitors) and failed to have a clinical response
    [34] Glycosylated hemoglobin (HbA1c) >9% at Visit 1.
    [35] Have a body mass index ≥ 35 kg/m2 at Visit 1
    [36] Invalid or unevaluable results from both the original and repeat baseline TRUS
    [37] Known or suspected hypersensitivity to tadalafil or any study drug components
    [38] Previously completed or withdrawn from this study or any other study investigating tadalafil
    [39] Are investigator site personnel directly affiliated with this study and/or their immediate families
    [40] Are Lilly employees
    [41] Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
    [42] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
    [43] History of loss of vision in 1 eye because of nonarteritic anterior ischemic optic neuropathy
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint, and basis for comparison between treatment groups, will be the change from baseline in prostatic transitional zone resistive index (RI) from baseline to Week 8.
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Mechanism of action
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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 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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 106
    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)
    Expected normal 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 Decision2011-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-23
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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