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    Summary
    EudraCT Number:2006-002922-51
    Sponsor's Protocol Code Number:H6D-MC-LVGH
    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:2006-09-14
    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 number2006-002922-51
    A.3Full title of the trial
    Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction
    and Sexual Quality of Life
    A.3.2Name or abbreviated title of the trial where available
    LVGH
    A.4.1Sponsor's protocol code numberH6D-MC-LVGH
    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 SponsorLilly ICOS LLC
    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
    D.2.1.1.2Name of the Marketing Authorisation holderLilly ICOS LLC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 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.3.9.3Other descriptive nameTADALAFIL
    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) Information not present in EudraCT
    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
    Erectile Dysfunction
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10061461
    E.1.2Term Erectile dysfunction
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the efficacy of tadalafil 5 mg compared with placebo, when taken orally once a day over 12 weeks, in improving erectile function in men with ED as measured by the Erectile Function Domain (Sum of Questions 1 through 5 and Question 15) of the International Index of Erectile Function (IIEF) and Sexual Encounter Profile (SEP) diary questions 2 and 3.
    • To evaluate the effect of tadalafil 5 mg compared with placebo, when taken once a day over 12 weeks in improving the sexual quality of life of the subject and partner as measured by the Sexual Quality of Life (QOL) domain of the Sexual Life Quality Questionnaire (SLQQ).

    E.2.2Secondary objectives of the trial
    Subject related objectives:
    •To evaluate the efficacy of tadalafil 5 mg once a day compared to placebo as measured by the Global Assessment Questionnaire.

    •To evaluate sexual satisfaction in men treated with tadalafil 5 mg once a day compared to placebo as measured IIEF Intercourse Satisfaction (IS) and Overall Satisfaction (OS) domains and SEP diary question 4 and 5 .
    •To evaluate treatment satisfaction of tadalafil 5 mg once a day compared to placebo as measured by the SLQQ treatment satisfaction domain.
    •To evaluate psychosocial outcomes of tadalafil 5 mg once a day compared to placebo.
    •To assess the safety of tadalafil 5 mg administered once a day compared to placebo in men with ED.

    Partner related objectives:
    •To evaluate the efficacy of tadalafil 5 mg once a day compared to placebo.
    •To evaluate sexual satisfaction in partners of men with ED treated with tadalafil 5 mg once a day compared to placebo.
    •To evaluate partner treatment satisfaction with tadalafil 5 mg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject Inclusion Criteria:
    [1] Are male and at least 18 years of age at Visit 1.
    [2] Are able to read, understand and provide signed informed consent.
    [3] Have a history of erectile dysfunction (ED: defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) of at least 3 months duration.
    [4] Anticipate having the same adult female sexual partner during the study who is willing to participate in recording responses to efficacy questionnaires, sexual quality of life questionnaires, and other instruments used in this study.
    [5] Agree to make at least four sexual intercourse attempts with the female sexual study partner during the 4-week run-in phase without medication.
    [6] Agree not to use any other ED treatment, including herbal therapy, during the 4-week run-in phase before being randomized to therapy for the double-blind treatment phase of the study, and for 96 hours after the final study visit.

    Partner Inclusion Criteria:
    [8] Are female and at least 18 years of age at Visit 1 and who will have the same male study subject as her sexual partner during the study.
    [9] Able to read, understand and provide signed informed consent.
    [10] Agree to make at least four sexual intercourse attempts with the male sexual study partner during the 4-week run-in phase without medication.
    [11] Adequate sexual function not consistent with sexual dysfunction as determined by a FSFI total score > 26.55
    [12] Motivated to support the male partner’s treatment for ED as demonstrated by a score of at least 2 on the following commitment items:
    •Item A; How important is sexual activity to you?
    •Item B; Overall, how important is it for you to maintain or improve sexual activity with your partner?
    [13] Willing to participate in recording responses to efficacy questionnaires, sexual quality of life questionnaires, and other instruments used in this study
    E.4Principal exclusion criteria
    Subjects will be excluded from the study if they meet any of the following criteria:
    [14] Previous or current treatment with tadalafil.
    [15] Present with ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated or inadequately treated endocrine disease (for example, hypopituitarism, hypogonadism, or uncorrected hypothyroidism,). The subject may be included if, in the opinion of the investigator, the ED persists after adequate treatment of the underlying endocrine disease.
    [16] Have a sexual partner that is not willing to complete the scales.
    [17] Have a history of radical prostatectomy, or other pelvic surgery with subsequent failure to achieve any erection.
    [18] Have a history of penile implant.
    [19] Have a clinically significant penile deformity in the opinion of the investigator.
    [20] Exhibit evidence of clinically significant renal insufficiency as determined by the investigator.
    [21] Exhibit evidence of clinically significant hepatobiliary disease as determined by the investigator.
    [22] Exhibit Hemoglobin A1c >13% at Visit 1.
    [23] Present with chronic stable angina treated with long-acting nitrates, or with chronic stable angina requiring short-acting nitrates in the last 90 days, or with angina occurring during sexual intercourse in the last 6 months.
    [24] Have met the criteria for unstable angina (Attachment LVGH.3) within 6 months before Visit 1, or have a history of myocardial infarction or coronary artery bypass graft surgery within 90 days before Visit 1, or percutaneous coronary intervention (for example, angioplasty or stent placement) within 90 days before Visit 1.
    [25] Have any supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate >100 bpm) at rest, or have any history of spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for ≥30 sec), or use an automatic internal cardioverter-defibrillator.
    [26] Have a history of sudden cardiac arrest.
    [27] Exhibit any evidence of congestive heart failure (NYHA Class 2 or above, Attachment LVGH.4) within 6 months before Visit 1.
    [28] Have had a new, significant cardiac conduction defect within 90 days before Visit 1.
    [29] Exhibit systolic blood pressure >170 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg at screening (if stress is suspected, retest under basal conditions), or have history of malignant hypertension.
    [30] Have a history of significant central nervous system injuries (including stroke or spinal cord injury) within the last 6 months.
    [31] Have a history of Human Immunodeficiency Virus (HIV) infection.
    [32] Have any condition that in the opinion of the investigator would interfere with the subject’s 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.
    [33] Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens [except finasteride taken as Propecia or Proscar, or Avodart (dutasteride)].
    [34] Have a history of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator.
    [35] Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    [36] Are employed by Lilly or ICOS (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    [37] Have previously completed or withdrawn from this study or any other study investigating tadalafil.
    [38] Have received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry.
    [39] Prior treatment with PDE5 inhibitors judged by the investigator to be ineffective.
    [40] History of loss of vision in one eye because of nonarteritic anterior
    ischemic optic neuropathy (NAION), regardless of whether this episode
    was in connection or not with previous PDE5 inhibitor exposure.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measures are:
    •The IIEF Erectile Function Domain defined as the sum of Questions 1, 2, 3, 4, 5 and Question 15 of the IIEF. The IIEF is a validated, multidimensional, self-administered questionnaire commonly employed to assess therapeutic efficacy of ED therapy.
    •The percentage of “yes” responses to Question 2 and 3 of the subject SEP diary. Question 2 asks if the subject was able to insert his penis into his partner’s vagina. Question 3 asks if the subject’s erection lasted long enough to have successful intercourse. The baseline and endpoint score for each SEP question 2 and 3 are the subject’s percentage of “yes” responses to those questions during the run-in period and postbaseline period, respectively.

    Sexual Quality of Life Measure:
    The SLQQ questionnaire is a validated, multidimensional instrument that consists of two domains; Sexual Quality of Life (QOL) [10 questions] and Treatment Satisfaction [6 questions]. The SLQQ-QOL domain compares the subject’s and his partner’s current sexual experience with their experience prior to the onset of the subject’s ED. (Woodward et al. 2002).
    The SLQQ-QOL domain will be the primary outcome measuring the change from baseline in improvement of the subjects’ and partners’ sexual quality of life. The SLQQ-QOL questions will be answered by the subject and partner at Visit 1, the end of the treatment free run-in phase (Visit 2), and Visit 4 or the final visit.
    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 No
    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 No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    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) 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 320
    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 Decision2006-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-01-03
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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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