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    Summary
    EudraCT Number:2017-000960-14
    Sponsor's Protocol Code Number:FM57
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-01-07
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2017-000960-14
    A.3Full title of the trial
    A Phase III, dose ranging, multi-centre, randomised, double blind, placebo controlled, home use, parallel group clinical trial of topically-applied glyceryl trinitrate (GTN) for the treatment of erectile dysfunction (ED) with an open label extension.
    Multicentrické, randomizované, dvojitě zaslepené, placebem kontrolované klinické hodnocení fáze III s navazujícím otevřeným prodloužením, které v paralelních skupinách zjišťuje dávku doma užívaného, topicky aplikovaného glycerol-trinitrátu (GNT) určeného k léčbě erektilní dysfunkce (ED)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To see how the medication MED2005 works (i.e. causes an erection) compared to placebo when applied to the penis by male volunteers who normally are unable to obtain an erection
    A.4.1Sponsor's protocol code numberFM57
    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 SponsorFutura Medical Developments Ltd.
    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 supportFutura Medical Developments Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFutura Medical Developments Ltd.
    B.5.2Functional name of contact pointTim Holland
    B.5.3 Address:
    B.5.3.1Street AddressSurrey Technology Centre, 40 Occam Road
    B.5.3.2Town/ cityGuildford, Surrey
    B.5.3.3Post codeGU2 7YG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(0)1483 685670
    B.5.5Fax number+44(0)1483 685671
    B.5.6E-mailFM57@futuramedical.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 No
    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 nameGlyceryl Trinitrate (GTN) 0.2%, 0.4%& 0.6% w/w Gels
    D.3.2Product code MED2005
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNitroglycerin
    D.3.9.1CAS number 55-63-0
    D.3.9.3Other descriptive nameGLYCERYL TRINITRATE
    D.3.9.4EV Substance CodeSUB13997MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.2 to 0.6
    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 placeboGel
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Erectile dysfunction
    E.1.1.1Medical condition in easily understood language
    Inability to achieve or maintain erection sufficient for satisfactory sexual performance
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10061461
    E.1.2Term Erectile dysfunction
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10015116
    E.1.2Term Erectile disturbance
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025503
    E.1.2Term Male erectile disorder
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10052003
    E.1.2Term Erectile dysfunction NOS
    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 demonstrate the efficacy of MED2005 versus placebo in male subjects clinically diagnosed with ED using the EF domain of the IIEF, the Sexual Encounter Profile (SEP) Question 2 and the SEP Question 3. The primary objective will be addressed by estimating the following estimand: difference between treatment policies (each MED2005 dose versus placebo) in all subjects who met the study inclusion/exclusion criteria and who were randomised and attempted intercourse post-randomisation at least once, assessed via the change compared to baseline in EF [IIEF EF], the ability to achieve vaginal penetration [SEP Question 2] and the ability to have successful intercourse [SEP Question 3] over 12 weeks of treatment
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of MED2005 in male subjects using the Self Esteem And Relationship (SEAR) questionnaire for men and women, the Global Assessment Questionnaire (GAQ), the additional domains of the IIEF, the Patient Global Impression of Severity (PGI S), the Patient Global Impression of Change (PGI C) as well as subjective measures of the time of onset and duration of action (erection) and erection hardness and additional questions on usage and application of MED2005
    - To evaluate the long-term (up to 12 months) efficacy of MED2005
    - To evaluate the safety of MED2005 using AEs and standard physico-chemical assessments
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subject is a male aged between 18 and 70 years inclusive, at screening
    2.Confirmed clinical diagnosis of ED for more than 3 months according to the NIH Consensus Statement (‘the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance at least once’)
    3.Subject answers ‘yes’ to the question regarding the presence of residual EF over the past 3 months: ‘At home over the past 3 months, have you experienced at least some growth of your penis in response to: (1) mechanical stimulation by yourself or your partner, or (2) visual stimulation?’
    4.Subject has been involved in a continuous heterosexual relationship for at least 6 months prior to screening
    5.Documented written informed consent from both subject and his female partner
    6.If the male subject's female partner is of childbearing potential from the time of first sexual intercourse attempt during the screening period until the last administration of study treatment, then the couple must have been using a medically acceptable form of contraception for at least 3 months prior to entering the study, and agree to continue such use for at least 1 month after the last study drug administration
    Acceptable methods of contraception are listed below; it should be noted that condoms, femidoms, diaphragms, caps or hormone rings are not permitted as a form of contraception in this study:
    -Surgical sterilisation of the male partner (vasectomy with documentation of azoospermia if possible)
    -The female partner has undergone documented tubal ligation (female sterilisation)
    -The female partner uses combined hormone injectables
    -The female partner uses medically prescribed hormonal implants
    -The female partner has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS)
    -The female partner uses combined oral contraceptives
    -The female partner uses progesterone only contraceptives
    -The female partner uses combined hormonal patches.
    Other than for male/female sterilisation, if any of these above listed methods are being used then their effectiveness must be determined by the PI or their delegate, taking into consideration the compliance and tolerance of the female partner with this method of contraception.
    Subjects who are or wish to become pregnant will not be included in the study.
    7.Subject and his female partner are capable of understanding and complying with the requirements of the protocol and must have signed the ICF prior to participation in any study related procedures
    8.Low IIEF-EF scores (≤ 25) during the screening period
    To continue in the open-label extension phase of the study, subjects must meet the following inclusion criteria at the follow-up visit of the double-blind phase (Visit 6):
    1.Subject and his female partner complete the double-blind phase
    2.Subject and his female partner were compliant to study procedures during the double blind phase
    3.Documented written informed consent from both subject and his female partner
    4.If the male subject's female partner is of childbearing potential from the time of first sexual intercourse attempt during the screening period until the last administration of study treatment, then the couple must have been using a medically acceptable form of contraception for at least 3 months prior to entering the study, and agree to continue such use for at least 1 month after the last study drug administration
    Acceptable methods of contraception are listed below; it should be noted that condoms, femidoms, diaphragms, caps or hormone rings are not permitted as a form of contraception in this study:
    - Surgical sterilisation of the male partner (vasectomy with documentation of azoospermia if possible)
    - The female partner has undergone documented tubal ligation (female sterilisation)
    - The female partner uses combined hormone injectables
    - The female partner uses medically prescribed hormonal implants
    - The female partner has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS)
    - The female partner uses combined oral contraceptives
    - The female partner uses progesterone only contraceptives
    - The female partner uses combined hormonal patches
    Other than for male/female sterilisation, if any of these above listed methods are being used then their effectiveness must be determined by the PI or their delegate, taking into consideration the compliance and tolerance of the female partner with this method of contraception.
    E.4Principal exclusion criteria
    1.Any significant or serious cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease which, in the opinion of the PI, renders the subject unfit to take part in the study
    2.Subject has any history of an unstable medical or psychiatric condition or using any medication that, in the opinion of the PI, is likely to affect the subject’s ability to complete the study or precludes the subject’s participation in the study
    Certain concomitant medications; e.g. other vasodilators, calcium channel blockers, angiotensin converting enzyme (ACE) inhibitors, beta blockers, diuretics, anti hypertensives, tricyclic anti depressants and major tranquillisers, as well as the consumption of alcohol, may potentiate the BP lowering effects of MED2005; at PI's discretion
    3.Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or their delegate at screening or during the study
    4.Any presence of chronic indwelling urethral catheterisation or penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair EF
    5.Any history of operations for Peyronie’s disease
    6.Primary hypoactive sexual desire or any history of hypogonadism
    7.Any history of radical prostatectomy
    8.Any history of severe/uncontrolled diabetes
    9.Subjects taking two or more anti hypertensives for the treatment of BP
    10.Hypersensitivity to GTN or to any of the excipients, or idiosyncratic reactions to other organic nitrates
    11.Concomitant treatment with PDE 5 inhibitors
    12.Subjects taking Alpha blockers
    13.Subjects receiving testosterone pellets
    14.Any penile surgery except circumcision
    15.Any treatment with acetyl cysteine within 6 months
    16.Any treatment with dihydroergotamine within 6 months
    17.Postural hypotension, hypotension or uncorrected hypovolaemia
    18.Increased intracranial pressure (e.g. head trauma or cerebral haemorrhage) or inadequate cerebral circulation
    19.Any history of migraine or recurrent headache
    20.Aortic or mitral stenosis
    21.Hypertrophic obstructive cardiomyopathy
    22.Constrictive pericarditis or pericardial tamponade
    23.Closed-angle glaucoma
    24.Subjects with nursing partners, known pregnant partners or with partners who wish to become pregnant during the course of the study
    25.Confirmed positive results from urine drug screen or from the alcohol breath test at screening
    26.Subject has recent (last 12 months) clinical evidence of alcoholism or drug abuse.
    27.Subject has a positive screen for hepatitis B, consisting of HBsAG, hepatitis C antibody, and HIV
    28.Any clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission
    29.Subjects unwilling to cease use of vacuum devices, intracavernosal injections, PDE-5s or other therapy for ED for the entire course of the study
    30.Unwillingness of the subject or their partner to agree to make the required attempts at sexual intercourse during treatment period
    31.Any history of unresponsiveness to PDE 5 treatment or significant side effects, excluding visual disturbances, with PDE 5s
    32.Fewer than 4 attempts at sexual intercourse during the screening period
    33.Subjects or their partners who are illiterate or are unable to understand the language in which the questionnaires are available
    34.Subject has received any investigational product during the 90 days prior to dosing for this study
    35.Subject or his partner cannot communicate reliably with the PI
    36.Subjects with severe premature ejaculation (little or no control of ejaculation at the time of penetration)
    Exclusion criteria for open-label extension:
    1.Subsequent to recruitment into the double-blind phase of the study, the development of any significant or serious cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease
    2.Subject using any medication that, in the opinion of the PI, is likely to affect the subject’s ability to complete or participate in the open-label phase of the study.
    3.Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or their delegate at the start of the open-label extension phase
    4.Subsequent to recruitment into the double-blind phase of the study, the development of postural hypotension, hypotension or uncorrected hypovolaemia, increased intracranial pressure or inadequate cerebral circulation, any clinically significant vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at Visit 6 prior to recruitment to the open-label phase
    E.5 End points
    E.5.1Primary end point(s)
    1. The change from baseline of the average of the Week 4, Week 8 and Week 12 IIEF EF domain scores
    2. The change in percentage of sexual intercourse attempts in which subjects were able to insert their penis into their partner’s vagina (SEP Question 2) between baseline and the 12 week treatment period
    3. The change in percentage of sexual intercourse attempts in which subjects were able to maintain an erection of sufficient duration to have successful intercourse (SEP Question 3) between baseline and the 12 week treatment period

    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Week 4, Week 8 and Week 12
    2. Week 12
    3. Week 12
    E.5.2Secondary end point(s)
    - The SEAR questionnaire, completed by the male subjects and their female partners
    - Global assessment via completion of the GAQ, completed by the male subjects and their female partners
    - The additional domains of the IIEF questionnaire, completed by the male subjects
    - The other SEP questions (Questions 1, 4 and 5), completed by the male subjects
    - The SEP questions completed by the female partners
    - The PGI-S scale, completed by the male subjects
    - The PGI-C scale, completed by the male subjects
    - Time of onset and duration of action (erection) and erection hardness, completed by the male subjects and their female partners
    - Questions on the usage and application of the gels, completed by the male subjects
    E.5.2.1Timepoint(s) of evaluation of this end point
    As all secondary end points are associated with study questionnaires and scales, timepoints for evaluation of these end points will be visits when corresponding questionnaires and scales will be completed (please refer to Table 2 in section 8.1 of the Study Protocol).
    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 Yes
    E.6.10Pharmacogenetic No
    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) 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.8.2.4Number of treatment arms in the trial4
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Bulgaria
    Czech Republic
    Georgia
    Hungary
    Latvia
    Poland
    Russian Federation
    Slovakia
    Ukraine
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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 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.1.2.1Number of subjects for this age range: 850
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 178
    F.4.2.2In the whole clinical trial 1000
    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)
    Standard treatment and care according to local practice and guidelines will be provided to trial subjects after end of their participation in the trial.
    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 Decision2019-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-17
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