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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2014-005571-89
    Sponsor's Protocol Code Number:FM53
    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:2015-05-05
    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 number2014-005571-89
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, home use, cross-over clinical trial of topically-applied glyceryl trinitrate (GTN) for the treatment of Erectile Dysfunction
    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) when applied to the penis by male volunteers who normally are unable to obtain an erection
    A.3.2Name or abbreviated title of the trial where available
    Clinical trial of topical GTN for treatment of Erectile dysfunction
    A.4.1Sponsor's protocol code numberFM53
    A.5.4Other Identifiers
    Name:C14063Number:Richmond Pharmacology Ltd. Study Number
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRichmond Pharmacology Ltd.
    B.5.2Functional name of contact pointCEO
    B.5.3 Address:
    B.5.3.1Street AddressSt George’s University of London, Cranmer Terrace, Tooting
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSW17 0RE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02086645200
    B.5.5Fax number02086645201
    B.5.6E-mailj.taubel@richmondpharmacology.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% w/w Gel
    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 INNGlyceryl Trinitrate (GTN)
    D.3.9.1CAS number 55-63-0
    D.3.9.2Current sponsor codeMED2005
    D.3.9.3Other descriptive nameGlycerol Trinitrate
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    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
    This study investigates a drug intended for the treatment of male patients self-diagnosed with Erectile Dysfunction
    E.1.1.1Medical condition in easily understood language
    Inability to get and maintain an erection
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess how well a new medication known as MED2005 works (i.e.causes an erection) when applied to the penis of male volunteers self-diagnosed with Erectile Dysfunction (ED) using scores from a validated questionnaire known as IIEF (International Index for Erectile Function).
    E.2.2Secondary objectives of the trial
    To assess how well a new medication known as MED2005 works (i.e. causes an erection) when applied to the penis of male volunteers self-diagnosed with Erectile Dysfunction (ED) using scores from validated questionnaire known as SEP (Sexual Encounter Profile) and GAQ (Global Assessment Questionnaire), including subjective measures of the time of onset of action, time to peak effect and offset of action.
    To assess how safe and acceptable MED2005 is in ED sufferers and their partners including the subject’s preference.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subject is a male aged between 18 and 70 years of age inclusive, at screening.
    2.Confirmed self-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.The IIEF question 1-5 and 15 will be used to determine pre-screening eligibility for the subject online. A score of 25 or less will be acceptable for inclusion to the run-in-period.
    4.Subject answers “yes” to the question regarding the presence of residual erectile function 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?”
    5.Subject has been involved in a continuous heterosexual relationship for at least 6 months prior to screening.
    6.Documented written informed consent from both subject and his female partner.
    7.Subjects and their partners must agree to use one of the acceptable methods of contraception listed below:
    •Use acceptable methods of contraception if the male subject's female partner could become pregnant from the time of the first administration of treatment or study medication until 1 month following administration of the last treatment or dose of study medication. The acceptable methods of contraception are as follows:
    -Occlusive cap (diaphragm or cervical/vault caps).
    -Surgical sterilisation (vasectomy with documentation of azoospermia).
    -The female partner uses oral contraceptives (combination oestrogen/progesterone pills), injectable progesterone or subdermal implants.
    -The female partner uses medically prescribed topically-applied transdermal contraceptive patch.
    -The female partner has undergone documented tubal ligation (female sterilisation).
    -The female partner has undergone documented placement of an IUD or IUS.
    8.Subject and their female partner are capable of understanding and complying with the requirements of the protocol and must have signed the informed consent form prior to participation of any study-related procedures.
    E.4Principal exclusion criteria
    1.Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological, psychiatric, or other disease.
    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.
    3.Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or delegate at screening (subjects may be enrolled 7 days after completion of antibiotic therapy with a clinical cure; if a subject develops a urinary tract infection after screening, they may be continued in the study if they receive appropriate antibiotic therapy).
    4.Any presence of chronic indwelling urethral catheterization or penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.
    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 blood pressure.
    10.Subjects with nursing partners, known pregnant partners or wish to become pregnant during the course of the study.
    11.Confirmed positive results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates, tricyclic antidepressants and methadone) or from the alcohol breath test at screening and on admission (Day -1).
    12.Subject has recent (last 12 months) clinical evidence of alcoholism or drug abuse. Alcohol abuse is defined as regular weekly intake of more than 14 units if female and 21 units if male (using alcohol tracker http://www.nhs.uk/Tools/Pages/NHSAlcoholtracker.aspx); drug abuse is defined as compulsive, repetitive and/or chronic use of drugs or other substances with or without problems related to their use and/or where stopping or a reduction in dose will lead to withdrawal symptoms.
    13.Subject has a positive screen for hepatitis B consisting of Hepatitis B surface antigen (HBsAG), hepatitis C antibody, and human immunodeficiency virus (HIV).
    14.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.
    15.Subjects unwilling to cease use of vacuum devices, intracavernosal injecton, Viagra® or other therapy for ED with the exception of erection / tension rings for the entire course of the study.
    16.Unwillingness of the subject to agree to make four attempts at sexual intercourse on four separate days during each treatment period.
    17.Any history of unresponsiveness to Viagra® treatment due to lack of efficacy with sexual stimulation after multiple attempts of sexual intercourse, or significant side-effects excluding visual disturbances of Viagra®.
    18.Less than 4 attempts at sexual intercourse or high IIEF scores (>25) during the run-in-period (excluded prior to entry into period 1).
    19.Any known hypersensitivity to any component of the IMP.
    20.Subjects who are illiterate or are unable to understand the language in which the online questionnaires are available.
    21.Subject has received any investigational product during the 90 days prior to dosing for this study.
    22.Subject or their partner cannot communicate reliably with the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    The efficacy of MED2005 will be assessed using the experience of male volunteers and their female partners based on the validated questionnaires [International Index for Erectile Function (IIEF) questionnaire (male volunteers only), the
    Sexual Encounter Profile (SEP) questionnaire, Global Assessment Questionnaire (GAQ)], Onset/Offset of Action questions, and an overall volunteer preference question, by comparing the active drug to placebo arm within each subject.
    E.5.2Secondary end point(s)
    Safety analysis
    Safety will be evaluated using standard clinical laboratory safety tests (haematology, biochemistry, coagulation and urinalysis), vital signs (temperature, blood pressure [BP] and heart rate [HR]), physical examinations, 12 lead ECG,
    and AE monitoring before and after each treatment period.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.1.7.1Other trial design description
    home use
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 No
    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 years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 192
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state192
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 192
    F.4.2.2In the whole clinical trial 192
    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 as the study drug is in development.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-30
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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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