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    Summary
    EudraCT Number:2013-001650-94
    Sponsor's Protocol Code Number:191622-133
    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:2013-06-20
    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 number2013-001650-94
    A.3Full title of the trial
    An Exploratory Study of the Safety and Efficacy of BOTOX® for the Treatment of Premature Ejaculation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Exploratory Study of the Safety and Efficacy of BOTOX® for the Treatment of Premature
    Ejaculation
    A.4.1Sponsor's protocol code number191622-133
    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 SponsorAllergan 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 supportAllergan Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Limited
    B.5.2Functional name of contact pointAllergan Ltd. EU Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address1st Floor Marlow International, The Parkway
    B.5.3.2Town/ cityMarlow, Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4401628494444
    B.5.5Fax number+4401628494449
    B.5.6E-mailml-eu_reg_affairs@allergan.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 BOTOX®
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameBOTOX®
    D.3.2Product code 9060X
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBOTULINUM TOXIN TYPE A
    D.3.9.1CAS number 93384-43-1
    D.3.9.2Current sponsor codeAGN 191622
    D.3.9.4EV Substance CodeSUB13117MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Premature Ejaculation
    E.1.1.1Medical condition in easily understood language
    Premature Ejaculation
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10036596
    E.1.2Term Premature ejaculation
    E.1.2System Organ Class 10037175 - Psychiatric 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 explore the safety and efficacy profile of a range of doses of BOTOX for the treatment of premature ejaculation in male patients
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ∙ written informed consent has been obtained from both the patient and his female partner
    ∙ male aged 18 to 50 years
    ∙ in a stable monogamous sexual relationship with a female partner for at least 6 months (with the
    intention to continue with the same partner for the duration of the study)
    ∙ diagnosed with lifelong PE (defined as symptoms starting at the time the patient became sexually
    active)
    ∙ meets PE criteria (based on the 2008 International Society of Sexual Medicine [ISSM] definition)
    ∙ previously tried at least one form of therapy for PE (eg, behavioral therapy, topical therapy, or oral
    therapy) but patient remains dissatisfied
    ∙ mean screening intravaginal ejaculatory latency time (IELT) of ≤ 1 minute (calculated from the 4 most
    recent evaluable events recorded on the screening sexual event log [SEL])
    -None of the 4 most recent evaluable events can have an IELT measurement > 2 minutes.
    -It must not have taken longer than 28 days to obtain 4 evaluable events.
    -Evaluable event is defined as an ejaculation which was recorded in the SEL to have occurred
    prior to intended vaginal penetration or during vaginal penetration (see Section 6.3.4.1 for
    further details).
    ∙ patient and partner are willing and able to engage in vaginal intercourse at least 4 times per month for
    the duration of the study
    ∙ patient and partner agree not to change their usual sexual practices during the study (eg, amount of
    foreplay, use of lubrication, use of behavioral techniques, and/or type of contraception)
    ∙ patient and partner agree not to use condoms for the duration of the study (screening and
    posttreatment)
    E.4Principal exclusion criteria
    ∙ any medical or surgical condition that could be associated with secondary (acquired) PE or patient has
    PE which is situational or attributable to relationship issues
    ∙ a score of < 25 on the International Index of Erectile Function - Erectile Dysfunction (IIEF-ED)
    questionnaire at screening
    ∙ patient is unable or unwilling to discontinue (ie, washout) prohibited medications from at least 28 days
    prior to efficacy measurements, and throughout the duration of the study. Prohibited medications
    include:
    1) dapoxetine (Priligy™, Kutub™) or any other medications with selective serotonin reuptake
    inhibitor (SSRI) activity
    2) tramadol or any other medications with serotonin norepinephrine reuptake inhibitor (SNRI)
    activity or with opiate activity
    3) antidepressant, antipsychotic, antiepileptic, neuroleptic medications, or medications with
    psychoactive properties
    4) topical penile treatments (eg, anesthetics, herbal treatments) for PE or any other indication
    5) penile injections (eg, intracavernosal injections) for PE or any other indication
    6) phosphodiesterase type 5 (PDE-5) inhibitors, alprostadil, or any other treatments for erectile
    dysfunction (ED) or any other type of sexual dysfunction
    7) See Section 4.5.2 for a full list of prohibited medications requiring washout.
    ∙ patient has had prior genital, prostatic or lower urinary tract surgery (other than vasectomy or
    circumcision)
    ∙ clinically significant sexual dysfunction in the female partner that could interfere with study
    participation or impact the sexual relationship (eg, decreased libido, painful intercourse)
    ∙ the partner is known to be pregnant or there is an intention for the partner to become pregnant during
    the course of the study
    ∙ any uncontrolled systemic disease
    ∙ history of any neurologic condition that may affect sexual function or findings at study entry which
    may be consistent with a neurological condition that may affect sexual function
    ∙ medication in the last 6 months for depression, psychiatric disorders (including post traumatic stress
    syndrome), mood disorders, schizophrenia, alcohol abuse, substance abuse, or anxiety disorders
    ∙ patient has excessive alcohol usage in the opinion of the investigator
    ∙ botulinum toxin therapy of any serotype for any non-urological condition or usage (eg, cosmetic,
    chronic migraine) during the 12 weeks prior to screening, or planned usage during the course of this
    study
    E.5 End points
    E.5.1Primary end point(s)
    Intravaginal ejaculatory latency time (IELT) as measured by stopwatch and captured on the sexual intercourse diary (SID) and provides an objective assessment of the pharmacologic effects of study treatment on PE.
    E.5.1.1Timepoint(s) of evaluation of this end point
    IELT change, across all the evaluable ejaculatory attempts recorded in the SID, from baseline to the end of the 12 weeks follow up period
    E.5.2Secondary end point(s)
    Not Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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) 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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Dose escalation
    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 concerned4
    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 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
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years1
    E.8.9.1In the Member State concerned months10
    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 months10
    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: 60
    F.1.3Elderly (>=65 years) No
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 60
    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 care
    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 Decision2013-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-15
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