Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42882   clinical trials with a EudraCT protocol, of which   7063   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-002161-56
    Sponsor's Protocol Code Number:NeM-CSM-FT-01
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-08-23
    Trial 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-002161-56
    A.3Full title of the trial
    Towards the understanding of neuronal mechanisms of compulsive sexual behaviors - pharmacotherapy
    Badania neuronalnych mechanizmów kompulsywnych zachowań seksualnych - farmakoterapia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Towards the understanding of neuronal mechanisms of compulsive sexual behaviors - pharmacotherapy
    Badania neuronalnych mechanizmów kompulsywnych zachowań seksualnych - farmakoterapia
    A.3.2Name or abbreviated title of the trial where available
    NeM-CSM-FT
    NeM-CSM-FT
    A.4.1Sponsor's protocol code numberNeM-CSM-FT-01
    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 SponsorMateusz Gola
    B.1.3.4CountryPoland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMateusz Gola
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentrum Terapii Lew-Starowicz
    B.5.2Functional name of contact pointSite Registration
    B.5.3 Address:
    B.5.3.1Street AddressNowogrodzka 62c/42
    B.5.3.2Town/ cityWarszawa
    B.5.3.3Post code02-002
    B.5.3.4CountryPoland
    B.5.6E-mailcentrum@lew-starowicz.pl
    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 Parogen
    D.2.1.1.2Name of the Marketing Authorisation holderGenerics [UK] Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.IMP: 2
    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 Naltrexone Hydrochloride Accord
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameNatrexone Hydrochloride Accord
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboCapsule, hard
    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
    compulsive sexual behavior (hypersexual disorder)
    kompulsywne zachowania seksualne (zaburzenie hiperseksualne)
    E.1.1.1Medical condition in easily understood language
    compulsive sexual behavior (sex addiction)
    kompulsywne zachowania seksualne (uzależnienie od seksu)
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To check if medication applied in accordance with current knowledge on the neuronal mechanisms of compulsive sexual behavior leads to a significant reduction of symptoms of this disorder
    sprawdzenie, czy odpowiednio dobrane w oparciu o wiedzę na temat mechanizmów neuronalnych kompulsywnych zachowań seksualnych leczenie farmakologiczne prowadzi do istotnej redukcji objawów tych zaburzeń
    E.2.2Secondary objectives of the trial
    Evaluation of the influence of the medication on particular aspects related to compulsive sexual behavior (e.g. behavioral control, impulsivity, frequency of compulsive sexual behavior, mood regulation, brain response to erotic cues)
    ocena wpływu zastosowanego leczenia na poszczególne aspekty związane z kompulsywnymi zachowaniami seksualnymi (m.in. kontrola zachowania, impulsywność, częstość kompulsywnych zachowań seksualnych, regulacja nastroju, reakcja mózgu na sygnały erotyczne)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Heterosexual male ≥ 18 years old
    2. Signed informed consent
    3. Perceived loss of control over one’s sexual behavior (pornography use, masturbation, partnered sexual activity, use of commercial sexual services) causing
    4. Help/treatment seeking (psychological/psychiatric/sexological/self-help groups/spiritual counseling)
    5. Meeting criteria of Hypersexual Disorder by Kafka (2010) – at least 4 out of 5 (A1-A5):
    A1. Time consumed by sexual fantasies, urges or behaviors repetitively interferes with other important (non-sexual) goals, activities and obligations.
    A2. Repetitively engaging in sexual fantasies, urges or behaviors in response to dysphoric mood states (e.g., anxiety, depression, boredom, irritability).
    A3. Repetitively engaging in sexual fantasies, urges or behaviors in response to stressful life events.
    A4. Repetitive but unsuccessful efforts to control or significantly reduce these sexual fantasies, urges or behaviors.
    A5. Repetitively engaging in sexual behaviors while disregarding the risk for physical or emotional harm to self or others.
    with
    B. Significant personal distress or impairment in social, occupational or other important areas of functioning associated with the frequency and intensity of these sexual fantasies, urges or behaviors
    C. These sexual fantasies, urges or behaviors are not due to the direct physiological effect of an exogenous substance (e.g., a drug of abuse or a medication)
    1. Płeć męska i wiek ≥ 18 lat.
    2. Podpisany formularz świadomej zgody na udział w badaniu
    3. Subiektywne poczucie utraty kontroli nad własnymi zachowaniami seksualnymi (oglądaniem pornografii, masturbacją, podejmowaniem kontaktów seksualnych, korzystaniem z płatnych usług seksualnych)
    4. Poszukiwanie pomocy/terapii z tego powodu (psychologicznej/psychiatrycznej/seksuologicznej/grup samopomocy/poradnictwa duchowego)
    5. Spełnienie kryteriów rozpoznania Zaburzenia Hiperseksualnego (Kafka, 2010):
    Min. 4 z 5 (A1-A5):
    A1. Poświęcanie dużej ilości czasu na fantazje lub zachowania seksualne, notorycznie zaniedbując inne ważne (nie związane z seksem) cele, aktywności i zobowiązania.
    A2. Powtarzające się zaangażowanie w zachowania i zachowania lub fantazje seksualne w odpowiedzi na dysforyczne stany emocjonalne (lęk, przygnębienie, znudzenie, poirytowanie).
    A3. Powtarzające się zaangażowanie w zachowania i zachowania lub fantazje seksualne w odpowiedzi na stresujące wydarzenia życiowe.
    A4. Powtarzające się, ale nieskuteczne próby kontroli lub znacznej redukcji zachowań lub fantazji seksualnych.
    A5. Powtarzające się zaangażowanie w zachowania seksualne, przy bagatelizowaniu ryzyka doznania lub zadania innym krzywdy fizycznej albo emocjonalnej.
    Oraz
    B. W związku z częstotliwością lub intensywnością zachowań i fantazji seksualnych, u pacjenta widoczny jest wysoki poziom stresu, dysfunkcji społecznych, zawodowych lub dysfunkcji obejmujących innych ważny obszar życia.
    C. Zachowania i fantazje seksualne nie są bezpośrednim efektem fizjologicznym stosowania substancji zewnętrznych (np. narkotyków lub leków).
    E.4Principal exclusion criteria
    1. Concomittant mania, bipolar disorder, psychotic disorders, obsessive-compulsive disorder or cognitive impairment according to ICD-10 diagnostic criteria
    2. Current use of any antidepressant, anxiolytic, antipsychotic or mood stabilizing medication
    3. Current psychotherapy
    4. History of any neurological disease
    5. Substance abuse or pathological gambling
    6. Medical contraindications for the use of paroxetine or naltrexone hydrochloride (according to medicinal product characteristics)
    and (because of planned fMRI examination):
    7. Implanted metal, electric or electronic devices (heart pacemaker, insulin pump, metal clips etc.)
    8. Claustrophobia
    9. Tattoos covering face area
    1. Współwystępowanie manii, zaburzenia afektywnego dwubiegunowego, zaburzeń psychotycznych, obsesyjno-kompulsyjnych lub upośledzenie funkcji poznawczych (otępienie, upośledzenie umysłowe) zgodnie z kryteriami ICD-10
    2. Aktualne stosowanie leków przeciwdepresyjnych, przeciwlękowych, przeciwpsychotycznych lub stabilizujących nastrój
    3. Aktualne korzystanie z psychoterapii
    4. Zaburzenia neurologiczne w wywiadzie
    5. Uzależnienie od substancji psychoaktywnych lub nałogowy hazard
    6. Przeciwwskazania medyczne do zastosowania paroksetyny lub chlorowodorku naltreksonu (zgodnie z Charakterystyką Produktu Leczniczego)
    Oraz (ze względu na planowane badanie w rezonansie magnetycznym:
    7. Obecność w ciele metalowych przedmiotów lub urządzeń elektrycznych (rozrusznik serca, pompa insulinowa, metalowe klipsy, itp.)
    8. Klaustrofobia
    9. Rozległe tatuaże w okolicach twarzy
    E.5 End points
    E.5.1Primary end point(s)
    Scores (change) in questionnaires: Sex Addiction Screening Test (SAST), Sexual Arousability Inventory (SAI), Multidimensional Sexuality Questionnaire (MSQ), Impulsivity Questionnaire (IVE)
    Wyniki punktowe (zmiana) uzyskiwane w kwestionariuszach Sex Addiction Screening Test (SAST), Sexual Arousability Inventory (SAI), Multidimensional Sexuality Questionnaire (MSQ), i Kwestionariusz impulsywności (IVE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, after 8 and 20 weeks of treatment, 20 weeks after completion of the medication
    Początek badania, po 8 i 20 tygodniach leczenia, następnie po 20 tygodniach od przerwania leczenia
    E.5.2Secondary end point(s)
    Changes within amygdala and ventral striatum activity in response to visual stimulation using standardized visual sexual cues
    zmiany aktywności w obrębie ciał migdałowatych i brzusznego prążkowia w odpowiedzi na stymulację wizualną za pomocą wystandaryzowanych wzrokowych bodźców seksualnych
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, after 20 weeks of medication, 20 weeks after completion of the medication
    Początek badania, po 20 tygodniach leczenia, następnie po 20 tygodniach od przerwania leczenia
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 trial3
    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 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
    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 months6
    E.8.9.1In the Member State concerned 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: 75
    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 state75
    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
    Brak
    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 Decision2017-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-18
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA