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    Summary
    EudraCT Number:2004-002172-42
    Sponsor's Protocol Code Number:Bay 38-9456/11336
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-11-23
    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 ConcernedFinland - Fimea
    A.2EudraCT number2004-002172-42
    A.3Full title of the trial
    A randomized, double-blind, double-dummy, multi-center, parallel group study to compare the tolerability and efficacy of once daily vardenafil versus vardenafil PRN versus placebo in men immediately after nerve-sparing prostatectomy for improving erectile function.
    REINVENT (Recovery of Erections: INtervention with Vardenafil Early Nightly Therapy)
    A.3.2Name or abbreviated title of the trial where available
    REINVENT
    A.4.1Sponsor's protocol code numberBay 38-9456/11336
    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 SponsorBayer Oy
    B.1.3.4CountryFinland
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Levitra
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameLevitra
    D.3.2Product code Bay 38-9456
    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 INNvardenafil (as hydrochloride)
    D.3.9.1CAS number 224785-91-5
    D.3.9.2Current sponsor codeBay 38-9456 / SB-785528
    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) No
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.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 Information not present in EudraCT
    D.2.1.1.1Trade name Levitra
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameLevitra
    D.3.2Product code Bay 38-9456
    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 INNvardenafil (as hydrochloride)
    D.3.9.1CAS number 224785-91-5
    D.3.9.2Current sponsor codeBay 38-9456 / SB-785528
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.IMP: 3
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Levitra
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameLevitra
    D.3.2Product code Bay 38-9456
    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 INNvardenafil (as hydrochloride)
    D.3.9.1CAS number 224785-91-5
    D.3.9.2Current sponsor codeBay 38-9456 / SB-785528
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Erektiohäiriö
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10061461
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Tämän tutkimuksen tarkoitus on verrata kahden vardenafiilihoidon ja plasebon tehoa ja turvallisuutta erektiohäiriön hoidossa, kun hoito aloitetaan 14 päivän kuluessa molemminpuoleisen hermojasäästävän eturauhasenpoisto (BNSRRP) leikkauksen jälkeen. Tutkimuksessa selvitetään erityisesti parantaako iltaisin otettu vardenafiili merkittävästi erektiokykyä verrattuna plaseboon, ja parantaako myöskin tarvittaessa otettu vardenafiili erektiokykyä verrattuna plaseboon.
    E.2.2Secondary objectives of the trial
    Arvioidaan 9 kuukauden hoidon ja sitä seuraavan 2 kuukauden lääkkeettömän jakson jälkeen, onko aikaisin aloitettavalla iltaisin otettavalla tai tarvittaessa otettavalla vardenafiilihoidolla merkittävä vaikutus myöhemmin tarvittaessa otettavan vardenafiilin tehoon kun sitä verrataan plaseboon.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Seulontavaihe:
    18-64 vuootias mies.
    Suunnitteilla normaalin hoitokäytännön mukaisesti molemminpuoleinen hermojasäästävä eturauhasenpoisto leikkaus (BNSRRP).
    Leikkaus suunniteltu tehtäväksi noin kuukauden kuluessa seulontakäynnistä (Käynti 1).
    Ilmoittanut halukkuutensa jatkaa seksuaalista kanssakäymistä mahdollisimman pian leikkauksen jälkeen.
    Heteroseksuaalinen parisuhde.
    Ei leikkausta edeltävää erektiohäiriötä: kansainvälisen erektioluokituksen (IIEF) muuttujan (EF domain) pistemäärä yhtäsuuri tai suurempi kuin 26 seulontakäynnillä (Käynti 1) kun käytössä ei ole mitään lääkettä tai apuvälinettä erektiokyvyn parantamiseksi.
    Ei ole käyttänyt mitään erektiohäiriön hoitoon tarkoitettuja lääkkeitä tai apuvälineitä.
    Aiemmin otettu prostataspesifinen antigeeni (PSA) alle 10 ng/mL.
    Koepalasta tehty kasvainluokitus (Gleason Tumor Score) korkeintaan 7.
    Kasvain ei ole läpäissyt prostatakapselia: kliininen tilanne ennen leikkausta T1c - T2a/2b.
    Tutkittava on antanut kirjallisen suostumuksen tutkimukseen osallistumisesta.

    Randomisointivaihe:
    Eturauhasenpoisto leikkaus on tehty hermoja säästävästi ja tämä on dokumentoitu leikkauskertomuksessa.
    Leikkaus on tehty noin kuukauden kuluttua seulontakäynnin (Käynti 1) jälkeen.
    Kasvain ei ole läpäissyt eturauhaskapselia: leikkauksen yhteydessä otetussa näytteessä ei patologin lausunnon mukaan ole merkkejä kasvaimesta ympäröivässä kudoksessa (tilanne korkeintaan T2).
    E.4Principal exclusion criteria
    Seulontavaihe:
    A) Aiemmat tai samanaikaiset sairaudet:
    Mikä tahansa sairaus, psyykkinen häiriö tai päihteiden väärinkäyttö, joka tutkijan mielestä voi vaikeuttaa tutkittavan osallistumista tai estää osallistumisen.
    Peniksen anatominen epämuodostuma (esim. peniksen fibroosi tai Peyronie'n tauti), joka tutkijan mielestä voi merkittävästi haitata seksuaalista kanssakäymistä.
    Hallitseva sukupuolinen haluttomuus.
    Selkäydinvamma.
    Etenevä, perinnöllinen verkkokalvon sairaus kuten retinitis pigmentosa.
    Aiemmin todettu B- tai C-virushepatiitti (positiivinen HbsAg tai HCVAb).
    Vakava krooninen tai akuutti maksasairaus, mukaanlukien aiemmin todettu keskivaikea (Child-Pugh B) tai vaikea (Child-Pugh C) maksan toimintahäiriö.
    Merkittävä krooninen hematologinen sairaus joka voi johtaa priapismiin, kuten sirppisoluanemia, multippeli myeloma tai leukemia.
    Verenvuotohäiriö.
    Merkittävä aktiivinen maha- tai pohjukkaissuolihaava.
    Sydän- tai verenkiertosairaus, myös epästabiili angina pectoris, jolloin sukupuolista kanssakäymistä ei suositella.
    6 kuukauden sisällä sairastettu sydän- tai aivoinfarkti, tai vakava rytmihäiriö.
    Hoitamaton flimmeri/flutteri seulontavaiheessa (yli 100 impulssia/min).
    Levossa otettu matala verenpaine (systolinen paine alle 90 mmHg) tai korkea verenpaine (systolinen RR yli 170 mmHg tai diastolinen RR yli 110 mmHg).
    Oireellinen, asentoriippuvainen matala verenpaine 6 kuukauden sisällä ennen Käynti 1:stä.
    5 vuoden sisällä todettu syöpä (muu kuin eturauhassyöpä, ihon levyepiteeli- tai tyvisolusyöpä).
    Odotettavissa oleva elinaika alle 3 vuotta.
    Diagnosoitu, merkittävä, hoitamaton uniapnea tai yötyö (klo 23-07).
    Sokeritauti: tyyppi I, tyyppi II silloin kun on jo todettu liitännäissairauksia (esim. perifeerinen neuropatia, nefropatia, retinopatia).

    B) Muut samanaikaiset lääkkeet:
    Nitraatit ja typpioksidien luovuttajat.
    Suun kautta otettavat tai pistoksina annettavat androgeenit.
    Antiandrogeenit.
    Potentit sytokromi P-450 3A4 estäjät: HIV proteaasin estäjät ritonaviiri tai indaviiri, antimykootit itrakonatsoli ja ketokonatsoli (paikalliset lääkemuodot ovat sallittuja); tai erytromysiini.
    Tutkimuslääke (myös plasebo) 30 päivän sisällä ennen Käynti 1:stä.
    Mikä tahansa erektiohäiriön hoitoon tarkoitettu lääke tai apuvälinen tutkimusta ennen tai sen aikana.
    Alfasalpaajat.

    C) Poikkeavat laboratoriotulokset:
    Seerumin kokonaistestosterolipitoisuus yli 25% alle normaaliarvon alarajan (käytetään paikallisen laboratorion normaaliarvoja).
    Seerumin kreatiniin yli 3 mg/dL.
    ASAT ja/tai ALAT yli 3-kertaiset normaaliarvoon verrattuna.

    D) Muita poissulkukriteerejä:
    Tiedossa oleva yliherkkyys vardenafiilille, Bay 38-9456 (tunnetaan myös koodilla SB-782528) tai jollekin tutkimuslääkkeen apuaineelle.
    Lukutaidoton tai kykenemätön ymmärtämään kyselylomakkeen tai päiväkirjan kysymyksiä.

    Randomisaatiovaihe:
    Eturauhassyöpäkasvainta jäljellä tai säde- tai muu lisähoito tarpeen.
    Uusintaleikkaus tehty verenvuodon takia.
    Virtsakatetri tarpeen yli 3 viikkoa leikkauksen jälkeen.
    E.5 End points
    E.5.1Primary end point(s)
    Tässä tutkimuksessa tehon mittaamiseen käytettävät päämuuttujat ovat:
    Niiden tutkittavien osuus, joiden pistemäärä on yli 22 (käytettäessä IIEF domain score, kysymykset 1-5 ja 15 yhteenlaskettuina) kun 9 kuukauden hoitojakso ja sitä seuraava 1-2 kuukauden lääkkeetön vaihe on ohi. Pisteet lasketaan lääkkeettömän jakson viimeisellä käynnillä, jolloin saadaan tulokset myös tutkimuksen mahdollisesti keskeyttäville.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    9 months double-blind, 2 months single-blind placebo, 2 months open label PRN active
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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) 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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 528
    F.4.2.2In the whole clinical trial 828
    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 Decision2005-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-02-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-09-26
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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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