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    Summary
    EudraCT Number:2021-004254-37
    Sponsor's Protocol Code Number:000400
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-13
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-004254-37
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of FE 999049 for treatment of men with idiopathic infertility
    Sperimentazione randomizzata, in doppio cieco, controllata con placebo per valutare l’efficacia e la sicurezza di FE 999049 per il trattamento di uomini con infertilità idiopatica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to compare efficacy and safety of follitropin delta versus placebo (inactive treatment) in the treatment of men with idiopathic infertility (unexplained reduction of semen quality).
    Sperimentazione per confrontare l’efficacia e la sicurezza della follitropina delta rispetto al placebo (trattamento inattivo) nel trattamento di uomini con infertilità idiopatica (riduzione inspiegata della qualità del liquido seminale)
    A.3.2Name or abbreviated title of the trial where available
    ADAM
    ADAM
    A.4.1Sponsor's protocol code number000400
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1268-6968
    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 SponsorFerring Pharmaceutical A/S
    B.1.3.4CountryDenmark
    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 supportFerring Pharmaceuticals A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFerring Pharmaceuticals A/S
    B.5.2Functional name of contact pointGlobal Clinical Development
    B.5.3 Address:
    B.5.3.1Street AddressKay Fiskers Plads 11
    B.5.3.2Town/ cityCopenhagen S
    B.5.3.3Post code2300
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4588338834
    B.5.6E-mailDK0-Disclosure@ferring.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 REKOVELLE
    D.2.1.1.2Name of the Marketing Authorisation holderFerring Pharmaceuticals A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameREKOVELLE
    D.3.2Product code [REKOVELLE]
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFOLLITROPINA DELTA
    D.3.9.1CAS number 146479-72-3
    D.3.9.2Current sponsor codeFE 999049
    D.3.9.3Other descriptive nameRecombinant human follicle-stimulating hormone
    D.3.9.4EV Substance CodeSUB178607
    D.3.10 Strength
    D.3.10.1Concentration unit µg/l microgram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number33300
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 Yes
    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 placeboSolution for injection in pre-filled pen
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic male infertility (including oligoasthenozoospermia)
    Infertilità idiopatica maschile (inclusa la oligoastenozoospermia)
    E.1.1.1Medical condition in easily understood language
    Unexplained reduction of semen quality in men
    Riduzione inspiegata della qualità dello sperma nell' uomo
    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 10021929
    E.1.2Term Infertility male
    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 investigate the effect of FE 999049 treatment of men with idiopathic infertility on the chance of spontaneous pregnancy in their female partners
    Studiare l’effetto del trattamento con FE 999049 sugli uomini con infertilità idiopatica rispetto alla possibilità di gravidanza spontanea nelle loro partner
    E.2.2Secondary objectives of the trial
    - To investigate the effect of FE 999049 on semen parameters and endocrine profiles in men with idiopathic infertility
    - To evaluate the safety and immunogenicity of FE 999049 in men with idiopathic infertility
    - Studiare l’effetto di FE 999049 sui parametri spermatici e sui profili endocrini in uomini con infertilità idiopatica
    - Valutare la sicurezza e l’immunogenicità di FE 999049 in uomini con infertilità idiopatica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • History of infertility for 12-60 months with current partner at randomisation.
    • Men between the ages of 18 and 50 years.
    • Total sperm count 5-39 million at screening; confirmed by two consecutive samples taken =2 weeks apart before randomisation.
    • Total motile sperm count of 5-16 million at screening; confirmed by two consecutive samples taken =2 weeks apart before randomisation.
    • Semen volume =1.4 mL at screening; confirmed by two consecutive samples taken =2 weeks apart before randomisation.
    • Serum follicle-stimulating hormone (FSH) levels of 1.5-8.0 IU/L (measured at central laboratory) at screening.
    • Serum luteinising hormone (LH) levels of 1.2-7.5 IU/L (measured at central laboratory) at screening.
    • Serum total testosterone levels of =300 ng/dL (equals =10.4 nmol/L; measured at central laboratory) at screening.
    • Agree to have regular intercourse with current female partner with the intent of spontaneous conception within 9 months from randomisation.
    • Agree to provide information on female partner's positive urine pregnancy test(s) and documentation of ultrasound(s), delivery, and neonatal/infant health.
    • Current partner fulfilling the criteria below:
    a) Pre-menopausal woman between the ages of 18 and 35 years.
    b) Regular menstrual cycles of 21-35 days.
    c) No history or current condition of pelvic inflammatory disease, endometriosis stage II-IV by definite or empirical diagnosis, or tubal ligation.
    - Agree not to obtain infertility treatment outside of this trial for 9 months from randomisation of male subject.
    - Anamnesi alla randomizzazione di infertilità da 12-60 mesi con la partner attuale.
    - Uomini di età compresa tra i 18 e i 50 anni.
    - Conta spermatica totale di 5-39 milioni allo screening; confermata da due campioni consecutivi raccolti a una distanza =2 settimane prima della randomizzazione.
    - Conta degli spermatozoi mobili totali pari a 5-16 milioni allo screening; confermata da due campioni consecutivi prelevati a una distanza =2 settimane prima della randomizzazione.
    - Volume del liquido seminale =1,4 ml allo screening; confermato da due campioni consecutivi prelevati a una distanza =2 settimane prima della randomizzazione.
    - Livelli sierici di ormone follicolo-stimolante (FSH) pari a 1,5-8,0 UI/l (misurati presso il laboratorio centrale) allo screening.
    - Livelli sierici di ormone luteinizzante (LH) pari a 1,2-7,5 UI/l (misurati presso il laboratorio centrale) allo screening.
    - Livelli sierici totali di testosterone =300 ng/dl (pari a =10,4 nmol/l; misurati presso il laboratorio centrale) allo screening.
    - Acconsentire ad avere rapporti sessuali regolari con la partner attuale con l’intento di concepire spontaneamente entro 9 mesi dalla randomizzazione.
    - Acconsentire a fornire informazioni sui test di gravidanza sulle urine positivi della partner e sulla documentazione relativa a ecografie, parto e salute neonatale/infantile.
    - La partner corrente deve soddisfare tutti i criteri indicati di seguito:
    a) Essere una donna in pre-menopausa di età compresa tra i 18 e i 35 anni (entrambi inclusi)
    b) Avere cicli mestruali regolari di 21-35 giorni.
    c) Non avere anamnesi o condizione attuale di malattia infiammatoria pelvica, endometriosi di stadio II-IV sulla base di una diagnosi definitiva o empirica oppure legatura delle tube.
    d) Acconsentire a non ottenere un trattamento per l’infertilità al di fuori di questa sperimentazione per 9 mesi dalla randomizzazione del soggetto di sesso maschile
    E.4Principal exclusion criteria
    • Previous FSH treatment not leading to conception.
    • Past or current use of finasteride within 3 months prior to screening.
    • Any history of anatomical disorder of the pituitary gland or testes.
    • Any structural abnormalities of the vas deferens (unilateral or bilateral) at screening.
    • Any known, clinically significant, systemic disease in addition to the trial indication that might negatively impact fertility.
    • Known history or presence of clinical varicocele (subclinical and Grade 1 varicocele are acceptable).
    • Known history of cryptorchidism, testicular torsion, or orchitis.
    • Known abnormal karyotype (including Y-chromosome microdeletion).
    • Current or past treatment of urogenital (kidney, bladder, testicular, or prostate) cancer as well as history of chemo- or radiotherapy that can have impact on testes.
    • Any known uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders).
    • Administration of hormonal preparations, agents known to impair testicular function or affect sex hormone secretion, and known or suspected teratogens within 3 months prior to screening. Administration of anabolic steroids within 12 months prior to screening.
    - Precedente trattamento con FSH che non porta a concepimento.
    - Uso pregresso o corrente di finasteride nei 3 mesi precedenti lo screening.
    - Qualunque anamnesi di disturbo anatomico della ghiandola pituitaria o dei testicoli.
    - Qualunque anomalia strutturale del vaso deferente (unilaterale o bilaterale) allo screening.
    - Qualunque malattia sistemica nota, clinicamente significativa, in aggiunta all’indicazione della sperimentazione che potrebbe influire negativamente sulla fertilità.
    - Anamnesi nota o presenza di varicocele clinico (il varicocele subclinico e di grado 1 è accettabile).
    - Anamnesi nota di criptorchidismo, torsione testicolare od orchite.
    - Cariotipo anomalo noto (compresa la microdelezione del cromosoma Y).
    - Trattamento attuale o pregresso di un tumore urogenitale (di rene, vescica, testicolo o prostata), nonché anamnesi di chemio o radioterapia che può avere un impatto sui testicoli.
    - Qualsiasi endocrinopatia non controllata non gonadale nota (disturbi tiroidei, surrenali, ipofisari).
    - Aver ricevuto preparati ormonali, agenti noti per compromettere la funzione testicolare o influenzare la secrezione di ormoni sessuali e teratogeni noti o sospetti nei 3 mesi precedenti lo screening. Aver ricevuto steroidi anabolizzanti nei 12 mesi precedenti lo screening.
    E.5 End points
    E.5.1Primary end point(s)
    Spontaneous pregnancy observed in female partner within 9 months after randomisation of male subject, where spontaneous pregnancy is defined as vital pregnancy (documentation of at least one intrauterine gestational sac with fetal heartbeat by ultrasound)
    Gravidanza spontanea osservata nella partner nei 9 mesi successivi alla randomizzazione del soggetto di sesso maschile, in cui la gravidanza spontanea è definita come gravidanza vitale (documentazione di almeno una sacca gestazionale intrauterina con battito cardiaco fetale mediante ecografia)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 9 months after randomisation
    Entro 9 mesi dalla randomizzazione
    E.5.2Secondary end point(s)
    - Positive ßhCG (positive urine ßhCG test) observed in female partner¿
    - Time from randomisation to spontaneous pregnancy observed in female partner in calendar time and number of menstrual cycles
    - Changes in semen parameters (semen volume, sperm concentration, total count, motility, morphology, and DNA fragmentation) from prerandomisation to 3, 6, and 9 months after randomisation
    - Treatment responders defined by either spontaneous pregnancy observed in female partner, or increase of total sperm count or total motile sperm count to 50% over average baseline at 6 and/or 9 months
    - Changes in serum hormone concentrations (follicle-stimulating hormone [FSH], luteinising hormone [LH], inhibin B, testosterone, and estradiol) from randomisation to 3 and 6 months after randomisation
    - Changes in free testosterone concentration from randomisation to 3 and 6 months after randomisation
    - Treatment-induced anti-FSH antibodies, overall as well as with neutralising capacity
    - Immune-related adverse events
    - Positività per ßhCG (test della ßhCG urinario positivo) osservata nella partner
    - Tempo dalla randomizzazione alla gravidanza spontanea osservata nella partner in termini di tempo di calendario e numero di cicli mestruali
    · Variazioni nei parametri spermatici (volume spermatico, concentrazione spermatica, conta totale, motilità, morfologia e frammentazione del DNA) dalla pre-randomizzazione a 3, 6 e 9 mesi post-randomizzazione
    - Rispondenti al trattamento, così definiti in base alla presenza di una gravidanza spontanea osservata nella partner o all’aumento della conta spermatica totale o della conta degli spermatozoi mobili totali del 50% rispetto alla media al basale, a 6 e/o 9 mesi
    - Variazioni nelle concentrazioni ormonali sieriche (ormone follicolo-stimolante [FSH], ormone luteinizzante [LH], inibina B, testosterone ed estradiolo) dalla randomizzazione a 3 e 6 mesi dopo la randomizzazione
    - Variazioni nella concentrazione di testosterone libero dalla randomizzazione a 3 e 6 mesi dopo la randomizzazione
    - Anticorpi anti-FSH indotti dal trattamento, totali e con capacità neutralizzante
    - Eventi avversi immuno-correlati
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint as indicated in each applicable endpoint.
    Tempo di rilevazione come indicato in ciascun endpoint applicabile
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    United States
    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
    End of trial is post-trial follow-up period completed Q3 2026
    La conclusione della sperimentazione è il periodo di follow up ost trial completato nel Q3 del 2026
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days10
    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: 400
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 400
    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
    Nessuno
    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 Decision2022-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-22
    P. End of Trial
    P.End of Trial StatusOngoing
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