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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44313   clinical trials with a EudraCT protocol, of which   7357   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2021-004254-37
    Sponsor's Protocol Code Number:000400
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-08-08
    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 ConcernedBelgium - FPS Health-DGM
    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
    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).
    A.3.2Name or abbreviated title of the trial where available
    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 Pharmaceuticals 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 AddressAmager Strandvej 405
    B.5.3.2Town/ cityKastrup
    B.5.3.3Post code2770
    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.3.4Pharmaceutical 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 INNFOLLITROPIN 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/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number33.3
    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 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)
    E.1.1.1Medical condition in easily understood language
    Unexplained reduction of semen quality in men
    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
    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
    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:
    - Pre-menopausal woman between the ages of 18 and 35 years.
    - Regular menstrual cycles of 21-35 days.
    - 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.
    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.
    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)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 9 months after randomisation
    E.5.2Secondary end point(s)
    - Positive βhCG (positive urine βhCG 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
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint as indicated in each applicable endpoint.
    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 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 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
    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 months6
    E.8.9.1In the Member State concerned days26
    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
    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 Decision2022-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-23
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA