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    Summary
    EudraCT Number:2017-002783-40
    Sponsor's Protocol Code Number:000304
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-12-11
    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 ConcernedNorway - NOMA
    A.2EudraCT number2017-002783-40
    A.3Full title of the trial
    A randomised, controlled, open label, parallel group, multicentre trial comparing the efficacy and safety of individualised FE 999049 (follitropin delta) dosing, using a long GnRH agonist protocol and a GnRH antagonist protocol in women undergoing controlled ovarian stimulation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to compare the efficacy and safety of individualised FE 999049 (follitropin delta) dosing in women undergoing controlled ovarian stimulation
    A.3.2Name or abbreviated title of the trial where available
    BEYOND
    A.4.1Sponsor's protocol code number000304
    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 R&D
    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.5.5Fax number004588338880
    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.3.2Product code FE 999049
    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 namehuman recombinant follicle-stimulating hormone
    D.3.9.4EV Substance CodeSUB121093
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Infertility in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle
    E.1.1.1Medical condition in easily understood language
    Infertility - Inability to conceive children
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10016398
    E.1.2Term Female infertility
    E.1.2System Organ Class 100000004872
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10016403
    E.1.2Term Female infertility of tubal origin
    E.1.2System Organ Class 100000004872
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025511
    E.1.2Term Male infertility, unspecified
    E.1.2System Organ Class 100000004872
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10014787
    E.1.2Term Endometriosis of uterus
    E.1.2System Organ Class 100000004872
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10014784
    E.1.2Term Endometriosis of ovary
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of individualised FE 999049 treatment on ovarian response in a long GnRH agonist protocol versus a GnRH antagonist protocol
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of individualised FE 999049 treatment on other pharmacodynamic parameters in a long GnRH agonist protocol versus a GnRH antagonist protocol
    • To evaluate the effect of individualised FE 999049 treatment on pregnancy rates in a long GnRH agonist protocol versus a GnRH antagonist protocol
    • To evaluate the safety of individualised FE 999049 treatment in a long GnRH agonist protocol versus a GnRH antagonist protocol
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed Consent Documents signed prior to screening evaluations.
    2. In good physical and mental health.
    3. The subjects must be at least 18 years (including the 18th birthday) when they sign the informed consent and no more than 40 years (up to the day before the 41st birthday) at the time of randomisation.
    4. Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor.
    5. Infertility for at least one year before randomisation for subjects < 38 years or for at least 6 months for subjects ≥38 years (not applicable in case of tubal or severe male factor infertility).
    6. The trial cycle will be the subject’s first controlled ovarian stimulation cycle for IVF/ICSI.
    7. Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.
    8. Hysterosalpingography, hysteroscopy, saline infusion sonography, or transvaginal ultrasound documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous or intramural fibroids larger than 3 cm in diameter, no polyps and no congenital structural abnormalities which are associated with a reduced chance of pregnancy) within 1 year prior to randomisation.
    9. Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality (e.g. no endometrioma greater than 2 cm or enlarged ovaries which would contraindicate the use of gonadotropins) and normal adnexa (e.g. no hydrosalpinx) within 1 year prior to randomisation. Both ovaries must be accessible for oocyte retrieval.
    10. Early follicular phase (cycle day 2-5) serum levels of FSH between 1 and 15 IU/L at screening.
    11. Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests within 1 year prior to randomisation.
    12. Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening.
    13. If < 38 years willing to accept single blastocyst transfer. If ≥38 years willing to accept transfer of a single good-quality blastocyst (double blastocyst transfer may be performed if no good-quality blastocyst is available).
    E.4Principal exclusion criteria
    1. AMH >35 pmol/L at screening.
    2. Strong preference of the subject for either treatment protocol.
    3. Known endometriosis stage III-IV (defined by the revised American Society for Reproductive Medicine [ASRM] classification, 1996).
    4. Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and before week 24 of pregnancy).
    5. Known abnormal karyotype of subject or of her partner / sperm donor, as applicable, depending on source of sperm used for insemination in this trial.
    6. Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).
    7. Known inherited or acquired thrombophilia disease.
    8. Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
    9. Known porphyria.
    10. Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) with the exception of controlled thyroid function disease.
    11. Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.
    12. Known moderate or severe impairment of renal or hepatic function.
    13. Currently breast-feeding.
    14. Undiagnosed vaginal bleeding.
    15. Known abnormal cervical cytology of clinical significance observed within 3 years prior to randomisation (unless the clinical significance has been resolved).
    16. Findings at the gynaecological examination at screening which preclude gonadotropin stimulation or are associated with a reduced chance of pregnancy, e.g. congenital uterine abnormalities or retained intrauterine device.
    17. Pregnancy (negative pregnancy test must be documented at screening) or contraindication to pregnancy.
    18. Known current active pelvic inflammatory disease.
    19. Use of fertility modifiers during the last menstrual cycle before randomisation, including dehydroepiandrosterone (DHEA), metformin or cycle programming with oral contraceptives, progestogen or estrogen preparations.
    20. Use of hormonal preparations (except for thyroid medication) during the last menstrual cycle before randomisation.
    21. Known history of chemotherapy (except for gestational conditions) or radiotherapy.
    22. Current or past (1 year prior to randomisation) abuse of alcohol or drugs and/or current (last month) intake of more than 14 units of alcohol per week.
    23. Current or past (3 months prior to randomisation) smoking habit of more than 10 cigarettes per day.
    24. Hypersensitivity to any active ingredient or excipients in the medicinal products used in the trial.
    25. Previous participation in the trial
    26. Use of any non-registered investigational drugs during the last 3 months prior to randomisation.

    See also Withdrawal Criteria in the study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Number of oocytes retrieved
    E.5.1.1Timepoint(s) of evaluation of this end point
    Oocyte retrieval will take place 36h (±2h) after triggering of final follicular maturation
    E.5.2Secondary end point(s)
    • Proportion of subjects with cycle cancellation due to poor ovarian response or excessive ovarian response
    • Proportion of subjects with blastocyst transfer cancellation after oocyte retrieval due to (risk of) ovarian hyperstimulation syndrome (OHSS)
    • Number and size of follicles on stimulation day 6 and end-of-stimulation
    • Proportion of subjects with <4, 4-7, 8-14, 15-19 and ≥20 oocytes retrieved
    • Number of metaphase II oocytes (only applicable for those inseminated using ICSI), fertilisation rate as well as number and quality of embryos on day 3 and blastocysts on day 5 after oocyte retrieval
    • Circulating concentrations of FSH, luteinising hormone (LH), estradiol, progesterone and inhibin B on stimulation day 6, end-of-stimulation and at oocyte retrieval
    • Total gonadotropin dose and number of stimulation days
    • Positive βhCG rate (positive serum βhCG test 13-15 days after transfer)
    • Implantation rate (number of gestational sacs 5-6 weeks after transfer divided by number of blastocysts transferred)
    • Clinical pregnancy rate (at least one gestational sac 5-6 weeks after transfer)
    • Vital pregnancy rate (at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer)
    • Ongoing pregnancy rate (at least one intrauterine viable fetus 10-11 weeks after transfer
    • Ongoing implantation rate (number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred)
    • Proportion of subjects with early OHSS (including OHSS of moderate/severe grade)
    • Proportion of subjects with late OHSS (including OHSS of moderate/severe grade)
    • Frequency and intensity of adverse events
    • Technical malfunctions of the prefilled injection pen
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint is included in the relevant 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    same product in long GnRH agonist arm or GnRH antagonist arm
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Austria
    Denmark
    Israel
    Italy
    Netherlands
    Norway
    Switzerland
    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 2021
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 400
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state77
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    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)
    Post-trial activities cover pregnancy and neonatal health follow-up. All subjects with an ongoing pregnancy will be followed till delivery to gather information on live birth rate. Furthermore, data will be gathered on neonatal health, including minor/major congenital anomalies, at birth and at 4 weeks after birth. These data will be reported separately.
    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 Decision2018-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-09-27
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