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    Summary
    EudraCT Number:2021-001785-38
    Sponsor's Protocol Code Number:000401
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-05
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-001785-38
    A.3Full title of the trial
    A randomised, controlled, assessor-blind, parallel groups, multicentre, multinational trial comparing the ovarian response of a starting dose of 15 µg follitropin delta (REKOVELLE) to a starting dose of 225 IU follitropin alfa (GONAL-F) in conventional regimens in controlled ovarian stimulation in women undergoing an assisted reproductive technology programme
    Estudio multicéntrico y multinacional, aleatorizado, controlado, con enmascaramiento para el evaluador, de grupos paralelos, que compara la respuesta ovárica de una dosis inicial de 15 μg de folitropina delta (REKOVELLE) con una dosis inicial de 225 UI de folitropina alfa (GONAL-F) en pautas convencionales de estimulación ovárica controlada en mujeres sometidas a un programa de tecnología de reproducción asistida
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of Conventional Dosing in Women undergoing ART with Follitropin Delta Treatment
    Evaluación de la dosis convencional en mujeres en tratamiento antirretroviral con folitropina delta
    A.3.2Name or abbreviated title of the trial where available
    ADAPT-1
    A.4.1Sponsor's protocol code number000401
    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 AddressKay Fiskers Plads 11
    B.5.3.2Town/ cityCopenhagen S
    B.5.3.3Post code2300
    B.5.3.4CountryDenmark
    B.5.4Telephone number+458833 8834
    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 namehuman recombinant 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 GONAL-F
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Europe B.V.
    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 alfa
    D.3.9.1CAS number 56832-30-5
    D.3.9.3Other descriptive nameFOLLITROPIN ALFA
    D.3.9.4EV Substance CodeSUB12426MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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
    Infertilidad en mujeres sometidas a un programa de tecnología de reproducción asistida (TRA) cómo fertilización in vitro (FIV) o ciclo de inyección intracitoplasmatica de esperma (IICS).
    E.1.1.1Medical condition in easily understood language
    Infertility - Inability to conceive children
    Infertilidad - Incapacidad de concebir hijos.
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10021928
    E.1.2Term Infertility female
    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 compare a starting dose of 15 µg REKOVELLE to a starting dose of 225 IU GONAL F in conventional regimens with respect to ovarian response in women undergoing controlled ovarian stimulation
    • Comparar una dosis inicial de 15 μg de REKOVELLE con una dosis inicial de 225 UI de GONAL‐F en pautas convencionales con respecto a la respuesta ovárica en mujeres sometidas a estimulación ovárica controlada.
    E.2.2Secondary objectives of the trial
    • To compare the follicular development, endocrine profile and embryo development associated with conventional dosing of REKOVELLE and GONAL-F
    • To compare the treatment efficiency associated with conventional dosing of REKOVELLE and GONAL-F
    • To compare the safety profile associated with conventional dosing of REKOVELLE and GONAL-F
    • Comparar el desarrollo folicular, el perfil endocrino y el desarrollo embrionario asociados a la pauta posológica convencional de REKOVELLE y GONAL-F.
    • Comparar la eficacia del tratamiento asociada a la pauta posológica convencional de REKOVELLE y GONAL-F.
    • Comparar el perfil de seguridad asociado a la pauta posológica convencional de REKOVELLE y GONAL-F.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed Consent Form signed prior to screening evaluations.
    2. In good physical and mental health.
    3. Pre-menopausal females between the ages of 18 and 40 years. 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 ≤37 years or for at least 6 months for subjects ≥38 years (not applicable in case of tubal or severe male factor infertility).
    6. Regular menstrual cycles of 21-35 days (both inclusive), presumed to be ovulatory.
    7. Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality (e.g. no endometrioma greater than 3 cm, and no enlarged ovaries or ovarian cyst not due to polycystic ovarian syndrome, 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.
    8. Early follicular phase (cycle day 2-4) serum levels of FSH between 1 and 15 IU/L (results obtained within 3 months prior to randomisation).
    1. Formulario de consentimiento informado firmado antes de las evaluaciones de selección.
    2. Buena salud física y mental.
    3. Mujeres premenopáusicas de entre 18 y 40 años de edad. Las pacientes deben tener al menos 18 años (incluido el 18.o cumpleaños) cuando firmen el consentimiento informado y no más de 40 años (hasta el día anterior al 41.er cumpleaños) en el momento de la aleatorización.
    4. Mujeres infértiles con diagnóstico de infertilidad tubárica, infertilidad inexplicable, endometriosis en estadio I/II o con parejas con diagnóstico de infertilidad de factor masculino, aptas para fecundación in vitro (FIV) o inyección intracitoplásmica de esperma (ICSI) utilizando esperma eyaculado fresco o congelado procedente de la pareja masculina o de un donante de esperma.
    5. Infertilidad durante al menos un año antes de la aleatorización para pacientes de ≤37 años o durante al menos 6 meses para pacientes de ≥38 años (no aplicable en caso de infertilidad tubárica o por factor masculino grave).
    6. Ciclos menstruales regulares de 21-35 días (ambos inclusive), presuntamente ovulatorios.
    7. Ecografía transvaginal que documenta la presencia y la visualización adecuada de ambos ovarios, sin signos de anomalía significativa (p. ej., ausencia de endometrioma mayor de 3 cm y ausencia de ovarios agrandados o quistes ováricos no debidos al síndrome del ovario poliquístico, lo que contraindicaría el uso de gonadotropinas) y apéndices normales (p. ej., ausencia de hidrosálpinx) en el plazo de 1 año antes de la aleatorización. Ambos ovarios deben ser accesibles para la recuperación de ovocitos.
    8. Concentración sérica de FSH en fase folicular temprana (días del ciclo 2-4) entre 1 y 15 UI/l (resultados obtenidos en los 3 meses anteriores a la aleatorización).
    E.4Principal exclusion criteria
    1. Primary ovarian failure.
    2. Known endometriosis stage III-IV.
    3. One or more follicles ≥10 mm (including cysts) observed on the transvaginal ultrasound prior to randomisation on stimulation day 1 (puncture of cysts is allowed prior to randomisation).
    4. Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the trial with the exception of controlled thyroid function disease.
    5. Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.
    6. Fibroid tumours of the uterus incompatible with pregnancy.
    7. Currently breast-feeding.
    8. Undiagnosed vaginal bleeding.
    9. 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.
    10. Pregnancy (negative urinary pregnancy tests must be documented at screening and prior to randomisation) or contraindication to pregnancy.
    11. Use of fertility modifiers during the last menstrual cycle before randomisation, including dehydroepiandrosterone (DHEA) or cycle programming with oral contraceptives, progestogen or estrogen preparations.
    12. Hypersensitivity to any active ingredient or excipients in the medicinal products used in the trial.
    13. Previous participation in the trial.
    14. Use of any non-registered investigational drugs during the last 3 months prior to randomisation
    1. Insuficiencia ovárica primaria.
    2. Endometriosis conocida en estadio III-IV.
    3. Uno o más folículos de ≥10 mm (incluidos quistes) observados en la ecografía transvaginal antes de la aleatorización el día 1 de la estimulación (se permite la punción de quistes antes de la aleatorización).
    4. Cualquier anomalía endocrina o metabólica conocida (hipofisaria, suprarrenal, pancreática, hepática o renal) que pueda comprometer la participación en el ensayo, con la excepción de enfermedad de la función tiroidea controlada.
    5. Constancia de tumores de ovario, mama, útero, glándula suprarrenal, hipófisis o hipotálamo que contraindicarían el uso de gonadotropinas.
    6. Tumores fibroides del útero incompatibles con el embarazo.
    7. Periodo de lactancia en curso.
    8. Hemorragia vaginal no diagnosticada.
    9. Hallazgos en la exploración ginecológica de la selección que impidan la estimulación con gonadotropinas o estén asociados a una menor probabilidad de embarazo, p. ej., anomalías uterinas congénitas o retención del dispositivo intrauterino.
    10. Embarazo (se deben documentar pruebas de embarazo en orina negativas en la selección y antes de la aleatorización) o contraindicación para el embarazo.
    11. Uso de modificadores de la fertilidad durante el último ciclo menstrual antes de la aleatorización, incluida la dehidroepiandrosterona (DHEA) o la programación de ciclos con anticonceptivos orales, o preparados de progesterona o estrógenos.
    12. Hipersensibilidad a cualquier principio activo o excipiente de los medicamentos utilizados en el ensayo.
    13. Participación previa en el ensayo.
    14. Uso de cualquier fármaco en investigación no registrado durante los últimos 3 meses antes de la aleatorización.
    E.5 End points
    E.5.1Primary end point(s)
    Number of oocytes retrieved
    Número de ovocitos recuperados.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Oocyte retrieval will take place 36h (±2h) after triggering of final follicular maturation
    La recuperación de ovocitos tendrá lugar 36 h (±2h) después de la provocación de la maduración folicular final.
    E.5.2Secondary end point(s)
    • Number of follicles (total and by size category) at end-of-stimulation
    • Serum concentrations of estradiol and progesterone at end-of-stimulation
    • Number of fertilised oocytes and fertilisation rate
    • Number of embryos and blastocysts (total and by quality)
    • Total gonadotropin dose and number of stimulation days
    • Early OHSS (overall and by grade) and/or preventive interventions for early OHSS
    • Número de folículos (total y por categoría de tamaño) al final de la estimulación.
    • Concentraciones séricas de estradiol y progesterona al final de la estimulación.
    • Número de ovocitos fecundados y tasa de fecundación.
    • Número de embriones y blastocistos (total y por calidad).
    • Dosis total de gonadotropina y número de días de estimulación.
    • Síndrome de hiperestimulación ovárica (SHEO) temprano (en general y por grado) o intervenciones preventivas para el SHEO temprano.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint is included in the relevant endpoint
    Momento de evaluación incluido en la variable relevante.
    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 No
    E.8.1.3Single blind Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    France
    Germany
    Italy
    Spain
    United Kingdom
    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 Q1 2024
    El Fin de Ensayo es el periodo de seguimiento post-ensayo completado, Q1 2024.
    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 months5
    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 months6
    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: 300
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 300
    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
    Ninguno
    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 Decision2021-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-19
    P. End of Trial
    P.End of Trial StatusOngoing
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