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    Summary
    EudraCT Number:2013-003817-16
    Sponsor's Protocol Code Number:EMR200061-005
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-03-04
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2013-003817-16
    A.3Full title of the trial
    A phase III, randomized, controlled, single-blind,
    multicentre, parallel arm trial to assess the
    efficacy and safety of Pergoveris® (follitropin alfa
    and lutropin alfa) and GONAL-f® (follitropin
    alfa) for multifollicular development as part of an
    assisted reproductive technology treatment cycle
    in poor ovarian responders, as defined by the
    European Society of Human Reproduction and
    Embryology criteria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare Pergoveris and GONAL-f in women who have responded poorly to previous infertiliy treatment cycles
    A.3.2Name or abbreviated title of the trial where available
    ESPART Evaluating the Efficacy and the Safety of Pergoveris® in ART
    A.4.1Sponsor's protocol code numberEMR200061-005
    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 SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 supportMerck KGaA, Darmstadt
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Centre Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number496151725200
    B.5.5Fax number496151722000
    B.5.6E-mailservice@merckgroup.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 Pergoveris 150 IU-75 IU Powder and solvent for solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono Europe Limited
    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 Powder and solvent for solution for injection
    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 international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLutropin alfa
    D.3.9.1CAS number 152923-57-4
    D.3.9.3Other descriptive nameLUTROPIN ALFA
    D.3.9.4EV Substance CodeSUB12524MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 450 IU/0.75 ml (33 micrograms/0.75 ml) powder and solvent for solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono Europe Limited
    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 Powder and solvent for solution for injection
    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
    Poor Ovarian Response i.e. a failure to respond adequately to standard ART (assisted reproductive technologies) protocols and to recruit adequate follicles
    E.1.1.1Medical condition in easily understood language
    Poor Ovarian Response describes a less than expected response to standard treatments for infertility due to reduced production of eggs in the ovaries
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10033140
    E.1.2Term Ovarian disorder NOS
    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
    The primary objective of the trial is to demonstrate superiority of Pergoveris® versus GONAL-f® in poor ovarian response (POR) patients.
    E.2.2Secondary objectives of the trial
    Key secondary objectives will include assessment of other clinical variables that reflect the efficacy of ovarian stimulation and safety assessment of combination treatment with recombinant human follicle-stimulating hormone (r-hFSH) and recombinant human luteinizing r-hLH (Pergoveris®) as compared to r-hFSH (GONAL-f®)-only treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The current trial will enroll poor ovarian responders as aligned with the 2011 Consensus Meeting of the ESHRE.
    1. Subject must be a poor responder
    at least 2 of the following 3 features must be present:
    - ESHRE criteria = Advanced maternal age (≥ 40 years) or any risk factor for POR - INCLUSION for this study: Yes (< 41 years), no for any risk factor
    - ESHRE criteria = A previous POR (≤ 3 oocytes with a conventional stimulation protocol)
    INCLUSION for this study: Yes
    -ESHRE criteria = An abnormal ovarian reserve test (ORT) (ie, anti-mullerian hormone [AMH] < 0.5 - 1.1 ng mL)
    INCLUSION for this study: Yes for AMH only (≥ lower limit of assay detection - 1.3 ng/mL, inclusive)

    Additional inclusion criteria are:
    2. Female subjects, 18 to < 41 years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including ICSI
    3. Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy
    4. Absence of any medical condition in which pregnancy is contraindicated
    5. Body mass index 18 to 30 kg/m2, inclusive
    6. Motile, ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed). Intracytoplasmic sperm injection will be allowed during this trial.
    7. Minimum of 1 month without treatment with either clomiphene citrate or gonadotrophins prior to screening
    8. Signed and dated informed consent indicating that the subject has been informed of all the pertinent aspects of the trial prior to enrollment
    E.4Principal exclusion criteria
    1. Primary ovarian failure
    2. Preimplantation genetic screening or diagnosis
    3. Two episodes of POR after maximal stimulation
    4. History or presence of tumors of the hypothalamus or pituitary gland
    5. History or presence of ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst > 25 mm on the day of randomization
    6. Presence of endometriosis Grade III – IV, confirmed or suspected
    7. Presence of uni- or bilateral hydrosalpinx
    8. Abnormal gynecological bleeding of undetermined origin
    9. Malformations of sexual organs incompatibile with pregnancy
    10. Contraindication to being pregnant and/or carrying a pregnancy to term
    11. Currently pregnant
    E.5 End points
    E.5.1Primary end point(s)
    Total number of retrieved oocytes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    On/before day 113 (Visit 12)
    E.5.2Secondary end point(s)
    • Ongoing pregnancy rate (assessed on/before day 185 -Visit 16).
    • Live birth rate (assessed on/before day 365 - Visit 17).
    • Embryo implantation rate (determined on/before day 154 - Visit 15).
    • Clinical pregnancy rate (determined on/before day 154 - Visit 15).
    • Biochemical pregnancy rate (determined on/before day 132 - Visit 14).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visits 14 to 17 as described above
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA79
    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
    Belgium
    Czech Republic
    Denmark
    Estonia
    Finland
    France
    Germany
    Hungary
    Italy
    Latvia
    Netherlands
    Poland
    Russian Federation
    Spain
    Sweden
    Turkey
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days12
    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: 946
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 862
    F.4.2.2In the whole clinical trial 946
    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)
    After a subject has completed the trial or has withdrawn early, usual treatment will be administered, if required, in accordance with the trial site’s standard of care and generally accepted medical practice and depending on the subject’s individual medical needs.
    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 Decision2014-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-08-05
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