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    Summary
    EudraCT Number:2007-002823-34
    Sponsor's Protocol Code Number:27818
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-11-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-002823-34
    A.3Full title of the trial
    A phase II, multicentre, randomised, assessor.blinded, active-comparator, parallel-group dose finding trial to evaluate AS900672-Enriched versus follitropin alfa (GONAL-f) in oligo-anovulatory infertile women undergoing ovulation induction (OI)
    A.3.2Name or abbreviated title of the trial where available
    AS900672-Enriched Phase II in OI
    A.4.1Sponsor's protocol code number27818
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Serono International SA
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 nameAS900672-Enriched
    D.3.4Pharmaceutical form Powder for injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameAS900672-enriched or GM-1
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number40
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typerecombinant biological
    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 holderSerono 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 Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1050
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typerecombinant biological
    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
    oligoanovulatory infertile women who are candidates for ovulation induction (OI)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10033312
    E.1.2Term Ovulation induction
    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:
    Identify the optimal dose of AS900672-
    Enriched to induce ovulation in oligo-anovulatory infertile women.
    E.2.2Secondary objectives of the trial
    Secondary objectives:

    Demonstrate that the clinical pregnancy rate of the optimal dose of
    AS900672-Enriched is within the range of the clinical pregnancy rate obtained with
    follitropin alfa daily dosing, and

    Evaluate safety and tolerability of AS900672-Enriched in oligo-anovulatory infertile
    women undergoing OI.

    Other objectives:
    Further evaluate the pharmacokinetics and pharmacodynamics of AS900672-Enriched.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Oligo-anovulation defined by a menstrual period duration of 35 days to 6 months,
    2. Spontaneous menses or a positive response to progestin within the prior 6 months or clomiphene citrate evidenced by ovulation within the prior 6 months,
    3. Aged between 18 and 36 years, inclusive, at time of informed consent signature,
    4. Body mass index 18 to 30 kg/m2, inclusive,
    5. No clinically significant abnormalities in serum TSH, DHEA-S, prolactin, and FSH levels in the early follicular phase,
    Subjects with low TSH level who receive replacement therapy can be
    enrolled at the discretion of the investigator if local laboratory results (T4)
    demonstrate satisfactory thyroid function,
    Subjects receiving stable dose of dopamine agonists can be enrolled at the discretion of the investigator if local laboratory results demonstrate adequate control of prolactin levels,
    6. No clinically significant abnormalities in fasting glucose and fasting insulin levels,
    7. Normal uterine cavity and presence of at least one ovary with ipsilateral patent
    fallopian tube, as determinded by means of histerosalpingography, laparoscopy, hysteroscopy or combination of these procedures within the prior 3 years,
    8. PAP smear test without clinically significant abnormalities within 6 months prior to
    the first screening procedure. If PAP smear was not done, it must be performed as part of screening procedure,
    9. Negative pregnancy test prior to randomisation,
    10. Male partner with semen analysis demonstrating adequacy for insemination via
    intercourse and/or IUI within 6 months prior to the first screening procedure. If semen analysis was not done, it must be performed as part of the screening procedure,
    Note: Use of donor or frozen sperm is not allowed.
    11.Willing and able to comply with all protocol procedure, including pregnancy, and neonatatal follow-up, and
    12. Voluntary provision of written informed consent, prior to any trial-related procedure that was not part of normal medical care, with the understanding that the subject can withdraw consent at any time without prejudice to her future medical care, including willingness to provide follow-up information on babies born as part of this trial.
    E.4Principal exclusion criteria
    1. History of ≥ 2 consecutive gonadotrophin stimulation cycles that did not lead to
    ovulation,
    2. History of clomiphene citrate stimulation cycles of which none led to ovulation,
    3. Prior excessive response to gonadotrophin stimulation, defined as the development of
    ≥4 mature follicles (>17 mm) or cancellation of the OI cycle due to excessive
    follicular response after treatment with FSH at a dose of ≤ 75 IU/day,
    4. Previous severe ovarian hyperstimulation syndrome (OHSS),
    5. Administration of any gonadotrophin, clomiphene citrate, GnRH analogue, tamoxifen
    or aromatase inhibitors within the prior 30 days,
    6. Laparoscopic ovarian drilling and/or ovarian cauterisation within the prior 6 months,
    7. Any contraindication to pregnancy and/or to carrying pregnancy to term,
    8. A clinical pregnancy that ended in a miscarriage within the prior 3 months,
    9. History of ≥ 3 consecutive miscarriages, due to any cause,
    10. Abnormal gynaecological bleeding of undetermined origin,
    11. Clinically significant abnormal findings of the uterine cavity evident on a
    transvaginal pelvic ultrasound performed during screening,
    12. Presence of endometriosis grade III – IV or requiring treatment,
    13. Ovarian cyst with a mean diameter of >25 mm and E2 > 80 pg/mL on the day of
    randomisation,
    14. History or suspicion of ovarian, uterine or mammary cancer,
    15. Adrenal congenital hyperplasia, partial or complete enzymatic block,
    16. Use of metformin or other insulin sensitising agents related to infertility within the prior 2 months,
    17. Known allergy or hypersensitivity to human gonadotrophin preparations or to
    compounds that are structurally similar to any of the other medications administered
    during the trial,
    18. Any contra-indication to gonadotrophin therapy,
    19. Known infection with human immunodeficiency virus (HIV), Hepatitis B or C in the trial subject or her male partner,
    20. Any active substance abuse or history of drug, medication or alcohol abuse within the
    prior 5 years,
    21. Smoker consuming more than 5 cigarettes per day,
    22. Serum testosterone (central laboratory) that is suggestive of ovarian tumour,
    23. Previously randomised in this trial or participation in another investigational drug clinical trial within the prior 3 months,
    24. Any medical condition, which in the judgment of the Investigator may interfere with the absorption, distribution, metabolism or excretion of r-hFSH, or
    25. Clinically significant systemic disease, including diabetes mellitus and autoimmune diseases) that would compromise subject safety or interfere with the study assesments or clinically significant abnormal laboratory finding.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is the ovulation rate.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Information not present in EudraCT
    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.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    E.8.7Trial has a data monitoring committee Yes
    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 defined as final clinical database lock
    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 months0
    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 months0
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 420
    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 for subject. Baby follow up
    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 Decision2007-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-05
    P. End of Trial
    P.End of Trial StatusCompleted
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    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.

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