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    Summary
    EudraCT Number:2007-002823-34
    Sponsor's Protocol Code Number:27818
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-10-24
    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 ConcernedItaly - Italian Medicines Agency
    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.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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.1.3.4CountryItaly
    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 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 µg microgram(s)
    D.3.10.2Concentration typeequal
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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 75
    D.2.1.1.2Name of the Marketing Authorisation holderIND.FARMACEUTICA SERONO SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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/l international unit(s)/litre
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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
    oligoanovulatory infertile women who are candiates for ovulation indujction (OI)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    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
    TO IDENTIFY THE OPTIMAL EFFECTIVE DOSE OF AS900672-ENRICHED TO INDUCE OVULATION IN OLIGO-ANOVULATORY INFERTILE WOMEN
    E.2.2Secondary objectives of the trial
    TO DEMONSTRATE THAT THE CLINICAL PREGNANCY RATE OF THE OPTIMAL EFFECTIVE DOSE OF AS900672-ENRICHED IS WITHIN THE RANGE OF THE CLINICAL PREGANANCY RATE OBTAINED WITH FOLLITROPIN ALFA DAILY DOSING AND TO EVALUATE SAFETY AND TOLERABILITY OF AS900672-ENRICHED IN OLIGO-ANOVULATORY INFERTILE WOMEN UNDERGOING OI
    E.2.3Trial contains a sub-study Information not present in EudraCT
    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 or clomiphene citrate withdrawal 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. Early follicular phase serum TSH, DHEA-S, prolactin, and FSH within the normal range for the central laboratory,Exception: 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, 6. Fasting glucose and fasting insulin within the normal range for the central laboratory, 7. Normal uterine cavity and presence of at least one ovary with ipsilateral patent fallopian tube, as determined by means of HSG and/or laparoscopy-hysteroscopy within the prior 3 years, 8. PAP smear test without clinically significant abnormalities within 6 months prior to randomisation, 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 randomisation,Note: Use of donor sperm is not allowed, 11. Willing and able to comply with the protocol, 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 &#8805; 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 &#8805;4 mature follicles (>17 mm) or cancellation of the OI cycle due to excessive follicular response after treatment with FSH at a dose of &#8804; 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 &#8805; 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, 13. Ovarian cyst with a mean diameter of >25 mm and E2 > 80 pg/mL on the day of randomisation, 14. History of ovarian, uterine or mammary cancer, 15. Adrenal congenital hyperplasia, partial or complete enzymatic block, 16. Use of metformin 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), or positive hepatitis B surface antigen (HBsAg) or anti-hepatitis C antibodies 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 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, or clinically significant abnormal laboratory finding.
    E.5 End points
    E.5.1Primary end point(s)
    OVULATION RATE
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-10-24. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 420
    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 Decision2007-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-03-11
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