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    Summary
    EudraCT Number:2013-001105-81
    Sponsor's Protocol Code Number:ACT-CYC-300-2013-01
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-13
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2013-001105-81
    A.3Full title of the trial
    Randomized Clinical Trial to Compare the Pregnancy Rates of Vaginally Applied Cyclogest® Pessary and Crinone® 8% Gel After In-vitro Fertilization
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Study to compare the effect of two different vaginal application forms of the hormone progesterone (Cyclogest® Pessary and Crinone® 8% Gel) on pregnancy rates after artificial fertilization.
    A.4.1Sponsor's protocol code numberACT-CYC-300-2013-01
    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 SponsorActavis Group PTC ehf.
    B.1.3.4CountryIceland
    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 supportActavis Group PTC ehf.
    B.4.2CountryIceland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmaplex bvba
    B.5.2Functional name of contact pointProject Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressAv St.-Hubert 51
    B.5.3.2Town/ cityWezembeek-Oppem
    B.5.3.3Post code1970
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3227843693
    B.5.5Fax number+3227843066
    B.5.6E-mailiklingmann@pharmaplex.be
    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 Cyclogest® 400 mg
    D.2.1.1.2Name of the Marketing Authorisation holderActavis UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Pessary
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROGESTERONE
    D.3.9.1CAS number 57-83-0
    D.3.9.4EV Substance CodeSUB10076MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 Crinone® 8%
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Vaginal gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROGESTERONE
    D.3.9.1CAS number 57-83-0
    D.3.9.4EV Substance CodeSUB10076MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    Luteal phase support after IVF
    E.1.1.1Medical condition in easily understood language
    Hormonal preparation of the uterus for pregnancy after artificial fertilization
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    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 non-inferiority in the achievement of pregnancy rate (fetal heart movement measured by TVUS) after 38 days of luteal phase support using Cyclogest® 400 mg bid compared to Crinone® 8% (90 mg) once daily.
    E.2.2Secondary objectives of the trial
    • To compare the safety and tolerability of Cyclogest® 400 mg bid to Crinone® 8% (90 mg) od when used for 10 weeks of luteal phase support.

    • To compare the achievement of clinical pregnancy rate (fetal heart movement measured by TVUS) after 10 weeks (70 ±3 days) of luteal phase support using Cyclogest® 400 mg bid or Crinone® 8% (90 mg) od.

    • To compare patient-rated convenience in the use of Cyclogest® 400 mg bid to Crinone® 8% (90 mg) od when used for 10 weeks of luteal phase support.

    • To compare biochemical pregnancy rates between Cyclogest® 400 mg bid and Crinone® 8% (90 mg) od after 18 days and 38 days relative to oocyte retrieval (OR).

    • To compare the clinical implantation rate (embryo with fetal heart movement measured by TVUS) per number of embryos transferred after 38 days of luteal phase support using Cyclogest 400 mg bid or Crinone 8% (90 mg) od.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age (calculated from date of birth) at randomization between 18 and 40 years
    2. Body mass index ≥ 18 and ≤ 30 kg/m2
    3. Infertility due to any of the following factors: tubal factor, mild endometriosis (American Society for Reproductive Medicine [ASRM] stage 1 to 2), male factor, unexplained infertility
    4. Presence of at least one ovary, and uterine cavity without significant abnormalities
    5. First, second, or third fresh cycle in the present series of assisted reproductive technology (ART)
    6. ≥ 4 oocytes were retrieved in the current ART cycle
    7. Serum follicle stimulating hormone (FSH) level ≤ 12 IU/L (on menstrual cycle day 1 to 5) within any menstrual cycle within one year prior to randomization
    8. ART procedure according to:
    • undergoing routine down-regulation with gonadotropin releasing-hormone (GnRH) agonist or using GnRH antagonist
    • undergoing stimulation regimen with FSH and/or human menopausal gonadotropin (hMG) with total starting dose ranging from 100 IU to 300 IU per day, and a maximum total dose of up to 450 IU per day
    • human chorionic gonadotropin (hCG 5000 or 10000 IU) trigger injection when at least 3 follicles with diameter ≥ 17 mm are observed during TVUS
    • oocyte retrieval (OR) is planned for 35 to 37 hours after hCG trigger injection
    • ET on Day 2 or 3 after OR (1 to 3 embryos depending on number of previous fresh cycles and age of woman according to the site's clinical practice and national legislation if applicable)
    E.4Principal exclusion criteria
    1. Presence of pregnancy
    2. More than two previously failed complete ART fresh cycles
    3. Donor egg recipient
    4. Any contraindication to being pregnant and/or carrying pregnancy to term
    5. Presence of any medical condition for which the use of progesterone is contraindicated, (e.g. porphyria, etc.)
    6. Known postmenopausal status
    7. Vaginal abnormalities (including untreatable abnormal discharges)
    8. History of gynecological neoplasia (breast, uterus, ovary, cervix, vagina)
    9. Presence of clinically significant endometriosis (> 1 cm ovarian endometrioma)
    10. Uterine fibroids suspected to affect study procedures (assessed by ultrasound or hysteroscopy (HSC) / hysterosalpingogram (HSG))
    11. Known blood coagulation disorders
    12.Epilepsy, migraine with neurological symptoms, cardiac or renal dysfunction, cholelithiasis
    13. History of or current clinically significant depression, at the discretion of the investigator
    14. Occurrence of severe ovarian hyperstimulation syndrome (OHSS) according to Golan (Grade IV, V or VI)
    15. Present use or use within 2 months prior to start of the study, medication of the following drugs: phenytoin, phenobarbitone, phenylbutazone, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, rifabutin, nevirapine, efavirenz, nelfinavir, ritonavir, griseofulvin, ketoconazole
    16. Administration of investigational drugs within 2 months prior to start of study medication
    17. Known hypersensitivity to one of the study drugs or any of the excipients
    E.5 End points
    E.5.1Primary end point(s)
    • The primary endpoint of the study is the clinical pregnancy rate achieved after 38 days of luteal phase support (fetal heart movement measured by TVUS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Final Analysis at the end of the trial
    E.5.2Secondary end point(s)
    • Clinical pregnancy rate achieved after 70 ±3 days (10 weeks) of luteal phase support (fetal heart movement measured by TVUS)
    • Clinical implantation rates per number of embryos transferred after 38 days of luteal phase support (fetal heart movement measured by TVUS)
    • Biochemical pregnancy rate at Day 18 and 38 after OR
    • The patient's evaluation of treatment convenience
    • The patient's evaluation of bleeding and leakage (diary)
    • Incidence of adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Final Analysis at the end of the trial
    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 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) 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 EEA10
    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
    Bulgaria
    Czech Republic
    Hungary
    Serbia
    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
    LPLV = March 2014
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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 years0
    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: 766
    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 Yes
    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 state186
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 646
    F.4.2.2In the whole clinical trial 766
    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)
    Patients will continue to be treated within the standard site-specific IVF procedure
    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 Decision2013-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-08
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