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    Summary
    EudraCT Number:2007-003158-27
    Sponsor's Protocol Code Number:FE 200440 CS09
    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:2007-09-12
    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 number2007-003158-27
    A.3Full title of the trial
    A randomised, double-blind, parallel groups, placebo-controlled, multi-centre study assessing the effects of a selective oxytocin antagonist (barusiban) and a mixed oxytocin antagonist – vasopressin V1a antagonist (atosiban) administered intravenously on luteal phase uterine contractions in oocyte donors supplemented with vaginal progesterone
    A.3.2Name or abbreviated title of the trial where available
    OVANCON
    A.4.1Sponsor's protocol code numberFE 200440 CS09
    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 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 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 nameBarusiban
    D.3.2Product code FE 200440
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbarusiban
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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) 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 No
    D.IMP: 2
    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 TRACTOCILE
    D.2.1.1.2Name of the Marketing Authorisation holderFerring AB
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNatosiban
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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) 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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Co-adjuvant therapy in the luteal phase to facilitate implantation and pregnancy in women undergoing assisted reproductive technologies (i.e. IVF/ICSI with embryo transfer)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10061400
    E.1.2Term Uterine contractions abnormal
    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 the effects of barusiban and atosiban compared to placebo on luteal phase uterine contractions in oocyte donors supplemented with progesterone
    E.2.2Secondary objectives of the trial
    •To evaluate the effects of a mock embryo transfer on uterine contractions in oocyte donors exposed to barusiban, atosiban or placebo and supplemented with progesterone
    •To evaluate the effects of discontinuing barusiban, atosiban or placebo on uterine contractions
    •To explore the relationship between barusiban / atosiban concentrations and uterine contractions
    •To explore the pharmacokinetics of barusiban and atosiban
    •To evaluate the safety profile of barusiban and atosiban
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed informed consent form, prior to screening evaluations
    2.Oocyte donors who have undergone controlled ovarian hyperstimulation in the long GnRH agonist protocol or the multiple-dose or single-dose GnRH antagonist protocols, have received hCG (≥ 5,000 IU urinary hCG or 250 μg recombinant hCG) for triggering final follicular maturation and have undergone oocyte retrieval (OR) in the current cycle
    3.In good physical and mental health
    4.Pre-menopausal, aged 18-35 years (both inclusive)
    5.Body mass index (BMI) between 18.5 and 29.9 kg/m2 (both inclusive)
    6.Retrieval of ≥ 6 cumulus-oocyte-complexes in the current controlled ovarian hyperstimulation cycle
    7.Good visualisation of the entire volume of the uterus in the maximum longitudinal (mid-sagittal) plane from cervix to fundus, including the entire endometrium, myometrium and serosa at the transvaginal ultrasound at screening (Day OR +1)
    8.Willing to not have sexual intercourse during the study and to either maintain sexual abstinence or to use a highly effective method of contraception (i.e. a failure rate of less than 1% per year, such as intrauterine device) from end-of-study until onset of next menses
    9.Willing to not have intake of alcoholic beverages during the study
    E.4Principal exclusion criteria
    1.Known clinically significant systemic diseases (e.g. insulin dependent diabetes)
    2.Known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study
    3.Known current severe cardiac disease
    4.Known history of hypertension or hypotension, or currently receiving medication to control blood pressure
    5.Supine blood pressure, after resting for 5-10 minutes, outside a systolic blood pressure range of 90-140 mmHg or a diastolic blood pressure outside range of 50-90 mmHg on two consecutive measurements taken 5 minutes apart on Day OR +1
    6.Past or current thrombophlebitis or venous thromboembolic disorders (including deep venous thrombosis); active or recent (within 1 year) arterial thromboembolic disease (e.g. stroke, myocardial infarction)
    7.Known endometriosis stage I-IV
    8.Moderate or severe ovarian hyperstimulation syndrome (OHSS) (according to Golan’s classification , ) in the current controlled ovarian hyperstimulation cycle
    9.Known premature LH surge, defined as LH concentration ≥ 10 IU/L and progesterone concentration ≥ 1 ng/mL, in the current controlled ovarian hyperstimulation cycle
    10.Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
    11.Undiagnosed vaginal bleeding
    12.Currently breast feeding
    13.Known current active pelvic inflammatory disease or vaginal infection
    14.Uterine pathology (e.g. fibroids, polyps) documented at a transvaginal ultrasound within 3 months prior to randomisation
    15.Previous major uterine surgery (e.g. myomectomy for leiomyomas), previous Caesarean section, congenital uterine abnormalities, or retained intrauterine device
    16.Use of concomitant medications with utero-relaxant properties, such as calcium channel blockers (ATC code C08), beta-sympathomimetic agonists (ATC code R03), nitroglycerine (ATC code C01D), magnesium sulphate (ATC code B05X), potassium channel openers (ATC code C02D) and drugs for functional gastrointestinal disorders (ATC code A03) that could interfere with evaluation of the investigational medicinal products or uterine contractions, within 4 weeks before randomisation
    17.Use of concomitant medications with uterotonic properties, such as dopamine (ATC code C01C), progesterone antagonists (ATC code G03XB) and prostaglandin analogues (ATC code A02B) that could interfere with evaluation of the investigational medicinal products or uterine contractions, within 4 weeks before randomisation
    18.Treatment with anti-psychotics (ATC code N05A) or anti-depressants (ATC code N06) within 4 weeks before randomisation
    19.Treatment with anxiolytics (ATC code N05B), hypnotics and sedatives (ATC code N05C) or continuous use of non-steroid anti-inflammatory drugs (NSAIDs), including aspirin, within 4 weeks before randomisation, with the exception of use in connection with oocyte retrieval
    20.Sexual intercourse in the period from last day of ovarian stimulation to randomisation
    21.Current or past (last 12 months) abuse of alcohol or drugs, and/or current (last month) use of alcohol of more than 7 units/week
    22.Intake of alcoholic beverages on the day of screening or day of randomisation
    23.Current or past (3 months) smoking of more than 10 cigarettes per day
    24.History of chemotherapy (except for gestational conditions) or radiotherapy
    25.Use of any non-registered investigational drug during 3 months before randomisation
    26.Previous participation in the study
    27.Hypersensitivity to any active ingredient or excipient in the medicinal products
    E.5 End points
    E.5.1Primary end point(s)
    • Frequency of uterine contractions at 3h after start of dosing
    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 Yes
    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) 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 No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 months6
    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 Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    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 2007-09-12. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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 Decision2007-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-11
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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
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