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    Summary
    EudraCT Number:2017-004864-37
    Sponsor's Protocol Code Number:ASP-OP3-1
    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:2018-03-26
    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 number2017-004864-37
    A.3Full title of the trial
    A Multinational, Phase 3, Double-blind, Placebo-Controlled, Randomized Study to Assess the Efficacy and Safety of Ovestin in the Treatment of Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the efficacy and safety of Ovestin in the treatment of symptoms of Vulvar and Vaginal Atrophy in women after menopause
    A.4.1Sponsor's protocol code numberASP-OP3-1
    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 SponsorAspen Global Incorporated
    B.1.3.4CountryMauritius
    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 supportAspen Global Incorporated
    B.4.2CountryMauritius
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAspen Pharmacare Holdings LimitedCompany
    B.5.2Functional name of contact pointClinical Operations Lead
    B.5.3 Address:
    B.5.3.1Street AddressWoodlands Dr, Woodmead
    B.5.3.2Town/ citySandton
    B.5.3.3Post code2191
    B.5.3.4CountrySouth Africa
    B.5.4Telephone number+2782 789 7445
    B.5.5Fax number+2711 239 3606
    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 Ovestin
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameOvestin
    D.3.4Pharmaceutical form Vaginal cream
    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 INNESTRIOL
    D.3.9.1CAS number 50-27-1
    D.3.9.4EV Substance CodeSUB01971MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    D.8.4Route of administration of the placeboVaginal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vulvovaginal atrophy associated with menopause
    E.1.1.1Medical condition in easily understood language
    Vulvar and vaginal atrophy in postmenopausal women
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10047782
    E.1.2Term Vulvovaginal atrophy
    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
    To evaluate the efficacy of Ovestin as Hormone Replacement Therapy (HRT) at 12 weeks after initiation of treatment of vulvar and vaginal atrophy symptoms in postmenopausal women
    E.2.2Secondary objectives of the trial
    To evaluate the safety profile of Ovestin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Female participants aged ≥ 45 to ≤ 85 years.
    2.Presence of at least one documented moderate or severe bothersome symptom of vulvovaginal atrophy. These symptoms include any of the following:
    •Pain during sexual intercourse (dyspareunia)
    •Vaginal dryness
    •Vaginal itching/irritation
    •Vaginal/vulvar soreness
    •Vulvar or vaginal bleeding (e.g. postcoital bleeding, fissures)
    •Vaginal discharge (leukorrhea or yellow and malodorous)
    •Pelvic pressure or a vaginal bulge
    •Urinary tract symptoms (e.g. urinary frequency, dysuria, urethral discomfort, hematuria)
    3.Postmenopausal women; postmenopausal defined as:
    •12 months of spontaneous amenorrhea, or
    •6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
    4.Participants will comprise treatment-naïve postmenopausal women and treatment-experienced postmenopausal women who have discontinued hormone replacement therapy (either local or systemic).
    5.Treatment-experienced participants should not be taking estrogen alone or estrogen/progestin containing drug products. The following washout periods are recommended before baseline assessments are made for participants previously on estrogen alone or estrogen/progestin containing products:
    •4 weeks or longer for prior vaginal hormonal products (rings, creams, gels)
    •4 weeks or longer for prior transdermal estrogen alone or estrogen/progestin products
    •8 weeks or longer for prior oral estrogen and/or progestin therapy
    •8 weeks or longer for prior intrauterine progestin therapy
    •3 months or longer for prior progestin implants and estrogen alone injectable drug therapy
    •6 months or longer for prior estrogen pellet therapy or progestin injectable drug therapy
    6.Women must have documentation of a negative screening mammogram (obtained at screening or within 12 months prior to study enrollment) and normal clinical breast examination prior to enrollment.
    7.Women must have documentation of a negative screening pap smear (obtained at screening or within six months prior to study enrollment). Negative defined as normal cytology or pap1 (normal cytomorphology) or pap2 (borderline dyskaryosis/ atypical squamous cells of undetermined significance (ASC-US)) and no suspected malignant abnormalities.
    8.Participants must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial.
    9.Women must have a documented negative urine pregnancy test unless they have had a bilateral oophorectomy and/or hysterectomy.
    10.Stated willingness to comply with all study procedures and availability for the duration of the study.
    E.4Principal exclusion criteria
    1.Clinical suspicion of endometrial hyperplasia, endometrial cancer or cervical cancer for participants who have a uterus.
    2.Known, previous or suspected breast cancer.
    3.Known, previous or suspected estrogen-dependent malignant tumors (e.g. endometrial cancer).
    4.Any malignancy unless free of disease for at least 5 years.
    5.Undiagnosed uterine bleeding.
    6.Known pelvic organ prolapse past the level of the hymen.
    7.Evidence of vaginal infection on physical examination.
    8.Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism).
    9.Known thrombophilic disorders or conditions that may adversely affect coagulation, including:
    •Protein C, Protein S, or antithrombin III deficiency
    •Factor XIII mutation, familial dysfibrinogenemia, antiphospholipid syndrome, heparin-induced thrombocytopenia, paroxysmal nocturnal hemoglobinuria, sickle-cell disease, polycythemia vera, essential thrombocytosis, nephrotic syndrome
    •History of elevated levels of factor VIII, factor IX, factor XI, fibrinogen and thrombin-activatable fibrinolysis inhibitor, or decreased levels of tissue factor pathway inhibitor.
    10.Acute or chronic liver disease.
    11.A history of significant alcohol or drug abuse in the opinion of the investigator.
    12.Use of any other investigational drug within 30 days or use of any of the prohibited medications, as outlined in section 7.5 of this protocol, leading up to the first dose of Ovestin.
    13.Any physical, psychiatric or social condition which in the opinion of the investigator may:
    •put the participant at risk because of participation in the study
    •influence the results of the study
    •cause concern regarding the participant’s ability to participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    •Mean change from baseline to Week 12 in at least one individual moderate to severe symptom that has been identified by the participant as being the most bothersome to her
    •Mean change from baseline to Week 12 in the percentage of superficial cells
    •Mean change from baseline to Week 12 in the percentage of parabasal cells
    •Mean change from baseline to Week 12 in vaginal pH
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    •Solicited and unsolicited adverse events
    •Change in serum estriol concentrations over time from baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout study duration
    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 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 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.8.2.4Number 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 EEA11
    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
    Bulgaria
    Poland
    South Africa
    Ukraine
    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 years0
    E.8.9.1In the Member State concerned months10
    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 months10
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 505
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state198
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 262
    F.4.2.2In the whole clinical trial 1005
    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
    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 Decision2018-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-28
    P. End of Trial
    P.End of Trial StatusCompleted
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