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    Summary
    EudraCT Number:2004-005022-45
    Sponsor's Protocol Code Number:3151A2-321
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-01-25
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-005022-45
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo- And Active-Controlled Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated with Menopause
    A.4.1Sponsor's protocol code number3151A2-321
    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 SponsorWyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development
    B.1.3.4CountryUnited States
    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 Information not present in EudraCT
    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 nameDesvenlafaxine succinate SR tablets
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDesvenlafaxine succinate
    D.3.9.1CAS number 386750-22-7
    D.3.9.2Current sponsor codeWY-45233-1
    D.3.9.3Other descriptive nameDVS-233, ODV
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 Information not present in EudraCT
    D.2.1.1.1Trade name Tibolone
    D.2.1.1.2Name of the Marketing Authorisation holderOrganon Laboratories Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameLivial 2.5mg tablets
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTibolone
    D.3.9.1CAS number 5630-53-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Generally healthy, postmenopausal women of age 40 to 65 seeking treatment for hot flushes with last natural menstrual period (LNMP) completed at least 12 months prior to screening (if LNMP is uncertain, the medical monitor or designee may approve a follicle-stimulating hormone [FSH] level; FSH level > 40 mIU/mL will allow enrollment).
    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 assess the efficacy and safety of DVS-233 SR compared with placebo for treatment of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence of DVS-233 SR and tibolone.
    E.2.2Secondary objectives of the trial
    To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators (Profile of Mood States [POMS], Greene Climacteric Scale [GCS], and Satisfaction Survey [SS]).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Generally healthy, postmenopausal women of age 40 to 65 seeking treatment for hot flushes with last natural menstrual period (LNMP) completed at least 12 months prior to screening (if LNMP is uncertain, the medical monitor or designee may approve a follicle-stimulating hormone [FSH] level; FSH level > 40 mIU/mL will allow enrollment).
    2. Intact uterus
    3. Minimum of 7 moderate to severe hot flushes per day or 50 per week recorded for 7 consecutive days during screening, using the following definitions:·
    Mild hot flush: sensation of heat without sweating·
    Moderate hot flush: sensation of heat with sweating, able to continue activity·
    Severe hot flush: sensation of heat with sweating, causing cessation of activity
    4. Subjects must have body mass index (BMI) less than or equal to 34 kg/m2 using the nomograph for BMI
    5. In the opinion of the investigator, the subject will comply with the protocol and has a high probability of completing the study
    E.4Principal exclusion criteria
    1. Known hypersensitivity to venlafaxine (Effexor or Effexor XR) or tibolone
    2. History, presence or suspicion of estrogen-dependent neoplasia (including endometrial hyperplasia)
    3. Undiagnosed vaginal bleeding
    4. Malignancy, or treatment for malignancy, within the previous 2 years, with the exception of basal cell carcinoma of the skin or squamous cell carcinoma of the skin. A history of breast cancer, melanoma, or any gynecologic cancer, at any time, excludes the subject
    5. Unresolved breast findings (on physical or imaging examinations) suggestive of malignant changes
    6. Unresolved cervical cytology smear report of atypical glandular cells (AGC). Unresolved atypical squamous cells (ASC). Cervical cytologic smear report of low-grade squamous intraepithelial lesion (LSIL), or greater, cervical intraepithelial neoplasia (CIN) I or greater, or any reported dysplasia
    7. History of a seizure disorder other than a single childhood febrile seizure
    8. Active or recent arterial thromboembolic disease (e.g., myocardial infarction or angina)
    9. History of cerebrovascular accident, stroke, or transient ischemic attack
    10. History of venous thromboembolism (e.g., deep venous thrombosis, pulmonary embolism)
    11. History or presence of clinically important hepatic or renal disease or other medical disease that might confound the study or be detrimental to the subject (e.g., clinically important cardiac arrhythmia, clinically important hyponatremia, uncontrolled diabetes, uncontrolled hypertension)
    12. Endocrine disease (except for controlled hypothyroidism or diet-controlled diabetes mellitus)
    13. Presence of major depressive disorder, bipolar disorder, psychotic disorder or generalized anxiety disorder requiring therapy
    14. Gallbladder disease (subjects who have had a cholecystecomy may be enrolled).
    15. Persistent elevated blood pressure (greater than 160 mm Hg systolic or greater than 100 mm Hg diastolic). Subjects may not be using more than 2 antihypertensive medications for the treatment of hypertension
    16. Known presence of raised intraocular pressure or history of narrow-angle glaucoma
    17. Neuro-ocular disorders (e.g., retinal vasculitis)
    18. Porphyria
    19. Clinically important abnormalities on screening physical examination, electrocardiogram (ECG) or laboratory tests (e.g., fasting total cholesterol greater than 300 mg/dL, fasting triglycerides greater than 300 mg/dL, fasting blood glucose greater than 125 mg/dL, or serum alanine aminotransferase [ALT] or serum aspartate aminotransferase [AST] greater than 1.5 times the upper limit of normal for the laboratory used)
    20. Presence of malabsorption disorder
    21. Use of oral estrogen-, progestin-, androgen- or selective estrogen receptor modulator (SERM)-containing drug products within 8 weeks prior to screening; use of transdermal hormone products within 8 weeks prior to screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to screening; use of intrauterine progestins within 8 weeks prior to screening; use of progestin implants or estrogen injectables within 3 months prior to screening; use of estrogen pellet or progestin injectables within 6 months prior to screening
    22. Use of any investigational drug within 30 days
    23. Use of medications thought to relieve VMS within 4 weeks prior to screening, such as aldomet, clonidine, dopaminergic or antidopaminergic drugs (e.g., veralipride), Bellergal (containing belladonna, phenobarbital and ergotamine), gabapentin, herbal remedies or nutritional supplements (e.g., soy-derived or red clover-derived isoflavone, black cohosh, vitamine E [at least 800 IU/day]).24. Use of psychoactive medications within 4 weeks prior to screening such as: SSRIs and SNRIs (e.g., fluoxetine [Prozac], sertraline [Zoloft], paroxetine [Paxil] or venlafaxine [Effexor]); regular use of triptans (e.g., sumatriptan [Imitrex], naratriptan [Amerge], zolmitriptan [Zomig]) or drugs with a similar mechanism of action indicated for the treatment of migraine; use of any monoamine oxidase inhibitors (MAOIs); use of any antidepressant, anxiolytic, antipsychotic, or sedative-hypnotic drugs
    25. Enrollment has been closed
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoints are the reduction from baseline in the average daily number of moderate to severe hot flushes and in the average daily severity score at weeks 4 and 12 compared with placebo.The primary safety endpoint is the bleeding incidence, defined as the proportion of subjects experiencing at least one episode of bleeding or spotting during treatment.
    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 Information not present in EudraCT
    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 No
    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 Yes
    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
    The end of the trial will be the last visit of the last subject undergiong trial.
    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 days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    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) Information not present in EudraCT
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Information not present in EudraCT
    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 No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 465
    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)
    A follow-up visit (visit 6) will be made approximately 15 days after the last day of test article intake to identify any study events that arise within this time period and to document bleeding and/or spotting episodes, symptoms/complaints, and medications/treatments taken during the 15 days following therapy.
    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 Decision2005-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-02-08
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