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    Summary
    EudraCT Number:2007-001295-36
    Sponsor's Protocol Code Number:SRM105106
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-06-19
    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 number2007-001295-36
    A.3Full title of the trial
    A parallel-group, double-blind, randomized, placebo-controlled, active comparator, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of two doses of GSK232802 administered orally as monotherapy for 12 weeks in healthy postmenopausal women with moderate to extremely severe vasomotor symptoms
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberSRM105106
    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 SponsorGlaxoSmithKline Research and Development Ltd
    B.1.3.4CountryUnited Kingdom
    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.3.2Product code GSK232802
    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.3.9.2Current sponsor codeGSK232802
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    D.2.1.1.1Trade name premarin
    D.2.1.1.2Name of the Marketing Authorisation holderWhYeth Medica
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Coated 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 INNSelective estrogen receptor modulators
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 placeboTablet
    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 placeboCoated tablet
    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
    Healthy postmenopausal women with moderate to extremely severe vasomotor symptoms
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 6.1
    E.1.2Level PT
    E.1.2Classification code 10058825
    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 safety and tolerability of two doses of GSK232802 administered once daily for 12 weeks in healthy postmenopausal women with moderate to extremely severe VMS. To evaluate the effect of two doses of GSK232802, administered over a 12-week treatment period, on change in frequency and severity of VMS from baseline compared to placebo. To characterize the PK of GSK232802 (and its primary oxidative metabolite GSK1132184A) and evaluate the relationship between individual measures of exposure to GSK232802, as estimated by population PK methods, versus frequency and severity of VMS, safety, and PD endpoints, as appropriate.
    E.2.2Secondary objectives of the trial
    To evaluate the change in frequency and severity of VMS at Weeks 4 and 8 of the treatment period for time to onset of efficacy for GSK232802 compared to placebo. To compare the proportion of subjects who achieve a reduction in frequency and severity of VMS of at least 50%, at least 75%, and 100% from baseline to Week 12,after treatment with GSK232802 versus placebo. To assess effects of GSK232802 on the following parameters over a 12-week treatment period in healthy postmenopausal women with moderate to extremely severe VMS: Questionnaires for menopause-related quality of life, sleep quality, fatigue,depressive symptoms, and work productivity. VVA symptoms. PD markers: including serum hormone levels and serum bone biomarkers. Body composition
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Postmenopausal women aged 40 to 65 years old; postmenopausal defined as: i. Amenorrheic for at least 12 consecutive months* OR ii. At least 6 weeks post-surgical bilateral oophorectomyﾆ with or without hysterectomy. *Note: Although duration of amenorrhea is initially determined by subject history at the time of the screening visit (Visit 1), menopausal status must be confirmed by demonstrating levels of follicle stimulating hormone (FSH) >40 IU/mL and estradiol <30ng/L at entry. Screening reports provided by the Central Laboratory must be carefully reviewed to determine menopause eligibility prior to conducting Visit 2 assessments. ﾆFor women who are surgically menopausal, a copy of the pathology report demonstrating both ovaries have been removed and/or biochemical evidence of postmenopausal status as noted above is required prior to conducting Visit 2 assessments. 2. A minimum average frequency of seven daily moderate to extremely severe hot flashes or episodes of night sweats sufficient to cause the patient to seek treatment (these episodes must be documented during the baseline period and the subject must have recorded frequency and severity of symptoms for a minimum of eight days in order to be eligible for randomization). This average frequency will be calculated by summing the number of moderate, severe, and extremely severe VMS events during the baseline period and dividing by the total number of non-missing days during this period. 3. BMI within the range 19 to 35 kg/m2, inclusive. 4. Subject has provided signed and dated written informed consent before admission to the study. 5. Subject is able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.
    E.4Principal exclusion criteria
    Investigator considers subject unfit for the study as a result of medical history,

    physical examination, or screening tests.

    2. Use of prescription or non-prescription drugs including:

    i. Hormone therapy (estrogen or estrogen/progestin combination or related

    products) within the following time period before the first dose of investigational

    product and during the study:

    4 weeks for prior vaginal hormonal products (rings, creams, gels) or

    transdermal estrogen or estrogen/progestin products.

    4 weeks for oral estradiol (e.g., micronized estradiol) or SERM products

    (e.g., raloxifene).

    8 weeks for prior oral conjugated (equine or synthetic) estrogen or

    estrogen/progestin products or for prior intrauterine progestin therapy.

    3 months for prior progestin implants or injectable estrogen.

    6 months for prior estrogen pellet therapy or injectable progestin.

    ii. Use of putative therapies for VMS relief (e.g., selective serotonin reuptake

    inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs],

    clonidine, gabapentin, tibolone, methyldopa, and phytoestrogens such as black

    cohosh, and red clover) within the past 30 days or 5 half-lives (whichever is

    longer) before the assessment of baseline VMS symptoms (half-lives will be

    provided in the SPM). Use of non-medication treatments for VMS, such as

    acupuncture and biofeedback.

    iii. Use of weight loss drugs (e.g., phentermine, sibutramine, orlistat, rimonabant)

    within 3 months of the first dose of investigational product.

    iv. Use of pravastatin [Pravachol/Lipostat], rosuvastatin [Crestor], or pitavastatin

    [Livalo] within 5 half-lives of the first dose of investigational product (note: halflives

    will be provided in the SPM. Uses of other statins, for example simvastatin

    [Zocor], atorvastatin [Lipitor], fluvastatin [Lescol], lovastatin [Mevacor] are

    allowed).

    v. Use of bupropion, orphenadine [Norflex], cyclophosphamide, efavirenz,

    ifosfamide, or methadone (because of the potential for GSK232802 to inhibit

    CYP2B6), or use of paclitaxel, torsemide, amodiaquine, or repaglinide (because

    of the potential for GSK232802 to inhibit CYP2C8).

    vi. Women on a concurrent anti-depressant, anti-hypertensive, or lipid-lowering

    therapy (except for medications specifically excluded above) may be included in

    the study, as long as they have been stable on these medications for at least 1 month.

    3. Use of investigational drug within the past 30 days or 5 half-lives (whichever is

    longer) before the first dose of investigational product.

    4. Uterine disease or medical condition including: Bi-layer endometrial thickness

    greater than or equal to 5mm as determined by TVUS; presence of fibroids that

    obscure evaluation of endometrium by TVUS; history of uterine cancer; evidence of

    endometrial hyperplasia or cancer as assessed by endometrial biopsy before

    enrollment (Note: if a subject has insufficient tissue for diagnosis at screening, but

    endometrial thickness by TVUS is <5mm, she may still be eligible for study entry if

    she meets the remaining inclusion/exclusion criteria); unexplained or unusual

    endometrial bleeding; or uterine surgery (within the past 6 months). Evidence of

    malignancy as assessed by cervical Pap smear.

    5. History of breast or ovarian cancer.
    E.5 End points
    E.5.1Primary end point(s)
    Safety: Incidence and severity of adverse events (AEs). Change from baseline in: vital signs, physical examination, clinical chemistry, hematology, thyroid-stimulating hormone (TSH), thyroxine (T4), fasting lipid profile, and thrombotic and inflammatory markers. Absolute change in bi-layer endometrial thickness measured by transvaginal ultrasound (TVUS) or saline infusion sonohysterography (SIS), endometrial biopsy pathology, and the occurrence of withdrawal bleeding. Efficacy: The primary efficacy endpoints include the following co-primary measures of VMS, with the second endpoint tested in a step-down fashion: Mean change in frequency of VMS from baseline to Week 12 Mean change in severity of VMS from baseline to Week 12 PK: Plasma concentrations of GSK232802 (and its primary oxidative metabolite GSK1132184A) allowing for characterization of population PK parameters and individual exposure to GSK232802 and GSK1132184A.
    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 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) 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
    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 months9
    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 months9
    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) Yes
    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 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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 400
    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 Decision2007-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-07-23
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