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    Summary
    EudraCT Number:2006-001322-25
    Sponsor's Protocol Code Number:A4291023
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-07-03
    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 number2006-001322-25
    A.3Full title of the trial
    A PHASE 2b MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED,
    PARALLEL-GROUP, DOSE-RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
    Estudio en fase 2b multicéntrico, doble ciego, controlado con placebo, con grupos paralelos y de determinación de dosis para evaluar la eficacia y la seguridad de PD-0299685 en el tratamiento de los síntomas vasomotores moderados o intensos asociados a la menopausia.
    A.4.1Sponsor's protocol code numberA4291023
    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 SponsorPfizer, S.A.
    B.1.3.4CountrySpain
    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 namePD 0299685
    D.3.2Product code PD 0299685
    D.3.4Pharmaceutical form Capsule, hard
    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 INNN/A
    D.3.9.1CAS number 313651-33-1
    D.3.9.2Current sponsor codePD 0299685
    D.3.9.3Other descriptive name(3S, 5R)-3-(Aminomethyl)-5-methyloctanoic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 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 namePD 0299685
    D.3.2Product code PD 0299685
    D.3.4Pharmaceutical form Capsule, hard
    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 INNN/A
    D.3.9.1CAS number 313651-33-1
    D.3.9.2Current sponsor codePD 0299685
    D.3.9.3Other descriptive name(3S, 5R)-3-(Aminomethyl)-5-methyloctanoic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 3
    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 namePD 0299685
    D.3.2Product code PD 0299685
    D.3.4Pharmaceutical form Capsule, hard
    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 INNN/A
    D.3.9.1CAS number 313651-33-1
    D.3.9.2Current sponsor codePD 0299685
    D.3.9.3Other descriptive name(3S, 5R)-3-(Aminomethyl)-5-methyloctanoic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboCapsule, hard
    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
    Treatment of moderate to severe vasomotor symptoms (hot flushes) associated with menopause
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10020408
    E.1.2Term Hot flushes
    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 of PD 0299685 in the treatment of moderate to severe vasomotor symptoms associated with the menopause;
    · To characterise the dose range and dose response relationships of PD 0299685 in the treatment of moderate to severe vasomotor symptoms associated with the menopause
    · To assess the safety and tolerability of PD 0299685.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Female patients must meet the following criteria to be eligible to participate in the study:
    • Good health as determined by medical history, physical examination, vital signs;
    • Age: ≥40 years and ≤70 years old;
    • Postmenopausal women defined as:
    • At least 6 months of spontaneous amenorrhea, and serum follicle-stimulating hormone (FSH) >40 mIU/mL and estradiol concentrations ≤25 pg/mL;
    • Surgical bilateral oophorectomy, with or without hysterectomy, at least 6 weeks ago, and serum follicle-stimulating hormone (FSH) >40 mIU/mL and estradiol concentrations ≤25 pg/mL.
    • Must have an average of at least 50 moderate to severe vasomotor symptoms per week during the screening period;
    • Vasomotor symptoms are defined as the combined daytime hot flashes and night sweats in a 24-hr period;
    • Number of vasomotor symptoms must be collected for 14 days, including at least 7 consecutive days. Seven consecutive days during the screening period will be used to compute the mean count of weekly vasomotor symptoms for the eligibility criteria and baseline assessment;
    • Vasomotor symptom data must be collected following the appropriate wash out periods for medications listed in the exclusion criteria.
    • Non clinically significant ECG abnormalities at screening, including QTc interval ≤450 msec;
    • Mammogram performed at screening within this protocol, or within last 9 months, that shows no evidence of cancer, or suspicion of cancer, warranting further investigation. Documentation of the mammogram report is required prior to randomization.
    • Papanicolaou (Pap) smear (cervical cytology) test performed at screening within this protocol, or within last 9 months that shows no evidence of malignant or pre-malignant abnormalities. Documentation of Pap smear is required prior to randomization.
    • An evaluable screening endometrial biopsy containing sufficient tissue for diagnosis in all patients that have a uterus.
    • Patients with insufficient tissue obtained by biopsy may be included in the study only when accompanied by a transvaginal ultrasound (TVU) within the past 3 months that demonstrates endometrial thickness <5 mm. Documentation of TVU is required prior to randomization.
    • Willing and able to provide written informed consent to participate;
    • Patients who are willing and able to comply with scheduled visits, trial related activities, procedures and lifestyle guidelines.
    E.4Principal exclusion criteria
    Patients will not be allowed to participate in the study if any of the following conditions exist:
    • Receiving estrogen monotherapy or estrogen/progesterone containing drug products. The following periods should be followed before baseline assessments and procedures are performed for patients previously on estrogen alone or estrogen/progesterone containing products:
    • 1 week or longer for prior vaginal hormonal products (rings, creams, gels);
    • 4 weeks or longer for prior transdermal estrogen alone or estrogen/ progesterone products;
    • 8 weeks or longer for prior oral estrogen, progesterone, and/or androgen therapy;
    • 8 weeks or longer for prior intrauterine progesterone therapy;
    • 3 months or longer for prior progesterone implants and estrogen alone injectable drug therapy;
    • 6 months or longer for prior estrogen pellet therapy or progesterone injectable drug therapy.
    • Use of tamoxifen, raloxifene, or clonidine less than 4 weeks before collection of screening/baseline Hot Flash diary data and during the conduct of the study;
    • Use of gabapentin or pregabalin less than 4 weeks before collection of screening/baseline Hot Flash diary data and during the conduct of the study;
    • Use of soy, black cohosh, phytoestrogens, vitamin E (regular multivitamins containing vitamin E are allowed), evening primrose oil, or any non-prescription/over-the-counter (OTC) treatment for hot flashes for less than 4 weeks before collection of screening/baseline Hot Flash diary data and during the conduct of the study;
    • Use of any drugs having pharmacology of serotonin reuptake inhibition (SRI), or combined serotonin/ noradrenalin receptor reuptake inhibition (SNRI) less than 4 weeks before collection of screening/baseline Hot Flash diary data and during the conduct of the study;
    • Use of any central nervous system (CNS)-active medication, including prescription and non-prescription/ over-the-counter (OTC) treatment for insomnia, less than 1 week before the collection of screening/baseline Hot Flash diary data and during the conduct of the study;
    • History of allergic reaction or significant adverse reaction to gabapentin or pregabalin;
    • Creatinine clearance (CLcr) ≤60 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft-Gault equation);
    • Clinically significant abnormal screening ECG or clinical laboratory (clinical chemistry, hematology, urinalysis) measurements;
    • Prior participation in a clinical trial involving PD 0299685;
    • Significant medical or psychiatric illness within the past 12 months;
    • Participation in a study of an investigational or marketed drug during the 30-day period before the start of the study or during the conduct of the study;
    • Smoking of >1 pack of cigarettes per day (or patients who cannot avoid nicotine overnight);
    • Substance abuse or dependence within the past 12 months, including suspicion or confirmation of excessive alcohol usage by 2 of 4 positive responses to the 4 question CAGE questionnaire;
    • Positive urine drug screen at screening;
    • Any findings indicating simple or complex hyperplasia or endometrial cancer through endometrial biopsy collected during screening.
    • Other severe acute or chronic medical or psychiatric condition or laboratory assay abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    · Change from baseline in average daily frequency of moderate to severe vasomotor symptoms (combined daytime hot flashes and night sweats) to Week 4;
    · Change from baseline in average daily frequency of moderate to severe vasomotor symptoms (combined daytime hot flashes and night sweats) to Week 12;
    · Change from baseline in average daily severity of moderate to severe vasomotor symptoms (combined daytime hot flashes and night sweats) to Week 4;
    · Change from baseline in average daily severity of moderate to severe vasomotor symptoms (combined daytime hot flashes and night sweats) to Week 12.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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.8.5.1Number of sites anticipated in the EEA9
    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 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
    As per protocol.
    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 months12
    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 months11
    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) 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 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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 455
    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)
    As per protocol.
    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 Decision2006-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-08
    P. End of Trial
    P.End of Trial StatusOngoing
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