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    Summary
    EudraCT Number:2007-001037-34
    Sponsor's Protocol Code Number:A8361015
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-05-02
    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 ConcernedSweden - MPA
    A.2EudraCT number2007-001037-34
    A.3Full title of the trial
    PHASE 2A MULTI-CENTRE, DOUBLE BLIND (3RD PARTY OPEN), PLACEBO CONTROLLED 3-WAY CROSS-OVER STUDY TO INVESTIGATE THE EFFECT OF SINGLE DOSES OF PF-00446687 ON SEXUAL AROUSAL AND SEXUAL DESIRE IN WOMEN SUFFERING FROM FEMALE SEXUAL DYSFUNCTION (FSD).
    A.3.2Name or abbreviated title of the trial where available
    n/a
    A.4.1Sponsor's protocol code numberA8361015
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbern/a
    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 Limited, Ramsgate Road, Sandwich, Kent. UK. CT13 9NJ
    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.3.1Product namePF-00446687
    D.3.2Product code PF-00446687
    D.3.4Pharmaceutical form Powder for oral solution
    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.3.9.1CAS number 862281-92-3
    D.3.9.2Current sponsor codePF-00446687
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboPowder for oral solution
    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
    Female Sexual Dysfunction
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10057671
    E.1.2Term Female sexual dysfunction
    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 effect of single doses of PF-00446687 on acute sexual arousal and sexual interest as assessed by questionnaires in post-menopausal women suffering from FSD.
    • To assess the effect of single doses of PF-00446687 on medium-term (one week) sexual arousal and sexual interest as assessed by a diary in post-menopausal women suffering from FSD.
    E.2.2Secondary objectives of the trial
    • To assess the variability of response and repeatability of study design between two similar doses of PF-00446687.
    • To assess PK of PF-00446687.
    • To assess the safety and toleration of PF-00446687.
    If possible to assess the effect of PF-00446687 on vaginal blood flow using the Heat
    Wash-Out (HWO) technique (one pre-selected site only - Norway).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Post-menopausal women (with/without systemic Hormone Replacement Therapy (HRT)) aged 45-65 defined by a documented history of
    Natural amenorrhoea for > 1 year, OR Bilateral oophorectomy OR
    Subjects who are surgically menopausal (hysterectomy).
    Subjects who are currently taking systemic (HRT) must have taken this at a stable dose for at least 3 months. This stable dose must be maintained throughout the duration of the study. (The exception is subjects who have already been on systemic HRT and who have switched to a new brand type. They will only need to establish stable use for 1 month). HRT is defined as any estrogenic hormonal medication administered alone or in combination with progesterone/progestogens and/or androgens. Subjects will only be included if the supplement has been prescribed for an approved indication, the delivery route is approved and a reliable assay is available to ensure resultant hormone levels are not supra-physiologic. Specifically testosterone replacement for libido enhancement, methyl-testosterone supplements and testosterone creams are excluded.
    2. Subjects must personally sign and date the informed consent documentation indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
    3. Subjects must have been in a stable heterosexual relationship for at least 6 months prior to study start and must remain in a stable relationship throughout the duration of the study.
    4. Subjects must be willing and able to comply with scheduled visits, laboratory tests and other trial procedures.
    5. Subjects must have evidence of female sexual arousal disorder (Arousal-Cognition with either Arousal-Sensation or Arousal-Lubrication) as determined by the ASFQ. The subject will be included if the Arousal-Cognition and Arousal-Sensation/Arousal-Lubrication scores are within the appropriate range as outlined in the scoring guidance.
    6. Subjects who experience personal distress due to FSD as assessed by the Measure of Female Sexual Distress (MFSD). The subject will be included if the score is within the appropriate range as outlined in the scoring guidance.
    E.4Principal exclusion criteria
    1. Subjects whose sexual dysfunction is considered to be situational ie, limited to certain types of stimulation, situation or specific partners.
    2. Subjects who have significant dyspareunia, which is due to an inflammatory or anatomical condition (eg, pelvic inflammatory disease, vulvovestibulitis, fibroids).
    3. 12-lead ECG demonstrating QTc >450 msec at screening.
    4. Subjects who have sexual aversion disorder.
    5. Subjects with any other major psychological or sexual disorder, not otherwise listed in the inclusion criteria, which is considered to be the primary diagnosis explaining the sexual dysfunction.
    6. Subjects with otherwise treatable causes of FSAD including inadequately controlled diabetes, thyroid dysfunction or clinical significant hyperprolactinemia.
    7. Subjects who currently participate in a structured psychosexual therapy program.
    8. Subjects with a recent (past 6 months) history of alcohol or controlled substance abuse.
    9. Subjects who drink more than 21 units of alcohol per week. (1 unit = 285 mL of beer or 25 mL of spirits or 125 mL of wine).
    10. Subjects who have undergone major surgery in the past 6 months.
    11. Subjects who have participated in another experimental trial within the last 30 days.
    12. Subjects with any clinically significant abnormality following review of pre-study laboratory data and full physical examination.
    13. Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
    14. Subjects with a history of seizure disorder.
    15. History of febrile illness within 5 days prior to the first dose.
    16. Subjects with any condition possibly affecting drug absorption (eg, gastrectomy).
    17. Subjects who are receiving drugs known to inhibit CYP3A4, such as ketoconazole
    (systemic), erythromycin, cimetidine, clarithromycin, fluvoxamine, itraconazole (systemic), voriconazole, protease inhibitors.
    18. Subjects who have received treatment for any major psychiatric disorder (eg, psychosis or hospitalization due to major depression) within the past 12 months. Subjects on SSRIs (selective serotonin re-uptake inhibitors), SNRIs (selective noradrenaline reuptake inhibitors), tricyclic antidepressants as well as bupropion will be allowed into the study as long as their dosage has been stable for at least three consecutive months prior to entry. This same dosage must be maintained throughout the study.
    19. Subjects who, in the opinion of the Investigator, have any medical or psychological condition or social circumstances which would impair their ability to participate reliably in the study, or who may increase the risk to themselves or others by participating.
    20. In the opinion of the investigator, a subject who is not likely to complete the study for whatever reason.

    Additional Exclusion Criteria (only for subjects undergoing Vaginal Blood Flow assessments)
    1. Subjects who have had previous surgery to the vagina (including that for stress incontinence or vaginal hysterectomy) and those who have any anatomical abnormality of the vagina.
    2. Subjects with a recent (past 3 months) exacerbation of pelvic inflammatory disease, a recent untreated vaginal infection, salpingitis, or other severe or chronic gynecologic disease.
    3. Subjects who have a history of gynaecological malignancy or those with recent abnormal cervical cytology suggestive of neoplastic changes.
    4. Subjects superficial/introital dyspareunia which makes them unable to have the vaginal probe inserted.
    The above inclusion and exclusion criteria are extensive, but may not cover every potential medical situation for otherwise appropriate trial subjects. Similarly, application of some inclusion/exclusion criteria may require clarification or interpretation based on local medical practice/customs.
    E.5 End points
    E.5.1Primary end point(s)
    Main endpoints:
    • Arousal and desire domain changes from pre-dose baseline as assessed by the Acute Female Sexual Desire and Arousal Scale (AFSDAS) questionnaire for each of the erotic and non-erotic segments (including the 2 hour immediate post-dose segment).
    • Diary days 1 to 7.

    Heat Wash-out endpoints (at one selected site only) – if performed:
    • Vaginal Blood Flow (VBF, measured as mL/(100 g tissue x min)) changes from pre-dose baseline for each of the erotic and non-erotic segments (including the 2 hours immediate post-dose segment). Additional summaries derived from the heat wash-out method will also be explored.
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    3rd party open
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    End of Trial in a Member State of the European Union is defined as the time at which it is deemed that sufficient subjects have been recruited and completed the trial as stated in the regulatory application (ie, Clinical Trial Application (CTA)) and ethics application in the Member State.

    End of Trial in all participating countries is defined as Last Subject Last Visit.
    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 months6
    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 months6
    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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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 Decision2007-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-02-25
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