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    Summary
    EudraCT Number:2004-001378-19
    Sponsor's Protocol Code Number:A5031003
    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:2004-08-02
    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 number2004-001378-19
    A.3Full title of the trial
    A two part study to a) investigate the reproducilibility of the vaginal photoplethysmograhpy (VPP) teqnique in healthy pre-menopausal volunteers and subjects suffering from Female Sexual Arousal Disorder (FSAD) and b) a randomised double blind, placebo conrolled 4-way crossover study to investigate the effect of single oral doses (10, 50 and 400 mg)of UK-447,841 on vaginal blood flow in pre-menopausal subjects suffering from FSAD.
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA5031003
    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 AB
    B.1.3.4CountrySweden
    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 nameN/A
    D.3.2Product code UK-447,841
    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.3.8INN - Proposed INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeUK-447,841
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 to 400
    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 Information not present in EudraCT
    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 Arousal Disorder (FSAD)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10062641
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A:
    Primary:To investigate the reproducibility of the vaginal photoplethysmography (VPP) technique in healthy pre-menopausal female volunteers and pre-menopausal subjects suffering from FSAD.
    Part B:
    Primary: To investigate the effect of single doses of UK-447,841 on vaginal blood flow (VBF) as measured by VPP in pre-menopausal subjects suffering from FSAD.
    E.2.2Secondary objectives of the trial
    Part A:
    To assess the degree of undesirable artefacts and fluctuations in the vaginal pulse amplitude (VPA) traces. To assess the variability of subjective feeling of arousal at baseline and during visual sexual stimulation (VSS). To investigate differences in VPA between healthy volunteers and subjects suffering from FSAD.
    Part B:
    To investigate the suitability of this technique in determining sensitivity to change on VBF following dosing with UK-447,841.To assess the correlation between changes in VPA and subjective feeling of arousal during sexual arousal.To investigate the safety and toleration of single oral doses of UK-447,841 in FSAD subjects.To determine plasma concentrations of UK-447,841 in FSAD subjects. To determine the effect of UK-447,841 on levels of plasma biomarkers such as VIP, ANP, big endothelin and cGMP.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    All subjects
    1. Pre-menopausal female subjects aged 18-40.
    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 3 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.

    FSAD subject group
    5. Subjects must suffer from FSAD that has been present for at least 6 months prior to study entry which may or may not be associated with female orgasmic disorder and/or superficial/introital dyspareunia.
    E.4Principal exclusion criteria
    All subjects
    1. Subjects who are post-menopausal. Post-menopausal status is defined by a documented history of Naturally amenorrhoeic for > 1 year, or A six-month history of amenorrhoea and an FSH level of >50 IU/L and serum estradiol <20 pg/mL, or Bilateral oophorectomy or Subjects who are surgically menopausal.
    2. Subjects who have an estradiol plasma concentration of less than 40pg/mL and a free plasma testosterone concentration <0.9pg/mL. Estradiol levels are only required in subjects not taking estrogen-containing oral contraception.
    3. Subjects with a recent (past 6 months) history of alcohol or controlled substance abuse.
    4. Subjects who have given birth in the previous 6 months, are pregnant, lactating or planning to become pregnant during this study.
    5. Subjects with recent (past 3 months) exacerbation of pelvic inflammatory disease, a recent untreated vaginal infection, salpingitis, or other severe or chronic gynecologic disease.
    6. 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.
    7. Subjects who have a history of gynaecological malignancy or those with recent abnormal cervical cytology suggestive of neoplastic changes.
    8. Subjects who drink more than 21 units of alcohol per week. (1 unit = 285mls of beer or 25ml of spirits or 125ml of wine).
    9. Subjects with a history of involuntary movement disorders.
    10. Subjects with any clinically significant abnormality following review of pre-study laboratory data and full physical examination.
    11. Subjects who, in the opinion of the PI, 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.
    12. In the opinion of the investigator, a subject who is not likely to complete the study for what ever reason.
    FSAD subject group
    13. Acceptable contraception includes, but is not limited to; oral contraceptives, IUDs, documented history of surgical sterilization, condoms or partner vasectomy. Unacceptable contraception includes, but is not limited to; withdrawal method, rhythm method or spermicides. (This criterion will only apply to subjects recruited for Part B of the study.)
    14. Subjects who suffer from HSDD as determined by the SFQ and subsequent semi-structured interview.
    15. Subjects whose sexual dysfunction is considered to be situational, i.e. limited to certain types of stimulation, situation or specific partners.
    16. Subjects who have significant dyspareunia, which is due to an inflammatory or anatomical condition (e.g. pelvic inflammatory disease, vulvovestibulitis, fibroids).
    17. Subjects who have received treatment for any major psychiatric disorder (e.g. 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 buproprion.
    18. Subjects who are currently receiving Hormone Replacement Treatment.
    19. Subjects who are currently receiving medication known to interact with NEP-inhibitors such as ACE inhibitors. (This criterion will only apply to subjects recruited for Part B of the study.)
    20. Subjects who suffers from hypo– or hypertension (treated as well as untreated) or have a resting supine blood pressure below 90/45mmHg or above 140/90 or who show a postural drop in either systolic blood pressure of >20mmHg and diastolic blood pressure of >10mmHg at screening. (This criterion will only apply to subjects recruited for Part B of the study.)
    21. 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.
    22. Subjects with otherwise treatable causes of FSAD including inadequately controlled diabetes, thyroid dysfunction or clinical significant hyperprolactinemia.
    23. Subjects who currently participate in a structured psychosexual therapy program.
    24. Subjects who have undergone major surgery in the past 6 months.
    25. Subjects with any clinically significant abnormality from the screening physical examination.
    Healthy Volunteer group:
    26. Subjects who are taking, or have taken, any prescribed or over the counter drug (with the exception of simple analgesics, oral contraceptives and simple vitamin and mineral supplements) in the three weeks prior to the first study period. Subjects who are taking other concomitant therapies than these may be enrolled, but this must be discussed and agreed with Pfizer prior to enrollment.
    27. Subjects with evidence of a female sexual disorder as determined by the Female SFQ.
    E.5 End points
    E.5.1Primary end point(s)
    Part A:
    VPA mean change from baseline to mean VSS as measured by VPP.
    VPA mean change from baseline to maximum level during VSS as measured by VPP.

    Part B:
    VPA mean change from pre-dose baseline to mean VSS as measured by VPP.
    VPA mean change from pre-dose baseline to maximum level during VSS as measured by VPP.
    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 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) 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 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.8.6 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 years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2004-08-02. Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 40
    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 physical examination, supine blood pressure and pulse rate, urine pregnancy test and laboratory safety tests (haematology, clinical chemistry and urinalysis) will be performed 7-14 days following the final dose.
    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 Decision2004-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-09-22
    P. End of Trial
    P.End of Trial StatusCompleted
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