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    Summary
    EudraCT Number:2016-004188-38
    Sponsor's Protocol Code Number:PHX401-14
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-28
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-004188-38
    A.3Full title of the trial
    Contraceptive Efficacy, Tolerance and Acceptability of A Benzalkonium Chloride Spermicide Cream In Women Aged Over 40 Years of Age - PHASE IV, INTERNATIONAL, OPEN-LABEL, MULTICENTRE, PROSPECTIVE STUDY
    Efficacité contraceptive, tolérance et acceptabilité d’un spermicide contenant du chlorure de benzalkonium chez les femmes de 40 ans et plus - ETUDE DE PHASE IV, INTERNATIONALE, EN OUVERT, MULTICENTRIQUE et PROSPECTIVE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Contraceptive Efficacy, Tolerance and Acceptability of A Benzalkonium Chloride Spermicide Cream In Women Aged Over 40 Years of Age
    Efficacité contraceptive, tolérance et acceptabilité d’un spermicide contenant du chlorure de benzalkonium chez les femmes de 40 ans et plus
    A.3.2Name or abbreviated title of the trial where available
    BZK40+
    BZK40+
    A.4.1Sponsor's protocol code numberPHX401-14
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLABORATOIRE INNOTECH INTERNATIONAL
    B.1.3.4CountryFrance
    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 supportLABORATOIRE INNOTECH INTERNATIONAL
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLABORATOIRE INNOTECH INTERNATIONAL
    B.5.2Functional name of contact pointMedical Affairs Department
    B.5.3 Address:
    B.5.3.1Street Address22 avenue Aristide Briand
    B.5.3.2Town/ cityARCUEIL
    B.5.3.3Post code94110
    B.5.3.4CountryFrance
    B.5.4Telephone number33146151883
    B.5.5Fax number33146151901
    B.5.6E-mailbzk40@innothera.com
    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 Yes
    D.2.1.1.1Trade name Pharmatex® 1.2% vaginal cream
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRE INNOTECH INTERNATIONAL
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Vaginal cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBENZALKONIUM CHLORIDE
    D.3.9.3Other descriptive nameBENZALKONIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB00714MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.2
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The current study is conducted in adult women over 40 years of age who need a contraceptive method and who accept to use a spermicide, according to the following inclusion/exclusion criteria and after the signature of the informed consent form.
    Only outpatients (women) are included in the study.
    E.1.1.1Medical condition in easily understood language
    The current study is conducted in adult women over 40 years of age who need a contraceptive method and who accept to use a spermicide.
    E.1.1.2Therapeutic area Body processes [G] - Chemical Phenomena [G02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10067045
    E.1.2Term Chemical contraception
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the contraceptive efficacy of a benzalkonium chloride spermicide (Pharmatex® cream) expressed by the Pearl Index (PI) over up to 12 months of typical use in women over 40 years of age (the Pearl Index is defined as the number of unintended pregnancies per 100 woman-years of a contraceptive method’s use).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    - Assessment of the contraceptive efficacy of this benzalkonium chloride spermicide (Pharmatex® cream) expressed by the Pearl Index (PI) over up to 12 months of perfect use and over up to 6 months of typical and perfect use,
    - Assessment of the contraceptive efficacy of this benzalkonium chloride spermicide (Pharmatex® cream) expressed by rate of pregnancy over up to 6 months and over up to 12 months of typical and perfect use,
    - Assessment of the tolerance of this benzalkonium chloride spermicide (Pharmatex® cream) in women over 40 years of age,
    - Assessment of the acceptability of this benzalkonium chloride spermicide (Pharmatex® cream) in women over 40 years of age.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Women ≥ 40 years of age, fertile, having had at least one menstrual cycle in the course of the last three months
    2. Women who need a contraceptive method and who accept to use a spermicide for at least 6 months
    3. Women who have a negative pregnancy test at inclusion (the urinary pregnancy test should be performed at investigator’s office then confirmed by a blood test performed in a local laboratory (quantitative beta hCG dosage))
    4. Women who accept to comply with the requirements of the protocol including visits assessments and diary completion after each sexual intercourse
    5. Women who have had a normal smear test < 3 years
    6. Women affiliated to a public health insurance coverage
    7. Women who have read, understood, dated and signed the informed consent form
    E.4Principal exclusion criteria
    1. Women who are not able to understand a birth control method with Pharmatex® cream
    2. Women who have had an unprotected sexual intercourse within 7 days before the Baseline Visit
    3. Allergy or hypersensitivity to one of the components of Pharmatex® cream
    4. Medical contraindication to pregnancy
    5. Abnormal results of cervico-vaginal and/or vulvo-vaginal clinical examination (e.g. severe atrophic vaginitis etc.)
    6. Women with history of > 2 induced abortions during lifetime (miscarriages and spontaneous abortions are not included)
    7. Women with history of infectious vaginitis within the last 6 months
    8. Women treated for STI within the last three months
    9. HIV positive women and high-risk women for HIV
    10. Breastfeeding women
    11. Women participating or having participated in a clinical trial within four weeks prior to inclusion
    12. Women deprived of liberty by a legal or administrative decision
    E.5 End points
    E.5.1Primary end point(s)
    EFFICACY
    Contraceptive efficacy of Pharmatex® cream expressed by the Pearl Index (PI) over up to 12 months of typical use. The Pearl Index is defined as the number of unintended pregnancies per 100 woman-years of a contraceptive method’s use.
    • Success: no fertilisation
    • Failure: unintended fertilisation (pregnancy or aborted pregnancy)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary end points over up to 12 months
    E.5.2Secondary end point(s)
    Efficacy Endpoints
    1. Contraceptive efficacy of Pharmatex® cream expressed by the Pearl Index (PI) over up to 12 months of perfect use
    2. Contraceptive efficacy of Pharmatex® cream expressed by the Pearl Index (PI) at Visit 3 (M6) over up to 6 months of typical use
    3. Contraceptive efficacy of Pharmatex® cream expressed by the Pearl Index (PI) at Visit 3 (M6) over up to 6 months of perfect use
    4. Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 6 months of typical use at Visit 3 (M6)
    5. Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 6 months of perfect use at Visit 3 (M6)
    6. Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 12 months of typical use at Visit 4 (M12)
    7. Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 12 months of perfect use at Visit 4 (M12)

    Tolerance Endpoints
    1. Number and percentage of adverse events during the study and causal role of study treatment

    Acceptability Endpoints
    1. Evaluation of the acceptability of the treatment by percentage of continuation until the end of follow-up (at 6 months for all the women and at 12 months for women who have accepted to continue at visit 3 (M6))
    2. Evaluation of the acceptability of the treatment through adherence: systematic use of benzalkonium chloride spermicide before each event of sexual intercourse recorded in the self-evaluation diary
    3. Evaluation of the acceptability of the treatment (ease of use) evaluated through the self-evaluation diary (Likert scale) up to M6 (V3) and up to M12 (V4) for women who have continued for 12 months
    4. Evaluation of the acceptability of the treatment through the lubricating effect at the end of study visit: V3 (M6), or V4 (M12) or at intermediate visit in case of early withdrawal
    5. Evaluation of the global satisfaction of the treatment by the woman at V2 (M2), V3 (M6) and V4 (M12) and during phone contacts PC1 (M1), PC2 (M4) and PC3 (M9)
    6. Evaluation of the global satisfaction of the treatment by the investigator at V2 (M2), V3 (M6) and V4 (M12).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end points over up to 6 or 12 months
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    acceptability
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    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.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States No
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    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
    The End of study Visit is performed 6 months after the Baseline Visit if the woman is not interested in a follow-up during 12 months (Visit 3) or 12 months after the Baseline Visit if the woman is interested in a follow-up during 12 months (Visit 4).
    The clinical trial will end when all the women included have performed their End of Study Visit.
    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 months6
    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 months6
    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.1.2.1Number of subjects for this age range: 150
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 150
    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)
    At the End of Study Visit, an urinary pregnancy test will be performed.
    If the test is negative, no follow-up of the woman is planned.
    If the test is positive, the woman's pregnancy will be followed-up until her delivery.
    A la visite de fin d'étude, un test urinaire de grossesse est réalisé.
    Si le test est négatif, aucun suivi de la femme n'est prévu.
    Si le test est positif, la grossesse de la femme sera suivie jusqu'à son terme.
    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 Decision2017-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-17
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