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Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies. (Frauen)

Primary Purpose

Sexual Active Women, Vaginal Discharge

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Clotrimazole + Metronidazole
Metronidazole
Clotrimazole
Sponsored by
Ache Laboratorios Farmaceuticos S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Active Women focused on measuring vaginal, discharge, women

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects that have already started sexual activity;
  • Subjects with complaints of vaginal discharge and had not received treatment in the 30 days before the enrollment visit;
  • Subjects in the premenopausal period must be under usage of acceptable contraceptive methods(oral contraceptive, injectable contraceptives, IUD, hormonal implant, hormone transdermal adhesive, tubal ligation) or are surgically sterile (bilateral oophorectomy or hysterectomy); or accept to utilize a barrier contraceptive provided by the sponsor during the period of the study;
  • Subjects with the capacity to comprehend and understand her participation in this clinical trial, manifested through informed consent form, even if with the help of another person (Legal representative).

Exclusion Criteria:

  • Subjects with chronic diseases (diabetes mellitus, neoplasia, renal failure, tuberculosis) or any clinical and/or laboratory find (anamnesis, physical exam and/or laboratory tests) that is interpreted, in the investigator's opinion, as a risk to the subject's participation in the clinical trial;
  • Menopausal women;
  • Known hyper-sensibility to any of the products' components;
  • Pregnant or lactating women;
  • Subjects with active genital ulcer and/or with Genital herpes diagnosis;
  • Diagnosis or suspicion of Inflammatory pelvic disease;
  • Diagnosis of Vulvar condyloma acuminata;
  • Subjects under the usage of systemic corticosteroids for a period superior than 2 (two) months or under the usage of chemotherapeutics;
  • Transplanted subjects;
  • Subjects with history of active autoimmune diseases or with immune suppression;
  • Subjects under the usage of medication or therapy described on the protocol item "Prohibited Treatments";
  • Subjects that have participated on a clinical trial in the last 12 months (Conselho Nacional de Saúde - Resolução 251, de 7 de agosto de 1997, item III, sub-item J), unless the subject can have a direct benefit, in the investigator opinion;
  • Subject that have a kinship or bond with any employees of Sponsor or Research center;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Colpistatin 5DT

    Gynecological Flagyl

    Gino-Canesten 3

    Arm Description

    Outcomes

    Primary Outcome Measures

    Ceasing of the symptoms of vaginal discharge after 3(three) days of the end of the treatment
    Examination of the breasts and internal and external examination of the female genital organ.

    Secondary Outcome Measures

    Registry of Adverse Effects occurrence throughout the study
    Evaluation of Clinical and Physical examination and the measure of vital signs; Evaluation of Adverse effects; Evaluation of Laboratory exams; And evaluation of urine beta-hcg test.
    Vaginal microflora reconstitution through microbiological evaluation of vaginal material
    Evaluation of the collected vaginal material with the microbiological tests(Whiff, Gram, Affirm VPIII) and PCR.
    Symptomatology recurrence and/or vaginal microflora alteration 30 days after the treatment's end
    Examination of the breasts and internal and external examination of the female genital organ. Evaluation of the collected vaginal material with the microbiological tests(Whiff, Gram, Affirm VPIII) and PCR.

    Full Information

    First Posted
    March 15, 2016
    Last Updated
    March 15, 2016
    Sponsor
    Ache Laboratorios Farmaceuticos S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02713139
    Brief Title
    Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies.
    Acronym
    Frauen
    Official Title
    Phase III, Multicenter, Randomized, Parallel, Open Label, Controlled and Comparative Study to Evaluate the Efficacy and Safety of the Association of Clotrimazole 200mg and Metronidazole 0,75% (Colpistatin 5DT®) Compared to Gynecological Flagyl®(Metronidazole 100mg/g) and the Vaginal Cream Gino-Canesten® 3 (Clotrimazole 20mg/g) in the Syndromic Treatment of the Vaginal Discharge From Different Etiologies.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Due to budget limitations, the company decided to withdraw this study.
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    March 2014 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ache Laboratorios Farmaceuticos S.A.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the efficacy and safety of the association clotrimazole 200mg and metronidazole 0,75%(Clopistatin 5DT®) and whether it is superior when compared with metronidazole 100mg/g (gynecologic Flagyl®) and clotrimazole 20mg/g (Gino-Canesten® 3) in the syndromic treatment of vaginal discharge from different etiologies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sexual Active Women, Vaginal Discharge
    Keywords
    vaginal, discharge, women

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Colpistatin 5DT
    Arm Type
    Experimental
    Arm Title
    Gynecological Flagyl
    Arm Type
    Active Comparator
    Arm Title
    Gino-Canesten 3
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Clotrimazole + Metronidazole
    Intervention Description
    Vaginal cream with Clotrimazole 200mg and Metronidazole 0,75%. Apply once per day, before bedtime, for 5 (five) days.
    Intervention Type
    Drug
    Intervention Name(s)
    Metronidazole
    Intervention Description
    Vaginal gel with Metronifdazole 100mg/g. Apply once per day, before bedtime, for 10(ten) days.
    Intervention Type
    Drug
    Intervention Name(s)
    Clotrimazole
    Intervention Description
    Vaginal cream with Clotrimazole 20mg/g. Apply once per day, before bedtime, for 3 (three) days.
    Primary Outcome Measure Information:
    Title
    Ceasing of the symptoms of vaginal discharge after 3(three) days of the end of the treatment
    Description
    Examination of the breasts and internal and external examination of the female genital organ.
    Time Frame
    From baseline to 3 days after the end of the treatment
    Secondary Outcome Measure Information:
    Title
    Registry of Adverse Effects occurrence throughout the study
    Description
    Evaluation of Clinical and Physical examination and the measure of vital signs; Evaluation of Adverse effects; Evaluation of Laboratory exams; And evaluation of urine beta-hcg test.
    Time Frame
    From baseline to 30 days after the end of the treatment
    Title
    Vaginal microflora reconstitution through microbiological evaluation of vaginal material
    Description
    Evaluation of the collected vaginal material with the microbiological tests(Whiff, Gram, Affirm VPIII) and PCR.
    Time Frame
    From baseline to 30 days after treatment's end
    Title
    Symptomatology recurrence and/or vaginal microflora alteration 30 days after the treatment's end
    Description
    Examination of the breasts and internal and external examination of the female genital organ. Evaluation of the collected vaginal material with the microbiological tests(Whiff, Gram, Affirm VPIII) and PCR.
    Time Frame
    From baseline to 30 days after treatment's end

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects that have already started sexual activity; Subjects with complaints of vaginal discharge and had not received treatment in the 30 days before the enrollment visit; Subjects in the premenopausal period must be under usage of acceptable contraceptive methods(oral contraceptive, injectable contraceptives, IUD, hormonal implant, hormone transdermal adhesive, tubal ligation) or are surgically sterile (bilateral oophorectomy or hysterectomy); or accept to utilize a barrier contraceptive provided by the sponsor during the period of the study; Subjects with the capacity to comprehend and understand her participation in this clinical trial, manifested through informed consent form, even if with the help of another person (Legal representative). Exclusion Criteria: Subjects with chronic diseases (diabetes mellitus, neoplasia, renal failure, tuberculosis) or any clinical and/or laboratory find (anamnesis, physical exam and/or laboratory tests) that is interpreted, in the investigator's opinion, as a risk to the subject's participation in the clinical trial; Menopausal women; Known hyper-sensibility to any of the products' components; Pregnant or lactating women; Subjects with active genital ulcer and/or with Genital herpes diagnosis; Diagnosis or suspicion of Inflammatory pelvic disease; Diagnosis of Vulvar condyloma acuminata; Subjects under the usage of systemic corticosteroids for a period superior than 2 (two) months or under the usage of chemotherapeutics; Transplanted subjects; Subjects with history of active autoimmune diseases or with immune suppression; Subjects under the usage of medication or therapy described on the protocol item "Prohibited Treatments"; Subjects that have participated on a clinical trial in the last 12 months (Conselho Nacional de Saúde - Resolução 251, de 7 de agosto de 1997, item III, sub-item J), unless the subject can have a direct benefit, in the investigator opinion; Subject that have a kinship or bond with any employees of Sponsor or Research center;
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eduardo A. Junior, MD
    Organizational Affiliation
    Scentryphar Pesquisa Clínica Ltda
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies.

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