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Open Study of the Efficacy of the Local Treatment With Polygynax of Bacterial and/or Mycotic Vaginitis

Primary Purpose

Vaginitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Polygynax combinaison of polymyxin, Neomycin and Nystatin
Sponsored by
Laboratoire Innotech International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginitis focused on measuring Mycotic Vaginitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female
  • Aged 18 years to 65 years
  • Agreeing to provide written informed consent
  • Presenting symptoms of vaginitis: unaccustomed leucorrhoea, pruritus, burning sensation on micturition, dyspareunia.

Exclusion Criteria:

  • Patients in menstrual period,
  • Virgins,
  • Clinically detectable sexually transmissible infections (STI): genital lesions, evocative leucorrhoea, recent history of STI (< 3 months), known STI in partner,
  • Sexually transmissible disease, including HIV,
  • Pregnancy,
  • Breastfeeding,
  • Known allergy or hypersensitivity to the treatment or to any of the ingredients of the treatment, and in particular, hypersensitivity to soya oil,
  • Use of male or female condoms,
  • Use of spermicide,
  • Use of diaphragm,
  • Clinical symptoms of non-sensitive bacterial vaginosis: runny and unpleasant smelling leucorrhoea suggesting Gardnerella vaginalis vaginitis,
  • Concomitant topical or systemic anti-infective treatment,
  • Topical or systemic anti-infective treatment in the 14 days prior to the study,
  • Immunodepression or any other major disease rendering completion of the study or interpretation of the study results difficult,
  • Immunosuppressant therapy,
  • Chemotherapy,
  • Participation in another clinical trial in the month prior to the study,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Polygynax, antibiotic, vaginal treatment

    Arm Description

    Polygynax combinaison of nystatine, polymyxin, neomycin, Local treatment of vaginal infection during 12 days. One vaginal capsule every evening.

    Outcomes

    Primary Outcome Measures

    Clinical efficacy on clinical symptoms as judged by the investigator
    Clinical efficacy is judged upon symptoms

    Secondary Outcome Measures

    Bacteriological efficacy on reduction of the presence of bacteria and /or fungus

    Full Information

    First Posted
    May 14, 2013
    Last Updated
    May 11, 2015
    Sponsor
    Laboratoire Innotech International
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02444481
    Brief Title
    Open Study of the Efficacy of the Local Treatment With Polygynax of Bacterial and/or Mycotic Vaginitis
    Official Title
    Open Multicenter Clinical Study of the Efficacy of the Local Treatment With Polygynax of Mycotic and/or Bacterial Vaginitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2009 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Laboratoire Innotech International

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Open prospective multicenter phase IV study in patients presenting with symptoms of bacterial and/or mycotic (mushroom) vaginitis for 12 days as specified in the product information. Investigators/centers: 20 gynacologists are previewed to do the study in ambulatory treatment. Objectifs of the study: Principal objectif: Evaluation of the efficacy of the treatment on the clinical symptoms of bacterial and/or mycotic vaginitis Secondary objectif: Evaluation of the efficacy of the treatment on eradication of the diagnosed germs Evaluation of the correspondence of the efficacy on the symptoms and on the eradication of the germs. Numbers of patients previewed: 100 patients for evaluation of the efficacy Criteria of evaluation Principal criteria: Clinical efficacy as judged by the investigator Secondary criteria:evaluation of clinical symptoms judged by the patient reduction or emlimination of bacteria and other germs the relationship between clinical and bacterial results Evaluation of tolerance Used Study Drug: Polygynax, vaginal capsule consisting of Polymyxin 35000 UI, Neomycin 35000UI and Nystatin 100000UI Application: vaginal application once daily in the evening for 12 days Study design: Visit 1: All patients presenting with the clinical symptoms, presenting all inclusion criteria and none of the exclusion criteria are included in the study at visit 1 and receive Polygynax treatment (one vaginal capsule once daily in the evening). A vaginal smear is obtained. Visit 2 (optional) If the results of the bacteriological examination confirms an infection with germs sensible to the treatment with Polygynax the treatment is continued. If other germs not sensible to Polygynax are present, the patients is contacted to stop the treatment, to come back to a second visit to her gynacologist who will change the treatment. The other patients continue the treatment. Visit 3: After the treatment the patients come back to the last visit. A clinical evaluation and a vaginal smear for control is obtained.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vaginitis
    Keywords
    Mycotic Vaginitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    169 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Polygynax, antibiotic, vaginal treatment
    Arm Type
    Experimental
    Arm Description
    Polygynax combinaison of nystatine, polymyxin, neomycin, Local treatment of vaginal infection during 12 days. One vaginal capsule every evening.
    Intervention Type
    Drug
    Intervention Name(s)
    Polygynax combinaison of polymyxin, Neomycin and Nystatin
    Primary Outcome Measure Information:
    Title
    Clinical efficacy on clinical symptoms as judged by the investigator
    Description
    Clinical efficacy is judged upon symptoms
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    Bacteriological efficacy on reduction of the presence of bacteria and /or fungus
    Time Frame
    15 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female Aged 18 years to 65 years Agreeing to provide written informed consent Presenting symptoms of vaginitis: unaccustomed leucorrhoea, pruritus, burning sensation on micturition, dyspareunia. Exclusion Criteria: Patients in menstrual period, Virgins, Clinically detectable sexually transmissible infections (STI): genital lesions, evocative leucorrhoea, recent history of STI (< 3 months), known STI in partner, Sexually transmissible disease, including HIV, Pregnancy, Breastfeeding, Known allergy or hypersensitivity to the treatment or to any of the ingredients of the treatment, and in particular, hypersensitivity to soya oil, Use of male or female condoms, Use of spermicide, Use of diaphragm, Clinical symptoms of non-sensitive bacterial vaginosis: runny and unpleasant smelling leucorrhoea suggesting Gardnerella vaginalis vaginitis, Concomitant topical or systemic anti-infective treatment, Topical or systemic anti-infective treatment in the 14 days prior to the study, Immunodepression or any other major disease rendering completion of the study or interpretation of the study results difficult, Immunosuppressant therapy, Chemotherapy, Participation in another clinical trial in the month prior to the study,
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jean Marc Bohbot
    Organizational Affiliation
    Institut Alfred Fournier
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Open Study of the Efficacy of the Local Treatment With Polygynax of Bacterial and/or Mycotic Vaginitis

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