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
About this trial
This is an interventional treatment trial for Vaginitis focused on measuring Mycotic Vaginitis
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,
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
NCT ID
NCT02444481
First Posted
May 14, 2013
Last Updated
May 11, 2015
Sponsor
Laboratoire Innotech International
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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