- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02444481
Open Study of the Efficacy of the Local Treatment With Polygynax of Bacterial and/or Mycotic Vaginitis
Open Multicenter Clinical Study of the Efficacy of the Local Treatment With Polygynax of Mycotic and/or Bacterial Vaginitis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Polygynax, antibiotic, vaginal treatment
Polygynax combinaison of nystatine, polymyxin, neomycin, Local treatment of vaginal infection during 12 days.
One vaginal capsule every evening.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical efficacy on clinical symptoms as judged by the investigator
Time Frame: 14 days
|
Clinical efficacy is judged upon symptoms
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bacteriological efficacy on reduction of the presence of bacteria and /or fungus
Time Frame: 15 days
|
15 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jean Marc Bohbot, Institut Alfred Fournier
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PGX401-08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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