Open Study of the Efficacy of the Local Treatment With Polygynax of Bacterial and/or Mycotic Vaginitis
Information source: Laboratoire Innotech International
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vaginitis
Intervention: Polygynax combinaison of polymyxin, Neomycin and Nystatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Laboratoire Innotech International Official(s) and/or principal investigator(s): Jean Marc Bohbot, Principal Investigator, Affiliation: Institut Alfred Fournier
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.
Clinical Details
Official title: Open Multicenter Clinical Study of the Efficacy of the Local Treatment With Polygynax of Mycotic and/or Bacterial Vaginitis
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical efficacy on clinical symptoms as judged by the investigator
Secondary outcome: Bacteriological efficacy on reduction of the presence of bacteria and /or fungus
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
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,
Locations and Contacts
Additional Information
Starting date: April 2009
Last updated: May 11, 2015
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