MedTrace Logo

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

NCT02444481 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2015-05-14

No results posted yet for this study

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.

Conditions

  • Vaginitis

Interventions

DRUG

Polygynax combinaison of polymyxin, Neomycin and Nystatin

Sponsors & Collaborators

  • Laboratoire Innotech International

    lead INDUSTRY

Principal Investigators

  • Jean Marc Bohbot · Institut Alfred Fournier

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-11-30
Completion
2009-11-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02444481 on ClinicalTrials.gov