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Open Multicenter Clinical Study of the Efficacy of the Local Treatment With Polygynax of Mycotic and/or Bacterial Vaginitis
Sponsor study identifier
interventional
169
0 countries
N/A
Study Start
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2009
Actual (reported)Study Completion
November 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 2009
Actual (reported)November 2009
Actual (reported)May 14, 2013
Actual (reported)May 14, 2015
Actual (reported)Clinical efficacy on clinical symptoms as judged by the investigator
Clinical efficacy is judged upon symptoms
14 days
Bacteriological efficacy on reduction of the presence of bacteria and /or fungus
15 days
Polygynax combinaison of nystatine, polymyxin, neomycin, Local treatment of vaginal infection during 12 days. One vaginal capsule every evening.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Polygynax combinaison of polymyxin, Neomycin and Nystatin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordJean Marc Bohbot
Institut Alfred Fournier
169 participants (actual enrollment reported by the registry).
First Submitted
May 14, 2013
First Posted
May 14, 2015
Study Start
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
November 2009
Actual (reported)Study Completion
November 2009
Actual (reported)Last Updated
May 14, 2015
Record last verified: 2015-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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