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

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ClinicalTrials.gov Identifier: NCT02444481
Recruitment Status : Completed
First Posted : May 14, 2015
Last Update Posted : May 14, 2015
Sponsor:
Information provided by (Responsible Party):
Laboratoire Innotech International

Study Description
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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.


Condition or disease Intervention/treatment Phase
Vaginitis Drug: Polygynax combinaison of polymyxin, Neomycin and Nystatin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Multicenter Clinical Study of the Efficacy of the Local Treatment With Polygynax of Mycotic and/or Bacterial Vaginitis
Study Start Date : April 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis

Arms and Interventions
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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.
 Drug: Polygynax combinaison of polymyxin, Neomycin and Nystatin


Outcome Measures
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Primary Outcome Measures :
  1. Clinical efficacy on clinical symptoms as judged by the investigator [ Time Frame: 14 days ]
    Clinical efficacy is judged upon symptoms


Secondary Outcome Measures :
  1. Bacteriological efficacy on reduction of the presence of bacteria and /or fungus [ Time Frame: 15 days ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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,
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444481


Sponsors and Collaborators
Laboratoire Innotech International
Investigators
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Principal Investigator: Jean Marc Bohbot Institut Alfred Fournier
More Information
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Responsible Party: Laboratoire Innotech International
ClinicalTrials.gov Identifier: NCT02444481    
Other Study ID Numbers: PGX401-08
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015
Keywords provided by Laboratoire Innotech International:
Mycotic Vaginitis
Additional relevant MeSH terms:
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Vaginitis
Vaginal Diseases
Nystatin
Polymyxins
Neomycin
Anti-Bacterial Agents
Anti-Infective Agents
 Antifungal Agents
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Enzyme Inhibitors