Clinical trial NCT02444481: Open Study of the Efficacy of the Local Treatment With Polygynax of Bacterial and/or Mycotic Vaginitis
Official title: Open Multicenter Clinical Study of the Efficacy of the Local Treatment With Polygynax of Mycotic and/or Bacterial Vaginitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaginitis
Keywords: Mycotic Vaginitis
Lead sponsor: Laboratoire Innotech International
Sponsor class: INDUSTRY
First posted: 2015-05-14
Enrollment: 169
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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,

Primary outcomes:
measure: Clinical efficacy on clinical symptoms as judged by the investigator
timeFrame: 14 days
Secondary outcomes:
measure: Bacteriological efficacy on reduction of the presence of bacteria and /or fungus
timeFrame: 15 days
Other outcomes:
Locations:
Study officials:
affiliation: Institut Alfred Fournier
name: Jean Marc Bohbot
role: PRINCIPAL_INVESTIGATOR
References: