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

NCT02444481 | Completed Phase 4

• 1 other identifier: PGX401-08
• Study Type: interventional
• Target: 169
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vaginitis

Keywords

Mycotic Vaginitis

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy on clinical symptoms as judged by the investigator

  Clinical efficacy is judged upon symptoms

  14 days

Secondary Outcomes (1)

• Bacteriological efficacy on reduction of the presence of bacteria and /or fungus

  15 days

Study Arms (1)

Polygynax, antibiotic, vaginal treatment

EXPERIMENTAL

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

Interventions

Polygynax combinaison of polymyxin, Neomycin and Nystatin DRUG

Polygynax, antibiotic, vaginal treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Laboratoire Innotech International: lead

MeSH Terms

Conditions

Vaginitis

Interventions

Neomycin; Nystatin

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates; Macrolides; Lactones; Organic Chemicals

Study Officials

• Jean Marc Bohbot

  Institut Alfred Fournier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 14, 2015
• Study Start: April 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 14, 2015

Record last verified: 2015-05