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OpenTrials
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NCT Number: NCT02444481

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Polygynax combinaison of polymyxin, Neomycin and Nystatin

Drug

Primary outcomes

  1. Clinical efficacy on clinical symptoms as judged by the investigator

    Time frame: 14 days

    Clinical efficacy is judged upon symptoms

Secondary outcomes

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

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Laboratoire Innotech International

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 14, 2015
Registry last updated
May 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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