Open Multicenter Clinical Study of the Efficacy of the Local Treatment With Polygynax of Mycotic and/or Bacterial Vaginitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 169
- 主要终点
- Clinical efficacy on clinical symptoms as judged by the investigator
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years to 65 years
- •Agreeing to provide written informed consent
- •Presenting symptoms of vaginitis: unaccustomed leucorrhoea, pruritus, burning sensation on micturition, dyspareunia.
排除标准
- •Patients in menstrual period,
- •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,
研究组 & 干预措施
Polygynax, antibiotic, vaginal treatment
Polygynax combinaison of nystatine, polymyxin, neomycin, Local treatment of vaginal infection during 12 days. One vaginal capsule every evening.
干预措施: Polygynax combinaison of polymyxin, Neomycin and Nystatin (Drug)
结局指标
主要结局
Clinical efficacy on clinical symptoms as judged by the investigator
时间窗: 14 days
Clinical efficacy is judged upon symptoms
次要结局
- Bacteriological efficacy on reduction of the presence of bacteria and /or fungus(15 days)