EUCTR2020-002489-15-SK
Active, not recruiting
Phase 1
Comparative study of the efficacy and safety of vaginally applied Dequalinium Chloride (10 mg) and orally applied Metronidazole (2 x 500 mg) in the treatment of bacterial vaginosis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medinova AG
- Enrollment
- 236
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Premenopausal woman \=18 years
- •2\. Diagnosis of bacterial vaginosis (all 4 Amsel criteria positive, i.e. 1\) greyish white thin discharge, 2\) KOH test or ‘fishy’ smell, 3\) microscopic presence of \> 20% clue cells, 4\) vaginal pH \> 4\.5\)
- •3\. Signed Written Informed Consent to participate in this study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 236
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\. Pregnancy and/or lactation based on urine Pregnancy test (women with childbearing potential should use any contraception excluding vaginal methods like vaginal ring, etc.)
- •2\. Uterine bleeding (including menstruation) or vaginal bleeding of unknown origin
- •3\. Ulcerations/erosions of vaginal mucosa or cervix uteri
- •4\. Patients with clinical symptoms and findings of Candida vulvovaginitis and/or Aerobic vaginitis
- •5\. Clinically manifest or suspicion of STIs (Neisseria gonorrhoeae, Chlamydia trachomatis, or Trichomonas vaginalis) based on signs, symptoms, and anamnesis
- •6\. Use of any antimicrobial treatment (local or systemic) 14 days before entry the study
- •7\. Use of any vaginal medication or vaginal douching 7 days before entry the study
- •8\. Unwillingness to refrain from alcohol consumption during treatment, and 48 hours after treatment
- •9\. Severe systemic diseases (HIV, cancer, tuberculosis, autoimmune diseases, diabetes mellitus, severe psychiatric conditions, etc.), including diseases treated with immunosuppressive therapies, systemic corticosteroids, or warfarin
- •10\. Known or suspected hypersensitivity to one of the study medications, inclusive of their excipients
Outcomes
Primary Outcomes
Not specified
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