Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis
Bacterial Vaginosis, Vaginal Infection, Vaginal Diseases
About this trial
This is an interventional treatment trial for Bacterial Vaginosis focused on measuring bacterial vaginosis, dequalinium chloride, metronidazole, vaginal infection treatment, comparative study, non inferiority
Eligibility Criteria
Inclusion Criteria: Premenopausal woman ≥18 years 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) Signed Written Informed Consent to participate in this study Exclusion Criteria: Pregnancy and/or lactation based on urine Pregnancy test (women with childbearing potential should use any contraception excluding vaginal methods like vaginal ring, etc.) Uterine bleeding (including menstruation) or vaginal bleeding of unknown origin Ulcerations/erosions of vaginal mucosa or cervix uteri Patients with clinical symptoms and findings of Candida vulvovaginitis and/or Aerobic vaginitis Clinically manifest or suspicion of STIs (Neisseria gonorrhoeae, Chlamydia trachomatis, or Trichomonas vaginalis) based on signs, symptoms, and anamnesis Use of any antimicrobial treatment (local or systemic) 14 days before entry the study Use of any vaginal medication or vaginal douching 7 days before entry the study Unwillingness to refrain from alcohol consumption during treatment, and 48 hours after treatment Severe systemic diseases (HIV, cancer, tuberculosis, autoimmune diseases, diabetes mellitus, severe psychiatric conditions, etc.), including diseases treated with immunosuppressive therapies, systemic corticosteroids, or warfarin Known or suspected hypersensitivity to one of the study medications, inclusive of their excipients Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant (including inability to fill-in electronic patient diary) Participation of patient in another investigational drug study concomitantly or within 30 days prior to entry in the study Patient is relative of, or staff directly reporting to, the investigator
Sites / Locations
- Centrum ambulantní gynekologie a primární péče, s.r.o.
- G-CENTRUM Olomouc s.r.o.
- GYNEKO spol. s r.o
- Gynekologicko-porodnická ambulance
- 1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
- KO-MED CENTRA KLINICZNE Sp. z o.o. Ośrodek
- Salve Medica Sp. z o. o. S. K.
- NZOZ All-Med Centrum Medyczne
- Prywatny Gabinet Ginekologiczno-Położniczy
- GPN, s.r.o.
- RADMA GYN s.r.o.
- GYNEDUR s.r.o
- MCM GYNPED s.r.o.
- GYNECARE s.r.o.
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Dequalinium chloride
Metronidazole
Dequalinium chloride 10 mg vaginal tablets
Metronidazole 500 mg oral tablets