Bacterial vaginosis MedDRA version: 20.1 Level: PT Classification code 10004055 Term: Bacterial vaginosis System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Medinova AG
Eligibility
Sex/Gender
All
Inclusion 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
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 11. 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) 12. Participation of patient in another investigational drug study concomitantly or within 30 days prior to entry in the study 13. Patient is relative of, or staff directly reporting to, the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether vaginal tablets containing 10 mg dequalinium chloride (Fluomizin) are comparable in clinical efficacy to metronidazole 500 mg oral tablets in women suffering from bacterial vaginosis;Secondary Objective: •To assess the clinical, bacteriological, and therapeutic cure rate on short-term and/or long-term follow-up • To evaluate subjective assessment of efficacy and tolerability • To further explore the safety profile of Fluomizin in this patient population;Primary end point(s): The primary efficacy variable is the clinical cure rate at C1 (8 to 10 days after randomization) defined as all Amsel criteria (greyish white thin discharge; KOH test or ‘fishy’ smell; presence of > 20% clue cells; vaginal pH > 4.5) are negative excluding the pH.;Timepoint(s) of evaluation of this end point: at C1 (8 to 10 days after randomization) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Clinical cure rate at follow-up (at C2 = at 24 to 30 days after randomization) 2. Bacteriological cure rate at C1 and C2 3. Therapeutic cure rate at C1 and C2 4. Individual Amsel criteria at C1 and C2 5. The development of the Nugent Score within 3 categories, i.e. (1) cured, (2) intermediate, and (3) BV positive 6. Subjective assessment of efficacy 7. Incidence of adverse events 8. Subjective assessment of tolerability;Timepoint(s) of evaluation of this end point: at C1 (8 to 10 days after randomization) and at C2 (24 to 30 days after randomization) | — |
Countries
Slovakia
Contacts
Public ContactDirector
Medinova AG
Outcome results
None listed