Bacterial Vaginosis Clinical Trial
Official title:
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
Verified date | March 2023 |
Source | Medinova AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clinical trial is to show the efficacy and safety of dequalinium chloride in the treatment of bacterial vaginosis compared to metronidazole.
Status | Terminated |
Enrollment | 151 |
Est. completion date | August 25, 2022 |
Est. primary completion date | August 25, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 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 |
Country | Name | City | State |
---|---|---|---|
Czechia | Centrum ambulantní gynekologie a primární péce, s.r.o. | Brno | |
Czechia | G-CENTRUM Olomouc s.r.o. | Olomouc | |
Czechia | Gynekologicko-porodnická ambulance | Ústí nad Labem | |
Czechia | GYNEKO spol. s r.o | Vsetín | |
Poland | NZOZ All-Med Centrum Medyczne | Lódz | |
Poland | Salve Medica Sp. z o. o. S. K. | Lódz | |
Poland | 1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ | Lublin | |
Poland | KO-MED CENTRA KLINICZNE Sp. z o.o. Osrodek | Lublin | |
Poland | Prywatny Gabinet Ginekologiczno-Polozniczy | Zurawica | |
Slovakia | GPN, s.r.o. | Bratislava | |
Slovakia | RADMA GYN s.r.o. | Bratislava | |
Slovakia | GYNEDUR s.r.o | Dubnica nad Vahom | |
Slovakia | MCM GYNPED s.r.o. | Dubnica Nad Váhom | |
Slovakia | GYNECARE s.r.o. | Puchov |
Lead Sponsor | Collaborator |
---|---|
Medinova AG |
Czechia, Poland, Slovakia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical cure rate | Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells | One week after randomization (C1) | |
Secondary | Clinical cure rate | Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells | One month after randomization (C2) | |
Secondary | Bacteriological cure rate | Nugent score =3 | One week & one month | |
Secondary | Therapeutic cure | Combination of clinical and bacteriological cures, | One week & one month | |
Secondary | Individual Amsel Criteria over time | greyish white thin discharge
Whiff test: 'fishy' smell with 10% KOH > 20% clue cells in saline wet mount vaginal pH > 4.5 |
One week & one month | |
Secondary | Nugent score over time | 0-3: normal flora 4-6: intermediate flora 7-10: bacterial vaginosis | One week & one month | |
Secondary | Subjective assessment of efficacy | Efficacy was assessed by patients and investigators as 'very good', good, moderare or 'poor'.
Patient satisfaction with the treatment ranged from 'very satisfied' to 'not satisfied' |
One week & one month | |
Secondary | Subjective assessment of tolerability | Tolerability was assessed by patients and investigators as 'very good', good, moderare or 'poor'.
Patient satisfaction with the treatment ranged from 'very satisfied' to 'not satisfied' |
One week & one month | |
Secondary | Adverse events | Up to end of study (one month) |
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