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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05788991
Other study ID # MNFM380119
Secondary ID 2020-002489-15
Status Terminated
Phase Phase 4
First received
Last updated
Start date July 26, 2021
Est. completion date August 25, 2022

Study information

Verified date March 2023
Source Medinova AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Eligible patients who signed informed consent were randomized to receive treatment with either dequalinium chloride (+ oral placebo) or metronidazole (+ vaginal placebo) for up to 7 days. Primary objective was clinical cure rate at one week after start of treatment. Control visits to assess outcomes were done after end of treatment and after one month.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Dequalinium Chloride
Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
Metronidazole Oral
Metronidazole oral tablets (500 mg) taken twice a day for 7 days

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Medinova AG

Countries where clinical trial is conducted

Czechia,  Poland,  Slovakia, 

Outcome

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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