Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis

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

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.

Study Overview

• Status: Terminated
• Conditions: Vaginal Diseases; Bacterial Vaginosis; Vaginal Infection
• Intervention / Treatment: Drug: Dequalinium Chloride; Drug: Metronidazole Oral

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Phase 4

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 602 00
    • Centrum ambulantní gynekologie a primární péče, s.r.o.
  • Olomouc, Czechia, 772 00
    • G-CENTRUM Olomouc s.r.o.
  • Vsetín, Czechia, 775 01
    • GYNEKO spol. s r.o
  • Ústí nad Labem, Czechia, 400 01
    • Gynekologicko-porodnická ambulance
• Poland
  • Lublin, Poland
    • 1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
  • Lublin, Poland
    • KO-MED CENTRA KLINICZNE Sp. z o.o. Ośrodek
  • Łódź, Poland, 91-211
    • Salve Medica Sp. z o. o. S. K.
  • Łódź, Poland
    • NZOZ ALL-MED Centrum Medyczne
  • Żurawica, Poland, 37-710
    • Prywatny Gabinet Ginekologiczno-Położniczy
• Slovakia
  • Bratislava, Slovakia
    • GPN, s.r.o.
  • Bratislava, Slovakia
    • RADMA GYN s.r.o.
  • Dubnica Nad Váhom, Slovakia
    • MCM GYNPED s.r.o.
  • Dubnica nad Vahom, Slovakia
    • GYNEDUR s.r.o
  • Puchov, Slovakia
    • GYNECARE s.r.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dequalinium chloride; Dequalinium chloride 10 mg vaginal tablets	Drug: Dequalinium Chloride; Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days; Other Names: Fluomizin
Active Comparator: Metronidazole; Metronidazole 500 mg oral tablets	Drug: Metronidazole Oral; Metronidazole oral tablets (500 mg) taken twice a day for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cure rate	Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells	One week after randomization (C1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cure rate	Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells	One month after randomization (C2)
Bacteriological cure rate	Nugent score ≤3	One week & one month
Therapeutic cure	Combination of clinical and bacteriological cures,	One week & one month
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
Nugent score over time	0-3: normal flora 4-6: intermediate flora 7-10: bacterial vaginosis	One week & one month
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
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
Adverse events		Up to end of study (one month)

Collaborators and Investigators

• Sponsor: Medinova AG
• Investigators: Study Director: Philipp Grob, PhD, Medinova AG

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2021
• Primary Completion (Actual): August 25, 2022
• Study Completion (Actual): August 25, 2022

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: metronidazole; dequalinium chloride; non inferiority; bacterial vaginosis; comparative study; vaginal infection treatment
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole; Dequalinium
• Other Study ID Numbers: MNFM380119; 2020-002489-15 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No