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

NCT05788991 | Terminated Phase 4 Results

• 2 other identifiers: MNFM3801192020-002489-15
• Study Type: interventional
• Target: 151
• Locations: 3 countries
• Sites: 14

Brief 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.

Conditions

Bacterial Vaginosis; Vaginal Infection; Vaginal Diseases

Keywords

bacterial vaginosis; dequalinium chloride; metronidazole; vaginal infection treatment; comparative study; non inferiority

Outcome Measures

Primary Outcomes (1)

• Clinical Cure Rate

  Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells

  One week after randomization (C1)

Secondary Outcomes (5)

• Clinical Cure Rate

  One month after randomization (C2)

• Bacteriological Cure Rate

  One week & one month

• Therapeutic Cure

  One week & one month

• Subjective Assessment of Efficacy

  One week

• Subjective Assessment of Tolerability

  One week

Study Arms (2)

Dequalinium chloride

EXPERIMENTAL

Dequalinium chloride 10 mg vaginal tablets

Drug: Dequalinium Chloride

Metronidazole

ACTIVE COMPARATOR

Metronidazole 500 mg oral tablets

Drug: Metronidazole Oral

Interventions

Dequalinium Chloride DRUG

Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days

Also known as: Fluomizin

Dequalinium chloride

Metronidazole Oral DRUG

Metronidazole oral tablets (500 mg) taken twice a day for 7 days

Metronidazole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Premenopausal woman ≥18 years
• Diagnosis of bacterial vaginosis (all 4 Amsel criteria positive, i.e. 1) greyish white thin discharge, 2) postassium hydroxide (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

You may not qualify if:

• 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 sexually transmitted infections (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

Sponsors & Collaborators

• Medinova AG: lead

Study Sites (14)

Centrum ambulantní gynekologie a primární péče, s.r.o.

Brno, 602 00, Czechia

Location

G-CENTRUM Olomouc s.r.o.

Olomouc, 772 00, Czechia

Location

Gynekologicko-porodnická ambulance

Ústí nad Labem, 400 01, Czechia

Location

GYNEKO spol. s r.o

Vsetín, 775 01, Czechia

Location

Salve Medica Sp. z o. o. S. K.

Lodz, 91-211, Poland

Location

NZOZ All-Med Centrum Medyczne

Lodz, Poland

Location

1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ

Lublin, Poland

Location

KO-MED CENTRA KLINICZNE Sp. z o.o. Ośrodek

Lublin, Poland

Location

Prywatny Gabinet Ginekologiczno-Położniczy

Żurawica, 37-710, Poland

Location

GPN, s.r.o.

Bratislava, Slovakia

Location

RADMA GYN s.r.o.

Bratislava, Slovakia

Location

GYNEDUR s.r.o

Dubnica nad Váhom, Slovakia

Location

MCM GYNPED s.r.o.

Dubnica nad Váhom, Slovakia

Location

GYNECARE s.r.o.

Púchov, Slovakia

Location

Related Publications (1)

• Raba G, Durkech A, Malik T, Bassfeld D, Grob P, Hurtado-Chong A; Fluomizin Study Group. Efficacy of Dequalinium Chloride vs Metronidazole for the Treatment of Bacterial Vaginosis: A Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e248661. doi: 10.1001/jamanetworkopen.2024.8661.

  PMID: 38696172 RESULT

MeSH Terms

Conditions

Vaginosis, Bacterial; Vaginitis; Vaginal Diseases

Interventions

Dequalinium; Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Quinolinium Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Anahí Hurtado
• Organization: Medinova

hurtado.anahi@medinova.ch

+41443061396

Study Officials

• Philipp Grob, PhD

  Medinova AG

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 29, 2023
• Study Start: July 26, 2021
• Primary Completion: August 25, 2022
• Study Completion: August 25, 2022
• Last Updated: October 16, 2024
• Results First Posted: October 16, 2024

Record last verified: 2024-06

Locations

PL (5); SL (5); CZ (4)