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

Phase 4

Terminated

• Conditions: Vaginal Infection; Vaginal Diseases; Bacterial Vaginosis
• Interventions: Drug: Dequalinium Chloride; Drug: Metronidazole Oral

• Registration Number: NCT05788991
• Lead Sponsor: Medinova AG

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.

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 Timeline

• Study Start: 2021-07-26
• Primary Completion: 2022-08-25
• Study Completion: 2022-08-25
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-28
• Study First Posted: 2023-03-29
• Status Verified: 2024-06
• Results First Submitted: 2024-06-20
• Results First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-11
• Results First Posted: 2024-10-16
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 151

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) postassium hydroxide (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 sexually transmitted infections (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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dequalinium chloride	Dequalinium Chloride	Dequalinium chloride 10 mg vaginal tablets
Metronidazole	Metronidazole Oral	Metronidazole 500 mg oral tablets

Primary Outcome Measures

Name	Time	Method
Clinical Cure Rate	One week after randomization (C1)	Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells

Secondary Outcome Measures

Name	Time	Method
Subjective Assessment of Efficacy	One week	Efficacy was assessed by patients and investigators as 'very good', 'good', 'moderate' or 'poor'.
Subjective Assessment of Tolerability	One week	Tolerability was assessed by patients as 'very good', 'good', 'moderate' or 'poor'.
Therapeutic Cure	One week & one month	Combination of clinical and bacteriological cure
Clinical Cure Rate	One month after randomization (C2)	Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells
Bacteriological Cure Rate	One week & one month	Nugent score ≤3; Nugent score uses a 0 - 10 scale (higher score mean a worse outcome): 0 - 3 = normal flora, 4 - 6 = intermediate flora, 7 - 10 = bacterial vaginosis

Trial Locations

Locations (14)

MCM GYNPED s.r.o.; 🇸🇰 Dubnica Nad Váhom, Slovakia

Salve Medica Sp. z o. o. S. K.; 🇵🇱 Łódź, Poland

NZOZ All-Med Centrum Medyczne; 🇵🇱 Łódź, Poland

Prywatny Gabinet Ginekologiczno-Położniczy; 🇵🇱 Żurawica, Poland

GYNEKO spol. s r.o; 🇨🇿 Vsetín, Czechia

Centrum ambulantní gynekologie a primární péče, s.r.o.; 🇨🇿 Brno, Czechia

GYNEDUR s.r.o; 🇸🇰 Dubnica nad Vahom, Slovakia

KO-MED CENTRA KLINICZNE Sp. z o.o. Ośrodek; 🇵🇱 Lublin, Poland

RADMA GYN s.r.o.; 🇸🇰 Bratislava, Slovakia

G-CENTRUM Olomouc s.r.o.; 🇨🇿 Olomouc, Czechia

Gynekologicko-porodnická ambulance; 🇨🇿 Ústí nad Labem, Czechia

1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ; 🇵🇱 Lublin, Poland

GPN, s.r.o.; 🇸🇰 Bratislava, Slovakia

GYNECARE s.r.o.; 🇸🇰 Puchov, Slovakia