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

Primary Purpose

Bacterial Vaginosis, Vaginal Infection, Vaginal Diseases

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Dequalinium Chloride
Metronidazole Oral
Sponsored by
Medinova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginosis focused on measuring bacterial vaginosis, dequalinium chloride, metronidazole, vaginal infection treatment, comparative study, non inferiority

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Premenopausal woman ≥18 years 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) Signed Written Informed Consent to participate in this study Exclusion Criteria: 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 STIs (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

Sites / Locations

  • Centrum ambulantní gynekologie a primární péče, s.r.o.
  • G-CENTRUM Olomouc s.r.o.
  • GYNEKO spol. s r.o
  • Gynekologicko-porodnická ambulance
  • 1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
  • KO-MED CENTRA KLINICZNE Sp. z o.o. Ośrodek
  • Salve Medica Sp. z o. o. S. K.
  • NZOZ All-Med Centrum Medyczne
  • Prywatny Gabinet Ginekologiczno-Położniczy
  • GPN, s.r.o.
  • RADMA GYN s.r.o.
  • GYNEDUR s.r.o
  • MCM GYNPED s.r.o.
  • GYNECARE s.r.o.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dequalinium chloride

Metronidazole

Arm Description

Dequalinium chloride 10 mg vaginal tablets

Metronidazole 500 mg oral tablets

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical cure rate
Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells
Bacteriological cure rate
Nugent score ≤3
Therapeutic cure
Combination of clinical and bacteriological cures,
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
Nugent score over time
0-3: normal flora 4-6: intermediate flora 7-10: bacterial vaginosis
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'
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'
Adverse events

Full Information

First Posted
March 15, 2023
Last Updated
March 28, 2023
Sponsor
Medinova AG
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1. Study Identification

Unique Protocol Identification Number
NCT05788991
Brief Title
Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
August 25, 2022 (Actual)
Study Completion Date
August 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medinova AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis, Vaginal Infection, Vaginal Diseases
Keywords
bacterial vaginosis, dequalinium chloride, metronidazole, vaginal infection treatment, comparative study, non inferiority

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dequalinium chloride
Arm Type
Experimental
Arm Description
Dequalinium chloride 10 mg vaginal tablets
Arm Title
Metronidazole
Arm Type
Active Comparator
Arm Description
Metronidazole 500 mg oral tablets
Intervention Type
Drug
Intervention Name(s)
Dequalinium Chloride
Other Intervention Name(s)
Fluomizin
Intervention Description
Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
Intervention Type
Drug
Intervention Name(s)
Metronidazole Oral
Intervention Description
Metronidazole oral tablets (500 mg) taken twice a day for 7 days
Primary Outcome Measure Information:
Title
Clinical cure rate
Description
Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells
Time Frame
One week after randomization (C1)
Secondary Outcome Measure Information:
Title
Clinical cure rate
Description
Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells
Time Frame
One month after randomization (C2)
Title
Bacteriological cure rate
Description
Nugent score ≤3
Time Frame
One week & one month
Title
Therapeutic cure
Description
Combination of clinical and bacteriological cures,
Time Frame
One week & one month
Title
Individual Amsel Criteria over time
Description
greyish white thin discharge Whiff test: 'fishy' smell with 10% KOH > 20% clue cells in saline wet mount vaginal pH > 4.5
Time Frame
One week & one month
Title
Nugent score over time
Description
0-3: normal flora 4-6: intermediate flora 7-10: bacterial vaginosis
Time Frame
One week & one month
Title
Subjective assessment of efficacy
Description
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'
Time Frame
One week & one month
Title
Subjective assessment of tolerability
Description
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'
Time Frame
One week & one month
Title
Adverse events
Time Frame
Up to end of study (one month)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Premenopausal woman ≥18 years 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) Signed Written Informed Consent to participate in this study Exclusion Criteria: 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 STIs (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Grob, PhD
Organizational Affiliation
Medinova AG
Official's Role
Study Director
Facility Information:
Facility Name
Centrum ambulantní gynekologie a primární péče, s.r.o.
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
G-CENTRUM Olomouc s.r.o.
City
Olomouc
ZIP/Postal Code
772 00
Country
Czechia
Facility Name
GYNEKO spol. s r.o
City
Vsetín
ZIP/Postal Code
775 01
Country
Czechia
Facility Name
Gynekologicko-porodnická ambulance
City
Ústí nad Labem
ZIP/Postal Code
400 01
Country
Czechia
Facility Name
1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
City
Lublin
Country
Poland
Facility Name
KO-MED CENTRA KLINICZNE Sp. z o.o. Ośrodek
City
Lublin
Country
Poland
Facility Name
Salve Medica Sp. z o. o. S. K.
City
Łódź
ZIP/Postal Code
91-211
Country
Poland
Facility Name
NZOZ All-Med Centrum Medyczne
City
Łódź
Country
Poland
Facility Name
Prywatny Gabinet Ginekologiczno-Położniczy
City
Żurawica
ZIP/Postal Code
37-710
Country
Poland
Facility Name
GPN, s.r.o.
City
Bratislava
Country
Slovakia
Facility Name
RADMA GYN s.r.o.
City
Bratislava
Country
Slovakia
Facility Name
GYNEDUR s.r.o
City
Dubnica nad Vahom
Country
Slovakia
Facility Name
MCM GYNPED s.r.o.
City
Dubnica Nad Váhom
Country
Slovakia
Facility Name
GYNECARE s.r.o.
City
Puchov
Country
Slovakia

12. IPD Sharing Statement

Learn more about this trial

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

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