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

Sponsor

Medinova AG (Industry)

Overall Status

Terminated

CT.gov ID

NCT05788991

Collaborator

(none)

151

Enrollment

Locations

Arms

Actual Duration (Months)

10.8

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Vaginosis Vaginal Infection Vaginal Diseases	Drug: Dequalinium Chloride Drug: Metronidazole Oral	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

151 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 26, 2021

Actual Primary Completion Date :

Aug 25, 2022

Actual Study Completion Date :

Aug 25, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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
Therapeutic cure [One week & one month]
Combination of clinical and bacteriological cures,
Individual Amsel Criteria over time [One week & one month]
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 [One week & one month]
0-3: normal flora 4-6: intermediate flora 7-10: bacterial vaginosis
Subjective assessment of efficacy [One week & one month]
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 [One week & one month]
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 [Up to end of study (one month)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centrum ambulantní gynekologie a primární péče, s.r.o.	Brno	Czechia	602 00
2	G-CENTRUM Olomouc s.r.o.	Olomouc	Czechia	772 00
3	GYNEKO spol. s r.o	Vsetín	Czechia	775 01
4	Gynekologicko-porodnická ambulance	Ústí nad Labem	Czechia	400 01
5	1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ	Lublin	Poland
6	KO-MED CENTRA KLINICZNE Sp. z o.o. Ośrodek	Lublin	Poland
7	Salve Medica Sp. z o. o. S. K.	Łódź	Poland	91-211
8	NZOZ All-Med Centrum Medyczne	Łódź	Poland
9	Prywatny Gabinet Ginekologiczno-Położniczy	Żurawica	Poland	37-710
10	GPN, s.r.o.	Bratislava	Slovakia
11	RADMA GYN s.r.o.	Bratislava	Slovakia
12	GYNEDUR s.r.o	Dubnica nad Vahom	Slovakia
13	MCM GYNPED s.r.o.	Dubnica Nad Váhom	Slovakia
14	GYNECARE s.r.o.	Puchov	Slovakia