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

Bacterial Vaginosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05788991
• Other study ID #: MNFM380119
• Secondary ID: 2020-002489-15
• Status: Terminated
• Phase: Phase 4
• Start date: July 26, 2021
• Est. completion date: August 25, 2022

Study information

• Verified date: March 2023
• Source: Medinova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 151
• Est. completion date: August 25, 2022
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginal Infection
• Vaginosis, Bacterial

Intervention

Drug:
• Dequalinium Chloride
Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
• Metronidazole Oral
Metronidazole oral tablets (500 mg) taken twice a day for 7 days

Locations

Country	Name	City	State
Czechia	Centrum ambulantní gynekologie a primární péce, s.r.o.	Brno
Czechia	G-CENTRUM Olomouc s.r.o.	Olomouc
Czechia	Gynekologicko-porodnická ambulance	Ústí nad Labem
Czechia	GYNEKO spol. s r.o	Vsetín
Poland	NZOZ All-Med Centrum Medyczne	Lódz
Poland	Salve Medica Sp. z o. o. S. K.	Lódz
Poland	1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ	Lublin
Poland	KO-MED CENTRA KLINICZNE Sp. z o.o. Osrodek	Lublin
Poland	Prywatny Gabinet Ginekologiczno-Polozniczy	Zurawica
Slovakia	GPN, s.r.o.	Bratislava
Slovakia	RADMA GYN s.r.o.	Bratislava
Slovakia	GYNEDUR s.r.o	Dubnica nad Vahom
Slovakia	MCM GYNPED s.r.o.	Dubnica Nad Váhom
Slovakia	GYNECARE s.r.o.	Puchov

Sponsors (1)

Lead Sponsor	Collaborator
Medinova AG

Countries where clinical trial is conducted

Czechia,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure rate	Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells	One week after randomization (C1)
Secondary	Clinical cure rate	Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells	One month after randomization (C2)
Secondary	Bacteriological cure rate	Nugent score =3	One week & one month
Secondary	Therapeutic cure	Combination of clinical and bacteriological cures,	One week & one month
Secondary	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
Secondary	Nugent score over time	0-3: normal flora 4-6: intermediate flora 7-10: bacterial vaginosis	One week & one month
Secondary	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
Secondary	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
Secondary	Adverse events		Up to end of study (one month)