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

NCT ID: NCT05788991

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-26
• Study Completion Date: 2022-08-25

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.

Conditions

Bacterial Vaginosis; Vaginal Infection; Vaginal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dequalinium chloride

Dequalinium chloride 10 mg vaginal tablets

Group Type: EXPERIMENTAL

Dequalinium Chloride

Intervention Type: DRUG

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

Metronidazole

Metronidazole 500 mg oral tablets

Group Type: ACTIVE_COMPARATOR

Metronidazole Oral

Intervention Type: DRUG

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

Interventions

Dequalinium Chloride

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

Intervention Type: DRUG

Metronidazole Oral

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

Intervention Type: DRUG

Other Intervention Names

Fluomizin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medinova AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philipp Grob, PhD

Role: STUDY_DIRECTOR

Medinova AG

Locations

Centrum ambulantní gynekologie a primární péče, 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, , Czechia

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

Lodz, , Poland

NZOZ All-Med Centrum Medyczne

Lodz, , Poland

1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ

Lublin, , Poland

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

Lublin, , Poland

Prywatny Gabinet Ginekologiczno-Położniczy

Żurawica, , Poland

GPN, s.r.o.

Bratislava, , Slovakia

RADMA GYN s.r.o.

Bratislava, , Slovakia

GYNEDUR s.r.o

Dubnica nad Váhom, , Slovakia

MCM GYNPED s.r.o.

Dubnica nad Váhom, , Slovakia

GYNECARE s.r.o.

Púchov, , Slovakia

Countries

Czechia; Poland; Slovakia

References

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.

Reference Type: RESULT

PMID: 38696172 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2020-002489-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MNFM380119

Identifier Type: -

Identifier Source: org_study_id