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

Last updated: October 11, 2024
Sponsor: Medinova AG
Overall Status: Terminated

Phase

4

Condition

Sexually Transmitted Diseases (Stds)

Gynecological Infections

Vaginal Atrophy

Treatment

Metronidazole Oral

Dequalinium Chloride

Clinical Study ID

NCT05788991
MNFM380119
2020-002489-15
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Premenopausal woman ≥18 years

  2. Diagnosis of bacterial vaginosis (all 4 Amsel criteria positive, i.e. 1) greyishwhite 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

Exclusion Criteria:

  1. Pregnancy and/or lactation based on urine Pregnancy test (women with childbearingpotential 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/orAerobic vaginitis

  5. Clinically manifest or suspicion of sexually transmitted infections (Neisseriagonorrhoeae, Chlamydia trachomatis, or Trichomonas vaginalis) based on signs,symptoms, and anamnesis

  6. Use of any antimicrobial treatment (local or systemic) 14 days before entry thestudy

  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 hoursafter treatment

  9. Severe systemic diseases (HIV, cancer, tuberculosis, autoimmune diseases, diabetesmellitus, severe psychiatric conditions, etc.), including diseases treated withimmunosuppressive therapies, systemic corticosteroids, or warfarin

  10. Known or suspected hypersensitivity to one of the study medications, inclusive oftheir 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 tofill-in electronic patient diary)

  12. Participation of patient in another investigational drug study concomitantly orwithin 30 days prior to entry in the study

  13. Patient is relative of, or staff directly reporting to, the investigator

Study Design

Total Participants: 151
Treatment Group(s): 2
Primary Treatment: Metronidazole Oral
Phase: 4
Study Start date:
July 26, 2021
Estimated Completion Date:
August 25, 2022

Study 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.

Connect with a study center

  • Centrum ambulantní gynekologie a primární péče, s.r.o.

    Brno, 602 00
    Czechia

    Site Not Available

  • G-CENTRUM Olomouc s.r.o.

    Olomouc, 772 00
    Czechia

    Site Not Available

  • GYNEKO spol. s r.o

    Vsetín, 775 01
    Czechia

    Site Not Available

  • Gynekologicko-porodnická ambulance

    Ústí nad Labem, 400 01
    Czechia

    Site Not Available

  • 1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ

    Lublin,
    Poland

    Site Not Available

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

    Lublin,
    Poland

    Site Not Available

  • NZOZ All-Med Centrum Medyczne

    Łódź,
    Poland

    Site Not Available

  • Salve Medica Sp. z o. o. S. K.

    Łódź, 91-211
    Poland

    Site Not Available

  • Prywatny Gabinet Ginekologiczno-Położniczy

    Żurawica, 37-710
    Poland

    Site Not Available

  • GPN, s.r.o.

    Bratislava,
    Slovakia

    Site Not Available

  • RADMA GYN s.r.o.

    Bratislava,
    Slovakia

    Site Not Available

  • MCM GYNPED s.r.o.

    Dubnica Nad Váhom,
    Slovakia

    Site Not Available

  • GYNEDUR s.r.o

    Dubnica nad Vahom,
    Slovakia

    Site Not Available

  • GYNECARE s.r.o.

    Puchov,
    Slovakia

    Site Not Available

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