Bacterial VaginosisPhase 4NCT05788991
Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis
A Phase 4 study testing Dequalinium Chloride and Metronidazole Oral in people with Bacterial Vaginosis and Vaginal Infection, run by Medinova AG at 14 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis, Vaginal Infection, Vaginal Diseases
- What is being tested?
- Dequalinium Chloride and Metronidazole Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 26 Jul 2021to 25 Aug 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Premenopausal woman ≥18 years
- 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)
- Signed Written Informed Consent to participate in this study
Who cannot join
- 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 sexually transmitted infections (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
Show all 13Show fewer
- 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
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Poland5 sites
Salve Medica Sp. z o. o. S. K.
Lodz, 91-211
NZOZ All-Med Centrum Medyczne
Lodz
1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Lublin
KO-MED CENTRA KLINICZNE Sp. z o.o. Ośrodek
Lublin
Prywatny Gabinet Ginekologiczno-Położniczy
Żurawica, 37-710
Slovakia5 sites
GPN, s.r.o.
Bratislava
RADMA GYN s.r.o.
Bratislava
GYNEDUR s.r.o
Dubnica nad Váhom
MCM GYNPED s.r.o.
Dubnica nad Váhom
GYNECARE s.r.o.
Púchov
Czechia4 sites
Centrum ambulantní gynekologie a primární péče, s.r.o.
Brno, 602 00
G-CENTRUM Olomouc s.r.o.
Olomouc, 772 00
Gynekologicko-porodnická ambulance
Ústí nad Labem, 400 01
GYNEKO spol. s r.o
Vsetín, 775 01
About this study
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
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.
Read the 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
- Being tested
- Dequalinium Chloride, Metronidazole Oral
- Keywords
- bacterial vaginosis, dequalinium chloride, metronidazole, vaginal infection treatment, comparative study, non inferiority
- Medical subject headings
- Vaginosis, Bacterial, Vaginitis, Vaginal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dequalinium ChlorideDrug
Also called Fluomizin
Fluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days
Metronidazole OralDrug
Metronidazole oral tablets (500 mg) taken twice a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Dequalinium chloride | Experimental | Dequalinium chloride 10 mg vaginal tablets Receives: Drug: Dequalinium Chloride |
| Metronidazole | Active comparator | Metronidazole 500 mg oral tablets Receives: Drug: Metronidazole Oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure Rate
Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells
Measured: One week after randomization (C1)
Secondary outcomes (5)
Clinical Cure Rate
Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells
Measured: One month after randomization (C2)
Bacteriological Cure Rate
Nugent score ≤3
Nugent score uses a 0 - 10 scale (higher score mean a worse outcome): 0 - 3 = normal flora, 4 - 6 = intermediate flora, 7 - 10 = bacterial vaginosis
Measured: One week & one month
Therapeutic Cure
Combination of clinical and bacteriological cure
Measured: One week & one month
Subjective Assessment of Efficacy
Efficacy was assessed by patients and investigators as 'very good', 'good', 'moderate' or 'poor'.
Measured: One week
Subjective Assessment of Tolerability
Tolerability was assessed by patients as 'very good', 'good', 'moderate' or 'poor'.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start26 Jul 2021
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medinova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philipp Grob, PhD, Study director, Medinova AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788991
- Sponsor's protocol ID
- MNFM380119
- Other IDs
- 2020-002489-15
- Status last verified
- Jun 2024
- First submitted
- 15 Mar 2023
- Last updated
- 16 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38696172
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05788991
- Acronym / sponsor ID
- MNFM380119
- Conditions
- Bacterial Vaginosis, Vaginal Infection, Vaginal Diseases
- Keywords
- bacterial vaginosis, dequalinium chloride, metronidazole, vaginal infection treatment, comparative study, non inferiority
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Medinova AGIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 29 Mar 2023 (actual)
- Results
- Posted 16 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dequalinium chloride | Experimental | Drug: Dequalinium ChlorideDequalinium chloride 10 mg vaginal tablets |
| Metronidazole | Active comparator | Drug: Metronidazole OralMetronidazole 500 mg oral tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Premenopausal woman ≥18 years
- 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)
- Signed Written Informed Consent to participate in this study
Key exclusion criteria (13 listed)
- 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 sexually transmitted infections (Neisseria gonorrhoeae, Chlamydia trachomatis, or Trichomonas vaginalis) based on signs, symptoms, and anamnesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dequalinium ChlorideAlso: FluomizinFluomizin vaginal tablets (10 mg dequalinium chloride) used once a day for 6 days | Drug | Dequalinium chloride |
| Metronidazole OralMetronidazole oral tablets (500 mg) taken twice a day for 7 days | Drug | Metronidazole |
Primary outcome
Clinical Cure Rate
Time frame: One week after randomization (C1)
Resolution of the abnormal vaginal discharge, negative whiff test, and less than 20% clue cells
5 secondary outcomes
Clinical Cure Rate
Time frame: One month after randomization (C2)
Bacteriological Cure Rate
Time frame: One week & one month
Therapeutic Cure
Time frame: One week & one month
Subjective Assessment of Efficacy
Time frame: One week
Subjective Assessment of Tolerability
Time frame: One week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38696172Raba 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.
- Full article- open accessLink provided by the sponsor.
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Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Grob, PhD study director
Medinova AG
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dequalinium Chloride and Metronidazole Oral in people with Bacterial Vaginosis and Vaginal Infection, run by Medinova AG at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Poland, Slovakia, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cure Rate (time frame: One week after randomization (C1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05788991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.