Bacterial VaginosisPhase 3NCT01125410
Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis
A Phase 3 study testing Dequalinium chloride and Clindamycin in people with Bacterial Vaginosis, run by Medinova AG at 14 sites in 5 countries.
Trial summary
The purpose of this clinical study was to evaluate whether vaginal tablets containing 10 mg dequalinium chloride (Fluomizin) are comparable in clinical efficacy and safety to clindamycin vaginal cream (2%) in patients suffering from bacterial vaginosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Dequalinium chloride and Clindamycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 14 sitesin 5 countries
- Study dates
- Jan 2007to Feb 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of bacterial vaginosis
- Women aged 18-55 years
Who cannot join
- Pregnancy or lactation
- Uterine bleeding (including menstruation but not including cervical contact bleeding on sampling) or vaginal bleeding of unknown origin
- Acute infections of the upper genital tract
- Clinical Symptoms of a vulvovaginal Candidiasis
- Use of anti-infectives (local or systemic) in the previous 14 days and/or during the study
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
Czechia6 sites
Centrum Ambulantni gynekologie a prodnictvi
Brno
Faculty Hospital Brno
Brno
University Hospital Hradec Kralove
Hradec Králové
Charles University
Prague
Fakultni nemocnice Na Bulovce
Prague
Ambulance pro gynekologie a prodnictvi
Telč
Belgium4 sites
AZ Imelda Ziekenhuis
Bonheiden
AZ St. Dimpna
Geel
AZ Ziekenhuis Oost-Limburg
Genk
AZ Heilig Hart
Tienen
Switzerland2 sites
University Hospital of Geneva and Faculty of Medicine
Geneva
CHUV
Lausanne
About this study
Official title: Phase III Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis
The purpose of this clinical study was to evaluate whether vaginal tablets containing 10 mg dequalinium chloride (Fluomizin) are comparable in clinical efficacy and safety to clindamycin vaginal cream (2%) in patients suffering from bacterial vaginosis.
Read the detailed description
An international, multi-center, single-blind, randomized, active-controlled study with two parallel groups in patients with bacterial vaginosis. Eligible patients were randomized to receive Fluomizin vaginal tablets for 6 days or Clindamycin vaginal cream (2%) for 7 days. Control examinations were performed 3 to 14 days and 2 to 6 weeks after the end of the therapy.
- Conditions
- Bacterial Vaginosis
- Being tested
- Dequalinium chloride, Clindamycin
- Keywords
- Fluomizin, Dequalinium chloride, Bacterial vaginosis, vaginal therapy
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dequalinium chlorideDrug
Vaginal tablet, 10mg, 1 tablet daily for 6 days
ClindamycinDrug
vaginal cream, 2%, once daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Dequalinium chloride 10mg | Experimental | Not described Receives: Drug: Dequalinium chloride |
| clindamycin vaginal cream 2% | Active comparator | Not described Receives: Drug: Clindamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical cure rate
Clinical cure rate based on Amsel criteria. For cure, clue cells have to be negative and not more than one of the other criteria positive
Measured: 1 week (on average)
Clinical cure rate
Clinical cure rate based on Amsel criteria, where cure was defined as clue cells being negative and not more than one of the other criteria positive
Measured: 4 weeks (on average)
Secondary outcomes (2)
Treatment failure
Treatment failures include non-responders and recurrences
Measured: 4 weeks
Incidence of ADRs
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startJan 2007
- Primary completionJul 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medinova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ernst Rainer Weissenbacher, MD, Principal investigator, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125410
- Sponsor's protocol ID
- Med380104
- Status last verified
- May 2010
- First submitted
- 11 May 2010
- Last updated
- 18 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Weissenbacher ER, Donders G, Unzeitig V, Martinez de Tejada B, Gerber S, Halaska M, Spacek J; Fluomizin Study Group. A comparison of dequalinium chloride vaginal tablets (Fluomizin(R)) and clindamycin vaginal cream in the treatment of bacterial vaginosis: a single-blind, randomized clinical trial of efficacy and safety. Gynecol Obstet Invest. 2012;73(1):8-15. doi: 10.1159/000332398. Epub 2011 Dec 24.
PubMed 22205034
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT01125410
- Acronym / sponsor ID
- Med380104
- Conditions
- Bacterial Vaginosis
- Keywords
- Fluomizin, Dequalinium chloride, Bacterial vaginosis, vaginal therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Medinova AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 18 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study was to evaluate whether vaginal tablets containing 10 mg dequalinium chloride (Fluomizin) are comparable in clinical efficacy and safety to clindamycin vaginal cream (2%) in patients suffering from bacterial vaginosis.
Detailed description
An international, multi-center, single-blind, randomized, active-controlled study with two parallel groups in patients with bacterial vaginosis. Eligible patients were randomized to receive Fluomizin vaginal tablets for 6 days or Clindamycin vaginal cream (2%) for 7 days. Control examinations were performed 3 to 14 days and 2 to 6 weeks after the end of the therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dequalinium chloride 10mg | Experimental | Drug: Dequalinium chloride |
| clindamycin vaginal cream 2% | Active comparator | Drug: Clindamycin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of bacterial vaginosis
- Women aged 18-55 years
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Uterine bleeding (including menstruation but not including cervical contact bleeding on sampling) or vaginal bleeding of unknown origin
- Acute infections of the upper genital tract
- Clinical Symptoms of a vulvovaginal Candidiasis
- Use of anti-infectives (local or systemic) in the previous 14 days and/or during the study
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 chlorideVaginal tablet, 10mg, 1 tablet daily for 6 days | Drug | Dequalinium chloride 10mg |
| Clindamycinvaginal cream, 2%, once daily for 7 days | Drug | clindamycin vaginal cream 2% |
Primary outcome
clinical cure rate
Time frame: 1 week (on average)
Clinical cure rate based on Amsel criteria. For cure, clue cells have to be negative and not more than one of the other criteria positive
Clinical cure rate
Time frame: 4 weeks (on average)
Clinical cure rate based on Amsel criteria, where cure was defined as clue cells being negative and not more than one of the other criteria positive
2 secondary outcomes
Treatment failure
Time frame: 4 weeks
Incidence of ADRs
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2010.
- Derived from this study: PubMed 22205034Weissenbacher ER, Donders G, Unzeitig V, Martinez de Tejada B, Gerber S, Halaska M, Spacek J; Fluomizin Study Group. A comparison of dequalinium chloride vaginal tablets (Fluomizin(R)) and clindamycin vaginal cream in the treatment of bacterial vaginosis: a single-blind, randomized clinical trial of efficacy and safety. Gynecol Obstet Invest. 2012;73(1):8-15. doi: 10.1159/000332398. Epub 2011 Dec 24.
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Enrolling by invitationObservational study
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WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
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Recruiting
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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.
Ernst Rainer Weissenbacher, MD principal investigator
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, LMU Munich
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dequalinium chloride and Clindamycin in people with Bacterial Vaginosis, run by Medinova AG at 14 sites in 5 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 18 May 2010. 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 Czechia, Belgium, Switzerland, Germany, Slovakia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 1 week (on average)). The study lists 2 primary outcomes in all. 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 NCT01125410, 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 18 May 2010.