Bacterial VaginosisPhase 3NCT02186145
Efficacy and Safety Study of Metronidazole, Nystatin and Dexamethasone Combination Therapy in Bacterial and Fungal Vaginal Infections
A Phase 3 study testing Association of metronidazole; nystatin and dexamethasone and Flagyl in people with Bacterial Vaginosis and Fungal Vaginal Infections, run by Marjan Industria e Comercio ltda at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of association of metronidazole, nystatin and dexamethasone in the treatment of bacterial and fungal vaginal infections. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Bacterial Vaginosis, Fungal Vaginal Infections
- What is being tested?
- Association of metronidazole; nystatin and dexamethasone and Flagyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2016to Jan 2017
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Post-menarche women and premenopausal women, between 18 and 50 years old;
- Diagnosis of bacterial vaginosis (Amsel criteria), fungal (positive KOH test)or mixed vaginal infection;
- Patients who have regular menstrual cycles (patients with regular menstrual cycles with intervals between 21 to 35 days, duration of 1 to 7 days)
Who cannot join
- Patients who have a known hypersensitivity to components of the formula ;
- Pregnant and lactating women ;
- Patients with other vaginal infections, such as infection by Trichomonas vaginalis , C. trachomatis, Neisseria gonorrhoeae , herpes or HPV.
- Knowledge of positive test result for human immunodeficiency virus ;
- Patients in treatment of cervical intraepithelial neoplasia or carcinoma of the cervix ;
- Patients who have undergone gynecological procedures in the month prior to inclusion (such as cauterization of the cervix , cervical biopsy, high-frequency surgery) ;
Show all 11Show fewer
- Patients with other vaginal or vulvar conditions that may confound interpretation of clinical response;
- Patients who received intravaginal or systemic antimicrobial or antifungal therapy 14 days before randomization ;
- Patients on immunosuppressive medications (such as corticosteroids , cyclosporine , etc. ) ;
- Known or suspected cancer ;
- Participation in any experimental study or ingestion of any experimental drug 12 months before the start of this study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculty of Medicine of ABC (FMABC)
Santo André, São Paulo, 09190-615
Marcus Vinícius Seroqui, Site Clinical Trials Manager, +55 11 2829-5148, mv_seroqui@yahoo.com.br
Emerson Oliveira, MD
About this study
Official title: Single Blind Randomized Study of Efficacy and Safety of Vaginal Cream With Association of Metronidazole, Nystatin and Dexamethasone in the Treatment of Bacterial and Fungal Vaginal Infections
The purpose of this study is to evaluate the efficacy and safety of association of metronidazole, nystatin and dexamethasone in the treatment of bacterial and fungal vaginal infections.
- Conditions
- Bacterial Vaginosis, Fungal Vaginal Infections
- Being tested
- Association of metronidazole; nystatin and dexamethasone, Flagyl
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Association of metronidazole; nystatin and dexamethasoneDrug
FlagylDrug
Also called Flagyl-Nistatina (Sanofi Aventis)
Vaginal cream of metronidazole and nystatin
| Study group | Role | What they receive |
|---|---|---|
| Association of metronidazole; nystatin and dexamethasone | Experimental | Intravaginal cream containing metronidazole (500 mg), nystatin ( 100.000 UI) and dexamethasone (0,32 mg) once a day. Period: 10 days. Receives: Drug: Association of metronidazole; nystatin and dexamethasone |
| Flagyl | Active comparator | Vaginal cream of metronidazole 500 mg, nystatin 100.000 UI - once a day. Period: 10 days Receives: Drug: Flagyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic cure
Therapeutic cure which is based on a combination of clinical outcome and Gram's stain results (Nugentscore)/mycological eradication.
Measured: Day 21-35
Secondary outcomes (1)
Evaluation on vulvovaginal inflammation
Time resolution of symptoms; percentage of patients with Nugent score between 0-3; negative fungal culture; and subjective assessment of patients on the intensity of vulvar itching.
Measured: 21 - 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marjan Industria e Comercio ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186145
- Sponsor's protocol ID
- MJ 3002-13
- Status last verified
- Jul 2014
- First submitted
- 7 Jul 2014
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Blind Randomized Study of Efficacy and Safety of Vaginal Cream With Association of Metronidazole, Nystatin and Dexamethasone in the Treatment of Bacterial and Fungal Vaginal Infections
- ClinicalTrials.gov ID
- NCT02186145
- Acronym / sponsor ID
- MJ 3002-13
- Conditions
- Bacterial Vaginosis, Fungal Vaginal Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Marjan Industria e Comercio ltdaIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 10 Jul 2014 (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 study is to evaluate the efficacy and safety of association of metronidazole, nystatin and dexamethasone in the treatment of bacterial and fungal vaginal infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Association of metronidazole; nystatin and dexamethasone | Experimental | Drug: Association of metronidazole; nystatin and dexamethasoneIntravaginal cream containing metronidazole (500 mg), nystatin ( 100.000 UI) and dexamethasone (0,32 mg) once a day. Period: 10 days. |
| Flagyl | Active comparator | Drug: FlagylVaginal cream of metronidazole 500 mg, nystatin 100.000 UI - once a day. Period: 10 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Post-menarche women and premenopausal women, between 18 and 50 years old;
- Diagnosis of bacterial vaginosis (Amsel criteria), fungal (positive KOH test)or mixed vaginal infection;
- Patients who have regular menstrual cycles (patients with regular menstrual cycles with intervals between 21 to 35 days, duration of 1 to 7 days)
Key exclusion criteria (11 listed)
- Patients who have a known hypersensitivity to components of the formula ;
- Pregnant and lactating women ;
- Patients with other vaginal infections, such as infection by Trichomonas vaginalis , C. trachomatis, Neisseria gonorrhoeae , herpes or HPV.
- Knowledge of positive test result for human immunodeficiency virus ;
- Patients in treatment of cervical intraepithelial neoplasia or carcinoma of the cervix ;
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 |
|---|---|---|
| Association of metronidazole; nystatin and dexamethasone | Drug | Association of metronidazole; nystatin and dexamethasone |
| FlagylAlso: Flagyl-Nistatina (Sanofi Aventis)Vaginal cream of metronidazole and nystatin | Drug | Flagyl |
Primary outcome
Therapeutic cure
Time frame: Day 21-35
Therapeutic cure which is based on a combination of clinical outcome and Gram's stain results (Nugentscore)/mycological eradication.
1 secondary outcome
Evaluation on vulvovaginal inflammation
Time frame: 21 - 35 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
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)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Association of metronidazole; nystatin and dexamethasone and Flagyl in people with Bacterial Vaginosis and Fungal Vaginal Infections, run by Marjan Industria e Comercio ltda at 1 site in Brazil.
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 11 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: status not confirmed, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic cure (time frame: Day 21-35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2015.