CClinicalTrials.gg
Sign In
Status unknownNCT02186145Updated Apr 9, 2015

Efficacy and Safety Study of Metronidazole, Nystatin and Dexamethasone Combination Therapy in Bacterial and Fungal Vaginal Infections

A Phase 3 interventional study of Association of metronidazole; nystatin and dexamethasone and Flagyl in Bacterial Vaginosis and Fungal Vaginal Infections, sponsored by Marjan Industria e Comercio ltda. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-04-09.

Sponsored by Marjan Industria e Comercio ltda · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Bacterial Vaginosis
  • Fungal Vaginal Infections
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 160 is above the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Marjan Industria e Comercio ltda is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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) ;
  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Association of metronidazole; nystatin and dexamethasone

    Intravaginal cream containing metronidazole (500 mg), nystatin ( 100.000 UI) and dexamethasone (0,32 mg) once a day. Period: 10 days.

    Drug: Association of metronidazole; nystatin and dexamethasone

  • Active comparator
    Flagyl

    Vaginal cream of metronidazole 500 mg, nystatin 100.000 UI - once a day. Period: 10 days

    Drug: Flagyl

Interventions

  • DrugAssociation of metronidazole; nystatin and dexamethasone
  • DrugFlagyl

    Vaginal cream of metronidazole and nystatin

    Also known as: Flagyl-Nistatina (Sanofi Aventis)

06

What researchers measure

Primary outcomes

  1. Therapeutic cure

    Therapeutic cure which is based on a combination of clinical outcome and Gram's stain results (Nugentscore)/mycological eradication.

    Time frame: 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.

    Time frame: 21 - 35 days

07

Study locations

1 site
  • Faculty of Medicine of ABC (FMABC)
    Santo André, SP 09190-615, Brazil
    • Marcus Vinícius Seroqui, Site Clinical Trials Manager · Contact · mv_seroqui@yahoo.com.br · +55 11 2829-5148
    • Emerson Oliveira, MD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02186145
Lead sponsor
Marjan Industria e Comercio ltda
Responsible party
Sponsor
First posted
Jul 10, 2014
Start date
Jan 2016
Primary completion
Jan 2017 (estimated)
Completion
Jan 2017 (estimated)
Last update
Apr 9, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Infections→

Other studies from this sponsor

Marjan Industria e Comercio ltda

Start the discussion