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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02186145

Enrollment

160

Registered

2014-07-10

Start date

2016-01-31

Completion date

2017-01-31

Last updated

2015-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginosis, Fungal Vaginal Infections

Brief 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.

Interventions

DRUGAssociation of metronidazole; nystatin and dexamethasone

DRUGFlagyl

Vaginal cream of metronidazole and nystatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Therapeutic cure	Day 21-35	Therapeutic cure which is based on a combination of clinical outcome and Gram's stain results (Nugentscore)/mycological eradication.

Secondary

Measure	Time frame	Description
Evaluation on vulvovaginal inflammation	21 - 35 days	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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026