None listed
Conditions
Interventions
Intravaginal application of Nitazoxanide 500 mg intravaginal monodose
Group name:Group 2 Type of group
Intravaginal application of Metronidazole 500 mg intravaginal monodose
Group 1 Type of group
Sponsors
GRUPO FARMAKONSUMA S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: Women aged 18 to 48 years who give their consent in writing and with a diagnosis of vaginal trichomoniasis, bacterial vaginosis or both, proven by clinical findings, defined by the researcher, fresh smear of positive vaginal secretion and 3 or more criteria of Amsel positive, respectively.
Exclusion criteria
Exclusion criteria: 1) Patients under 18 years and over 48 years of age. 2) Patients with suspected concomitant diagnosis of mycosis vaginal or other pathology not considered in the inclusion criteria. 3) Patients in which a breach is foreseen in the follow up of the study. 4) Patients who do not sign informed consent. 5) Patients with concomitant diseases that, in the opinion of the researcher, discourage their inclusion in the study. 6) Patients with known hypersensitivity to imidazoles. 7) Patients with suspected blood dyscrasias. 8) Patients with suspicion or history of deterioration of the liver or kidney function. 9) Patients with suspected pregnancy or breast-feeding. 10) Patients with suspected acute or chronic disease of the SNC. 11) Patients whose pathological situation may interfere with the development of the study. 12) Patients who use concomitant coumarins and / or warfarin. 13) Patients with NSAID use up to seven days before the administration of the treatment. 14) Patients who are consuming at the time of the study some antiparasitic medication, antibiotic or whatever Consumed up to 15 days before its inclusion. 15) Patients with suspected digestive pathology (gastritis, hepatitis, ulcer, etc.). 16) Patients with more than one sexual partner reported. 17) Patients with BMI less than 18.85 and greater than 26.9.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Measure:Response to treatment Timepoints:At 24 hours and 7 days after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Measure:Safety of treatment: Occurrence of adverse events. Severity of the adverse event Timepoints:At 24 hours and 7 days after treatment | — |
Countries
Peru
Outcome results
None listed