None listed
Conditions
Interventions
Nistalizol Type of group
Pharmaceutical form: Ovules
Dosage: a daily intravaginal ovum for 7 days
Method of administration: Intravaginal
Active principle and concentrations: Nistatina 100 000 UI, Metronidazol 500mg y Lidocaina 7mg
Sponsors
Laboratorio Farmaceutico San Joaquin - ROXFARMA Sociedad Anonima,
Eligibility
Inclusion criteria
Inclusion criteria: Be able to understand, sign and date an informed consent document according to the guidelines of good clinical practice and local regulations. • Female patients between 18 years of age and under 45 years of age • Diagnosis of vaginitis defined by the presence of burning, pruritus or vaginal itching plus evidence of abnormal vaginal discharge. • Commitment to not have sex during the duration of treatment. • Commitment to not use any other vagina product during the duration of the treatment. • Commitment to comply with the assigned treatment. • Desire to join the treatment program
Exclusion criteria
Exclusion criteria: • If you are participating in another clinical trial or in the last 30 days • Presence of 3 abnormal vaginal discharge pictures in the last year • Presence of any sexually transmitted disease or gynecological condition that requires treatment. • Predisposing factors such as diabetes mellitus, chronic use of corticosteroids or other immunosuppression • Pregnant or breast-feeding patients • Have used an antifungal in the last 7 days • Date of next expected menstruation within 7 days after starting treatment • Diagnosis of epilepsy • Diseases of the central nervous system • History of liver disease • History of leukopenia • Use of oral anticoagulants • Use of any of the study components • Use of Disulfiram • Use of phenobarbital • Allergy to the components of research drugs to be used • Consistent consumption of alcohol or use of prohibited substances
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:ITT population (intention tp treat) and Population PP (per protocol) Measure:effectiveness Timepoints: It will be done at the indication of the treatment indicated in the protocol (seven days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Evaluation of all randomized subjects who have received the treatment dose: -Vital signs and any tendency or arnormality. discontinuations due to adverse drug reactions or death. -Adverse reactions to medications during treatment with the study medication or within 7 days after their suspensions. -Adverse reaction to emergency medications associated with the treatment. -In addition, the differences will be analyzed statistically. Measure:Safety evaluation Timepoints:7 days of treatment and 7 days of follow-ups. | — |
Countries
Peru
Contacts
Public ContactRAUL JAVIER YEPEZ
PERUVIAN CLINICAL RESEARCH S.A.C
Outcome results
None listed