The purpose of this study is to determine the efficacy and safety of the association clotrimazole 200mg and metronidazole 0,75%(Clopistatin 5DT®) and whether it is superior when compared with metronidazole 100mg/g (gynecologic Flagyl®) and clotrimazole 20mg/g (Gino-Canesten® 3) in the syndromic treatment of vaginal discharge from different etiologies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Vaginal cream with Clotrimazole 200mg and Metronidazole 0,75%. Apply once per day, before bedtime, for 5 (five) days.
Vaginal gel with Metronifdazole 100mg/g. Apply once per day, before bedtime, for 10(ten) days.
Vaginal cream with Clotrimazole 20mg/g. Apply once per day, before bedtime, for 3 (three) days.
Ceasing of the symptoms of vaginal discharge after 3(three) days of the end of the treatment
Examination of the breasts and internal and external examination of the female genital organ.
Time frame: From baseline to 3 days after the end of the treatment
Registry of Adverse Effects occurrence throughout the study
Evaluation of Clinical and Physical examination and the measure of vital signs; Evaluation of Adverse effects; Evaluation of Laboratory exams; And evaluation of urine beta-hcg test.
Time frame: From baseline to 30 days after the end of the treatment
Vaginal microflora reconstitution through microbiological evaluation of vaginal material
Evaluation of the collected vaginal material with the microbiological tests(Whiff, Gram, Affirm VPIII) and PCR.
Time frame: From baseline to 30 days after treatment's end
Symptomatology recurrence and/or vaginal microflora alteration 30 days after the treatment's end
Examination of the breasts and internal and external examination of the female genital organ. Evaluation of the collected vaginal material with the microbiological tests(Whiff, Gram, Affirm VPIII) and PCR.
Time frame: From baseline to 30 days after treatment's end
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.