Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies. (Frauen)
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|ClinicalTrials.gov Identifier: NCT02713139|
Recruitment Status : Withdrawn (Due to budget limitations, the company decided to withdraw this study.)
First Posted : March 18, 2016
Last Update Posted : March 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sexual Active Women Vaginal Discharge||Drug: Clotrimazole + Metronidazole Drug: Metronidazole Drug: Clotrimazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III, Multicenter, Randomized, Parallel, Open Label, Controlled and Comparative Study to Evaluate the Efficacy and Safety of the Association of Clotrimazole 200mg and Metronidazole 0,75% (Colpistatin 5DT®) Compared to Gynecological Flagyl®(Metronidazole 100mg/g) and the Vaginal Cream Gino-Canesten® 3 (Clotrimazole 20mg/g) in the Syndromic Treatment of the Vaginal Discharge From Different Etiologies.|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||March 2014|
|Experimental: Colpistatin 5DT||
Drug: Clotrimazole + Metronidazole
Vaginal cream with Clotrimazole 200mg and Metronidazole 0,75%. Apply once per day, before bedtime, for 5 (five) days.
|Active Comparator: Gynecological Flagyl||
Vaginal gel with Metronifdazole 100mg/g. Apply once per day, before bedtime, for 10(ten) days.
|Active Comparator: Gino-Canesten 3||
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 [ Time Frame: From baseline to 3 days after the end of the treatment ]Examination of the breasts and internal and external examination of the female genital organ.
- Registry of Adverse Effects occurrence throughout the study [ Time Frame: From baseline to 30 days after the end of the treatment ]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.
- Vaginal microflora reconstitution through microbiological evaluation of vaginal material [ Time Frame: From baseline to 30 days after treatment's end ]Evaluation of the collected vaginal material with the microbiological tests(Whiff, Gram, Affirm VPIII) and PCR.
- Symptomatology recurrence and/or vaginal microflora alteration 30 days after the treatment's end [ Time Frame: From baseline to 30 days after 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713139
|Principal Investigator:||Eduardo A. Junior, MD||Scentryphar Pesquisa Clínica Ltda|