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Due to budget limitations, the company decided to withdraw this study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colpistatin 5DT | Experimental |
| |
| Gynecological Flagyl | Active Comparator |
| |
| Gino-Canesten 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clotrimazole + Metronidazole | Drug | Vaginal cream with Clotrimazole 200mg and Metronidazole 0,75%. Apply once per day, before bedtime, for 5 (five) days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 3 days after the end of the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 30 days after the end of the treatment |
| Vaginal microflora reconstitution through microbiological evaluation of vaginal material |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo A. Junior, MD | Scentryphar Pesquisa ClÃnica Ltda | Principal Investigator |
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| Metronidazole | Drug | Vaginal gel with Metronifdazole 100mg/g. Apply once per day, before bedtime, for 10(ten) days. |
|
| Clotrimazole | Drug | Vaginal cream with Clotrimazole 20mg/g. Apply once per day, before bedtime, for 3 (three) days. |
|
Evaluation of the collected vaginal material with the microbiological tests(Whiff, Gram, Affirm VPIII) and PCR. |
| 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. | From baseline to 30 days after treatment's end |
| ID | Term |
|---|---|
| D019522 | Vaginal Discharge |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D003022 | Clotrimazole |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
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