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The purpose of this study is to determine the Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clindamycin 100mg and Ketoconazole 400mg | Experimental |
| |
| Tetracycline 100mg and Amphotericin B 50mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clindamycin 100mg and Ketoconazole 400mg | Drug | 1 vaginal capsule once a day at night |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy based on cure rate evaluated by clinical and laboratory criteria. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability based on adverse events reports and patient's information | 7 days | |
| Safety based on adverse events reports and laboratory criterion | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rogerio Bonassi Machado, MD | Contact | +55 11 4521-6466 | rogeriobonassi@terra.com.br | |
| Paula Fabrini, MD | Contact | +55 11 4521-6466 |
| Name | Affiliation | Role |
|---|---|---|
| Rogerio Bonassi Machado, MD | CRM Regional Council of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vox Femina | Jundiaà | São Paulo | Brazil |
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| Tetracycline 100mg and Amphotericin B 50mg | Drug | One full applicator, once a day at night |
|
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001424 | Bacterial Infections |
| D014627 | Vaginitis |
| 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 |
|---|---|
| D002981 | Clindamycin |
| D007654 | Ketoconazole |
| D013752 | Tetracycline |
| D000666 | Amphotericin B |
| ID | Term |
|---|---|
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010879 | Piperazines |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
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