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| ID | Type | Description | Link |
|---|---|---|---|
| BR 001-09 | Other Identifier | Schering Study Number |
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This is a study to compare the safety and efficacy of the use of a intravaginal ovule containing a combination of Ketoconazole and Clindamycin to the use of an intravaginal cream containing a combination Tetracycline and Amphotericin B for the treatment of bacterial vaginosis and/or mixed or isolated vaginal candidiasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clindamycin/ketoconazole combination | Experimental |
| |
| tetracycline hydrochloride/amphotericin B combination | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100 mg clindamycin /800 mg ketoconazole vaginal ovule | Drug | 1 vaginal ovule for 3 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants that obtain clinical cure | Baseline up to Day 10 | |
| Percentage of participants that obtain microbiological cure | Baseline up to Day 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| 100 mg tetracycline hydrochloride /50 mg amphotericin B cream | Drug | 1 applicator (4 g) full of cream intravaginally for 7 to 10 days |
|
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| D002181 | Candidiasis, Vulvovaginal |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | 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 |
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D014848 | Vulvovaginitis |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
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| ID | Term |
|---|---|
| D002981 | Clindamycin |
| D013752 | Tetracycline |
| ID | Term |
|---|---|
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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