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Terminated for site documentation and monitoring issues - not safety, study drug, or adverse event issues.
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This purpose of this study will be to conduct a double-blind, randomized, controlled clinical trial to determine the association between intravaginal high dose metronidazole (750mg), intravaginal high dose metronidazole combined with an antifungal agent(750mg metronidazole + 200mg miconazole) and low dose (37.5mg) intravaginal metronidazole, with the rate of persistent bacterial vaginosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | intravaginal metronidazole 750mg + 200mg miconazole |
|
| 2 | Active Comparator | intravaginal metronidazole 750mg |
|
| 3 | Active Comparator | intravaginal metronidazole 37.5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravaginal metronidazole | Drug | high dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| The specific aim of this study is to compare the rate of persistence of BV in non-pregnant women randomized to one of three different schemes of intravaginal metronidazole given nightly for 5 nights | 28 days after therapy initiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cayetano Heredia Hospital | Lima | Urb Ingenieria | Peru |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 27, 2013 | |
| Reset | Apr 8, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 27, 2013 | Apr 8, 2013 |
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |