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The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle | Placebo Comparator | Treatment with the vehicle (placebo) |
|
| Product 55394 | Experimental | Treatment with product 55394 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Product 55394 | Drug | Product 55394 vaginal gel in a prefilled applicator. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure | The proportion of subjects with a clinical cure at the Day 21 visit, as assessed by the investigator. | Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Cure | The proportion of subjects with a therapeutic cure at the Day 21 visit. Therapeutic cure is defined as both a clinical cure and bacteriological cure as assessed by the investigator and the central laboratory, respectively. | Day 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ron Staugaard | Medicis Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| Placebo Vehicle (non-treatment) |
| Drug |
The vehicle vaginal gel in an applicator (placebo). |
|
| Phoenix |
| Arizona |
| United States |
| La Mesa | California | United States |
| Los Angeles | California | United States |
| San Diego | California | United States |
| Torrance | California | United States |
| Denver | Colorado | United States |
| Groton | Connecticut | United States |
| Boyton Beach | Florida | United States |
| Clearwater | Florida | United States |
| Miami | Florida | United States |
| North Miami | Florida | United States |
| Sunrise | Florida | United States |
| Atlanta | Georgia | United States |
| Augusta | Georgia | United States |
| Roswell | Georgia | United States |
| Chicago | Illinois | United States |
| Marrero | Louisiana | United States |
| Falls River | Massachusetts | United States |
| Detroit | Michigan | United States |
| Saginaw | Michigan | United States |
| Lincoln | Nebraska | United States |
| Lawrenceville | New Jersey | United States |
| Neptune City | New Jersey | United States |
| Plainsboro | New Jersey | United States |
| Columbus | Ohio | United States |
| Jenkintown | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Columbia | South Carolina | United States |
| Jackson | Tennessee | United States |
| Corpus Christi | Texas | United States |
| Houston | Texas | United States |
| Schertz | Texas | United States |
| Williston | Vermont | United States |
| Virginia Beach | Virginia | United States |
| Seattle | Washington | United States |
| Tacoma | Washington | United States |
| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| 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 |
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