Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| AC2PS-US12-002 | Other Identifier | Gen-Probe | |
| ATVPS-US12-001 | Other Identifier | Gen-Probe | |
| ATVTS-US12-003 | Other Identifier | Gen-Probe |
Not provided
Not provided
Not provided
Corporate decision to spend money on other development programs.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and TIGRIS® Systems.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays | Device | In Vitro Diagnostic Assays |
|
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) to aid in the diagnosis of chlamydial and/or gonococcal and/or trichomonal urogenital disease | approximately one year |
Not provided
Not provided
Inclusion Criteria:
In addition, the subject must meet at least one of the following criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Female subjects at least 16 years of age, with or without symptoms of sexually transmitted disease.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Renee Wait | Gen-Probe, Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Diseases STD Program University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
Not provided
Not provided
Not provided
Not provided
urine; endocervical and vaginal swabs
| Medical Center for Clinical Research |
| San Diego |
| California |
| 92108 |
| United States |
| Healthcare Clinical Data | North Miami | Florida | 33161 | United States |
| Mount Vernon Clinical Research | Sandy Springs | Georgia | 30328 | United States |
| Louisiana State University Health Sciences Center Dept. of Medicine, Infectious Disease | New Orleans | Louisiana | 70112 | United States |
| John Hopkins University | Baltimore | Maryland | 21205 | United States |
| New England Center for Clinical Research | Fall River | Massachusetts | 02720 | United States |
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27599-7030 | United States |
| Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology | Cincinnati | Ohio | 45229-3039 | United States |
| Planned Parenthood Southeastern Pennsylvania | Philadelphia | Pennsylvania | 19107 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| The Jackson Clinic | Jackson | Tennessee | 38305 | United States |
| Planned Parenthood Gulf Coast | Houston | Texas | 77023 | United States |
| Tidewater Clinical Research | Norfolk | Virginia | 23502 | United States |
| ID | Term |
|---|---|
| D002690 | Chlamydia Infections |
| D006069 | Gonorrhea |
| D014245 | Trichomonas Infections |
| ID | Term |
|---|---|
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D016870 | Neisseriaceae Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
Not provided
Not provided