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This study will evaluate the efficacy and safety of a vaginal product compared with that of another vaginal product in the treatment of vaginal infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | clindamycin phosphate/butoconazole nitrate |
|
| 2 | Active Comparator | butoconazole nitrate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clindamycin phosphate/butoconazole nitrate | Drug | semi-solid, single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical symptom resolution | baseline, 7 to 10 days and 21 to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Yeast Culture for Candida | Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response | baseline, 7 to 10 days and 21 to 30 days |
| Gram Stain Nugent Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jim Joffrion | Lumara Health, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brookwood Ob-GYN, PC/Women's Medical Plaza | Birmingham | Alabama | 35209 | United States | ||
| Drug Research Analysis Corp |
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| butoconazole nitrate |
| Drug |
semi-solid, single dose |
|
Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution
| baseline, 7 to 10 days and 21 to 30 days |
| Saline wet mount for clue cells | Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution | baseline, 7 to 10 days and 21 to 30 days |
| Montgomery |
| Alabama |
| 36106 |
| United States |
| Drug Research and Analysis Corp. | Montgomery | Alabama | 36106 | United States |
| Ob/Gyn Associates | Jonesboro | Arkansas | 72401 | United States |
| The Woman's Clinic, PA | Little Rock | Arkansas | 72205 | United States |
| Peak Health Medical Group | Los Angeles | California | 90025 | United States |
| Women's Health Care at Frost Street | San Diego | California | 30035 | United States |
| Steven Freedman, MD, Inc. | West Hills | California | 91307 | United States |
| Red Rocks OB/GYN | Lakewood | Colorado | 80228 | United States |
| SHE Medical Center | Hartford | Connecticut | 06105 | United States |
| Debra Hemsath, MD | Largo | Florida | 33774 | United States |
| International Research Associates | Miami | Florida | 33156 | United States |
| Suncoast Clinical Research | Palm Harbor | Florida | 34684 | United States |
| University Clinical Research | Pines | Florida | 33024 | United States |
| Total Women's Health and Wellness | Decatur | Georgia | 30030 | United States |
| Dekalb Gynecology Associates | Decatur | Georgia | 30035 | United States |
| New Millennium Ob/Gyn | Riverdale | Georgia | 30274 | United States |
| The Woman's Clinic | Boise | Idaho | 83712 | United States |
| The Iowa Clinic Department of Ob/Gyn | West Des Moines | Iowa | 50266 | United States |
| Steven Z. Lenowitz, MD, LLC | Bel Air | Maryland | 21014 | United States |
| Lawrence Ob/Gyn Associates | Lawrenceville | New Jersey | 08648 | United States |
| Women's Health Research Center, LLC | Lawrenceville | New Jersey | 08648 | United States |
| Triangle Ob/Gyn | Cary | North Carolina | 27518 | United States |
| Women's Wellness Center | Fayetteville | North Carolina | 28304 | United States |
| Meridian Clinical Research, LLC | Greensboro | North Carolina | 27455 | United States |
| Holzer Clinic | Gallipolis | Ohio | 45631 | United States |
| Family Practice Center of Wadsworth, Inc | Wadsworth | Ohio | 44281 | United States |
| Lynn Institute of Norman | Norman | Oklahoma | 73069 | United States |
| Pacific Women's Center, LLC/Clinical Trials of America | Eugene | Oregon | 97401 | United States |
| Center for Women's Health of Lansdale | Lansdale | Pennsylvania | 19446 | United States |
| Creekside Women's Care | Charleston | South Carolina | 29414 | United States |
| The Family Healthcare Center, PA | Clinton | South Carolina | 29325 | United States |
| Greenville Pharmaceutical Research | Greenville | South Carolina | 29615 | United States |
| James T. Martin, Jr., MD, Ob/Gyn | North Charleston | South Carolina | 29406 | United States |
| Brown Clinical, PLLP | Watertown | South Dakota | 57201 | United States |
| Gynecology and Obstetrics | Memphis | Tennessee | 38120 | United States |
| Mid-South Ob/Gyn | Memphis | Tennessee | 38120 | United States |
| Kaner Medical Group, PA | Euless | Texas | 76039 | United States |
| Advanced Reserch Associates | McAllen | Texas | 78505 | United States |
| Willowbend Health & Wellness | Plano | Texas | 75093 | United States |
| Taylor/Wade Medical | Bountiful | Utah | 84010 | United States |
| Vermont Urogynecology Associates, PC | Williston | Vermont | 05495 | United States |
| Tidewater Clinical Research | Virginia Beach | Virginia | 23456 | United States |
| Bangalore Diabetes Centre | Bangalore | Karnataka | 560043 | India |
| AJ Medical College and Hospital | Mangalore | Karnataka | 575004 | India |
| Mayani Hosptial and Research Centre | Ajmer | Rajasthan | 305001 | India |
| Sharda Hospital | Jaipur | Rajasthan | 302020 | India |
| MV Hospital and Research Centre | Lucknow | Uttar Pradesh | 226003 | India |
| Care Hospital | Hyderabad | 500034 | India |
| Shri Krishna Hospital | Jaipur | 302001 | India |
| Mediciti Institute of Medical Sciences | Ranga Reddy District | 501401 | India |
| Krishna Institute of Medical Sciences | Secunderabad | 500003 | India |
| King George Hospital | Visakhapatnam | 530002 | India |
| Kurortniy Ward City Hospital #40 | Sestroretsk | Sankt-Peterburg | 197706 | Russia |
| Medical University Clinic | Kazan' | 420012 | Russia |
| Clinical Dermatovenerologic Dispensary | Krasnodar | 350020 | Russia |
| State Dermatovenerology Research Center of the Federal Agency for Provision of High Technology Medical Aid | Moscow | 107076 | Russia |
| State Health Care Institution Moscow City Clinical Hospital #12 | Moscow | 115516 | Russia |
| Russian Medical Academy of Postgraduate Studies of Roszdrav | Moscow | 123995 | Russia |
| State Healthcare Institution Moscow Clinical Hospital #68 | Moscow | 127473 | Russia |
| Novisibirsk Municipal Dermatovenerologic Dispensary #1 | Novosibirsk | 630082 | Russia |
| State Health Care Institution Orenburg Regional Clinical Hospital #2 | Orenburg | 460000 | Russia |
| Republican Dermatovenerologic Dispensary, MoH of Karelia Republic | Petrozavodsk | 185002 | Russia |
| Maximillian City Hospital #28 | Saint Petersburg | 190000 | Russia |
| State Healthcare Institution Regional Dermatovenerologic Dispensary | Saint Petersburg | 190020 | Russia |
| S.M. Kirov Military Medical Academy, MoD of the Russian Federation | Saint Petersburg | 194044 | Russia |
| City Multifield Hospital | Saint Petersburg | 194354 | Russia |
| Medical Research Institute, LLC | Saint Petersburg | 196084 | Russia |
| City Hospital #26 | Saint Petersburg | 196247 | Russia |
| St. Petersburg I.P. Pavlov State Medical University of Roszdrav | Saint Petersburg | 197022 | Russia |
| Railway Clinic Hospital of the Voronezh-,1 Railway Station, RJD JSC | Voronezh | 394024 | Russia |
| Voronezh Regional Clinical Dermatovenerologic Dispensary | Voronezh | 394038 | Russia |
| Yaroslavl Regional Maternity Hospital | Yaroslavl | 150003 | Russia |
| ID | Term |
|---|---|
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C007084 | clindamycin phosphate |
| C017125 | butoconazole |
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