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This study will evaluate the efficacy and safety of a vaginal product compared with that of other vaginal products in the treatment of vaginal infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | clindamycin phosphate/butoconazole nitrate |
|
| 2 | Active Comparator | clindamycin phosphate |
|
| 3 | 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 |
|---|---|---|---|---|---|---|
| Clinical Research Consultants, Inc | Birmingham | Alabama | 35209 | United States | ||
| Jefferson Clinic, PC |
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| clindamycin phosphate |
| Drug |
semi solid, single dose |
|
| 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 |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| Choice Research, LLC | Enterprise | Alabama | 36330 | United States |
| Star W. Research | Chandler | Arizona | 85225 | United States |
| Precision Trials, LLC/Desert West OB/GYN | Glendale | Arizona | 85304 | United States |
| Women's Health Research | Phoenix | Arizona | 85015 | United States |
| Precision Trials LLC | Phoenix | Arizona | 85032 | United States |
| Visions Clinical Research - Tucson | Tucson | Arizona | 85712 | United States |
| NEA Women's Clinic | Jonesboro | Arkansas | 33760 | United States |
| Arkansas Primary Care Clinic, PA | Little Rock | Arkansas | 72204 | United States |
| The Woman's Clinic, P.A. | Little Rock | Arkansas | 72205 | United States |
| Precision Clinical Research | Searcy | Arkansas | 72143 | United States |
| Med Center | Carmichael | California | 95608 | United States |
| Universal Biopharma Research Institute, Inc./Alta Family Health Clinic, Inc. | Dinuba | California | 93618 | United States |
| Sierra Medical Research | Fresno | California | 93611 | United States |
| Grossmont Center for Clinical Research | La Mesa | California | 91942 | United States |
| San Diego Clinical Research Center | San Diego | California | 92103 | United States |
| Lynn Institute of the Rockies | Colorado Springs | Colorado | 80909 | United States |
| Red Rocks OB/GYN | Lakewood | Colorado | 80228 | United States |
| Lynn Institute of Pueblo | Pueblo | Colorado | 81001 | United States |
| Women's Health Care Associates, PC | Hartford | Connecticut | 06105 | United States |
| Greater Hartford Womens Association/Women's Health | West Hartford | Connecticut | 06117 | United States |
| Women's Medical Research Group, LLC | Clearwater | Florida | 33759 | United States |
| Segal Institute for Clinical Research | North Miami | Florida | 33161 | United States |
| Physician Care Clinical Research | Sarasota | Florida | 34239 | United States |
| Insignia Clinical Research | Tampa | Florida | 33607 | United States |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | United States |
| Atlanta Medical Research Institute | Alpharetta | Georgia | 30005 | United States |
| AMR Research Associates | Bogart | Georgia | 30622 | United States |
| Medical Network for Educators and Research | Decatur | Georgia | 30033 | United States |
| Soapstone Center for Clinical Research | Decatur | Georgia | 30034 | United States |
| Atlanta West Women's Center | Douglasville | Georgia | 30134 | United States |
| The Woman's Clinic | Boise | Idaho | 83712 | United States |
| Rosemark Women Care Specialists | Idaho Falls | Idaho | 83404 | United States |
| Womans Health Practice, LLC | Champaign | Illinois | 61820 | United States |
| Northern Indiana Womens Health Research | South Bend | Indiana | 46601 | United States |
| Clinical Trials Management | Mandeville | Louisiana | 70471 | United States |
| Regional Research Specialists, LLC | Shreveport | Louisiana | 71106 | United States |
| New England Center for Clinical Research, Inc. | Fall River | Massachusetts | 02720 | United States |
| Activmed Practices & Research, Inc. | Haverhill | Massachusetts | 01830 | United States |
| Healthcare for Women | New Bedford | Massachusetts | 02740 | United States |
| Female Pelvic Medicine and Urogynecology Institute of Michigan | Grand Rapids | Michigan | 49506 | United States |
| Women's Health Care Specialists, PC | Paw Paw | Michigan | 49079 | United States |
| Women's Health Partner | St Louis | Missouri | 63117 | United States |
| Consultants in Women's Healthcare | St Louis | Missouri | 63131 | United States |
| New Ballas OB-GYN, Inc. | St Louis | Missouri | 63141 | United States |
| The Medical Group of Northern Nevada | Reno | Nevada | 89502 | United States |
| Suffolk Ob/Gyn | Port Jefferson | New York | 11777 | United States |
| Preferred OB/GYN/ Women's Health | Woodbury | New York | 11797 | United States |
| Eastowne OB-GYN and Infertility | Chapel Hill | North Carolina | 27514 | United States |
| Eastern Carolina Women's Center | New Bern | North Carolina | 28562 | United States |
| Hawthorne Medical Research, Inc. | Winston-Salem | North Carolina | 27103 | United States |
| Valaores & Lewis Obstetrics & Gynocology | Winston-Salem | North Carolina | 27103 | United States |
| Mid Dakota Clinic Center for Women | Bismarck | North Dakota | 58501 | United States |
| Complete Healthcare for Women | Columbus | Ohio | 43231 | United States |
| HWC Women's Research Center | Englewood | Ohio | 45322 | United States |
| Holzer Clinic | Gallipolis | Ohio | 45631 | United States |
| Pacific Women's Center, LLC | Eugene | Oregon | 97401 | United States |
| Medford Women's Clinic, LLP | Medford | Oregon | 97504 | United States |
| Laurel Highlands Ob/Gyn, PC | Hopwood | Pennsylvania | 15445 | United States |
| Clinical Trials Research Services, LLC | Natrona Heights | Pennsylvania | 15065 | United States |
| Associates Ob/Gyn | Germantown | Tennessee | 38138 | United States |
| Women's Care Center, PLC | Memphis | Tennessee | 38119 | United States |
| Women Partners in Health | Austin | Texas | 78705 | United States |
| Advanced Research Associates | Corpus Christi | Texas | 78414 | United States |
| Research Across America | El Paso | Texas | 79902 | United States |
| Planned Parenthood of Houston | Houston | Texas | 77004 | United States |
| The Woman's Hospital of Texas Clinical Research Center | Houston | Texas | 77054 | United States |
| TMC Life Research, Inc | Houston | Texas | 77054 | United States |
| Bexar Clinical Trials, LLC | Irving | Texas | 75061 | United States |
| Willowbend Health and Wellness | Plano | Texas | 75093 | United States |
| InVisions Consultants, LLC c/o Northeast Ob/Gyn | San Antonio | Texas | 78217 | United States |
| King's Daughter Clinic | Temple | Texas | 76502 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |
| Mt. Timpangos Women's Healthcare | Pleasant Grove | Utah | 84062 | United States |
| Salt Lake Research | Salt Lake City | Utah | 84107 | United States |
| Salt Lake Women's Center | Sandy City | Utah | 84070 | United States |
| Tidewater Clinical Research, Inc | Virginia Beach | Virginia | 23456 | United States |
| Walla Walla Clinic | Walla Walla | Washington | 99362 | United States |
| Hyperion Clinical Research, LLC | Charleston | West Virginia | 25301 | United States |
| Aurora Advanced Healthcare, Inc | Milwaukee | Wisconsin | 53209 | United States |
| Institute of Kidney Disease and Research Centre | Ahmedabad | Gujarat | 380016 | India |
| Krishna Hospital Surgical & Maternity 201/2/3 Suryadeep Complex | Vadodara | Gujarat | 390006 | India |
| Father Muller Medical College Hospital | Mangalore | Kamataka | 575002 | India |
| Neha Prakash Hospital | Bangalore | Karnataka | 560064 | India |
| KMC Hospital | Mangalore | Karnataka | 575001 | India |
| Yenepoya Medical College and Hospital | Mangalore | Karnataka | 575018 | India |
| Om Women's Hospital | Nagpur | Maharashtra | 440010 | India |
| Avanti Institute of Cardiology | Nagpur | Maharashtra | 440012 | India |
| Nagpur Test Tube Baby Centre | Nagpur | Maharashtra | 440022 | India |
| VSG Healthcare, Dr. Ganorkar Hospital | Nashik | Maharashtra | 422001 | India |
| Nivedita Hospital | Nashik | Maharashtra | 422002 | India |
| Deenanath Mangeshkar Hospital and Research Centre | Pune | Maharashtra | 411004 | India |
| KEM Hospital Research Centre | Pune | Maharashtra | 411011 | India |
| Dr. D. Y. Patil Medical College & Hospital | Pune | Maharashtra | India |
| Sri Ramachandra Medical College | Chennai | Tamil Nadu | 600116 | India |
| Chopra Nursing and Maternity Home | Agra | 282001 | India |
| Yashoda Super Speciality Hospital | Ghaziabad | 201001 | India |
| Government Maternity Hospital | Hyderabad | 500002 | India |
| Government Maternity Hospital | Hyderabad | 500095 | India |
| Makker Medical Center | Lucknow | 226991 | India |
| M.K.W. Hospital and Research Centre | New Delhi | 110027 | India |
| Sri Ramachandra Medical College | Tamil Nadu | 600116 | India |
| Ponce School of Medicine | Ponce | 00716 | Puerto Rico |
| Dermatovenerologic Dispensary | Korolyov | Moscow Oblast | 141074 | Russia |
| D.O. Ott Research Institute of Ob/Gyn--Family Planning and Female Health Center | Mendeleevskaya Line | Sankt-Peterburg | 199034 | Russia |
| D.O. Ott Research Institute of Ob/Gyn--Gynecologic Endocrinology | Mendeleyevskaya | Sankt-Peterburg | 199034 | Russia |
| Orkli, LLC | V.o. | Sankt-Peterburg | 199178 | Russia |
| Smolensk State Medical Academy of Roszdrav | Smolensk | Smolensk Oblast | 214019 | Russia |
| Kaluga Regional Dermatovenerologic Dispensary | Kaluga | 24800 | Russia |
| Moscow Regional Research Insitute of Obstetrics and Gynecology | Moscow | 101000 | Russia |
| Dermatovenerologic Dispensary #15 | Moscow | 111538 | Russia |
| Family Planning and Reproductive Centre | Moscow | 117152 | Russia |
| The Peoples' Friendship University of Russia | Moscow | 117198 | Russia |
| City Clinical Hospital #52 | Moscow | 117997 | Russia |
| City Clinical Hospital #31 | Moscow | 119415 | Russia |
| Clinic of Skin and Sexual Transmitted Diseases | Moscow | 119435 | Russia |
| City Clinical Hospital #51 | Moscow | 121309 | Russia |
| Nizhegorodskiy Dermatovenerologic Scientific Research Institute of Federal Agency for Public Health and Human Services | Nizhny Novgorod | 603950 | Russia |
| Regional Dermatovenerologic Dispensary | Rostov-on-Don | 344007 | Russia |
| Ryazan Regional Clinical Dermatovenerologic Dispensary | Ryazan | 390046 | Russia |
| Juventa--Reproductive Health | Saint Petersburg | 190020 | Russia |
| Medical Mycology Scientific Research Institute at St. Petersburg Medical Academy of Postgraduate Studies of Roszdrav | Saint Petersburg | 191015 | Russia |
| 442 District Military Clinical Hospital of Leningradsky Military District | Saint Petersburg | 191124 | Russia |
| City Dermatovenerologic Dispensary | Saint Petersburg | 192102 | Russia |
| S.M. Kirov Military Medical Academy, MoD of the Russian Federation | Saint Petersburg | 194044 | Russia |
| L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#321 | Saint Petersburg | 194291 | Russia |
| L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#322 | Saint Petersburg | 194291 | Russia |
| Leningradskiy Regional Clinical Hospital | Saint Petersburg | 194291 | Russia |
| Family Planning and Reproductive Centre | Saint Petersburg | 195008 | Russia |
| St. Petersburg State I.I. Mechnikov Medical Academy of Roszdrav | Saint Petersburg | 195067 | Russia |
| Andros Clinic, LLC | Saint Petersburg | 197136 | Russia |
| Smolensk Dermatovenerologic Dispensary | Smolensk | 214000 | Russia |
| ID | Term |
|---|---|
| D014848 | Vulvovaginitis |
| 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 |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C007084 | clindamycin phosphate |
| C017125 | butoconazole |
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