Vaginitis Clinical Trial
| Verified date | February 2012 |
| Source | Lumara Health, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1443 |
| Est. completion date | December 2009 |
| Est. primary completion date | December 2009 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 16 Years and older |
| Eligibility |
Inclusion Criteria: - Patients must have a clinical diagnosis of vaginal infection. - Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control. Exclusion Criteria: - Patients must not have any other infections - May not be pregnant or nursing - May not be receiving any other antimicrobial therapies or any medications that would interfere with the outcome of the study. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| India | Chopra Nursing and Maternity Home | Agra | |
| India | Institute of Kidney Disease and Research Centre | Ahmedabad | Gujarat |
| India | Neha Prakash Hospital | Bangalore | Karnataka |
| India | Sri Ramachandra Medical College | Chennai | Tamil Nadu |
| India | Yashoda Super Speciality Hospital | Ghaziabad | |
| India | Government Maternity Hospital | Hyderabad | |
| India | Government Maternity Hospital | Hyderabad | |
| India | Makker Medical Center | Lucknow | |
| India | Father Muller Medical College Hospital | Mangalore | Kamataka |
| India | KMC Hospital | Mangalore | Karnataka |
| India | Yenepoya Medical College and Hospital | Mangalore | Karnataka |
| India | Avanti Institute of Cardiology | Nagpur | Maharashtra |
| India | Nagpur Test Tube Baby Centre | Nagpur | Maharashtra |
| India | Om Women's Hospital | Nagpur | Maharashtra |
| India | Nivedita Hospital | Nashik | Maharashtra |
| India | VSG Healthcare, Dr. Ganorkar Hospital | Nashik | Maharashtra |
| India | M.K.W. Hospital and Research Centre | New Delhi | |
| India | Deenanath Mangeshkar Hospital and Research Centre | Pune | Maharashtra |
| India | Dr. D. Y. Patil Medical College & Hospital | Pune | Maharashtra |
| India | KEM Hospital Research Centre | Pune | Maharashtra |
| India | Sri Ramachandra Medical College | Tamil Nadu | |
| India | Krishna Hospital Surgical & Maternity 201/2/3 Suryadeep Complex | Vadodara | Gujarat |
| Puerto Rico | Ponce School of Medicine | Ponce | |
| Russian Federation | Kaluga Regional Dermatovenerologic Dispensary | Kaluga | |
| Russian Federation | Dermatovenerologic Dispensary | Korolev | Moscow Region |
| Russian Federation | D.O. Ott Research Institute of Ob/Gyn--Family Planning and Female Health Center | Mendeleevskaya line | Saint Petersburg |
| Russian Federation | D.O. Ott Research Institute of Ob/Gyn--Gynecologic Endocrinology | Mendeleyevskaya | Saint Petersburg |
| Russian Federation | City Clinical Hospital #31 | Moscow | |
| Russian Federation | City Clinical Hospital #51 | Moscow | |
| Russian Federation | City Clinical Hospital #52 | Moscow | |
| Russian Federation | Clinic of Skin and Sexual Transmitted Diseases | Moscow | |
| Russian Federation | Dermatovenerologic Dispensary #15 | Moscow | |
| Russian Federation | Family Planning and Reproductive Centre | Moscow | |
| Russian Federation | Moscow Regional Research Insitute of Obstetrics and Gynecology | Moscow | |
| Russian Federation | The Peoples' Friendship University of Russia | Moscow | |
| Russian Federation | Nizhegorodskiy Dermatovenerologic Scientific Research Institute of Federal Agency for Public Health and Human Services | Nizhny Novgorod | |
| Russian Federation | Regional Dermatovenerologic Dispensary | Rostov-on-Don | |
| Russian Federation | Ryazan Regional Clinical Dermatovenerologic Dispensary | Ryazan | |
| Russian Federation | 442 District Military Clinical Hospital of Leningradsky Military District | Saint Petersburg | |
| Russian Federation | Andros Clinic, LLC | Saint Petersburg | |
| Russian Federation | City Dermatovenerologic Dispensary | Saint Petersburg | |
| Russian Federation | Family Planning and Reproductive Centre | Saint Petersburg | |
| Russian Federation | Juventa--Reproductive Health | Saint Petersburg | |
| Russian Federation | L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#321 | Saint Petersburg | |
| Russian Federation | L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#322 | Saint Petersburg | |
| Russian Federation | Leningradskiy Regional Clinical Hospital | Saint Petersburg | |
| Russian Federation | S.M. Kirov Military Medical Academy, MoD of the Russian Federation | Saint Petersburg | |
| Russian Federation | St. Petersburg State I.I. Mechnikov Medical Academy of Roszdrav | Saint Petersburg | |
| Russian Federation | Smolensk Dermatovenerologic Dispensary | Smolensk | |
| Russian Federation | Smolensk State Medical Academy of Roszdrav | Smolensk | Smolensk Region |
| Russian Federation | Medical Mycology Scientific Research Institute at St. Petersburg Medical Academy of Postgraduate Studies of Roszdrav | St. Petersburg | |
| Russian Federation | Orkli, LLC | V.o. | Saint Petersburg |
| United States | Atlanta Medical Research Institute | Alpharetta | Georgia |
| United States | Women Partners in Health | Austin | Texas |
| United States | Clinical Research Consultants, Inc | Birmingham | Alabama |
| United States | Jefferson Clinic, PC | Birmingham | Alabama |
| United States | Mid Dakota Clinic Center for Women | Bismark | North Dakota |
| United States | AMR Research Associates | Bogart | Georgia |
| United States | The Woman's Clinic | Boise | Idaho |
| United States | Med Center | Carmichael | California |
| United States | Womans Health Practice, LLC | Champaign | Illinois |
| United States | Star W. Research | Chandler | Arizona |
| United States | Eastowne OB-GYN and Infertility | Chapel Hill | North Carolina |
| United States | Hyperion Clinical Research, LLC | Charleston | West Virginia |
| United States | Women's Medical Research Group, LLC | Clearwater | Florida |
| United States | Lynn Institute of the Rockies | Colorado Springs | Colorado |
| United States | Complete Healthcare for Women | Columbus | Ohio |
| United States | Advanced Research Associates | Corpus Christi | Texas |
| United States | Medical Network for Educators and Research | Decatur | Georgia |
| United States | Soapstone Center for Clinical Research | Decatur | Georgia |
| United States | Universal Biopharma Research Institute, Inc./Alta Family Health Clinic, Inc. | Dinuba | California |
| United States | Atlanta West Women's Center | Douglasville | Georgia |
| United States | Research Across America | El Paso | Texas |
| United States | HWC Women's Research Center | Englewood | Ohio |
| United States | Choice Research, LLC | Enterprise | Alabama |
| United States | Pacific Women's Center, LLC | Eugene | Oregon |
| United States | New England Center for Clinical Research, Inc. | Fall River | Massachusetts |
| United States | Sierra Medical Research | Fresno | California |
| United States | Holzer Clinic | Gallipolis | Ohio |
| United States | Associates Ob/Gyn | Germantown | Tennessee |
| United States | Precision Trials, LLC/Desert West OB/GYN | Glendale | Arizona |
| United States | Female Pelvic Medicine and Urogynecology Institute of Michigan | Grand Rapids | Michigan |
| United States | Women's Health Care Associates, PC | Hartford | Connecticut |
| United States | Activmed Practices & Research, Inc. | Haverhill | Massachusetts |
| United States | Laurel Highlands Ob/Gyn, PC | Hopwood | Pennsylvania |
| United States | Planned Parenthood of Houston | Houston | Texas |
| United States | The Woman's Hospital of Texas Clinical Research Center | Houston | Texas |
| United States | TMC Life Research, Inc | Houston | Texas |
| United States | Rosemark Women Care Specialists | Idaho Falls | Idaho |
| United States | Bexar Clinical Trials, LLC | Irving | Texas |
| United States | NEA Women's Clinic | Jonesboro | Arkansas |
| United States | Grossmont Center for Clinical Research | La Mesa | California |
| United States | Red Rocks OB/GYN | Lakewood | Colorado |
| United States | Tanner Clinic | Layton | Utah |
| United States | Arkansas Primary Care Clinic, PA | Little Rock | Arkansas |
| United States | The Woman's Clinic, P.A. | Little Rock | Arkansas |
| United States | Clinical Trials Management | Mandeville | Louisiana |
| United States | Medford Women's Clinic, LLP | Medford | Oregon |
| United States | Women's Care Center, PLC | Memphis | Tennessee |
| United States | Aurora Advanced Healthcare, Inc | Milwaukee | Wisconsin |
| United States | Clinical Trials Research Services, LLC | Natrona Heights | Pennsylvania |
| United States | Healthcare for Women | New Bedford | Massachusetts |
| United States | Eastern Carolina Women's Center | New Bern | North Carolina |
| United States | Segal Institute for Clinical Research | North Miami | Florida |
| United States | Women's Health Care Specialists, PC | Paw Paw | Michigan |
| United States | Precision Trials LLC | Phoenix | Arizona |
| United States | Women's Health Research | Phoenix | Arizona |
| United States | Willowbend Health and Wellness | Plano | Texas |
| United States | Mt. Timpangos Women's Healthcare | Pleasant Grove | Utah |
| United States | Suffolk Ob/Gyn | Port Jefferson | New York |
| United States | Lynn Institute of Pueblo | Pueblo | Colorado |
| United States | The Medical Group of Northern Nevada | Reno | Nevada |
| United States | Salt Lake Research | Salt Lake City | Utah |
| United States | InVisions Consultants, LLC c/o Northeast Ob/Gyn | San Antonio | Texas |
| United States | San Diego Clinical Research Center | San Diego | California |
| United States | Salt Lake Women's Center | Sandy | Utah |
| United States | Physician Care Clinical Research | Sarasota | Florida |
| United States | Precision Clinical Research | Searcy | Arkansas |
| United States | Regional Research Specialists, LLC | Shreveport | Louisiana |
| United States | Northern Indiana Womens Health Research | South Bend | Indiana |
| United States | Consultants in Women's Healthcare | St. Louis | Missouri |
| United States | New Ballas OB-GYN, Inc. | St. Louis | Missouri |
| United States | Women's Health Partner | St. Louis | Missouri |
| United States | Insignia Clinical Research | Tampa | Florida |
| United States | King's Daughter Clinic | Temple | Texas |
| United States | Visions Clinical Research - Tucson | Tucson | Arizona |
| United States | Tidewater Clinical Research, Inc | Virginia Beach | Virginia |
| United States | Walla Walla Clinic | Walla Walla | Washington |
| United States | Greater Hartford Womens Association/Women's Health | West Hartford | Connecticut |
| United States | Comprehensive Clinical Trials, LLC | West Palm Beach | Florida |
| United States | Hawthorne Medical Research, Inc. | Winston-Salem | North Carolina |
| United States | Valaores & Lewis Obstetrics & Gynocology | Winston-Salem | North Carolina |
| United States | Preferred OB/GYN/ Women's Health | Woodbury | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Lumara Health, Inc. |
United States, India, Puerto Rico, Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical symptom resolution. | baseline, 7 to 10 days and 21 to 30 days | No | |
| Secondary | 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 | No |
| Secondary | Gram stain Nugent score | 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 | No |
| Secondary | 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 | No |
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