Vaginal Infection 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 another vaginal product in the treatment of vaginal infections.
Status | Completed |
Enrollment | 843 |
Est. completion date | November 2009 |
Est. primary completion date | November 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 | Mayani Hosptial and Research Centre | Ajmer | Rajasthan |
India | Bangalore Diabetes Centre | Bangalore | Karnataka |
India | Care Hospital | Hyderabad | |
India | Sharda Hospital | Jaipur | Rajasthan |
India | Shri Krishna Hospital | Jaipur | |
India | MV Hospital and Research Centre | Lucknow | Uttar Pradesh |
India | AJ Medical College and Hospital | Mangalore | Karnataka |
India | Mediciti Institute of Medical Sciences | Ranga Reddy District | |
India | Krishna Institute of Medical Sciences | Secunderabad | |
India | King George Hospital | Visakhapatnam | |
Russian Federation | Medical University Clinic | Kazan | |
Russian Federation | Clinical Dermatovenerologic Dispensary | Krasnodar | |
Russian Federation | Russian Medical Academy of Postgraduate Studies of Roszdrav | Moscow | |
Russian Federation | State Dermatovenerology Research Center of the Federal Agency for Provision of High Technology Medical Aid | Moscow | |
Russian Federation | State Health Care Institution Moscow City Clinical Hospital #12 | Moscow | |
Russian Federation | State Healthcare Institution Moscow Clinical Hospital #68 | Moscow | |
Russian Federation | Novisibirsk Municipal Dermatovenerologic Dispensary #1 | Novosibirsk | |
Russian Federation | State Health Care Institution Orenburg Regional Clinical Hospital #2 | Orenburg | |
Russian Federation | Republican Dermatovenerologic Dispensary, MoH of Karelia Republic | Petrozavodsk | |
Russian Federation | City Hospital #26 | Saint Petersburg | |
Russian Federation | City Multifield Hospital | Saint Petersburg | |
Russian Federation | Maximillian City Hospital #28 | Saint Petersburg | |
Russian Federation | Medical Research Institute, LLC | Saint Petersburg | |
Russian Federation | S.M. Kirov Military Medical Academy, MoD of the Russian Federation | Saint Petersburg | |
Russian Federation | St. Petersburg I.P. Pavlov State Medical University of Roszdrav | Saint Petersburg | |
Russian Federation | State Healthcare Institution Regional Dermatovenerologic Dispensary | Saint Petersburg | |
Russian Federation | Kurortniy Ward City Hospital #40 | Sestroretsk | Saint Petersburg |
Russian Federation | Railway Clinic Hospital of the Voronezh-,1 Railway Station, RJD JSC | Voronezh | |
Russian Federation | Voronezh Regional Clinical Dermatovenerologic Dispensary | Voronezh | |
Russian Federation | Yaroslavl Regional Maternity Hospital | Yaroslavl | |
United States | Steven Z. Lenowitz, MD, LLC | Bel Air | Maryland |
United States | Brookwood Ob-GYN, PC/Women's Medical Plaza | Birmingham | Alabama |
United States | The Woman's Clinic | Boise | Idaho |
United States | Taylor/Wade Medical | Bountiful | Utah |
United States | Triangle Ob/Gyn | Cary | North Carolina |
United States | Creekside Women's Care | Charleston | South Carolina |
United States | The Family Healthcare Center, PA | Clinton | South Carolina |
United States | Dekalb Gynecology Associates | Decatur | Georgia |
United States | Total Women's Health and Wellness | Decatur | Georgia |
United States | Pacific Women's Center, LLC/Clinical Trials of America | Eugene | Oregon |
United States | Kaner Medical Group, PA | Euless | Texas |
United States | Women's Wellness Center | Fayetteville | North Carolina |
United States | Holzer Clinic | Gallipolis | Ohio |
United States | Meridian Clinical Research, LLC | Greensboro | North Carolina |
United States | Greenville Pharmaceutical Research | Greenville | South Carolina |
United States | SHE Medical Center | Hartford | Connecticut |
United States | Ob/Gyn Associates | Jonesboro | Arkansas |
United States | Red Rocks OB/GYN | Lakewood | Colorado |
United States | Center for Women's Health of Lansdale | Lansdale | Pennsylvania |
United States | Debra Hemsath, MD | Largo | Florida |
United States | Lawrence Ob/Gyn Associates | Lawrenceville | New Jersey |
United States | Women's Health Research Center, LLC | Lawrenceville | New Jersey |
United States | The Woman's Clinic, PA | Little Rock | Arkansas |
United States | Peak Health Medical Group | Los Angeles | California |
United States | Advanced Reserch Associates | McAllen | Texas |
United States | Gynecology and Obstetrics | Memphis | Tennessee |
United States | Mid-South Ob/Gyn | Memphis | Tennessee |
United States | International Research Associates | Miami | Florida |
United States | Drug Research Analysis Corp | Montgomery | Alabama |
United States | Drug Research and Analysis Corp. | Montgomery | Alabama |
United States | Lynn Institute of Norman | Norman | Oklahoma |
United States | James T. Martin, Jr., MD, Ob/Gyn | North Charleston | South Carolina |
United States | Suncoast Clinical Research | Palm Harbor | Florida |
United States | University Clinical Research | Pines | Florida |
United States | Willowbend Health & Wellness | Plano | Texas |
United States | New Millennium Ob/Gyn | Riverdale | Georgia |
United States | Women's Health Care at Frost Street | San Diego | California |
United States | Tidewater Clinical Research | Virginia Beach | Virginia |
United States | Family Practice Center of Wadsworth, Inc | Wadsworth | Ohio |
United States | Brown Clinical, PLLP | Watertown | South Dakota |
United States | The Iowa Clinic Department of Ob/Gyn | West Des Moines | Iowa |
United States | Steven Freedman, MD, Inc. | West Hills | California |
United States | Vermont Urogynecology Associates, PC | Williston | Vermont |
Lead Sponsor | Collaborator |
---|---|
Lumara Health, Inc. |
United States, India, 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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