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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00694928
Other study ID # CBC-303-603-622467
Secondary ID
Status Completed
Phase Phase 3
First received June 9, 2008
Last updated February 29, 2012
Start date May 2008
Est. completion date November 2009

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
clindamycin phosphate/butoconazole nitrate
semi-solid, single dose
butoconazole nitrate
semi-solid, single dose

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Lumara Health, Inc.

Countries where clinical trial is conducted

United States,  India,  Russian Federation, 

Outcome

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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