Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort
NCT ID: NCT00590590
Last Updated: 2012-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
105 participants
INTERVENTIONAL
2007-10-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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3 (Placebo)
placebo
semi solid, twice weekly for 4 months
1 (Lidocaine)
lidocaine
semi solid, twice weekly for 4 months
2 (Lidocaine/Diphenhydramine)
Lidocaine/Diphenhydramine
semi solid, twice weekly, 4 months
Interventions
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Lidocaine/Diphenhydramine
semi solid, twice weekly, 4 months
lidocaine
semi solid, twice weekly for 4 months
placebo
semi solid, twice weekly for 4 months
Eligibility Criteria
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Inclusion Criteria
* Patients must be having menstrual cycles.
Exclusion Criteria
* Patients must not be pregnant or nursing.
* Must not be receiving any other medicinal therapies or any medications that would interfere with the outcome of the study.
18 Years
50 Years
FEMALE
No
Sponsors
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Lumara Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jim Joffrion
Role: STUDY_DIRECTOR
Lumara Health, Inc.
Locations
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Montgomery Women's Health Associates, P.C.
Montgomery, Alabama, United States
Star W. Research
Chandler, Arizona, United States
Precision Trials LLC
Phoenix, Arizona, United States
Searcy Medical Center
Searcy, Arkansas, United States
Universal Biopharma Research Institute, Inc.
Dinuba, California, United States
San Diego Clinical Research Center
San Diego, California, United States
Red Rocks OB/GYN
Lakewood, Colorado, United States
Taylor Associates/Gynecology
Farmington, Connecticut, United States
Women's Medical Research Group, LLC
Clearwater, Florida, United States
Clinical Research of Tampa Bay
Hudson, Florida, United States
Innovative Research of W. Florida
Largo, Florida, United States
Women's Health Care Specialists, PC
Paw Paw, Florida, United States
Tampa Bay Women's Healthcare Alliance, LLP
Tampa, Florida, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States
Atlanta Women's Research Institute, Inc.
Atlanta, Georgia, United States
Atlanta North Gynecology, PC
Roswell, Georgia, United States
Womans Clinic
Boise, Idaho, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, United States
Women's Health Practice, LLC
Champaign, Illinois, United States
Northern Indiana Womens Health Research
South Bend, Indiana, United States
Female Pelvic Medicine and Urogynecology
Grand Rapids, Michigan, United States
Boro Park ObGyn
Brooklyn, New York, United States
Eastern Carolina Womens Center
New Bern, North Carolina, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Winston-Salem Woman Care, PA
Winston-Salem, North Carolina, United States
Holzer Clinic
Gallipolis, Ohio, United States
HWC Women's Research Center
Miamisburg, Ohio, United States
Advanced Clinical Research
Medford, Oregon, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Advanced Clinical Concepts
West Reading, Pennsylvania, United States
Hillcrest Clinical Research, LLC
Simpsonville, South Carolina, United States
Southeastern Clinical Research
Chattanooga, Tennessee, United States
The Jackson Clinic, PA
Jackson, Tennessee, United States
Women's Care Center, PLC
Memphis, Tennessee, United States
Gynecology and Obstetrics, P.C.
Memphis, Tennessee, United States
Professional Quality Research/Women Partners
Austin, Texas, United States
Advanced Research Associates
Corpus Christi, Texas, United States
Woman's Hospital of Texas
Houston, Texas, United States
Bexar Clinical Trials
Irving, Texas, United States
Salt Lake Research
Salt Lake City, Utah, United States
Salt Lake Women's Center
Sandy City, Utah, United States
Gain Medical Centre
Coquitlam, British Columbia, Canada
Stephen Kaye, MD
North Vancouver, British Columbia, Canada
Southern Healthcare Centre
White Rock, British Columbia, Canada
Common Wealth Medical Clinic
Mount Pearl, Newfoundland and Labrador, Canada
The Ottawa Hospital-Soundcare Medical Centre
Ottawa, Ontario, Canada
Royal Health Care Centre
Toronto, Ontario, Canada
Windsor Metropolitan Hospital
Windsor, Ontario, Canada
Countries
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Other Identifiers
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LDC-201-601-669020
Identifier Type: -
Identifier Source: org_study_id
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