Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort
- Conditions
- Vulvodynia
- Interventions
- Registration Number
- NCT00590590
- Lead Sponsor
- Lumara Health, Inc.
- Brief Summary
This study will evaluate the efficacy and safety of two vaginal products compared with that of placebo to determine if the two products are better than placebo in the relief of vaginal discomfort.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 105
- Patients must have sought doctor's care for this condition.
- Patients must be having menstrual cycles.
- Patients must not have any vaginal infections.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 (Placebo) placebo - 1 (Lidocaine) lidocaine - 2 (Lidocaine/Diphenhydramine) Lidocaine/Diphenhydramine -
- Primary Outcome Measures
Name Time Method Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks) 12 weeks The MDSS consists of a participant rating of their dyspareunia (painful sexual intercourse) on a 0- to 3-point scale. Each numerical value on the scale coincides with a level of pain experienced during sexual intercourse; 0 = no dyspareunia (no pain with intercourse) and 3 = completely prevents intercourse
- Secondary Outcome Measures
Name Time Method Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks) Baseline -12 Weeks 0-3 scale with 0=no dyspareunia and 3= completely prevents intercourse
Change From Baseline in Overall Vulvar Vestibulitis Syndrome (VVS)-Related Discomfort Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Discomfort and 100 = Most Severe Discomfort] 12 Weeks Change From Baseline in Overall Intercourse-Related Pain Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Pain and 100 = Most Severe Pain] 12 weeks Change From Baseline in Overall Vulvar Vestibulitis Symptoms Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Symptoms and 100 = As Bad as They Can be] 12 Weeks Change From Baseline in Tenderness (on a 0- to 3-point Scale) on Palpation at End of Treatment (12 Weeks) [Scale Rates the Severity of Pain; 0 =Absent and 3 = Severe] 12 Weeks
Trial Locations
- Locations (48)
Advanced Clinical Research
🇺🇸Medford, Oregon, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Woman's Hospital of Texas
🇺🇸Houston, Texas, United States
Royal Health Care Centre
🇨🇦Toronto, Ontario, Canada
Precision Trials LLC
🇺🇸Phoenix, Arizona, United States
Salt Lake Research
🇺🇸Salt Lake City, Utah, United States
Stephen Kaye, MD
🇨🇦North Vancouver, British Columbia, Canada
Gain Medical Centre
🇨🇦Coquitlam, British Columbia, Canada
Southeastern Clinical Research
🇺🇸Chattanooga, Tennessee, United States
Women's Care Center, PLC
🇺🇸Memphis, Tennessee, United States
Gynecology and Obstetrics, P.C.
🇺🇸Memphis, Tennessee, United States
Atlanta North Gynecology, PC
🇺🇸Roswell, Georgia, United States
Common Wealth Medical Clinic
🇨🇦Mt. Pearl, Newfoundland and Labrador, Canada
Lyndhurst Clinical Research
🇺🇸Winston Salem, North Carolina, United States
Montgomery Women's Health Associates, P.C.
🇺🇸Montgomery, Alabama, United States
Advanced Clinical Concepts
🇺🇸West Reading, Pennsylvania, United States
Women's Medical Research Group, LLC
🇺🇸Clearwater, Florida, United States
Searcy Medical Center
🇺🇸Searcy, Arkansas, United States
Innovative Research of W. Florida
🇺🇸Largo, Florida, United States
Eastern Carolina Womens Center
🇺🇸New Bern, North Carolina, United States
Rosemark Women Care Specialists
🇺🇸Idaho Falls, Idaho, United States
Comprehensive Clinical Trials, LLC
🇺🇸West Palm Beach, Florida, United States
Taylor Associates/Gynecology
🇺🇸Farmington, Connecticut, United States
Atlanta Women's Research Institute, Inc.
🇺🇸Atlanta, Georgia, United States
Star W. Research
🇺🇸Chandler, Arizona, United States
Clinical Research of Tampa Bay
🇺🇸Hudson, Florida, United States
Tampa Bay Women's Healthcare Alliance, LLP
🇺🇸Tampa, Florida, United States
Bexar Clinical Trials
🇺🇸Irving, Texas, United States
The Jackson Clinic, PA
🇺🇸Jackson, Tennessee, United States
San Diego Clinical Research Center
🇺🇸San Diego, California, United States
The Ottawa Hospital-Soundcare Medical Centre
🇨🇦Ottawa, Ontario, Canada
Universal Biopharma Research Institute, Inc.
🇺🇸Dinuba, California, United States
HWC Women's Research Center
🇺🇸Miamisburg, Ohio, United States
Red Rocks OB/GYN
🇺🇸Lakewood, Colorado, United States
Womans Clinic
🇺🇸Boise, Idaho, United States
Northern Indiana Womens Health Research
🇺🇸South Bend, Indiana, United States
Boro Park ObGyn
🇺🇸Brooklyn, New York, United States
Women's Health Practice, LLC
🇺🇸Champaign, Illinois, United States
Women's Health Care Specialists, PC
🇺🇸Paw Paw, Florida, United States
Female Pelvic Medicine and Urogynecology
🇺🇸Grand Rapids, Michigan, United States
Holzer Clinic
🇺🇸Gallipolis, Ohio, United States
Winston-Salem Woman Care, PA
🇺🇸Winston-Salem, North Carolina, United States
Windsor Metropolitan Hospital
🇨🇦Windsor, Ontario, Canada
Hillcrest Clinical Research, LLC
🇺🇸Simpsonville, South Carolina, United States
Advanced Research Associates
🇺🇸Corpus Christi, Texas, United States
Salt Lake Women's Center
🇺🇸Sandy, Utah, United States
Professional Quality Research/Women Partners
🇺🇸Austin, Texas, United States
Southern Healthcare Centre
🇨🇦White Rock, British Columbia, Canada