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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (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
Time frame: 12 weeks
Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks)
0-3 scale with 0=no dyspareunia and 3= completely prevents intercourse
Time frame: Baseline -12 Weeks
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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 12 Weeks
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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
...and 38 more locations