The purpose of the study is to determine if WC3011 is safe and effective in treating the symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant self-assessment when compared to vehicle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
550
Daily for 14 days followed by 3 times per week for 10 weeks
Daily for 14 days followed by 3 times per week for 10 weeks
Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment
Participant's self-assessment of the symptom of VVA (dyspareunia) was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher score indicates the most bothersome symptoms. A negative change from Baseline indicates improvement. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
Time frame: Baseline (Day 0) to final assessment (Up to Week 12)
Change From Baseline in Vaginal pH to Final Assessment
Vaginal pH was obtained at baseline and final visit of the study. The pH was a numeric value from 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
Time frame: Baseline (Day 0) to final assessment (Up to Week 12)
Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment
Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. A positive change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.
Time frame: Baseline (Day 0) to final assessment (Up to Week 12)
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment
Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.
Time frame: Baseline (Day 0) to final assessment (Up to Week 12)
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Warner Chilcott Investigational Study Site
Birmingham, Alabama, United States
Warner Chilcott Investigational Study Site
Mobile, Alabama, United States
Warner Chilcott Investigational Study Site
Chandler, Arizona, United States
Warner Chilcott Investigational Study Site
Phoenix, Arizona, United States
Warner Chilcott Investigational Study Site
Scottsdale, Arizona, United States
Warner Chilcott Investigational Study Site
Tucson, Arizona, United States
Warner Chilcott Investigational Study Site
Tucson, Arizona, United States
Warner Chilcott Investigational Study Site
Sacramento, California, United States
Warner Chilcott Investigational Study Site
San Diego, California, United States
Warner Chilcott Investigational Study Site
San Diego, California, United States
...and 47 more locations
Change From Baseline in Participant's Self-Assessment of the Symptom of VVA: Dyspareunia to Weeks 2, 4, 8, and 12
Participant's self-assessment of the symptom of VVA (dyspareunia) was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher score indicates the most bothersome symptoms. A negative change from Baseline indicates improvement.
Time frame: Baseline to Weeks 2, 4, 8 and 12
Change From Baseline in Participant's Self-Assessment of the Other Symptoms of VVA to Weeks 2, 4, 8, 12, and Final Assessment
Self-Assessment of the symptoms of VVA, other than dyspareunia and vaginal bleeding associated with sexual activity, (vaginal and/or vulvar irritation/itching, dysuria and vaginal dryness) were evaluated by a questionnaire. Each symptom was scored on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores indicate the most bothersome symptoms. A negative change from Baseline indicates improvement. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
Time frame: Baseline (Day 0) to Weeks 2, 4, 8, 12, and final assessment (Up to Week 12)
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity at Each Visit
Vaginal bleeding associated with sexual activity was assessed by participants as either "present" or "absent". Number of participants with assessment "present" are reported. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint.
Time frame: Baseline (Day 0), Weeks 2, 4, 8, 12 and final assessment (Up to Week 12)
Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to the signs of VVA: atrophy, pallor, vaginal dryness, friability, and petechiae each graded on a 4-point scale where: 0=none, 1=mild, 2=moderate or 3=severe. Higher scores are worse. A negative change from Baseline indicates improvement. Final assessment is defined as the last available postbaseline assessment.
Time frame: Baseline (Day 0) to Week 12 and Final assessment (Up to Week 12)
Change From Baseline in Vaginal pH to Week 12
Vaginal pH was obtained at baseline and final visit of the study. The pH was a numeric value from 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement.
Time frame: Baseline to Week 12
Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12
Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. A positive change from Baseline indicates improvement.
Time frame: Baseline to Week 12
Change From Baseline in the Percentage of Vaginal Parabasal Cells to Week 12
Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. A negative change from Baseline indicates improvement.
Time frame: Baseline to Week 12