Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit |
The severity of vaginal dryness was assessed and recorded on a questionnaire by the participants using the following 4 point scale where, 0=None (The symptom is not present), 1=Mild (The symptom is present but may be intermittent; does not interfere with participants activities or lifestyle), 2=Moderate (The symptom is present. Participant is usually aware of the symptom, but activities and lifestyle are only occasionally affected), and 3=Severe (The symptom is present. Participant is usually aware and bothered by the symptom and have modified participant's activities and/or lifestyle due to the symptom. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
Baseline (Day 0) to Week 12/Final Visit |
|
| Primary |
Change From Baseline in Vaginal pH to Week 12/Final Visit |
Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
Baseline (Day 0) to Week 12/Final Visit |
|
| Primary |
Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit |
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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
Baseline (Day 0) to Week 12/Final Visit |
|
| Primary |
Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit |
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. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
Baseline (Day 0) to Week 12/Final Visit |
|
| Secondary |
Change From Baseline in Investigator's Assessment of Atrophy to Week 12 and Week 12/Final Visit |
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to atrophy scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
Baseline (Day 0) to Week 12 and Week 12/Final visit |
|
| Secondary |
Change From Baseline in Investigator's Assessment of Pallor to Week 12 and Week 12/Final Visit |
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to pallor scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
Baseline (Day 0) to Week 12 and Week 12/Final visit |
|
| Secondary |
Change From Baseline in Investigator's Assessment of Vaginal Dryness to Week 12 and Week 12/Final Visit |
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to vaginal dryness scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
Baseline (Day 0) to Week 12 and Week 12/Final visit |
|
| Secondary |
Change From Baseline in Investigator's Assessment of Friability to Week 12 and Week 12/Final Visit |
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to friability scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
Baseline (Day 0) to Week 12 and Week 12/Final visit |
|
| Secondary |
Change From Baseline in Investigator's Assessment of Petechiae to Week 12 and Week 12/Final Visit |
Investigator's assessment of vaginal health was performed by visual inspection of the vagina with respect to petechiae scored on a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
Baseline (Day 0) to Week 12 and Week 12/Final visit |
|
| Secondary |
Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Weeks 2, 4, 8 and 12 |
Participant's self-assessment of symptoms of VVA (severity of vaginal dryness) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. |
Baseline (Day 0) to Weeks 2, 4, 8 and 12 |
|
| Secondary |
Change From Baseline in Participant's Self-Assessment of Vaginal and/or Vulvar Irritation/Itching to Weeks 2, 4, 8, 12 and Week 12/Final Visit |
Participant's self-assessment of symptoms of VVA (vaginal and/or vulvar irritation/itching) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit |
|
| Secondary |
Change From Baseline in Participant's Self-Assessment of Dysuria (Painful or Difficult Urination) to Weeks 2, 4, 8, 12 and Week 12/Final Visit |
Participant's self-assessment of symptoms of VVA (dysuria) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit |
|
| Secondary |
Change From Baseline in Participant's Self-Assessment of Dyspareunia (Pain Associated With Sexual Activity) to Weeks 2, 4, 8, 12 and Week 12/Final Visit |
Participant's self-assessment of symptoms of VVA (dyspareunia) was scored according to a 4-point scale where: 0= none, 1= mild, 2= moderate, or 3= severe. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit |
|
| Secondary |
Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity as Per Participant's Self-Assessment to Weeks 2, 4, 8, 12 and Week 12/Final Visit |
Vaginal bleeding associated with sexual activity was assessed by participants as either "present" or "absent". Percentage of participants with assessment "present" are reported. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12. |
Baseline (Day 0) and Weeks 2, 4, 8, 12 and Week 12/Final visit |
|
| Secondary |
Change From Baseline in Vaginal pH to Week 12 |
Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 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. |
Baseline (Day 0) to Week 12 |
|
| Secondary |
Change From Baseline in 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. |
Baseline (Day 0) to Week 12 |
|
| Secondary |
Change From Baseline in 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. |
Baseline (Day 0) to Week 12 |
|
