A Phase 3 interventional study of WC3011 Estradiol Vaginal Cream and Vehicle in Postmenopausal Vulvovaginal Atrophy, sponsored by Warner Chilcott. Completed at 70 sites in United States. Open to female participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2022-05-09.
Sponsored by Warner Chilcott · Phase 3, Interventional, and Treatment
Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.
828 studies on the registry are indexed under Atrophy; 122 are open to participants now.
This study's enrollment of 722 is above the median of 34 across 603 interventional studies indexed under Atrophy.
Browse Atrophy studies →Warner Chilcott is the lead sponsor of 57 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
Drug: WC3011 Estradiol Vaginal Cream
Vehicle applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks.
Drug: Vehicle
WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
Drug: WC3011 Estradiol Vaginal Cream
Vehicle applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
Drug: Vehicle
WC3011 estradiol vaginal cream administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks
Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.
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.
Time frame: Baseline (Day 0) to Week 12/Final Visit
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.
Time frame: Baseline (Day 0) to Week 12/Final Visit
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.
Time frame: Baseline (Day 0) to Week 12/Final Visit
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.
Time frame: Baseline (Day 0) to Week 12/Final Visit
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.
Time frame: Baseline (Day 0) to Week 12 and Week 12/Final visit
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.
Time frame: Baseline (Day 0) to Week 12 and Week 12/Final visit
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.
Time frame: Baseline (Day 0) to Week 12 and Week 12/Final visit
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.
Time frame: Baseline (Day 0) to Week 12 and Week 12/Final visit
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.
Time frame: Baseline (Day 0) to Week 12 and Week 12/Final visit
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.
Time frame: Baseline (Day 0) to Weeks 2, 4, 8 and 12
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.
Time frame: Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit
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.
Time frame: Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit
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.
Time frame: Baseline (Day 0) to Weeks 2, 4, 8, 12 and Week 12/Final visit
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.
Time frame: Baseline (Day 0) and Weeks 2, 4, 8, 12 and Week 12/Final visit
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.
Time frame: Baseline (Day 0) to Week 12
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.
Time frame: Baseline (Day 0) to Week 12
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.
Time frame: Baseline (Day 0) to Week 12
| Milestone | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Started | 238 | 124 | 237 | 123 |
| Completed | 217 | 119 | 209 | 114 |
| Not completed | 21 | 5 | 28 | 9 |
| Withdrew: Adverse event | 7 | 2 | 9 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 | 4 | 1 |
| Withdrew: Withdrew consent | 4 | 2 | 6 | 1 |
| Withdrew: Protocol deviation | 6 | 1 | 5 | 2 |
| Withdrew: Reason not specified | 3 | 0 | 4 | 3 |
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.
| score on a scale | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Baseline | 2.49 ± 0.50 | 2.46 ± 0.52 | 2.50 ± 0.50 | 2.50 ± 0.50 |
| Change from Baseline to Week 12/Final Visit | -1.27 ± 0.90 | -0.99 ± 0.89 | -1.31 ± 0.93 | -1.17 ± 0.97 |
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.
| score on a scale | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Baseline | 6.51 ± 0.96 | 6.49 ± 0.86 | 6.40 ± 0.93 | 6.40 ± 0.86 |
| Change from Baseline to Week 12/Final Visit | -1.08 ± 1.14 | -0.37 ± 0.92 | -0.99 ± 1.05 | -0.46 ± 0.90 |
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.
| percentage of superficial cells | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Baseline | 0.85 ± 3.76 | 0.66 ± 1.62 | 0.79 ± 1.63 | 0.66 ± 1.21 |
| Change from Baseline to Week 12/Final Visit | 11.44 ± 14.74 | 3.05 ± 7.11 | 17.30 ± 19.27 | 4.02 ± 12.16 |
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.
| percentage of parabasal cells | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Baseline | 48.36 ± 43.46 | 47.78 ± 44.51 | 42.56 ± 41.03 | 45.24 ± 42.47 |
| Change from Baseline to Week 12/Final Visit | 41.7 ± 42.76 | -8.20 ± 29.56 | -38.5 ± 39.78 | -16.0 ± 32.75 |
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.
| score on a scale | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Baseline | 1.88 ± 0.60 | 1.94 ± 0.70 | 1.90 ± 0.64 | 1.88 ± 0.63 |
| Change from Baseline to Week 12 | -0.77 ± 0.80 | -0.47 ± 0.71 | -0.76 ± 0.81 | -0.44 ± 0.76 |
| Change from Baseline to Week 12/Final Visit | -0.74 ± 0.80 | -0.48 ± 0.72 | -0.75 ± 0.81 | -0.44 ± 0.77 |
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.
| score on a scale | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Baseline | 1.76 ± 0.67 | 1.72 ± 0.76 | 1.74 ± 0.70 | 1.83 ± 0.67 |
| Change from Baseline to Week 12 | -0.73 ± 0.81 | -0.36 ± 0.75 | -0.78 ± 0.79 | -0.59 ± 0.81 |
| Change from Baseline to Week 12/Final Visit | -0.71 ± 0.82 | -0.39 ± 0.76 | -0.77 ± 0.80 | -0.59 ± 0.81 |
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.
| score on a scale | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Baseline | 1.92 ± 0.68 | 1.85 ± 0.73 | 1.83 ± 0.75 | 1.87 ± 0.76 |
| Change from Baseline to Week 12 | -0.94 ± 0.88 | -0.53 ± 0.82 | -0.90 ± 0.89 | -0.74 ± 0.91 |
| Change from Baseline to Week 12/Final Visit | -0.91 ± 0.89 | -0.55 ± 0.83 | -0.89 ± 0.90 | -0.76 ± 0.92 |
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.
| score on a scale | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Baseline | 1.04 ± 0.91 | 1.02 ± 0.94 | 0.94 ± 0.89 | 1.04 ± 0.93 |
| Change from Baseline to Week 12 | -0.66 ± 0.90 | -0.47 ± 0.86 | -0.60 ± 0.87 | -0.52 ± 0.89 |
| Change from Baseline to Week 12/Final Visit | -0.64 ± 0.89 | -0.48 ± 0.86 | -0.61 ± 0.86 | -0.52 ± 0.89 |
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.
| score on a scale | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Baseline | 0.74 ± 0.78 | 0.89 ± 0.89 | 0.70 ± 0.83 | 0.71 ± 0.81 |
| Change from Baseline to Week 12 | -0.47 ± 0.74 | -0.38 ± 0.72 | -0.47 ± 0.82 | -0.29 ± 0.73 |
| Change from Baseline to Week 12/Final Visit | -0.44 ± 0.73 | -0.40 ± 0.71 | -0.46 ± 0.82 | -0.30 ± 0.75 |
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.
| score on a scale | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Baseline | 2.49 ± 0.50 | 2.46 ± 0.52 | 2.50 ± 0.50 | 2.50 ± 0.50 |
| Change from Baseline to Week 2 | -0.83 ± 0.86 | -0.79 ± 0.88 | -0.95 ± 0.90 | -0.79 ± 0.84 |
| Change from Baseline to Week 4 | -1.07 ± 0.82 | -0.93 ± 0.90 | -1.12 ± 0.91 | -0.95 ± 0.90 |
| Change from Baseline to Week 8 | -1.25 ± 0.84 | -1.02 ± 0.90 | -1.43 ± 0.90 | -1.11 ± 0.91 |
| Change from Baseline to Week 12 | -1.30 ± 0.91 | -0.97 ± 0.90 | -1.36 ± 0.94 | -1.20 ± 0.98 |
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.
| score on a scale | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Baseline | 1.26 ± 0.96 | 1.33 ± 1.00 | 1.11 ± 0.96 | 1.20 ± 0.89 |
| Change from Baseline to Week 2 | -0.54 ± 1.09 | -0.67 ± 0.95 | -0.48 ± 1.05 | -0.48 ± 1.04 |
| Change from Baseline to Week 4 | -0.62 ± 1.14 | -0.71 ± 0.92 | -0.48 ± 1.08 | -0.65 ± 1.01 |
| Change from Baseline to Week 8 | -0.71 ± 1.11 | -0.82 ± 1.03 | -0.57 ± 0.97 | -0.58 ± 1.00 |
| Change from Baseline to Week 12 | -0.75 ± 1.03 | -0.74 ± 1.02 | -0.59 ± 1.04 | -0.70 ± 0.86 |
| Change from Baseline to Week 12/Final Visit | -0.74 ± 1.01 | -0.74 ± 1.03 | -0.58 ± 1.02 | -0.63 ± 0.92 |
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.
| score on a scale | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Baseline | 0.38 ± 0.70 | 0.49 ± 0.75 | 0.45 ± 0.75 | 0.53 ± 0.80 |
| Change from Baseline to Week 2 | -0.24 ± 0.67 | -0.22 ± 0.71 | -0.28 ± 0.74 | -0.38 ± 0.77 |
| Change from Baseline to Week 4 | -0.20 ± 0.68 | -0.30 ± 0.60 | -0.28 ± 0.76 | -0.42 ± 0.77 |
| Change from Baseline to Week 8 | -0.20 ± 0.75 | -0.28 ± 0.72 | -0.32 ± 0.75 | -0.34 ± 0.85 |
| Change from Baseline to Week 12 | -0.28 ± 0.68 | -0.28 ± 0.64 | -0.36 ± 0.72 | -0.41 ± 0.79 |
| Change from Baseline to Week 12/Final Visit | -0.27 ± 0.66 | -0.27 ± 0.64 | -0.34 ± 0.75 | -0.39 ± 0.78 |
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.
| score on a scale | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Baseline | 2.29 ± 0.93 | 2.23 ± 0.88 | 2.29 ± 0.85 | 2.38 ± 0.86 |
| Change from Baseline to Week 2 | -0.79 ± 1.06 | -0.78 ± 1.07 | -0.86 ± 1.06 | -0.67 ± 1.01 |
| Change from Baseline to Week 4 | -1.04 ± 1.06 | -1.03 ± 0.90 | -1.06 ± 1.03 | -0.78 ± 0.91 |
| Change from Baseline to Week 8 | -1.08 ± 1.01 | -1.04 ± 0.96 | -1.36 ± 0.97 | -1.07 ± 1.09 |
| Change from Baseline to Week 12 | -1.15 ± 1.09 | -1.06 ± 0.96 | -1.39 ± 1.01 | -1.09 ± 1.05 |
| Change from Baseline to Week 12/Final Visit | -1.15 ± 1.07 | -1.03 ± 1.00 | -1.35 ± 1.02 | -1.06 ± 1.07 |
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.
| percentage of participants | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Baseline | 15.81 | 17.89 | 17.75 | 24.79 |
| Week 2 | 6.55 | 7.32 | 6.11 | 9.24 |
| Week 4 | 5.29 | 6.50 | 2.64 | 5.00 |
| Week 8 | 4.61 | 4.96 | 2.74 | 6.90 |
| Week 12 | 6.94 | 5.04 | 3.35 | 6.19 |
| Week 12/Final Visit | 6.44 | 4.88 | 3.03 | 5.79 |
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.
| score on a scale | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Baseline | 6.51 ± 0.96 | 6.49 ± 0.86 | 6.40 ± 0.93 | 6.40 ± 0.86 |
| Change from Baseline to Week 12 | -1.10 ± 1.15 | -0.34 ± 0.89 | -1.01 ± 1.06 | -0.47 ± 0.87 |
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.
| percentage of superficial cells | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Baseline | 0.85 ± 3.76 | 0.66 ± 1.62 | 0.79 ± 1.63 | 0.66 ± 1.21 |
| Change from Baseline to Week 12 | 11.66 ± 14.51 | 3.17 ± 7.02 | 17.66 ± 19.37 | 3.36 ± 10.31 |
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.
| percentage of parabasal cells | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Baseline | 48.36 ± 43.46 | 47.78 ± 44.51 | 42.56 ± 41.03 | 45.24 ± 42.47 |
| Change from Baseline to Week 12 | -42.3 ± 42.90 | -8.08 ± 29.90 | -39.5 ± 39.46 | -14.9 ± 31.93 |
Collected over From first dose through the last study visit (Up to 12 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | 0/238 (0%) | 1/238 (0.4%) | 46/238 (19.3%) |
| Vehicle (2 Times/Week) | 0/124 (0%) | 0/124 (0%) | 20/124 (16.1%) |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | 0/237 (0%) | 0/237 (0%) | 57/237 (24.1%) |
| Vehicle (3 Times/Week) | 0/123 (0%) | 1/123 (0.8%) | 23/123 (18.7%) |
| Event | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| CholecystitisHepatobiliary disorders | 0/238 | 0/124 | 0/237 | 1/123 |
| Large intestine perforationGastrointestinal disorders | 1/238 | 0/124 | 0/237 | 0/123 |
| Small intestinal obstructionGastrointestinal disorders | 1/238 | 0/124 | 0/237 | 0/123 |
| Event | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Vulvovaginal mycotic infectionInfections and infestations | 12/238 | 3/124 | 26/237 | 8/123 |
| NasopharyngitisInfections and infestations | 3/238 | 2/124 | 11/237 | 8/123 |
| Urinary tract infectionInfections and infestations | 12/238 | 7/124 | 7/237 | 7/123 |
| Vaginal dischargeReproductive system and breast disorders | 13/238 | 4/124 | 10/237 | 3/123 |
| Upper respiratory tract infectionInfections and infestations | 8/238 | 5/124 | 12/237 | 2/123 |
The safety population included all participants who were randomized and received at least one dose of study drug.
| Age, Continuous(years) | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) | Total |
|---|---|---|---|---|---|
| Mean | 58.4 ± 6.27 | 57.8 ± 6.34 | 58.0 ± 6.03 | 58.7 ± 6.58 | 58.2 ± 6.26 |
| Sex: Female, Male(Participants) | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) | Total |
|---|---|---|---|---|---|
| Female | 238 | 124 | 237 | 123 | 722 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 14 | 6 | 15 | 10 | 45 |
| Not Hispanic or Latino | 224 | 118 | 222 | 113 | 677 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 0 | 0 | 1 |
| Asian | 2 | 1 | 2 | 1 | 6 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 0 | 1 | 3 |
| Black or African American | 29 | 18 | 27 | 14 | 88 |
| White | 202 | 105 | 208 | 106 | 621 |
| More than one race | 1 | 0 | 0 | 0 | 1 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 | 2 |
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Warner Chilcott