Trial · NCT01845649
Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia
NCT01845649, Phase 3, Completed, Warner Chilcott; results first posted 2022-05-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia. Trials, record NCT01845649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01845649
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia
- NCT number
- NCT01845649
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 550 participants, actual
- Lead sponsor
- Warner Chilcott
- Conditions
- Vulvovaginal Atrophy
- Interventions
- WC3011 Estradiol Vaginal Cream, Vehicle
- First posted
- 2013-05-03
- Last updated
- 2022-05-09
- Results first posted
- 2022-05-09
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment | Baseline (Day 0) to final assessment (Up to Week 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. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint. |
| Primary | Change From Baseline in Vaginal pH to Final Assessment | Baseline (Day 0) to final assessment (Up 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. Final Assessment is defined as the last available post-baseline assessment for the given efficacy endpoint. |
| Primary | Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment | Baseline (Day 0) to final assessment (Up 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. Final assessment is defined as the last available postbaseline assessment. |
| Primary | Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment | Baseline (Day 0) to final assessment (Up 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. Final assessment is defined as the last available postbaseline assessment. |
| Secondary | Change From Baseline in Participant's Self-Assessment of the Symptom of VVA: Dyspareunia to Weeks 2, 4, 8, and 12 | Baseline 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. |
| Secondary | Change From Baseline in Participant's Self-Assessment of the Other Symptoms of VVA to Weeks 2, 4, 8, 12, and Final Assessment | Baseline (Day 0) to Weeks 2, 4, 8, 12, and final assessment (Up to Week 12) | 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. |
| Secondary | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity at Each Visit | Baseline (Day 0), Weeks 2, 4, 8, 12 and final assessment (Up to Week 12) | 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. |
| Secondary | Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment | Baseline (Day 0) to Week 12 and Final assessment (Up to Week 12) | 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. |
| Secondary | Change From Baseline in Vaginal pH to Week 12 | Baseline 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. |
| Secondary | Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12 | Baseline 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment | Baseline (Day 0) to final assessment (Up to Week 12) | Modified Intent-to-treat (mITT) Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH \>5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Vaginal pH to Final Assessment | Baseline (Day 0) to final assessment (Up to Week 12) | mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH \>5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment | Baseline (Day 0) to final assessment (Up to Week 12) | mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH \>5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | percentage of superficial cells | MEAN |
| PRIMARY | Change From Baseline in the Percentage of Vaginal Parabasal Cells to Final Assessment | Baseline (Day 0) to final assessment (Up to Week 12) | mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH \>5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | percentage of parabasal cells | MEAN |
| SECONDARY | Change From Baseline in Participant's Self-Assessment of the Symptom of VVA: Dyspareunia to Weeks 2, 4, 8, and 12 | Baseline to Weeks 2, 4, 8 and 12 | mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH \>5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Participant's Self-Assessment of the Other Symptoms of VVA to Weeks 2, 4, 8, 12, and Final Assessment | Baseline (Day 0) to Weeks 2, 4, 8, 12, and final assessment (Up to Week 12) | mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH \>5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | score on a scale | MEAN |
| SECONDARY | Percentage of Participants With Vaginal Bleeding Associated With Sexual Activity at Each Visit | Baseline (Day 0), Weeks 2, 4, 8, 12 and final assessment (Up to Week 12) | mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH \>5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Investigator's Assessment of Each of the Signs of VVA to Week 12 and Final Assessment | Baseline (Day 0) to Week 12 and Final assessment (Up to Week 12) | mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH \>5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Vaginal pH to Week 12 | Baseline to Week 12 | mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH \>5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Percentage of Vaginal Superficial Cells to Week 12 | Baseline to Week 12 | mITT Population included participants in the Safety population who had at least 1 postbaseline primary efficacy assessment and met all of the following inclusion criteria: ≤5% superficial cells on a vaginal wall smear, a vaginal pH \>5.0, and the participants most bothersome symptom of VVA was dyspareunia with moderate to severe intensity. Number analyzed is the number of participants with available data at the given timepoint. | percentage of superficial cells | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group116
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment | Vehicle (3 Times/Week) | Baseline | 2.7 | Standard Deviation 0.44 | score on a scale |
| Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Baseline | 2.7 | Standard Deviation 0.45 | score on a scale |
| Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment | Vehicle (3 Times/Week) | Change from Baseline to Final Assessment | -1.2 | Standard Deviation 0.93 | score on a scale |
| Change From Baseline in Participant's Self-Assessment of Symptom of Vulvovaginal Atrophy (VVA): Dyspareunia (Pain Associated With Sexual Activity) to Final Assessment | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change from Baseline to Final Assessment | -1.5 | Standard Deviation 0.97 | score on a scale |
| Change From Baseline in Vaginal pH to Final Assessment | Vehicle (3 Times/Week) | Baseline | 6.35 | Standard Deviation 0.66 | score on a scale |
| Change From Baseline in Vaginal pH to Final Assessment | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Baseline | 6.37 | Standard Deviation 0.66 | score on a scale |
| Change From Baseline in Vaginal pH to Final Assessment | Vehicle (3 Times/Week) | Change from Baseline to Final Assessment | -0.53 | Standard Deviation 0.92 | score on a scale |
| Change From Baseline in Vaginal pH to Final Assessment | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Change from Baseline to Final Assessment | -1.36 | Standard Deviation 0.89 | score on a scale |
| Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment | Vehicle (3 Times/Week) | Baseline | 0.2 | Standard Deviation 0.75 | percentage of superficial cells |
| Change From Baseline in the Percentage of Vaginal Superficial Cells to Final Assessment | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Baseline | 0.2 | Standard Deviation 0.70 | percentage of superficial cells |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vehicle (3 Times/Week) | 273 | |
| Overall Study | STARTED | WC3011 Estradiol Vaginal Cream (3 Times/Week) | 277 | |
| Overall Study | Safety Population | Vehicle (3 Times/Week) | 271 | |
| Overall Study | Safety Population | WC3011 Estradiol Vaginal Cream (3 Times/Week) | 277 | |
| Overall Study | Modified Intent-to-treat (mITT) Population | Vehicle (3 Times/Week) | 233 | |
| Overall Study | Modified Intent-to-treat (mITT) Population | WC3011 Estradiol Vaginal Cream (3 Times/Week) | 239 | |
| Overall Study | COMPLETED | Vehicle (3 Times/Week) | 242 | |
| Overall Study | COMPLETED | WC3011 Estradiol Vaginal Cream (3 Times/Week) | 255 | |
| Overall Study | NOT COMPLETED | Vehicle (3 Times/Week) | 31 | |
| Overall Study | NOT COMPLETED | WC3011 Estradiol Vaginal Cream (3 Times/Week) | 22 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Urinary tract infection | Infections and infestations | Vehicle (3 Times/Week) | 21 | 271 | |
| other | Urinary tract infection | Infections and infestations | WC3011 Estradiol Vaginal Cream (3 Times/Week) | 10 | 277 | |
| other | Application site pain | General disorders | Vehicle (3 Times/Week) | 15 | 271 | |
| other | Application site pain | General disorders | WC3011 Estradiol Vaginal Cream (3 Times/Week) | 9 | 277 | |
| other | Vulvovaginal mycotic infection | Infections and infestations | Vehicle (3 Times/Week) | 9 | 271 | |
| other | Vulvovaginal mycotic infection | Infections and infestations | WC3011 Estradiol Vaginal Cream (3 Times/Week) | 19 | 277 | |
| serious | Atrial Fibrillation | Cardiac disorders | Vehicle (3 Times/Week) | 1 | 271 | |
| serious | Atrial Fibrillation | Cardiac disorders | WC3011 Estradiol Vaginal Cream (3 Times/Week) | 0 | 277 | |
| serious | Appendicitis | Infections and infestations | Vehicle (3 Times/Week) | 0 | 271 | |
| serious | Appendicitis | Infections and infestations | WC3011 Estradiol Vaginal Cream (3 Times/Week) | 1 | 277 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vehicle (3 Times/Week) | 0 | 271 |
| Total, all-cause mortality | WC3011 Estradiol Vaginal Cream (3 Times/Week) | 0 | 277 |
| Total, other adverse events | Vehicle (3 Times/Week) | 42 | 271 |
| Total, other adverse events | WC3011 Estradiol Vaginal Cream (3 Times/Week) | 38 | 277 |
| Total, serious adverse events | Vehicle (3 Times/Week) | 1 | 271 |
| Total, serious adverse events | WC3011 Estradiol Vaginal Cream (3 Times/Week) | 3 | 277 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| WC3011 Estradiol Vaginal Cream (3 Times/Week) vs Vehicle (3 Times/Week): deaths from any cause | Trial comparisons |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) vs Vehicle (3 Times/Week): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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