This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women (NCT01400776), a randomized phase 3 study. The primary outcome is Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01400776 |
| Phase | Phase 3 |
| Condition | Postmenopausal Vulvovaginal Atrophy |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 722 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Warner Chilcott |
| Results posted | Yes |
2. Clinical Question
Population
Postmenopausal women with vulvovaginal atrophy were the population of interest. The registry record reports enrollment of 722 participants. The primary outcome population was the modified Intent-to-Treat Population: participants in the safety population with at least one postbaseline primary efficacy result. The number analyzed at a particular timepoint was defined as the number with evaluable data at that timepoint.
Intervention
WC3011 estradiol vaginal cream was studied using two schedules. Both began with daily application for 2 weeks. After that, one schedule used application 2 times a week for 10 weeks, and the other used application 3 times a week for 10 weeks.
Comparator
Vehicle was used on matching schedules: daily application for 2 weeks, followed by application either 2 times a week or 3 times a week for 10 weeks. The registry lists the study as randomized and triple-masked; its official title describes it as double-blind and vehicle-controlled.
Primary question
The primary endpoint was change from baseline in participants’ self-assessment of vaginal dryness severity to Week 12/Final Visit. The registry defines a negative change as improvement. It does not report the arm-level endpoint results, an estimated treatment contrast, a confidence interval, or a p-value, so the size and precision of any difference between WC3011 and vehicle cannot be described from the registry record.
3. Trial Design
This was a randomized, parallel-group, phase 3 study of WC3011 estradiol vaginal cream and vehicle in postmenopausal women with vulvovaginal atrophy. The study is marked as completed, with enrollment of 722. The recorded start date is 2011-06-29 and the primary completion date is 2012-02-27. Warner Chilcott is listed as the sponsor.
The record describes four regimens. WC3011 and vehicle were each used in a schedule of daily application for 2 weeks followed by application 2 times a week for 10 weeks, or in a schedule of daily application for 2 weeks followed by application 3 times a week for 10 weeks. These schedules allow the registry to list two frequency groups for each treatment. The record does not report the allocation ratio, the number randomized to each group in the primary outcome analysis, or the reasons participants may not have contributed evaluable endpoint data.
The registry identifies masking as triple. The official title uses the term double-blind. The exact roles included in the masking are not reported in the registry record, so the meaning of the triple-masked designation cannot be specified further. The record also does not describe the randomization sequence, concealment procedures, or whether the analysis followed the randomized group assignment in every case.
The primary outcome was assessed from Baseline (Day 0) to Week 12/Final Visit. The registry defines Week 12/Final Visit as the last available postbaseline assessment up to Week 12. It lists 17 outcome measures, including investigator assessments of atrophy, pallor, dryness, friability, and petechiae, as well as participants’ assessments of dryness, irritation or itching, and dysuria at stated follow-up times. Numerical results for these measures are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | 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 |
Reasons for not completing this period:
| Reason | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|
| Adverse Event | 7 | 2 | 9 | 2 |
| Lost to Follow-up | 1 | 0 | 4 | 1 |
| Withdrew Consent | 4 | 2 | 6 | 1 |
| Protocol Deviation | 6 | 1 | 5 | 2 |
| Reason not Specified | 3 | 0 | 4 | 3 |
Analysis population for the primary outcome, as defined in the registry: Modified Intent-to-Treat Population (mITT) included all participants in the safety population who had at least one postbaseline primary efficacy result. Number analyzed is the number of participants with evaluable data at the given timepoint.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: The safety population included all participants who were randomized and received at least one dose of study drug.
| Characteristic | Unit | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 238 | 124 | 237 | 123 | 722 | |
| Age, Continuous | years | 58.4 (SD 6.27) | 57.8 (SD 6.34) | 58.0 (SD 6.03) | 58.7 (SD 6.58) | 58.2 (SD 6.26) |
| Sex: Female, Male: Female | Participants | 238 | 124 | 237 | 123 | 722 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 14 | 6 | 15 | 10 | 45 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 224 | 118 | 222 | 113 | 677 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 0 | 0 | 0 | 1 |
| Race (NIH/OMB): Asian | Participants | 2 | 1 | 2 | 1 | 6 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 2 | 0 | 0 | 1 | 3 |
| Race (NIH/OMB): Black or African American | Participants | 29 | 18 | 27 | 14 | 88 |
| Race (NIH/OMB): White | Participants | 202 | 105 | 208 | 106 | 621 |
| Race (NIH/OMB): More than one race | Participants | 1 | 0 | 0 | 0 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 0 | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit, measured over Baseline (Day 0) to Week 12/Final Visit.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in participants’ self-assessment of vaginal dryness severity to Week 12/Final Visit. It is a continuous score, reported as a mean with a standard deviation, on a 4 point scale. The categories range from 0, meaning the symptom is not present, through 1 for mild, 2 for moderate, and 3 for severe. The descriptions distinguish symptom presence and intensity by how much the symptom is noticed, bothers the participant, or affects activities and lifestyle.
Change scores express how a participant’s assessment at follow-up differs from baseline. The registry specifies that a negative change indicates improvement. The endpoint therefore captures the participant’s own report of symptom severity rather than an investigator’s assessment of physical signs. It is relevant to the study question because vaginal dryness was the symptom named in the brief summary and is among the symptoms of vulvovaginal atrophy being studied.
General statistical explanation: a mean change describes the average change in scores within a group. A standard deviation describes the spread of individual scores around that group mean; it is not the uncertainty of the mean itself. Comparing group means can estimate an average difference between assigned regimens, but interpretation also depends on uncertainty around that contrast and on the analysis population. The registry record describes the endpoint and its direction but does not report its group means, standard deviations, treatment contrast, or confidence interval.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record makes the clinical question and measurement direction clear, but it does not provide the primary endpoint estimates needed to interpret the observed treatment comparison. It states that the endpoint is change in participants’ vaginal dryness severity score from baseline to Week 12/Final Visit, and that negative change indicates improvement. However, arm-level means, standard deviations, the difference between WC3011 and vehicle, confidence intervals, and p-values are not reported in the registry record. Consequently, the amount of change in either group and the precision of a between-group estimate cannot be assessed from this record.
The trial included two WC3011 schedules and two corresponding vehicle schedules. The registry record does not report numerical primary outcome results separately for these four groups, nor does it state a single pooled contrast or explain how a pooled comparison would be formed. It would not be appropriate to assume that the frequencies were combined or to infer that the schedules had the same results.
General statistical explanation: an estimate describes the magnitude and direction of a result, while a confidence interval describes the range of values compatible with the data and the analysis assumptions. A narrow interval indicates greater precision than a wide interval, but neither an interval nor a p-value can be interpreted without knowing the estimate and the analysis used. Statistical significance alone would not describe the clinical magnitude of a difference. No such estimate or uncertainty measure is reported for the primary outcome in the registry record.
The endpoint is a participant-reported score on a scale with ordered categories. Summarizing change as a mean treats score steps as numerically meaningful for the purpose of the stated analysis. The registry names the mean and standard deviation as the summary measures, but it does not report details of the model, any covariate adjustment, or assumptions used to compare groups. Those features are important context when interpreting a statistical contrast, and are not reported in the registry record.
The posted safety figures separately list serious and other adverse events for each regimen group. They describe counts of affected participants and the numbers at risk, but they do not give a statistical comparison between regimens. The figures should be read as descriptive safety information, not as evidence of a causal difference. In particular, the registry record does not provide event-specific attribution by regimen for the serious terms it lists.
Overall, the record supports a description of the design, endpoint, and recorded safety counts, but not a conclusion about the size or precision of the primary efficacy comparison. Missing endpoint estimates should not be replaced by assumptions based on the trial title, the planned schedule, or the number enrolled.
9. Statistical Methods Explained
What does the primary measure represent?
The primary measure is a continuous change score: the participant’s self-assessment of vaginal dryness severity at follow-up in relation to baseline. Its scale runs from 0 to 3, with higher categories describing greater severity. The registry states that negative change indicates improvement. The specified summary is a mean with a standard deviation. A mean gives the average score change in a group; a standard deviation describes how dispersed individual values are around that average. These quantities answer different questions. Neither a group mean nor a standard deviation alone gives the estimated difference between treatment groups or its uncertainty.
How would a group comparison be interpreted?
General statistical explanation: a treatment comparison for a continuous endpoint usually centers on a contrast between group averages, with a measure of uncertainty around that contrast. The contrast describes the direction and size of the estimated difference under the analysis used. A confidence interval describes uncertainty in that estimate under the model and assumptions. A p-value addresses compatibility with a specified null hypothesis under those assumptions; it does not measure the size or clinical importance of an effect. In this case, the registry record does not report the group averages, a contrast, a confidence interval, or a p-value, so no numerical comparison can be interpreted.
The endpoint includes a final assessment defined as the last available postbaseline assessment up to Week 12. This definition allows the final measure to use an available assessment within that window, but it does not explain how the analysis handled participants without any such assessment. It also does not state whether the assessment timing varied across participants or how any variation was accounted for in the analysis. Those details are not reported in the registry record.
Why do the four schedules matter?
The record describes two active-treatment frequencies and two matching vehicle frequencies. Each schedule starts with daily application for 2 weeks and continues with its assigned frequency for 10 weeks. Because the record lists four groups, interpretation depends on which groups were compared and whether the two frequencies were analyzed separately or combined. The registry record does not report that analysis structure for the primary endpoint. It would be unjustified to treat the four groups as a single two-group comparison without an explicit analysis description.
General statistical explanation: randomization is used to make treatment-group comparisons less vulnerable to systematic differences at baseline, on average, when allocation and follow-up are handled appropriately. Masking can limit the influence of treatment knowledge on participant reports, clinical assessments, and other study procedures. These design features do not remove all uncertainty, and they do not replace reporting the actual estimates and analysis methods. The record identifies the study as randomized and triple-masked, while its official title describes it as double-blind; the specific masking roles and implementation are not reported in the registry record.
What does the sample-size illustration mean?
The registry describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect, and that continuous outcomes use participants per arm. The numerical planning outputs are not reported in the registry record. The illustration is not a report of the trial’s original design justification, and the record does not give the protocol’s sample-size rationale or the effect assumption used to plan enrollment. Planning estimates describe hypothetical requirements under stated assumptions; they are not observed power and do not establish what the trial found.
General statistical explanation: a normal approximation can be used to estimate how much information a design might need for a specified target effect and error criterion. Such an illustration depends on assumptions, including the variability of the outcome, allocation, and the effect size of interest. The record’s description does not give the numerical inputs or outputs needed to evaluate the illustration further. It should not be confused with an analysis of the trial’s actual endpoint data.
What information is missing for a full appraisal?
The registry record lists zero analyses and does not report numerical primary outcome results. It does not identify a fitted statistical model, adjustment variables, a confidence-interval method, or handling of missing observations. It also does not report whether there were interim analyses, how the primary analysis treated protocol deviations, or whether any sensitivity analyses were performed. These matters are not reported in the registry record, and their absence prevents a detailed assessment of the statistical analysis beyond the endpoint definition and population description.
General statistical explanation: over-dispersion matters when observed variability exceeds what a model assumes; if unaccounted for, uncertainty estimates can be too optimistic. That concept is not a reported feature of this continuous endpoint analysis, and there is no basis in the registry record to say whether over-dispersion was assessed or relevant. More broadly, choosing an analysis requires aligning the outcome scale, data completeness, allocation structure, and planned estimand. The posted record does not provide enough analysis detail to reconstruct those choices.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 17 outcome measures. The secondary outcomes include investigator assessments of atrophy, pallor, vaginal dryness, friability, and petechiae at Week 12 and Week 12/Final Visit, along with participant assessments of dryness, irritation or itching, and dysuria at multiple stated follow-up times. Considering multiple outcomes, timepoints, treatment schedules, or comparisons can increase the chance of finding an apparently notable result by chance if many tests are interpreted without an appropriate plan.
General statistical explanation: multiplicity procedures can control or otherwise address the consequences of making multiple statistical comparisons. Whether an adjustment is needed, and which approach is suitable, depends on the planned testing strategy and the claims being evaluated. The registry record does not report a multiplicity strategy, a hierarchy of outcomes, or which comparisons were designated for formal testing. It also lists zero analyses, so there are no reported endpoint tests to assess for multiplicity adjustment. The statistical plan is not reported in the registry record.
The primary analysis population is defined as the modified Intent-to-Treat Population: participants in the safety population with at least one postbaseline primary efficacy result. The number analyzed at each timepoint is defined as those with evaluable data at that timepoint. The record does not provide the number with evaluable primary endpoint data in each group or the reasons data may have been unavailable.
General statistical explanation: excluding participants without postbaseline outcome data can make an analysis vulnerable to bias if having data is related to prognosis or treatment response. Methods for addressing missing data depend on the reasons for missingness and the assumptions made. The registry record does not report imputation, a missing-data model, sensitivity analyses, or other procedures for handling missing primary outcome observations. The extent and potential effect of missing data therefore cannot be assessed from the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | 1 | 238 | 0.4% |
| Vehicle (2 Times/Week) | 0 | 124 | 0.0% |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | 0 | 237 | 0.0% |
| Vehicle (3 Times/Week) | 1 | 123 | 0.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | 0 of 238 |
| Vehicle (2 Times/Week) | 0 of 124 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | 0 of 237 |
| Vehicle (3 Times/Week) | 0 of 123 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| WC3011 Estradiol Vaginal Cream (2 Times/Week) | 46 of 238 |
| Vehicle (2 Times/Week) | 20 of 124 |
| WC3011 Estradiol Vaginal Cream (3 Times/Week) | 57 of 237 |
| Vehicle (3 Times/Week) | 23 of 123 |
Most frequent serious adverse event terms
| Event term | Organ system | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | 0 of 238 | 0 of 124 | 0 of 237 | 1 of 123 |
| Large intestine perforation | Gastrointestinal disorders | 1 of 238 | 0 of 124 | 0 of 237 | 0 of 123 |
| Small intestinal obstruction | Gastrointestinal disorders | 1 of 238 | 0 of 124 | 0 of 237 | 0 of 123 |
Most frequent non-serious adverse event terms
| Event term | Organ system | WC3011 Estradiol Vaginal Cream (2 Times/Week) | Vehicle (2 Times/Week) | WC3011 Estradiol Vaginal Cream (3 Times/Week) | Vehicle (3 Times/Week) |
|---|---|---|---|---|---|
| Vulvovaginal mycotic infection | Infections and infestations | 12 of 238 | 3 of 124 | 26 of 237 | 8 of 123 |
| Urinary tract infection | Infections and infestations | 12 of 238 | 7 of 124 | 7 of 237 | 7 of 123 |
| Vaginal discharge | Reproductive system and breast disorders | 13 of 238 | 4 of 124 | 10 of 237 | 3 of 123 |
| Upper respiratory tract infection | Infections and infestations | 8 of 238 | 5 of 124 | 12 of 237 | 2 of 123 |
| Nasopharyngitis | Infections and infestations | 3 of 238 | 2 of 124 | 11 of 237 | 8 of 123 |
Serious events with the highest arm-level rate: cholecystitis (0.8%), large intestine perforation (0.4%), small intestinal obstruction (0.4%).
The registry presents serious adverse event counts and other adverse event counts for each of the four regimen groups. For WC3011 used 2 times a week, 238 participants were at risk for serious events and 1 was affected; 238 were at risk for other events and 46 were affected. For vehicle used 2 times a week, the corresponding figures were 124 at risk and 0 affected for serious events, and 124 at risk and 20 affected for other events. For WC3011 used 3 times a week, 237 were at risk and 0 were affected for serious events, while 237 were at risk and 57 were affected for other events. For vehicle used 3 times a week, 123 were at risk and 1 was affected for serious events, while 123 were at risk and 23 were affected for other events. The recorded deaths were 0 in every group.
The registry lists Cholecystitis at 0.8%, Large intestine perforation at 0.4%, and Small intestinal obstruction at 0.4% among the top serious terms. It does not report the group assignment for these terms in the listed summary, so they cannot be attributed to a particular regimen from this information alone.
General statistical explanation: these counts are descriptive and do not establish whether a difference between groups is statistically reliable or caused by treatment. The record does not report an adjusted comparison, exposure-time analysis, or detailed event narratives. The serious and other event counts also describe different categories and should not be treated as interchangeable measures.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, parallel-group phase 3 study evaluated WC3011 estradiol vaginal cream against vehicle in postmenopausal women with vulvovaginal atrophy. It describes two schedules for each treatment and defines a participant-reported vaginal dryness endpoint assessed from baseline to Week 12/Final Visit. It also provides descriptive adverse event counts and the number at risk in each regimen group.
It does not report the primary endpoint’s numerical results or a statistical comparison. The direction of the score is defined, but there are no reported mean changes, standard deviations, estimated treatment differences, confidence intervals, or p-values. The registry record therefore does not support a description of how much the groups changed, how different their changes were, or how precisely any difference was estimated. The title and stated study aim are not substitutes for outcome estimates.
The safety figures give counts of affected participants for serious and other adverse events, but they do not establish causal attribution or statistical differences between regimens. The listed serious-event terms are not assigned to specific treatment groups in the summary. No deaths are recorded in the listed groups. These registry entries are descriptive and should be interpreted within the limits of the registry’s reporting.
General statistical explanation: a trial result is more informative when the estimated effect, its uncertainty, the analysis population, and the handling of missing observations are all reported. Design features such as randomization and masking help frame interpretation, but they cannot supply missing outcome estimates. The registry record does not report the detailed statistical plan, missing-data procedures, or multiplicity strategy. Accordingly, the study question and intended endpoint are identifiable, but the efficacy result and its precision cannot be judged from the registry record.
This interpretation concerns what the record documents. It does not resolve whether additional results were reported elsewhere, because such information is not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable for combining a participant-reported continuous endpoint with multiple treatment schedules and a set of additional outcomes. The primary measure is a change score on a 4 point severity scale, with negative values defined as improvement. That clear direction helps readers understand what a reported change would mean, but it does not reveal the size of any observed change. The registry record gives no numerical primary outcome results.
The four listed groups make the comparison structure important. There are active and vehicle regimens at both 2 times a week and 3 times a week after the initial daily application period. Without a reported analysis plan or group-specific endpoint estimates, readers cannot tell whether the intended inference was frequency-specific, pooled across schedules, or organized in another way. A design can be described without the analysis choices needed to interpret its treatment contrasts.
The record also identifies 17 outcome measures, which raises a general statistical issue: interpretation across several outcomes and assessment times depends on a prespecified approach to multiplicity. The registry does not report that approach or any analyses. It likewise defines a modified Intent-to-Treat Population but does not give the evaluable endpoint counts by group or the methods used for missing observations. These omissions matter because analysis populations and missing-data assumptions can affect the meaning of a comparison.
The posted adverse event counts add descriptive safety information, but they do not include comparative estimates or detailed attribution. Taken together, the record is useful for understanding the trial’s design, endpoint, and reporting gaps. Its statistical importance lies in distinguishing a defined research question from a reportable estimate: without the estimated effects and their uncertainty, the primary comparison cannot be appraised quantitatively.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
A central limitation of the registry record is that it does not report numerical results for the primary endpoint. It defines the measure and direction, but provides no group means, standard deviations, estimated contrasts, confidence intervals, or p-values. This prevents assessment of the observed magnitude, precision, and statistical compatibility of the primary comparison.
The record lists four regimen groups but does not describe the primary comparison or whether the treatment frequencies were analyzed separately or together. It does not give group-specific counts analyzed for the primary endpoint. Although the modified Intent-to-Treat Population and timepoint-specific evaluable-data definition are described, the number of participants with evaluable data in each group and reasons for missing data are not reported in the registry record.
Further analysis details are also absent. The statistical model, any covariate adjustment, the method for calculating uncertainty, sensitivity analyses, and any procedures for addressing multiple outcomes or timepoints are not reported in the registry record. The record does not give the original sample-size justification or explain whether interim analyses were planned or conducted. The planning illustration described by the registry is based on an observed effect, but its numerical output is not reported and it cannot fill the role of a documented original design rationale.
The masking description is not fully reconciled: the registry design field says triple-masked, while the official title says double-blind. The roles masked and the implementation are not reported in the registry record. Safety reporting is also limited to group-level counts and listed serious-event terms; event attribution by regimen and detailed event descriptions are not given. These reporting limitations constrain interpretation and should not be resolved by inference.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety & Efficacy WC3011 (Estradiol Vaginal Cream) in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women — NCT01400776.
- Registry record last updated 2022-05-09; status last verified 2021-09.
- Results first posted 2022-05-09.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT01400776 is a completed randomized phase 3 parallel-group study sponsored by Warner Chilcott. It enrolled 722 participants with postmenopausal vulvovaginal atrophy. The study compared WC3011 estradiol vaginal cream with vehicle using schedules that began with daily application for 2 weeks and continued at either 2 times a week or 3 times a week for 10 weeks.
The primary outcome was change from baseline in participants’ self-assessment of vaginal dryness severity to Week 12/Final Visit. It used a 4 point scale, and negative change was defined as improvement. The registry record describes the modified Intent-to-Treat Population and lists 17 outcome measures, but reports zero analyses and no numerical primary outcome results or statistical comparison.
Adverse event counts are recorded by regimen group, including serious events, other events, and deaths. The record does not provide detailed statistical methods, a multiplicity strategy, or methods for handling missing primary outcome data.