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 Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women (NCT00242710), a randomized phase 3 study. The primary outcome is Percentage of Participants With Hyperplasia at Screening.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00242710 |
| Phase | Phase 3 |
| Condition | Endometrial Hyperplasia, Osteoporosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 1083 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Postmenopausal women were the population of interest. The study concerned prevention of endometrial hyperplasia and osteoporosis. Women with endometrial hyperplasia at screening were excluded, so the screening outcome could not describe the enrolled population’s treatment-period experience.
Intervention
The study included two bazedoxifene and conjugated estrogen combinations: bazedoxifene 20 mg with conjugated estrogen 0.625 mg, and bazedoxifene 20 mg with conjugated estrogen 0.45 mg. The registry record lists these as separate treatment arms.
Comparator
The comparison groups were conjugated estrogen 0.45 mg with medroxyprogesterone acetate 1.5 mg, an active control, and placebo. The record describes a randomized, double-blind, parallel-group study with these four arms. It does not report the allocation ratio.
Primary question
The listed primary outcome is the percentage of participants with endometrial hyperplasia at screening. Because hyperplasia at screening was an exclusion criterion, participants with that condition were not included in the analysis, and the record says the data are unavailable. This outcome therefore cannot answer whether the study treatments differed in prevention of hyperplasia during treatment. The stated study purpose also included prevention of osteoporosis, but the record does not provide results for the listed bone-density outcomes.
3. Trial Design
This was a randomized, double-blind, parallel-group Phase 3 study sponsored by Pfizer. The record lists enrollment of 1083 and a completed status. Its start is recorded as 2005-09 and its primary completion as 2008-09. The listed arms were bazedoxifene 20 mg with conjugated estrogen 0.625 mg, bazedoxifene 20 mg with conjugated estrogen 0.45 mg, conjugated estrogen 0.45 mg with medroxyprogesterone acetate 1.5 mg, and placebo. The allocation ratio and the number of participants analyzed for each efficacy outcome are not reported in the registry record.
Randomization is a design method intended to make treatment groups comparable on average with respect to measured and unmeasured characteristics. Double masking means that the record describes the study as double-blind, but it does not specify which individuals were masked or how masking was maintained. A parallel-group design assigns participants to a treatment group for comparison rather than describing a crossover sequence.
The stated aims were prevention of endometrial hyperplasia and osteoporosis in postmenopausal women. The registry lists 11 outcome measures and 90 analyses. Secondary outcomes include breast pain, uterine bleeding or spotting, hyperplasia at Month 24, and changes from baseline in lumbar spine and total hip bone mineral density at Month 24. The existence of these outcome listings does not establish that numerical results or comparative estimates are available for them. The specific analysis populations, follow-up procedures, allocation ratio, and details of treatment adherence 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.
Before assignment: This main study also included osteoporosis substudy only for the purpose of the assessment of relevant parameters.
Core Study (up to Year 1)
| Stage | Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg | Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg | Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|
| STARTED | 373 | 353 | 183 | 174 |
| Treated | 361 | 349 | 179 | 172 |
| COMPLETED | 287 | 289 | 132 | 143 |
| NOT COMPLETED | 86 | 64 | 51 | 31 |
Reasons for not completing this period:
| Reason | Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg | Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg | Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|
| Adverse Event | 30 | 25 | 23 | 14 |
| Death | 0 | 0 | 1 | 0 |
| Physician Decision | 0 | 1 | 0 | 1 |
| Lost to Follow-up | 8 | 8 | 7 | 3 |
| Other | 6 | 1 | 0 | 2 |
| Protocol Violation | 2 | 9 | 1 | 3 |
| Withdrawal by Subject | 27 | 16 | 15 | 6 |
| Lack of Efficacy | 1 | 0 | 0 | 0 |
| Randomized but not Treated | 12 | 4 | 4 | 2 |
Period Between Core Study and Extension
| Stage | Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg | Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg | Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|
| STARTED | 287 | 289 | 132 | 143 |
| COMPLETED | 168 | 177 | 84 | 94 |
| NOT COMPLETED | 119 | 112 | 48 | 49 |
Reasons for not completing this period:
| Reason | Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg | Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg | Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|
| Adverse Event | 2 | 3 | 5 | 2 |
| Physician Decision | 1 | 1 | 0 | 0 |
| Other | 24 | 24 | 9 | 11 |
| Extension not Available | 17 | 21 | 8 | 7 |
| Protocol Violation | 0 | 0 | 2 | 1 |
| Withdrawal by Subject | 75 | 63 | 24 | 28 |
Study Extension (up to Year 2)
| Stage | Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg | Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg | Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|
| STARTED | 168 | 177 | 84 | 94 |
| COMPLETED | 141 | 148 | 69 | 84 |
| NOT COMPLETED | 27 | 29 | 15 | 10 |
Reasons for not completing this period:
| Reason | Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg | Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg | Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|
| Adverse Event | 7 | 9 | 2 | 4 |
| Death | 0 | 0 | 0 | 1 |
| Lost to Follow-up | 7 | 7 | 5 | 0 |
| Other | 3 | 5 | 4 | 3 |
| Protocol Violation | 0 | 2 | 0 | 1 |
| Withdrawal by Subject | 10 | 6 | 4 | 1 |
Analysis population for the primary outcome, as defined in the registry: Endometrial hyperplasia at screening was an exclusion criterion and participants who had hyperplasia were not included in the analysis. Therefore this data is not available.
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: Safety analysis set included all randomly assigned participants who took at least 1 dose of test article.
| Characteristic | Unit | Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg | Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg | Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 361 | 349 | 179 | 172 | 1061 | |
| Age Continuous | years | 54.62 (SD 4.74) | 54.44 (SD 4.62) | 54.30 (SD 4.56) | 54.19 (SD 4.62) | 54.44 (SD 4.65) |
| Sex: Female, Male: Female | Participants | 361 | 349 | 179 | 172 | 1061 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Hyperplasia at Screening, measured over Screening.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The listed primary endpoint is the percentage of participants with endometrial hyperplasia at screening. The record says endometrial hyperplasia was assessed using endometrial biopsies. Two primary pathologists read each biopsy centrally. A diagnosis required both readers to identify hyperplasia; if they disagreed about its presence, a third pathologist was consulted and the majority opinion determined the final diagnosis. The diagnosis could include simple or complex hyperplasia, with or without atypia.
In general, a clearly defined tissue-based endpoint can provide a structured way to identify a condition, while central reading and a prespecified resolution process can reduce variation in how samples are interpreted. That general rationale does not change the timing problem in this trial’s listed primary outcome. The registry record states that hyperplasia at screening was an exclusion criterion and that participants with hyperplasia were not included in the analysis. It therefore says this outcome data are unavailable. Screening status is not a post-treatment comparison and cannot establish whether the treatment groups differed in hyperplasia during the study.
The record also lists hyperplasia at Month 24 as a secondary outcome, but does not report its results in the registry record for this analysis. Results for that outcome, including group-specific estimates and uncertainty, are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The available record does not support an estimate of the treatment effect for the listed primary outcome. That outcome concerns hyperplasia at screening, and the record explains that participants with hyperplasia were excluded. It explicitly states that the data are unavailable. There is consequently no reported group comparison for this primary endpoint to interpret, and no basis for describing a treatment difference, its direction, or its precision.
The study’s stated aims extend to prevention of osteoporosis and endometrial hyperplasia. The outcome listings include bone mineral density changes at Month 24 and hyperplasia at Month 24, but numerical results for those endpoints are not reported in the registry record. The study is described as completed, but completion status alone does not provide evidence about the magnitude or uncertainty of any treatment effect. No effect estimates, confidence intervals, p-values, or comparative conclusions for these efficacy outcomes are present in the record details.
The record does contain safety counts by group, including counts of participants affected by serious adverse events and by other adverse events. These are descriptive counts, not a complete comparative safety analysis. Their interpretation depends on the outcome definitions, observation periods, and analysis populations, details that are not reported in the registry record. The record also lists percentages for several serious adverse event terms, but does not identify a treatment group for those terms in the information. Such percentages should not be read as treatment-specific comparative risks.
In general, an estimate describes the observed difference or association, while a confidence interval describes the statistical uncertainty around an estimate under the analysis assumptions. Neither can be assessed for the efficacy question without a reported estimate and its uncertainty. A nonsignificant result, if one existed, would not by itself establish equivalence or absence of an effect; no such statistical result is reported. The appropriate interpretation is therefore limited: the registry describes the trial design and outcomes, but the available results do not establish the efficacy comparison for the stated prevention aims.
The listed analysis count and outcome count indicate that multiple outcomes and analyses were registered. They do not reveal which comparisons were primary in the final analysis, how multiplicity was handled, or whether any reported analysis was prespecified. Those details are not reported in the registry record. As a result, the record does not permit assessment of the evidence hierarchy or the degree to which a selected result might reflect multiple testing.
9. Statistical Methods Explained
What does randomization contribute?
Randomization assigns participants to study groups by chance. In general, this helps limit systematic differences between groups at the time treatment begins, supporting a fair comparison. It does not guarantee that every measured characteristic will be identical across groups, and it does not correct problems in outcome measurement, missing data, or analysis choices. The record identifies this trial as randomized but does not report the allocation ratio or the sequence-generation and concealment procedures.
What does double masking mean?
The registry describes the study as double-blind. In general, masking is intended to reduce the influence of treatment knowledge on participant reporting, care, and outcome assessment. The exact people masked and the practical methods used are not reported in the registry record. Central biopsy reading by pathologists is described for the endometrial assessment, but the record does not say whether those readers were masked to treatment assignment.
How should the primary endpoint be understood?
The listed primary outcome is the percentage of participants with hyperplasia at screening. The record describes a biopsy-based diagnostic process with central readings by two primary pathologists and a third-reader process when the first two disagreed. In general, this kind of adjudication aims to apply a consistent diagnostic rule. However, the screening timing and exclusion rule prevent this listed outcome from serving as an observed treatment-period comparison: participants with screening hyperplasia were not included in the analysis, and the record says the data are unavailable. A separate secondary outcome is listed for hyperplasia at Month 24, but its result is not reported.
What do confidence intervals and p-values ordinarily add?
In general, a confidence interval expresses the uncertainty around an estimated effect under a specified statistical model and analysis. A narrow interval indicates greater precision than a wide interval, but the interval must be considered alongside the endpoint definition and the clinical question. A p-value summarizes how compatible observed data are with a specified null model under the test assumptions; it does not measure the probability that a treatment works, nor does it establish the size or importance of an effect. The registry record details do not include efficacy estimates, confidence intervals, or p-values, so these measures cannot be interpreted for the prevention questions.
Why can multiple analyses matter?
In general, testing many outcomes, time points, or treatment comparisons can increase the chance of obtaining a seemingly notable result by chance if the analyses are considered together. Multiplicity methods can control or describe that issue, but the appropriate approach depends on the planned testing hierarchy and the intended claims. The record lists 11 outcome measures and 90 analyses. It does not report a multiplicity strategy, a hierarchy of hypotheses, or which analyses were designated confirmatory. The count alone does not indicate whether a correction was applied.
What does over-dispersion mean in general?
For outcomes that are counts, over-dispersion means that the variability in the data is greater than expected under a simple count model. Ignoring extra variability can make uncertainty appear smaller than it is. This is a general statistical issue, not a reported feature of this trial’s analyses. The endpoint details do not establish that a count model was used, or that over-dispersion was assessed. The statistical models used for the efficacy analyses are not reported in the registry record.
How should the planning assumptions be read?
The record describes its sample-size calculations as planning illustrations based on an 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. These are planning assumptions, not observed results, and they do not constitute observed power. The record does not provide a trial-specific sample-size justification or explain how the original design enrollment was chosen. Because the listed primary outcome has no available result and a comparison has not been reduced to a single effect, such illustrations cannot supply an efficacy conclusion.
For time-to-event tables, the record’s planning note refers to a total number of events; for other outcomes, it refers to participants per arm. This describes the convention for those planning illustrations, not an observed trial result. The specific statistical analysis plan, model specifications, covariate adjustments, handling of repeated measures, and sensitivity analyses are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 11 outcome measures and 90 analyses, but the multiplicity strategy is not reported in the registry record. It does not identify which outcome comparisons formed a confirmatory testing hierarchy, whether results were adjusted for multiple comparisons, or whether any analyses were exploratory. In general, examining multiple outcomes, time points, and treatment contrasts can make chance findings more likely when many tests are interpreted without a plan to account for them. The number of listed analyses alone cannot establish that a particular method was or was not used.
Missing-data methods are not reported in the registry record. The record does not describe how participants with incomplete outcome measurements were handled, whether imputation was used, or what sensitivity analyses were conducted. The efficacy analysis populations are also not reported: it is not stated whether analyses used all randomized participants, participants who received treatment, or another defined population. Randomization supports group comparability, but exclusions or incomplete outcome measurement can affect the validity of a comparison, depending on their extent and reasons.
The primary outcome has a specific availability limitation: screening hyperplasia was an exclusion criterion, so affected participants were not included in the analysis, and the record says the data are unavailable. This is different from ordinary loss to follow-up after randomization. For the secondary outcomes, including Month 24 hyperplasia and bone mineral density, the analysis populations and missing-data handling are not reported in the registry record. Those omissions limit assessment of how complete and representative the outcome comparisons are.
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 |
|---|---|---|---|
| Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg | 22 | 361 | 6.1% |
| Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg | 19 | 349 | 5.4% |
| Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg | 7 | 179 | 3.9% |
| Placebo | 7 | 172 | 4.1% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg | 322 of 361 |
| Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg | 309 of 349 |
| Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg | 165 of 179 |
| Placebo | 152 of 172 |
Most frequent serious adverse event terms
| Event term | Organ system | Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg | Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg | Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 0 of 361 | 3 of 349 | 1 of 179 | 0 of 172 |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 361 | 3 of 349 | 1 of 179 | 0 of 172 |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 361 | 1 of 349 | 0 of 179 | 2 of 172 |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 361 | 0 of 349 | 1 of 179 | 1 of 172 |
| Deep vein thrombosis | Vascular disorders | 3 of 361 | 0 of 349 | 0 of 179 | 0 of 172 |
| Vomiting | Gastrointestinal disorders | 0 of 361 | 1 of 349 | 0 of 179 | 1 of 172 |
| Cholecystitis | Hepatobiliary disorders | 1 of 361 | 1 of 349 | 0 of 179 | 0 of 172 |
| Ankle fracture | Injury, poisoning and procedural complications | 2 of 361 | 0 of 349 | 0 of 179 | 0 of 172 |
| Intentional overdose | Injury, poisoning and procedural complications | 2 of 361 | 0 of 349 | 0 of 179 | 0 of 172 |
| Biopsy endometrium abnormal | Investigations | 1 of 361 | 1 of 349 | 0 of 179 | 0 of 172 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg | Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg | Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg | Placebo |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | 94 of 361 | 78 of 349 | 58 of 179 | 41 of 172 |
| Nasopharyngitis | Infections and infestations | 83 of 361 | 82 of 349 | 42 of 179 | 30 of 172 |
| Back pain | Musculoskeletal and connective tissue disorders | 60 of 361 | 66 of 349 | 33 of 179 | 23 of 172 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 55 of 361 | 56 of 349 | 22 of 179 | 28 of 172 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 39 of 361 | 39 of 349 | 19 of 179 | 27 of 172 |
| Influenza | Infections and infestations | 43 of 361 | 35 of 349 | 24 of 179 | 14 of 172 |
| Myalgia | Musculoskeletal and connective tissue disorders | 34 of 361 | 28 of 349 | 16 of 179 | 16 of 172 |
| Hot flush | Vascular disorders | 38 of 361 | 37 of 349 | 11 of 179 | 7 of 172 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 37 of 361 | 29 of 349 | 16 of 179 | 10 of 172 |
| Upper respiratory tract infection | Infections and infestations | 29 of 361 | 35 of 349 | 15 of 179 | 12 of 172 |
Serious events with the highest arm-level rate: malignant melanoma (1.2%), abdominal pain (0.9%), basal cell carcinoma (0.9%), deep vein thrombosis (0.8%), vomiting (0.6%).
The serious adverse event figures are reported as affected participants and participants at risk within each listed group. For bazedoxifene 20 mg with conjugated estrogen 0.45 mg, 22 of 361 participants were affected; for bazedoxifene 20 mg with conjugated estrogen 0.625 mg, 19 of 349 were affected. For conjugated estrogen 0.45 mg with medroxyprogesterone acetate 1.5 mg, 7 of 179 were affected; for placebo, 7 of 172 were affected. These are descriptive counts and should not be treated as adjusted comparisons.
The record also gives counts for participants affected by other adverse events: 322 of 361, 309 of 349, 165 of 179, and 152 of 172 in the corresponding groups. The definitions and observation periods underlying these categories are not reported in the registry record. The listed serious adverse event terms include malignant melanoma, abdominal pain, basal cell carcinoma, deep vein thrombosis, vomiting, and sudden death, with percentages reported for those terms. The record details do not identify those percentages by treatment group, so they cannot be used to compare groups or infer group-specific risk. Death counts are not reported in the registry record.
In general, safety comparisons require attention to how events were defined, how long participants were observed, and whether groups were analyzed consistently. A count alone does not show causation or establish whether a difference is statistically meaningful. These figures describe reported event counts only.
12. What the Result Does, and Does Not, Mean
This record establishes that a randomized, double-blind, parallel-group Phase 3 study was conducted to evaluate bazedoxifene and conjugated estrogen combinations in postmenopausal women, with an active-control group and placebo. It also identifies the prevention aims, the listed outcomes, and the biopsy reading procedure for endometrial hyperplasia. The registry entries do not provide numerical efficacy results for the listed primary endpoint or for the Month 24 secondary outcomes.
The primary outcome cannot be interpreted as a treatment comparison because it concerns screening and participants with hyperplasia at screening were excluded. The record states that the resulting data are unavailable. The separate Month 24 hyperplasia outcome could address a later comparison in principle, but its result is not reported in the registry record. Similarly, the bone mineral density outcomes are listed at Month 24, but no numerical results are available in these record details.
In general, absence of a reported result is not evidence that treatment groups were the same. Nor does a completed status, a large enrollment entry, or the presence of a planned sample-size calculation establish a treatment effect. To assess an effect, readers need the endpoint-specific estimates, the groups included in each analysis, and measures of uncertainty, along with enough information about the analysis to judge its assumptions.
The safety counts add descriptive information about adverse events recorded in the study, but do not by themselves establish whether an event was caused by treatment or whether treatment groups differed reliably. The serious-event term percentages are not linked to groups in the available record details, and death counts are not reported. Overall, the registry information supports a description of the study design and some event counts, but not a conclusion about efficacy or comparative safety.
13. Why This Trial Matters Statistically
This trial raises several important statistical distinctions. First, the title and stated purpose concern prevention, but the listed primary outcome is measured at screening. Since participants with hyperplasia at screening were excluded and the record says the data are unavailable, that primary outcome cannot provide the intended treatment-period comparison. The distinction between a baseline or screening measure and an outcome assessed after treatment matters when deciding whether an endpoint answers the research question.
Second, a trial can list multiple outcomes and analyses without making their inferential roles clear. Here, the record lists 11 outcome measures and 90 analyses, while the multiplicity plan and testing hierarchy are not reported. In general, prespecifying which comparisons are confirmatory helps readers distinguish a focused test from a broad set of analyses. Without that information, a reader cannot fully assess how selective interpretation of results might affect confidence.
Third, reporting estimates and their uncertainty is essential. Group counts alone do not show the size or precision of an efficacy effect, and a planning calculation is not an observed treatment result. The record’s safety counts are useful descriptions, but they cannot replace endpoint-specific comparisons or establish causality. This trial therefore illustrates why readers need more than a completed status and an outcome list: they need analyzable results, analysis-population definitions, missing-data procedures, and a transparent account of statistical methods to judge what the evidence supports.
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 is that the listed primary endpoint is screening hyperplasia, while hyperplasia at screening was an exclusion criterion. The registry record states that affected participants were not included in the analysis and that the data are unavailable. As a result, this outcome does not provide a treatment comparison for the study’s prevention aim. The separate Month 24 hyperplasia outcome is listed as secondary, but its result is not reported in the registry record.
The stated osteoporosis aim is not accompanied by numerical results for the listed lumbar spine and total hip bone mineral density outcomes at Month 24. Without group-specific estimates and measures of uncertainty, the magnitude and precision of any difference cannot be assessed. The record also does not report the analysis populations or the handling of incomplete measurements, limiting assessment of how participants contributed to these outcomes.
Further limitations are the absence of reported efficacy models, confidence intervals, p-values, a multiplicity strategy, and a detailed statistical analysis plan. The 90 analyses and 11 outcome measures do not reveal which analyses were confirmatory. For safety, event counts are available, but the definitions and observation periods are not reported in the registry record; listed serious-event term percentages are not attributed to treatment groups in the registry record. Death counts are not reported. These gaps constrain interpretation of both comparative efficacy and safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women — NCT00242710.
- Registry record last updated 2013-12-20; status last verified 2013-10.
- Results first posted 2013-12-20.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The record describes a completed, randomized, double-blind, parallel-group Phase 3 study sponsored by Pfizer, with enrollment of 1083. It evaluated two bazedoxifene and conjugated estrogen combinations against conjugated estrogen with medroxyprogesterone acetate and placebo in postmenopausal women. The stated aims were prevention of endometrial hyperplasia and osteoporosis.
The listed primary outcome concerns hyperplasia at screening. Because hyperplasia at screening was an exclusion criterion, the record says the data are unavailable. Secondary outcomes include Month 24 hyperplasia and bone mineral density changes, but their numerical results are not reported in the registry record details analyzed. Safety counts are reported by group, while the study’s statistical analysis plan, multiplicity approach, missing-data methods, and analysis populations are not reported.