Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women (NCT01901679), a na early/phase 1 study. The primary outcome is To Determine Whether Oral Administration of Celebrex to Obese Women Will Reduce the PGE-M in Urine.

2. Clinical Question

3. Trial Design

This was a completed early-phase study registered as a pilot and described as a single-group study. The intervention was Celebrex, and the arm description refers to 10 days of treatment. Allocation is listed as NA and masking as none. Those details do not support interpreting the registry record as a masked randomized comparison.

The record separately names a 1st Group with a 3 Day run-in Period and a 2nd Group with a 14 Day run-in Period. It does not explain whether or how those labels map to the treatment schedule, or why the groups have different run-in periods. The registry also cautions that the arms are not a like-for-like control comparison. Accordingly, differences between the groups should not be treated as a controlled estimate of treatment effect.

Enrollment is listed as 10. The record identifies Rockefeller University as sponsor, the condition as obesity, and the phase as early phase 1. The study status is completed. Its registered primary endpoint concerned a change in urinary PGE-M over 10 days, but the samples for that endpoint were not analyzed. The record lists one outcome measure and no analyses.

The registry record does not report a statistical design rationale, a sample-size justification, a detailed analysis plan, or the relationship between the run-in labels and any planned endpoint analysis. The posted information therefore supports a description of the study's aim and structure, but not a reconstruction of the intended statistical comparison or of an effect estimate.

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: All participants were screened for their usual dietary intake and instructed to continue to follow their usual diet during weeks prior to hospital admission and thoughout the entire study. . First group underwent 3 day run-in period inpatient, the second group underwent 14 day run-in period prior to starting Celecoxib 200mg po BID X 10 days.

Overall Study

Analysis population for the primary outcome, as defined in the registry: These samples were collected but not analyzed due to technical reasons. Investigator has retired and access to results was not available for this outcome. Best efforts were made to obtain the data; however, they were unsuccessful.

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.

6. Primary Endpoint

The registry lists the primary outcome as To Determine Whether Oral Administration of Celebrex to Obese Women Will Reduce the PGE-M in Urine, measured over 10 days.

The primary endpoint was whether oral Celebrex administration to obese women would reduce PGE-M in urine. The registry gives a 10-day timeframe and describes the endpoint as a reduction in urinary PGE-M after treatment. It does not specify a unit, a summary parameter, or a measure of dispersion for this outcome.

As a general statistical principle, a prespecified endpoint gives a study a defined outcome against which its research question can be assessed. A measurement collected before and after treatment could, if analyzed under an appropriate plan, describe a change over time. In this study, the registry says that samples were collected but not analyzed due to technical reasons. It also reports that the investigator had retired and access to the results was unavailable despite efforts to obtain them. Thus, the endpoint's intended role is clear, but its observed value and any change cannot be assessed from the registry record.

The study summary frames the broader rationale as investigating inflammation in fat tissue and the production of substances such as estrogens. That context does not substitute for the urinary PGE-M result: the registry record does not report an analyzed primary endpoint, a treatment effect, or evidence connecting an endpoint change to a clinical outcome.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record describes the design and intended endpoint, but it does not report the statistical methods used to analyze the primary outcome. The endpoint samples were collected but not analyzed due to technical reasons, and the record lists no analyses. The methods below explain general statistical ideas relevant to reading a study of this type; they should not be mistaken for methods documented as having been used in this trial.

What would an endpoint estimate describe?

For a urinary measure assessed after treatment, an analysis might describe the observed endpoint value or a change from an earlier measurement, depending on the protocol. The registry describes the target as reduction in PGE-M in urine after treatment, but it does not specify the baseline measurement, the precise calculation of change, or a summary parameter. It would therefore be inappropriate to presume that the intended statistic was a mean change, a median change, or another particular quantity.

An estimate is a concise description of the observed data under a defined analysis. A confidence interval, as a general concept, expresses uncertainty around an estimate under the assumptions of the statistical model. It does not resolve systematic problems in how data were collected or analyzed, and it cannot be constructed meaningfully without analyzed endpoint data and a specified method. No such estimate or interval is reported for the primary outcome.

Why does the design matter?

In a controlled comparison, a control group can provide information about outcomes that might occur without the intervention, subject to the study's design and assumptions. This record describes a single-group study and explicitly says the groups with different run-in periods are not a like-for-like control comparison. Differences between those groups could reflect their differing structure or other factors, and cannot automatically be interpreted as treatment effects.

Masking is listed as none. In general, masking can reduce the possibility that knowledge of treatment assignment influences measurements, reporting, or assessment. The record does not specify which endpoint assessment procedures were planned, so the practical implications of no masking for this urinary outcome cannot be determined. The registry also does not report whether the intervention was compared with any untreated or placebo condition.

What does statistical significance tell a reader?

As a general concept, a statistical test evaluates how compatible observed data are with a specified null hypothesis under the model assumptions. A p-value is not the probability that a treatment works, nor does it measure the size or clinical importance of an effect. In this record there is no analyzed primary outcome and no reported primary-outcome test, so there is no p-value to interpret. The registry does not report the statistical plan or its testing procedure.

Precision is also important. A confidence interval can show which effect sizes are relatively compatible with the data and model, while a point estimate alone does not show that uncertainty. Here, neither a primary endpoint estimate nor its precision is reported. The listed enrollment cannot be used to infer the precision of an outcome that was not analyzed.

How should planning illustrations be read?

Planning calculations are not observed trial findings. The registry's sample-size assumptions describe illustrations based on a stated fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. They are explicitly described as planning illustrations rather than the trial's own design. In general, such calculations ask how much information a hypothetical future study might need under chosen assumptions; they do not demonstrate that a study had a particular probability of finding an effect.

The record does not report a design-based sample-size justification. Nor does it report an analyzed primary effect that can be interpreted from the endpoint record. Any planning illustration should therefore be kept separate from the study's observed results and should not be described as observed power. The assumptions used for a planning exercise also do not establish that its model fits this study's design or endpoint.

Why can over-dispersion matter?

As a general statistical concept, over-dispersion occurs when variation in count data exceeds what a simple model assumes. If present, it can make uncertainty estimates from that simple model too small and tests too optimistic. This concept is relevant in some analyses of event counts, but the registry does not report an analysis of the primary endpoint or a model for the adverse-event counts. It also does not establish that over-dispersion was assessed or present in this study.

More broadly, model choice depends on the outcome scale, design, and data structure. A method suitable for continuous measurements may differ from one used for counts or time-to-event outcomes. The registry does not identify a model, adjustment strategy, missing-data method, or estimation procedure for the primary endpoint. It is therefore possible to explain what those methods generally do, but not to attribute any particular method or assumption to this trial.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure and no analyses. The primary endpoint is urinary PGE-M reduction over 10 days, but the samples were collected and not analyzed due to technical reasons. The record also says access to the results was unavailable. As a result, there is no reported endpoint estimate or analysis from which to assess the handling of missing data, the analysis population, or the consequences of any exclusions.

Multiplicity refers, in general, to the statistical issue that can arise when several hypotheses or outcomes are tested. Repeated testing can increase the chance of a seemingly notable result unless the analysis plan accounts for it. The registry does not report a multiplicity plan, and it does not report analyses for the primary endpoint. The listed outcome count alone does not establish which tests, if any, were planned or performed.

The record does not describe an intention-to-treat population, a per-protocol population, or another analysis population. It also does not state whether endpoint data were available for every enrolled participant. The reason given for the absent outcome result is that collected samples were not analyzed for technical reasons, alongside lack of access to results. Those details are not enough to identify the extent or pattern of missing measurements or to assess whether missingness could bias an estimate.

Because no primary endpoint analysis is reported, it is not possible to compare alternative missing-data assumptions or determine whether a sensitivity analysis was conducted. These details are not reported in the registry record.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: hemorrhage (20.0%).

The safety summary distinguishes serious adverse events, other adverse events, and deaths by the two run-in group labels. In the 3 Day run-in group, the record reports 1 participant affected by a serious event and 2 affected by other events; it lists 0 deaths. In the 14 Day run-in group, it reports 0 affected by a serious event and 4 affected by other events; it lists 0 deaths. The record lists 5 at risk in each group for these summaries.

Hemorrhage is listed among the top serious adverse-event terms at 20.0%. The registry record does not report a group attribution or further context for that term in the information, so it should not be assigned to a particular run-in group or interpreted as a treatment-related rate.

These figures are descriptive. The group labels refer to different run-in periods, and the registry cautions that they are not a like-for-like control comparison. The record does not provide event timing, severity details beyond the serious classification, attribution to treatment, or enough information to estimate a comparative risk. The counts therefore do not establish that Celebrex caused or prevented an event. They should be read alongside the absence of an analyzed primary endpoint, not as a substitute for that missing outcome result.

12. What the Result Does, and Does Not, Mean

This trial's intended question was whether oral Celebrex would reduce urinary PGE-M in obese women after 10 days of treatment. The registry record confirms that samples were collected, but says they were not analyzed due to technical reasons and that the results could not be accessed. The study therefore contributes a documented research question and a record of planned measurement, but no reported answer to that question.

The record does not show the direction or size of any change in PGE-M. It provides no primary endpoint estimate, confidence interval, or statistical test. It cannot establish whether an observed change occurred, how precisely it could be estimated, or whether a change would correspond to the broader aims described in the study summary. The research rationale is not itself a finding.

The single-group design and the different run-in group labels also limit causal interpretation. The registry explicitly says those groups are not a like-for-like control comparison. The information does not provide a controlled estimate of what would have happened in the absence of Celebrex, and it does not support attributing differences between the groups to the drug.

Safety figures are reported descriptively, but they do not establish causation or comparative safety. The available registry information does not describe event attribution or timing in enough detail to support those conclusions.

In general, a trial's registration and completion status do not ensure that its planned endpoint has an available result. This record illustrates the distinction between collecting measurements and analyzing them: without an analysis of the primary endpoint, the intended treatment question remains unanswered in the posted results. No conclusion about clinical benefit or harm follows from the missing endpoint result.

13. Why This Trial Matters Statistically

This study is statistically notable because its central outcome was planned and samples were collected, yet the registry reports that the samples were not analyzed. A completed study can therefore leave its primary question unresolved in the public record. The distinction between enrollment, data collection, and an analyzable result is essential when interpreting trial registrations.

The design information also matters. The record calls the study single-group, lists allocation as NA, and describes groups with different run-in periods while cautioning that they are not a like-for-like control comparison. This makes it important not to read group-level safety counts as a randomized treatment contrast. The study's structure places limits on the causal claims that could be supported even if descriptive group data are available.

For biostatistical interpretation, the lack of an endpoint estimate means that uncertainty cannot be assessed. There is no basis for a confidence interval, test result, or comparison of the planned outcome with the study's rationale. Planning illustrations, where present, are distinct from observed evidence and from the trial's own design justification.

The registry also makes the limits of safety summaries visible: counts can be reported without enough context to infer attribution, timing, or a comparative risk. Reporting the counts is useful, but interpretation depends on design and analysis information that is not reported in the registry record.

More broadly, the record demonstrates why statistical conclusions depend on the analysis as well as the study question and design. A measurement that was collected but not analyzed cannot support an effect estimate, and an absent result should not be replaced by an assumption based on the study's aim.

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.

The primary limitation specific to this trial is that its registered primary endpoint was not analyzed. The registry says the samples were collected but not analyzed for technical reasons, and that access to the results was unavailable after the investigator retired. It reports that efforts to obtain the data were unsuccessful. No endpoint estimate or analysis is available in the registry record.

The record gives limited detail about how the study was conducted. It describes 10 days of Celebrex treatment and separately names groups with 3 Day and 14 Day run-in periods, but does not explain how the run-in labels relate to the treatment schedule. Dose, measurement procedures, baseline endpoint values, and the precise calculation intended for reduction are not reported in the registry record.

The study is described as single-group, with allocation listed as NA and masking as none. The registry explicitly warns that the arms are not a like-for-like control comparison. This prevents treating the group labels as a standard randomized contrast and limits what can be inferred about treatment effects from differences between them.

The registry lists enrollment as 10 but does not report a statistical sample-size justification, a detailed analysis plan, or the analysis populations. It also does not report endpoint data completeness, missing-data assumptions, or sensitivity analyses. Safety summaries lack reported event timing and treatment attribution. These limitations restrict interpretation of both the intended efficacy question and the descriptive safety counts.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women — NCT01901679.
• Registry record last updated 2021-02-01; status last verified 2021-01.
• Results first posted 2021-02-01.
• 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.

18. Record Summary

This completed early-phase pilot study examined Celebrex in obese postmenopausal women. Its primary question was whether oral treatment would reduce PGE-M in urine over 10 days. The study is registered as single-group, with allocation listed as NA and masking as none. The record names groups with 3 Day and 14 Day run-in periods and cautions that they are not a like-for-like control comparison.

Enrollment is listed as 10. The primary endpoint samples were collected but not analyzed for technical reasons, and access to the results was unavailable. No primary outcome result or analysis is reported. Safety summaries include serious and other adverse events, deaths, and hemorrhage among the top serious terms, but do not establish causation or a comparative safety effect.