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 Testosterone Gel in Preventing Weakness Caused by Steroid Therapy in Men With Glioma (NCT00631137), a randomized na study. The primary outcome is Time to Event, Defined as ≥ 50% Loss of Strength in the Hip Flexors as Assessed by Dynamometry Peak Force Measures at Baseline and at 1, 3, 5, and 7 Months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00631137 |
| Phase | NA |
| Condition | Brain and Central Nervous System Tumors, Musculoskeletal Complications |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Results posted | Yes |
2. Clinical Question
Population
Men receiving glucocorticoids for newly diagnosed high-grade glioma were the intended population. The rationale focuses on weakness associated with steroid therapy in these patients. The registry says only 1 subject accrued, so the record does not provide a substantial body of participant outcome data for assessing the proposed question.
Intervention
The treatment was testosterone gel applied to the skin, described in the treatment arm as a 10g pouch/day. The study asked whether this intervention could prevent or lessen weakness associated with steroid therapy. The record does not report an analyzable estimate of its effect on the primary outcome.
Comparator
The control arm received whey protein powder. This was the randomized comparison specified in the record. The available information does not report outcome results that would allow a meaningful comparison of changes in strength between the arms.
Primary question
The primary endpoint was time to at least 50% loss of hip-flexor strength, assessed using peak-force measurements from dynamometry at baseline and at 1, 3, 5, and 7 months. The clinical question was whether testosterone gel delayed or prevented that degree of strength loss compared with whey protein powder. The registry states that only 1 subject accrued and there were not enough data to analyze this endpoint, so it does not answer the comparative question.
3. Trial Design
This was a randomized, controlled, parallel-group comparative trial. The registry lists triple masking, meaning the study was intended to use masking at multiple levels, but it does not identify which roles were masked or describe how masking was implemented. Allocation concealment and the procedures used to maintain masking are not reported in the registry record.
The treatment arm received testosterone gel applied to the skin, specified as a 10g pouch/day. The control arm received whey protein powder. The intended participants were men receiving glucocorticoids for newly diagnosed high-grade glioma. The registry lists the phase as NA. It records an enrollment of 1 and a status of terminated. The study start is listed as 2008-01 and primary completion as 2008-09.
The registry's primary outcome concerned time to at least 50% loss of hip-flexor strength, measured by dynamometry at baseline and at 1, 3, 5, and 7 months. Other listed outcomes included strength in other proximal muscles, timed functional tests, leg muscle mass by CT scan, activities of daily living, testosterone levels, and side effects. The record does not provide analyzable results for the primary endpoint. It also does not report why the study was terminated, how randomization was generated, or whether any changes to the planned design occurred.
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 | ARM 2 : Treatment Group | Arm 1: Control Group |
|---|---|---|
| STARTED | 1 | 0 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 1 | 0 |
Reasons for not completing this period:
| Reason | ARM 2 : Treatment Group | Arm 1: Control Group |
|---|---|---|
| Withdrawal by Subject | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Only 1 subject accrued. Not enough data to analysis
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: No participants were assigned to the Control Group Arm
| Characteristic | Unit | ARM 2 : Treatment Group | Arm 1: Control Group | Total |
|---|---|---|---|---|
| Participants analysed | 1 | 0 | 1 | |
| Age, Customized | years | 29 | — | 29 |
| Sex: Female, Male: Female | Participants | 0 | — | 0 |
| Sex: Female, Male: Male | Participants | 1 | — | 1 |
| Region of Enrollment: United States | participants | 1 | — | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Time to Event, Defined as ≥ 50% Loss of Strength in the Hip Flexors as Assessed by Dynamometry Peak Force Measures at Baseline and at 1, 3, 5, and 7 Months, measured over baseline and at 1, 3, 5, and 7 months.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was time to an event: a loss of at least 50% of hip-flexor strength, based on peak-force measurements from dynamometry. Strength was scheduled for assessment at baseline and at 1, 3, 5, and 7 months. The endpoint therefore combined the magnitude of a strength decline with when that decline was first identified at a scheduled assessment. The record does not specify how event timing between assessments would be assigned, or how participants without a recorded event would be handled in the analysis.
Dynamometry measures force produced during a muscle-strength test. Hip-flexor strength was selected as the primary focus because the trial sought to evaluate weakness associated with glucocorticoid therapy. In general, defining an endpoint in advance helps distinguish the main question from other measurements collected during a trial. A time-to-event measure can describe how long participants remain without the specified event, but interpretation depends on adequate follow-up and a stated approach to events that are not observed.
Here, the registry states that only 1 subject accrued and that there were not enough data to analyze the primary outcome. It reports no event count, time-to-event estimate, treatment comparison, or uncertainty interval. The endpoint definition describes what the trial intended to measure; it does not establish whether the event occurred or whether the groups differed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The main statistical message is that the registry does not report an analyzable primary-outcome result. It states that only 1 subject accrued and that there were not enough data to analyze the primary endpoint. Consequently, there is no reported estimate of time to at least 50% loss of hip-flexor strength, no comparison between the testosterone gel and whey protein powder arms, and no confidence interval or hypothesis-test result for that comparison.
This absence of an estimate should not be read as evidence that the treatments had the same effect. It also does not show that testosterone gel prevented weakness or that it failed to do so. The data recorded in the registry are insufficient to distinguish among possible treatment effects. The study's randomized design describes the intended way to compare arms, but randomization cannot produce a reliable comparative estimate when the available outcome information is inadequate.
The study status is terminated. The record does not state why it was terminated. It would be speculative to attribute termination to recruitment, safety, feasibility, an interim result, or any other cause. The enrollment of 1 and the primary-outcome note are important context for interpreting the record, but they do not identify the reason for the study's status.
The listed secondary outcomes broaden the intended assessment beyond hip-flexor strength. They include other muscle-strength tests, timed functional tests, leg muscle mass, activities of daily living, testosterone levels, and side effects. Their presence in the registry describes planned measures, not findings. The record does not report analyzable treatment comparisons for these outcomes. It lists 0 analyses, and no summary statistics or uncertainty estimates are reported for them.
The adverse-event information is also limited. It records one other adverse event affecting one at-risk participant in the treatment arm, no serious adverse events in that arm, and zero participants at risk in the control arm. Deaths are recorded as 0 in both arms. These counts do not establish whether an event was caused by the intervention, and the event term and clinical details are not reported. The control arm's zero at-risk count means its adverse-event figures cannot serve as a meaningful comparison of safety between treatment strategies.
Any sample-size calculations associated with the record are planning illustrations under stated assumptions, not observed trial findings and not evidence of observed power. The registry does not report a usable primary treatment-effect estimate from which to draw a substantive conclusion. The appropriate interpretation is therefore limited: the trial record documents the intended comparison and some sparse safety counts, but it does not answer the primary effectiveness question.
9. Statistical Methods Explained
The registry describes a randomized, parallel-group trial with triple masking. In general, random allocation aims to make treatment groups comparable with respect to factors that may affect outcomes. Masking can reduce the influence of knowledge about assignment on care, assessments, or interpretation. Those design features do not guarantee a precise result: the amount and quality of outcome information also matter. In this record, only 1 subject accrued, and the registry explicitly says that the primary outcome could not be analyzed.
What does a time-to-event endpoint represent?
In general, a time-to-event endpoint records the time until a defined event occurs. For this trial, the event was a loss of at least 50% of hip-flexor strength, identified from peak-force measurements at scheduled visits. A time-to-event analysis can use information about when an event is observed, while also accounting for participants whose event time is not observed during follow-up. The record does not report an event time, an event count, a censoring rule, or a statistical model for this outcome. With insufficient data for analysis, the endpoint definition alone cannot establish a treatment effect.
Scheduled measurements introduce a practical distinction between the biological time an event may occur and the visit at which it is detected. General statistical practice requires a prespecified rule for assigning event times when assessments are intermittent. That rule, along with procedures for missed visits and incomplete measurements, is not reported in the registry record. It is not possible to infer which approach would have been used.
How should uncertainty be understood?
In general, a treatment-effect estimate describes the observed contrast between groups, while a confidence interval describes the range of values compatible with the data under the statistical model and its assumptions. A narrow interval indicates greater precision than a wide interval; neither an estimate nor an interval can be interpreted without considering the design and measurement process. The registry does not report a primary effect estimate or confidence interval, so there is no basis for describing the size or precision of the comparative effect.
A hypothesis test, when prespecified, evaluates how compatible the observed data are with a stated null model. A p-value is not the probability that a treatment works, nor does it measure the clinical importance of an effect. No primary-outcome p-value is reported. The record also does not report a statistical analysis plan, a prespecified test, or a model for the primary outcome. Those details should not be reconstructed from the endpoint description alone.
What do the planning illustrations mean?
The registry describes sample-size calculations as planning illustrations based on a stated fraction of the observed effect. Its assumptions include a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It states that time-to-event calculations give a total number of events, while other calculations give participants per arm. The fraction of the observed effect and a numerical observed effect are not reported in the registry record.
Such calculations are prospective illustrations of how much information a future study might require under particular assumptions. They are not the number of participants who actually enrolled, a description of the study's original design justification, or evidence that the trial had a particular probability of detecting an effect. They do not replace a treatment-effect estimate. The registry does not report the trial's own sample-size justification, and the planning assumptions should not be mistaken for a statistical plan used in this trial.
Why do sparse data matter?
In general, very limited outcome information makes estimates unstable and leaves little basis for assessing uncertainty or comparing groups. For a time-to-event endpoint, analysis depends on event information and follow-up; merely having scheduled assessment times does not create an analyzable event history. The registry's statement that there were not enough data to analyze the primary outcome is therefore central to interpretation. No numerical treatment comparison can be recovered from the endpoint title or the intended measurement schedule.
The record lists 0 analyses. It does not report handling of missing observations, analysis populations, treatment adherence, departures from assigned treatment, or sensitivity analyses. It also does not report whether any interim analyses were planned or conducted. These omissions mean that standard methodological details needed to assess an analysis cannot be evaluated from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists the primary endpoint alongside several secondary outcomes, including strength in other proximal muscles, timed functional tests, leg muscle mass, activities of daily living, side effects, and serum testosterone levels. When multiple outcomes or repeated assessments are examined, the chance of finding an apparently notable result by chance can increase. General methods for addressing multiplicity include prioritizing outcomes, adjusting inference, or clearly labeling analyses as exploratory. The approach used in this trial is not reported in the registry record.
The primary endpoint was scheduled for assessment at baseline and at 1, 3, 5, and 7 months. Several secondary measures also had repeated assessment times. The record does not explain how repeated measurements would be modeled, how a primary time point would be selected for any secondary measure, or whether any multiplicity adjustment was planned. The record reports 0 analyses and does not provide outcome estimates for these measures.
Missing-data methods are not reported in the registry record. There is no description of how missed visits, incomplete dynamometry tests, withdrawal, or loss to follow-up would be handled. The record also does not specify the analysis population, such as whether the intended primary analysis would follow randomized assignment or require receipt of treatment. Because only 1 subject accrued and the primary endpoint could not be analyzed, these omissions cannot be resolved by interpreting reported outcome estimates. They should be treated as unreported methods, not as evidence that missing data or multiplicity were handled in a particular way.
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 |
|---|---|---|---|
| ARM 2 : Treatment Group | 0 | 1 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| ARM 2 : Treatment Group | 0 of 1 |
| Arm 1: Control Group | 0 of 0 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| ARM 2 : Treatment Group | 1 of 1 |
| Arm 1: Control Group | 0 of 0 |
Most frequent non-serious adverse event terms
| Event term | Organ system | ARM 2 : Treatment Group | Arm 1: Control Group |
|---|---|---|---|
| rash: acne/acneiform | Skin and subcutaneous tissue disorders | 1 of 1 | 0 of 0 |
The adverse-event figures distinguish serious adverse events, other adverse events, and deaths. In the treatment arm, the record lists 1 participant at risk for serious adverse events and 0 affected; for other adverse events, it lists 1 at risk and 1 affected. In the control arm, it lists 0 at risk and 0 affected for both categories. Deaths are recorded as 0 in each arm.
These are counts, not a reliable comparison of safety between the assigned treatments. With zero participants at risk in the control arm, its zero affected count does not indicate that the control intervention had lower risk. The record does not report the term or clinical description of the other adverse event, its timing, severity, duration, or whether investigators considered it related to testosterone gel. It also does not describe how adverse events were collected. The figures should therefore be read as sparse registry counts, not as evidence that the intervention caused or did not cause an event.
12. What the Result Does, and Does Not, Mean
The registry supports a limited description of what the trial set out to study: testosterone gel applied to the skin was compared with whey protein powder in a randomized design for men receiving glucocorticoids for newly diagnosed high-grade glioma. The primary endpoint was time to at least 50% loss of hip-flexor strength, assessed by dynamometry at baseline and at 1, 3, 5, and 7 months. The study status is terminated, and only 1 subject accrued.
The record does not provide an analyzable primary result. It therefore does not establish whether the treatment arms differed in the timing or occurrence of the defined strength loss. Lack of a reported analysis is not equivalent to a finding of no difference, and it is not evidence of benefit. No effect size or precision estimate is available for the primary comparison.
The listed secondary outcomes likewise describe planned measurements rather than demonstrated changes. No comparative results are reported for other muscle strength, timed function, CT-assessed leg muscle mass, activities of daily living, serum testosterone, or the broader side-effect assessment. The limited adverse-event counts cannot determine comparative safety, particularly because the control arm has zero participants at risk in the registry's safety figures.
General statistical interpretation distinguishes an inconclusive or unavailable estimate from evidence supporting a particular conclusion. Here, the trial record does not resolve the clinical question. It also does not report why the study ended, the intended analysis population, methods for missing data, or the statistical analysis plan. Those limits prevent stronger conclusions about the conduct and interpretation of the trial.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the difference between a well-defined research question and an answer supported by analyzable data. The registry identifies a population, randomized treatment strategies, a comparator, and a primary endpoint. Those elements make the intended comparison understandable. Yet the record also states that only 1 subject accrued and that there were not enough data to analyze the primary outcome. A clear endpoint cannot compensate for an absence of usable outcome information.
Randomization is valuable because it can support fair comparisons when there is sufficient information and the analysis is appropriately conducted. It does not, by itself, guarantee that a trial will produce a precise or conclusive estimate. Sparse accrual can leave both the magnitude and direction of a treatment contrast unresolved. It also limits the ability to evaluate secondary outcomes and to characterize adverse events across treatment strategies.
The record is also a reminder to distinguish planned outcomes from results. A list of measurements and assessment times documents intended data collection, but it is not evidence that outcomes were measured successfully or analyzed. Likewise, planning illustrations are not observed trial findings and do not establish that a study had adequate information to answer its question.
For readers assessing clinical evidence, this record is most useful as an example of a trial whose design can be described while its primary comparative effect remains unknown. Understanding that distinction prevents a terminated, under-informative record from being misread as either positive evidence or evidence of no effect.
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 principal limitation is the very limited accrual: the registry reports that only 1 subject accrued and explicitly says there were not enough data to analyze the primary outcome. No primary effect estimate, confidence interval, event count, or hypothesis-test result is reported. The record therefore cannot support a comparative conclusion about the primary endpoint.
The registry does not report why the study was terminated. It also does not provide a statistical analysis plan, sample-size justification for the trial itself, randomization procedures, analysis population, missing-data methods, or rules for assigning time to events detected at scheduled visits. Interim analyses and changes to the planned methods are not reported. These details cannot be inferred from the randomized, triple-masked, parallel-group design description.
For safety, the control arm has zero participants at risk in the registry figures, and the one other adverse event in the treatment arm is not identified by term or clinical description. The record does not state the event's seriousness beyond its placement in the other-event category, its timing, or its assessed relationship to treatment. The adverse-event information is therefore too sparse and incomplete for a comparative safety assessment.
Although secondary outcomes are listed, the record does not report analyzable results for them. Planned measurements at multiple visits do not establish that measurements were completed or that they can be compared. The registry also does not explain how multiplicity or missing assessments would have been addressed. These limitations are specific to the available record and leave both efficacy and broader outcome interpretation unresolved.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Testosterone Gel in Preventing Weakness Caused by Steroid Therapy in Men With Glioma — NCT00631137.
- Registry record last updated 2018-08-27; status last verified 2018-08.
- Results first posted 2018-08-27.
- 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 registry describes a randomized, controlled, parallel-group trial with triple masking comparing testosterone gel applied to the skin with whey protein powder. The intended population was men receiving glucocorticoids for newly diagnosed high-grade glioma. The primary endpoint was time to at least 50% loss of hip-flexor strength, assessed by dynamometry at baseline and at 1, 3, 5, and 7 months.
The record lists enrollment of 1, status as terminated, and study dates of 2008-01 to 2008-09 for start and primary completion. It states that only 1 subject accrued and there were not enough data to analyze the primary outcome. No primary treatment-effect estimate is reported. The registry lists 0 analyses. Sparse adverse-event counts are reported, but they do not allow a comparative safety conclusion. The reason for termination and key analysis details are not reported in the registry record.