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 Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients (NCT00965341), a randomized phase 3 study. The primary outcome is Functional Assessment of Cancer Therapy-Fatigue Subscale (FACIT-F) at Day 29 (+/- 3 Days).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00965341 |
| Phase | Phase 3 |
| Condition | Advanced Cancer |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | Triple |
| Enrollment | 53 |
| Arms in the primary outcome | n/a |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
Males with advanced cancer and low testosterone levels were the population of interest. The record describes the study as concerning hypogonadic male patients with advanced cancer, but it does not report the criteria used to define low testosterone or hypogonadism, nor does it provide further eligibility details.
Intervention
The intervention was testosterone replacement: a starting dose of 150 or 200 mg testosterone enanthate/cypionate injected into the buttock muscle every 15 days through Day 72. The record does not report whether the starting dose was selected by a stated rule or how treatment was managed after the starting dose.
Comparator
The comparator was sesame seed oil placebo, with a starting dose of 150 mg or 200 mg injected into the buttock muscle about every 15 days through Day 72. The record identifies the placebo as an injection and reports triple masking, but does not describe who was masked or how masking was maintained.
Primary question
The main question was whether testosterone replacement affected fatigue, assessed with the Functional Assessment of Cancer Therapy-Fatigue subscale (FACIT-F) at Day 29 (+/- 3 days). The registry record describes the intended direction of improvement as a positive change from baseline, but does not report the group results or a treatment comparison. It therefore does not show the size or precision of any difference in fatigue.
3. Trial Design
The registry record identifies NCT00965341 as a completed study sponsored by M.D. Anderson Cancer Center. It lists the study as phase 3, randomized, and triple-masked, with enrollment of 53. The recorded start was 2009-09, and primary completion was 2012-09. The title describes the work as a preliminary trial, while the registry lists phase 3; those labels are both recorded, and the record does not explain their relationship.
Two treatment arms are described: testosterone and placebo. The testosterone arm used testosterone enanthate/cypionate by injection into the buttock muscle, with a starting dose of 150 or 200 mg every 15 days through Day 72. The placebo arm used sesame seed oil by the same route, with a starting dose of 150 mg or 200 mg about every 15 days through Day 72. The record does not state how the alternative starting doses were assigned, or provide further details about dose changes or adherence.
There is an internal design-label ambiguity. The record labels allocation as randomized and identifies two arms, but also labels the model as single-group. It does not explain this combination. The design should therefore be described using both recorded labels rather than resolving the discrepancy by assumption. Although triple masking is recorded, the masked roles and operational details are not reported in the registry record.
The primary endpoint was FACIT-F at Day 29 (+/- 3 days). The listed secondary outcomes were the Hospital Anxiety and Depression Scale (HADS) and symptoms scored by the Edmonton Symptom Assessment Scale (ESAS). The registry record includes no group outcome values or analysis results for these measures, so the results cannot be compared across the treatment arms from the information recorded.
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: Of the 53 participants enrolled only 43 subjects met eligibility criteria. Ten participants either did not meet criteria or withdrew consent prior to assignment to groups.
Overall Study
| Stage | Testosterone | Placebo |
|---|---|---|
| STARTED | 19 | 24 |
| COMPLETED | 13 | 16 |
| NOT COMPLETED | 6 | 8 |
Reasons for not completing this period:
| Reason | Testosterone | Placebo |
|---|---|---|
| Withdrew consent | 1 | 5 |
| Lost to Follow-up | 1 | 0 |
| Transportation issues | 4 | 3 |
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.
| Characteristic | Unit | Testosterone | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 19 | 24 | 43 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 12 | 11 | 23 |
| Age, Categorical: >=65 years | Participants | 7 | 13 | 20 |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 19 | 24 | 43 |
| Region of Enrollment: United States | participants | 19 | 24 | 43 |
6. Primary Endpoint
The registry lists the primary outcome as Functional Assessment of Cancer Therapy-Fatigue Subscale (FACIT-F) at Day 29 (+/- 3 Days), measured over Day 29 (+/- 3 days).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was the Functional Assessment of Cancer Therapy-Fatigue subscale (FACIT-F), measured at Day 29 (+/- 3 days). It is intended to capture fatigue and related symptoms as reported by participants. The record describes a 13-item fatigue subscore ranging from 0 to 52, with higher scores representing better, or less, fatigue. It also describes a broader FACIT-F instrument with 27 general quality-of-life questions across physical, social, emotional, and functional domains, and says that its total score ranges from 0 to 108. These are distinct score descriptions; the primary endpoint is identified as the fatigue subscale, not the broader total score.
A fatigue measure is relevant to the stated research question because the trial aimed to evaluate fatigue in males with advanced cancer and low testosterone levels. The registry record says a positive difference between Day 29 and baseline represents improvement, with a greater positive difference representing greater improvement. However, the primary endpoint title identifies the score at Day 29, while the description also explains the interpretation of a change from baseline. The record does not provide score values, change estimates, or a treatment contrast that would clarify how the endpoint was analyzed.
The registry record specifies a mean as the summary measure and standard deviation as the dispersion measure. It does not report the mean or standard deviation for either arm. Without those results, the direction, size, and precision of any difference in fatigue cannot be assessed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central limitation for interpreting this trial is that the registry record does not report the primary-outcome results. It identifies FACIT-F at Day 29 (+/- 3 days) as the primary endpoint and describes how higher fatigue-subscale scores should be interpreted, but supplies no arm-specific means, standard deviations, change estimates, or comparison. The record also lists zero analyses. Consequently, there is no reported treatment-effect estimate to interpret, and no reported uncertainty measure with which to judge its precision.
The study is described as randomized and placebo-controlled, which identifies the intended basis for a comparison between testosterone and placebo. Yet the record’s single-group model label conflicts with the presence of randomized allocation and two named arms. The record does not resolve that discrepancy. It is therefore safest to report the labels as recorded and avoid inferring details about the design beyond the stated arms, masking, and treatment schedules.
The outcome description gives useful context for what a score would mean: higher FACIT-F fatigue-subscale scores represent better, or less, fatigue, and a positive change from baseline represents improvement. These definitions do not establish that either group improved, or that one group differed from the other. No direction or magnitude of effect can be inferred from the endpoint definition alone.
The registry lists HADS and ESAS as secondary outcomes, but does not report their results. It also does not report confidence intervals, p-values, or an analysis plan. Without results and their uncertainty, it is not possible to distinguish a precise estimate from an imprecise one, or to determine whether an observed difference would be compatible with a range of effects.
Safety information is recorded separately. Serious adverse events were recorded for 1 of 19 participants at risk in the testosterone group and 0 of 24 at risk in the placebo group. Other adverse events were recorded for 13 of 19 and 9 of 24, respectively. The registry also lists Death with a percentage of 5.3% among the serious-event terms, but does not report deaths by group. These are descriptive counts, not an efficacy result or an adjusted safety comparison. The record does not provide enough context to infer causation or to reconcile the term listing with group-specific death counts.
Overall, the posted information supports a description of the trial question, design labels, endpoint, and recorded adverse-event counts. It does not support a conclusion about the effect of testosterone on fatigue or a comparative safety judgment. Missing outcome analyses are not evidence that the treatments were equivalent or that the study found no effect; the results are simply not reported in the registry record.
9. Statistical Methods Explained
The registry record gives some descriptive details about the intended endpoint but does not report the statistical methods used to analyze the primary or secondary outcomes. It identifies the primary summary as a mean and the dispersion measure as a standard deviation, while listing zero analyses. The following explains these statistical concepts generally; it does not imply that any particular unreported method was used in this trial.
What does a mean and standard deviation describe?
For a continuous outcome such as a questionnaire score, the mean describes the average score in a group. The standard deviation describes how spread out individual scores are around that group average. They answer different questions: the mean gives a summary of the group’s level, while the standard deviation describes variation among participants. Neither alone establishes whether groups differ reliably. The registry specifies these summary measures but does not report their values for FACIT-F.
Why does the score definition matter?
Interpreting an outcome requires knowing what higher and lower scores mean. The record says higher FACIT-F fatigue-subscale scores represent better, or less, fatigue. It also says that a positive difference between Day 29 and baseline represents improvement. This direction matters when reading any estimate: a positive change would have a favorable score interpretation under the stated definition. But a score definition is not a result. No observed score or change is reported, so it cannot establish whether participants’ fatigue changed or whether the arms differed.
The endpoint is described as FACIT-F at Day 29 (+/- 3 days), and the description also explains change from baseline. A statistical analysis might summarize the Day 29 score, the change from baseline, or use another approach, but the registry record does not report which analysis was performed. It would be inappropriate to assume a particular baseline adjustment, model, or estimand.
What would an uncertainty interval add?
In general, a confidence interval expresses the uncertainty around an estimated effect under the assumptions of the analysis. Its width is informative about precision: a narrower interval indicates a more precise estimate than a wider interval, all else being equal. Interpreting the interval also depends on its location relative to values that would matter scientifically or clinically, and on the method used to construct it. No confidence interval for the primary endpoint is reported in the registry record. A p-value is also not reported; even if one were available, it would not by itself describe the size or precision of an effect.
Why does the design information matter?
Random allocation can support a comparison between assigned groups by limiting systematic differences at assignment, subject to how the trial was conducted and analyzed. The registry identifies allocation as randomized and names testosterone and placebo arms. It also identifies triple masking, but does not specify who was masked. In contrast, its model label says single-group. The record does not resolve this inconsistency or describe the allocation process, concealment, adherence, or treatment received. These details are relevant when assessing how well a reported comparison would represent the assigned treatment contrast, but they cannot be reconstructed from the labels alone.
The arm descriptions specify starting doses and a treatment schedule through Day 72. The primary endpoint is assessed at Day 29 (+/- 3 days), so the record places the primary measurement within the stated treatment period. It does not report whether the primary measurement was collected for all participants, whether treatment exposure differed, or how deviations were handled. No conclusion about implementation should be drawn from the schedule alone.
What does over-dispersion mean in general?
Over-dispersion is a general issue for outcomes whose variability is greater than a statistical model expects. If the model understates variability, standard errors can be too small and uncertainty can appear overstated in precision. Appropriate modeling depends on the outcome distribution and analysis plan. The primary FACIT-F measure is identified as continuous, with mean and standard deviation summaries; the record does not report a model or any assessment of over-dispersion. This concept therefore explains a general modeling concern, not a reported feature of this trial.
How should planning illustrations be read?
Planning sample sizes are not observed trial results and are not observed power. The record’s stated planning assumptions describe an illustration based on a fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. For non-time-to-event outcomes, such an illustration is expressed as participants per arm for 80% power or another stated power level. The record does not report the observed primary effect or the calculations needed to evaluate a specific illustration. Any planning value should therefore be read as conditional on its assumptions, not as evidence about what the trial demonstrated or as the trial’s own design justification.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists FACIT-F as the primary endpoint and identifies HADS and ESAS as secondary outcomes. It does not report a multiplicity strategy, such as whether the primary endpoint was tested separately from secondary outcomes, whether adjustment was planned, or how multiple analyses would affect interpretation. Multiplicity is a general statistical concern when several outcomes or comparisons are examined: the more opportunities there are to identify an apparently unusual result, the more important it is to understand which analyses were prespecified and how results were interpreted. No such plan is reported.
The record also indicates that the primary outcome has several categories or time points and was not reduced to one comparison. It does not explain which categories or time points are involved beyond the named Day 29 assessment, or how that description relates to the primary endpoint summary. Since no analysis results are reported, there is no basis for determining which endpoint comparisons were made or whether their interpretation accounts for multiplicity.
Missing-data handling is not reported in the registry record. The record does not state how missing questionnaire scores, missed visits, withdrawal, or incomplete treatment were handled. It also does not identify analysis populations, such as whether participants were analyzed according to assignment or according to treatment received. These choices can affect the estimate and its interpretation, especially when outcome availability or treatment adherence differs between groups.
The registry reports enrollment of 53, but does not provide an outcome analysis population or arm-specific primary-outcome denominators. The safety counts have their own at-risk numbers, which should not be treated as denominators for the fatigue endpoint. Without outcome-specific denominators and missing-data methods, completeness of the primary endpoint cannot be assessed. These omissions limit interpretation, but they do not show that data were missing or that any particular handling method was used.
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 |
|---|---|---|---|
| Testosterone | 1 | 19 | 5.3% |
| Placebo | 0 | 24 | 0.0% |
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 |
|---|---|
| Testosterone | 13 of 19 |
| Placebo | 9 of 24 |
Most frequent serious adverse event terms
| Event term | Organ system | Testosterone | Placebo |
|---|---|---|---|
| Death | General disorders | 1 of 19 | 0 of 24 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Testosterone | Placebo |
|---|---|---|---|
| Fatigue | General disorders | 2 of 19 | 3 of 24 |
| Anorexia | General disorders | 2 of 19 | 2 of 24 |
| Pain (NOS) | General disorders | 2 of 19 | 1 of 24 |
| Dyspnea | General disorders | 0 of 19 | 3 of 24 |
| Neuropathy: Sensory | General disorders | 2 of 19 | 0 of 24 |
| Hemoglobin | General disorders | 1 of 19 | 0 of 24 |
| Infection (Other) | General disorders | 1 of 19 | 0 of 24 |
| Neuropathy: Cranial | General disorders | 1 of 19 | 0 of 24 |
| Pain (Other) | General disorders | 1 of 19 | 0 of 24 |
| Pain (Skin) | General disorders | 1 of 19 | 0 of 24 |
Serious events with the highest arm-level rate: death (5.3%).
The safety record distinguishes serious adverse events from other adverse events. In the testosterone group, the record lists 1 affected participant among 19 at risk for serious adverse events and 13 among 19 for other adverse events. In the placebo group, it lists 0 among 24 for serious adverse events and 9 among 24 for other adverse events. These are descriptive counts from the registry; they do not establish that an event was caused by treatment, and they are not adjusted comparisons.
The serious-event terms include Death, listed with a percentage of 5.3%. The record does not give group-specific death counts, explain the percentage’s denominator, or clarify how this term relates to the group counts. The death information should therefore be reported as recorded, without inferring which arm or participants it concerns. Death counts in the group fields are not reported.
The record does not provide event definitions, severity grades beyond the serious/non-serious distinction, timing, duration, exposure-adjusted rates, or a detailed account of how adverse events were collected. It also does not report whether the counts represent participants with at least one event or total event episodes. The at-risk counts are safety-specific and should not be substituted for the number assessed for fatigue. The available figures describe recorded safety counts, but do not by themselves support a causal or comparative safety conclusion.
12. What the Result Does, and Does Not, Mean
The registry record describes a trial asking whether testosterone replacement affects fatigue among males with advanced cancer and low testosterone levels. It identifies a randomized, triple-masked study with testosterone and placebo arms, and specifies FACIT-F at Day 29 (+/- 3 days) as the primary endpoint. It also supplies score interpretation and safety counts. These details explain the intended research question and some of the information collected.
What the record does not provide is the central efficacy result: it reports no FACIT-F arm summaries, change estimates, treatment contrast, confidence interval, or p-value. Therefore, it cannot show whether fatigue scores differed between the groups, the direction or size of any difference, or how precisely an effect was estimated. The same absence applies to the listed HADS and ESAS secondary outcomes. No result should be inferred from the trial title, endpoint definition, completion status, or the fact that a study was conducted.
The safety entries are also limited. They record affected counts for serious and other adverse events and list Death with a percentage among serious-event terms. Those entries do not establish that treatment caused an event, and the group-specific death counts are not reported. The design and analysis information also has gaps: the randomized allocation label sits alongside a single-group model label, and the record does not report masking roles, missing-data procedures, analysis populations, or a statistical plan.
These limitations do not mean that testosterone had no effect, that it was equivalent to placebo, or that no adverse events occurred beyond those listed. They mean that the registry record does not contain enough reported results to estimate the fatigue effect or make a comparative safety assessment. Any planning sample-size illustration should be understood as conditional on its stated assumptions, not as evidence of observed power or as a substitute for outcome results.
13. Why This Trial Matters Statistically
This trial is statistically interesting because its clinical question concerns a patient-reported fatigue outcome in a population described as having advanced cancer and low testosterone levels. The record specifies FACIT-F as the primary measure and explains the direction of its scores. That makes clear what an eventual estimate would need to represent: a difference in fatigue-related scores, interpreted in light of the scale’s definition and the time of assessment.
The trial also highlights why design labels and analysis reporting matter. It is recorded as randomized and triple-masked, with testosterone and placebo arms, but its model is labeled single-group. Without an explanation, readers cannot confidently resolve that inconsistency. Similarly, a stated primary endpoint does not by itself reveal whether the analysis used the Day 29 score or change from baseline, how missing assessments were handled, or which analysis population was used. Those details are part of the basis for evaluating an effect estimate.
There is an important distinction between having an endpoint and reporting its result. The registry gives a detailed outcome description but no primary-outcome analysis. In statistical education, this is a useful example of why interpretation requires both the outcome’s meaning and the observed estimate with its uncertainty. A score range and favorable direction do not tell readers whether groups differed or how precisely any difference was measured.
The recorded safety counts likewise illustrate the limits of descriptive data. Counts can describe what the registry lists, but without context about event definitions, timing, exposure, and attribution, they cannot establish a treatment-caused risk. The missing group-specific death counts further constrain interpretation of the serious-event term listing. Overall, the record supports careful description of the trial’s question and reporting gaps, not a conclusion about comparative efficacy or safety.
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 main trial-specific limitation is the absence of reported primary-outcome results. Although FACIT-F at Day 29 (+/- 3 days) is identified as the primary endpoint and its score direction is described, no group means, standard deviations, changes, or treatment comparisons are reported. The record lists zero analyses. As a result, the central question about fatigue cannot be answered from the registry record.
The endpoint description refers both to a Day 29 score and to a difference between Day 29 and baseline as the measure of improvement. The record does not state which quantity was used in the analysis. It does not report baseline scores, endpoint-specific denominators, confidence intervals, p-values, or a statistical model. It also does not describe missing-data handling, analysis populations, or how the listed secondary outcomes were accounted for in the analysis.
The design labels are not fully aligned: allocation is recorded as randomized, two arms are described, and the model is labeled single-group. The record does not explain this combination. It also does not identify the roles covered by triple masking or describe implementation of randomization and masking. The trial is listed as phase 3, while its title describes it as preliminary; no explanation of these labels is reported.
Safety reporting is limited to affected and at-risk counts and a serious-event term listing. Event definitions, timing, severity details, attribution, and the basis for the Death percentage are not reported. Group-specific death counts are not reported. These limitations do not imply that particular methods were absent or that unlisted events did not occur; they identify information that is not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients — NCT00965341.
- Registry record last updated 2016-09-13; status last verified 2016-07.
- Results first posted 2016-09-13.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT00965341 is recorded as a completed, randomized, triple-masked phase 3 study sponsored by M.D. Anderson Cancer Center, with enrollment of 53. It concerns testosterone replacement for fatigue in males with advanced cancer and low testosterone levels. The listed arms are testosterone and sesame seed oil placebo, administered by buttock-muscle injection through Day 72.
The primary endpoint is FACIT-F at Day 29 (+/- 3 days), with HADS and ESAS listed as secondary outcomes. The record describes the score interpretation and specifies a mean and standard deviation as summary measures, but reports no outcome analyses or primary-result estimates. It also labels the model single-group, despite recording randomized allocation and two arms, without explaining the inconsistency.
Safety counts are recorded for serious and other adverse events, and Death is listed among serious-event terms with a percentage of 5.3%. Group-specific death counts and further event context are not reported. Overall, the registry record documents the trial question and selected design and safety details, but does not report the results needed to assess the primary fatigue comparison.