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 ITT4 Intratesticular Hormonal Milieu in Man (ITT4) (NCT01215292), a randomized phase 1, phase 2 study. The primary outcome is Intratesticular Testosterone (IT-T) Level.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01215292 |
| Phase | Phase 1, Phase 2 |
| Condition | Healthy Males |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 46 |
| Arms in the primary outcome | 5 |
| Lead sponsor | University of Washington |
| Results posted | Yes |
2. Clinical Question
Population
Healthy males. The registry lists an enrollment of 46 and reports a 10-day primary endpoint. The number of participants contributing to the primary endpoint is listed as 8 in each of the five groups; how these endpoint counts relate to the enrollment figure is not reported in the registry record.
Intervention
All five groups received acyline and testosterone gel. The additional oral treatment was placebo ketoconazole, ketoconazole 400mg, ketoconazole 800mg, dutasteride 2.5mg, or anastrazole 1mg, depending on the group. The registry describes these treatments as part of a study of the intratesticular hormonal milieu.
Comparator
The placebo ketoconazole group is the reference group in the posted primary outcome results. The other groups received ketoconazole at either listed dose, dutasteride, or anastrazole alongside acyline and testosterone gel. The reported primary analysis considers all five groups together rather than presenting separate pairwise comparisons.
Primary question
What intratesticular testosterone levels were observed after the different treatment combinations, and did the overall distribution differ among the groups? The registry's stated aims also concern intratesticular dihydrotestosterone and estradiol, but the posted primary endpoint is intratesticular testosterone. Results for the other aims are not reported in the registry record.
3. Trial Design
This was a randomized, single-masked, parallel-group phase 1/phase 2 study listed as completed. The registry identifies healthy males as the study population and lists enrollment of 46. The study's stated purpose was to examine the hormonal environment inside the testis, including the amount of testosterone needed to maintain sperm production, as background for research into male hormonal contraception. That purpose describes the research rationale; the posted primary result concerns intratesticular testosterone levels.
Five treatment groups are represented in the primary outcome. Each included acyline and testosterone gel, with placebo ketoconazole, ketoconazole 400mg, ketoconazole 800mg, dutasteride 2.5mg, or anastrazole 1mg as the additional treatment. The registry describes acyline as 300 mcg/kg on Day 1 and testosterone gel as 5 gm daily over the listed treatment days. The oral treatment schedules are listed as beginning on Days 3-10. The ketoconazole placebo group is described as taking a daily placebo tablet over Days 3-10. These descriptions are registry entries and do not establish adherence or actual exposure for individual participants.
The primary endpoint was measured at 10 days. The registry reports a median and inter-quartile range for each group, with 8 participants listed for each group. It does not report the randomization procedure, allocation concealment, who was masked, the sample-size justification, or the intended analysis population. Although enrollment is listed as 46, the relationship between that figure and the reported endpoint group counts is not explained in the registry record. Further details on participant flow, withdrawals, and treatment completion 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: Fifty-two men were screened for the study and 46 met all inclusion criteria. Six subjects withdrew from the study prior to any procedures and 40 were randomized (n=8/group. Exclusion criteria included liver disease or adrenal insufficiency, Body Mass Index \> 32, abnormal test results, skin conditions for gel, alcohol/drug abuse etc.
Overall Study
| Stage | Acyline & T Gel & Ketoconazole 400 | Acyline & T Gel & Dutasteride | Acyline & T Gel & Placebo Ketoconazole | Acyline & T Gel & Ketoconazole 800 | Group 5: Anastrazole |
|---|---|---|---|---|---|
| STARTED | 8 | 8 | 8 | 8 | 8 |
| COMPLETED | 8 | 8 | 8 | 8 | 8 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 |
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: Fifty two men were screened for the study and 46 met all inclusion criteria. Six subject withdrew from the study prior to any procedures and 40 were randomized to treatment 8/group.
| Characteristic | Unit | Acyline & T Gel & Ketoconazole 400 | Acyline & T Gel & Dutasteride | Acyline & T Gel & Placebo Ketoconazole | Acyline & T Gel & Ketoconazole 800 | Group 5: Anastrazole | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 8 | 8 | 8 | 8 | 8 | 40 | |
| Age, Continuous | years | 22.5 (20 to 26) | 21.5 (20 to 24) | 24 (21 to 35.5) | 22 (20.5 to 25.5) | 21.5 (20.5 to 24.5) | 22 (20 to 26) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 8 | 8 | 8 | 8 | 8 | 40 |
| Region of Enrollment: United States | participants | 8 | 8 | 8 | 8 | 8 | 40 |
| Serum FSH | IU/L | 2.3 (1.5 to 3.5) | 2.7 (1.8 to 3.0) | 2.7 (2.3 to 2.9) | 2.4 (1.7 to 2.8) | 2.3 (1.4 to 3.0) | 2.6 (1.7 to 3.0) |
| Serum Testosterone | ng/mL | 5.5 (5.2 to 6.2) | 5.4 (4.4 to 6.4) | 5.2 (4.6 to 6.3) | 5.3 (4.7 to 6.3) | 5.2 (4.2 to 5.8) | 5.3 (4.8 to 6.2) |
| Serum DHT | ng/mL | 0.44 (0.35 to 0.54) | 0.5 (0.43 to 0.89) | 0.5 (0.37 to 0.59) | 0.44 (0.35 to 0.53) | 0.42 (0.3 to 0.5) | 0.46 (0.36 to 0.56) |
| Serum E2 | pg/mL | 39 (16.5 to 65.8) | 24 (20.9 to 30) | 28.3 (21.3 to 39.6) | 39 (23.4 to 69.4) | 39.4 (21.1 to 51.2) | 28.3 (20.9 to 53.9) |
| Serum ADD | ng/mL | 0.7 (0.57 to 1.1) | 0.75 (0.5 to 1.1) | 0.76 (0.52 to 1.12) | 0.69 (0.59 to 0.76) | 0.65 (0.6 to 0.81) | 0.67 (0.57 to 0.95) |
| Serum DHEA | ng/mL | 3.9 (2.7 to 7.1) | 3.9 (3.2 to 6.6) | 4.2 (3.3 to 6.5) | 4.6 (2.8 to 5.9) | 3.8 (2.8 to 4.4) | 3.9 (2.9 to 6.1) |
| Serum 17-OHP | ng/mL | 6 (4.2 to 7.9) | 6.1 (5.1 to 9.1) | 7.2 (5.9 to 9.5) | 4.8 (4.2 to 6.7) | 6 (4.6 to 9) | 6.1 (4.7 to 8.1) |
| Serum LH | IU/L | 5 (3.1 to 6.6) | 4.7 (4.2 to 5.4) | 4.3 (3.3 to 5.2) | 5.8 (4.7 to 7.4) | 4.9 (4.2 to 6.6) | 4.8 (3.9 to 6.4) |
6. Primary Endpoint
The registry lists the primary outcome as Intratesticular Testosterone (IT-T) Level, measured over 10 days.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | ng/mL |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is intratesticular testosterone (IT-T) level, measured in ng/mL at 10 days. It represents testosterone measured within the testicular environment, rather than a general measure of circulating testosterone. The registry records the result as a median and inter-quartile range for each treatment group. The reported intervals are the group inter-quartile ranges, not confidence intervals for the medians or for differences between groups.
The endpoint fits the study's stated interest in how treatment combinations affect the hormonal milieu within the testis. A measure in that compartment can address a different biological question from a blood hormone measurement. In general, a median describes the middle of an observed distribution, while the inter-quartile range describes the central spread of the observations. These summaries can be useful when the data are skewed or when a few extreme values could make a mean less representative. That is a general statistical rationale; the registry does not report why this summary was selected for this study.
The posted primary outcome gives a group-level summary at the stated time point. It does not report individual measurements, a baseline value, change from baseline, or a confidence interval for any treatment contrast. The registry's other stated aims concern intratesticular dihydrotestosterone and intratesticular estradiol, but their results are not reported in the registry record. The primary endpoint alone therefore addresses only the reported IT-T outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The placebo ketoconazole group had a reported IT-T median of 14.0 ng/mL, with an inter-quartile range of 8.0 to 21.2. The ketoconazole 400mg group had a median of 3.7 ng/mL, with an inter-quartile range of 2.6 to 7.2. The ketoconazole 800mg group had a median of 1.7 ng/mL, with an inter-quartile range of 0.9 to 4.0. The dutasteride 2.5mg group had a median of 18.4 ng/mL, with an inter-quartile range of 15.3 to 24.8. The anastrazole 1mg group had a median of 24.0 ng/mL, with an inter-quartile range of 17.7 to 42.0. Each group has 8 participants listed for this outcome.
The registry reports a Kruskal-Wallis analysis across the five groups with p <0.05. This is evidence, under the assumptions of that test, against the null hypothesis that the groups have the same distribution. It is an overall test: it does not identify which groups differ from one another, nor does it quantify the size or precision of any particular pairwise difference. The registry does not report pairwise estimates or confidence intervals. The reported p-value is not a measure of the probability that the null hypothesis is true, and it does not describe the clinical or biological importance of the observed pattern.
The medians are descriptively lower in the two ketoconazole groups than in the placebo ketoconazole group, while the dutasteride and anastrazole group medians are higher than the placebo-group median. These are descriptions of the posted group summaries, not estimates from adjusted comparisons. The inter-quartile ranges also show the spread of observations within each group. They should not be interpreted as uncertainty intervals around the medians, and overlap or non-overlap between them does not replace a formal contrast analysis.
The registry labels the reported analysis as non-inferiority or equivalence, but it does not give a non-inferiority margin, an equivalence margin, a contrast estimate, or a confidence interval. The posted Kruskal-Wallis result therefore does not, by itself, demonstrate non-inferiority or equivalence. Nor does the p-value establish that a particular treatment combination caused the observed group pattern. The randomized design is relevant to comparisons, but the registry does not provide enough detail about allocation, analysis population, missing data, or pairwise analyses to assess those issues fully.
Overall, the posted outcome describes different observed IT-T distributions across the five treatment groups and reports an overall statistical test with p <0.05. It does not establish the magnitude or precision of specific treatment contrasts, resolve the study's other stated hormonal aims, or show what happened beyond the 10-day endpoint.
9. Statistical Methods Explained
What does the Kruskal-Wallis test assess?
The registry reports a Kruskal-Wallis test across all five treatment groups. In general, this is a rank-based method for comparing the distributions of a continuous outcome among multiple independent groups. It uses the ordering of observations rather than relying on the raw values being normally distributed. The test provides an overall assessment: it asks whether the group distributions are compatible with a common distribution, rather than estimating each pairwise contrast separately.
The registry reports p <0.05. In general, a p-value measures how unusual data at least as inconsistent with the null hypothesis would be if that hypothesis and the test assumptions were correct. It is not the probability that the null is true, and it does not give the size of a difference. Because this is an overall test, the result does not establish which groups account for the evidence against a common distribution. A follow-up analysis with defined contrasts would be needed to estimate and assess specific group comparisons; such results are not reported in the registry record.
How should the medians and inter-quartile ranges be read?
The primary outcome is reported as a median with an inter-quartile range. In general, the median is the central ordered observation or midpoint of the data, while the inter-quartile range spans the central half of the observed values. These summaries describe the distribution within each group. They do not directly provide the uncertainty around a treatment effect. A confidence interval for a group contrast would answer a different question by describing the precision of an estimated difference or other comparison.
The registry reports the group medians and the lower and upper values of their inter-quartile ranges, but no confidence interval for a median or contrast. It also does not report the individual observations or a distribution plot's underlying values in the registry record. Consequently, the listed summaries do not allow reconstruction of the full data distribution or a separate estimate of pairwise precision.
What is the significance of the overall result?
As a general principle, statistical significance and effect size are different. A p-value can provide evidence against a specified null model, but the magnitude and practical meaning of a result depend on the estimated effect and its uncertainty, as well as the scientific context. Here, the posted analysis gives an overall p-value but no pairwise effect estimates, confidence intervals, or stated threshold for a meaningful difference. The group medians convey a descriptive pattern, but they are not a substitute for those missing estimates.
The registry marks the analysis type as non-inferiority or equivalence. In general, such conclusions require a prespecified margin defining how large a difference can be while still meeting the relevant criterion, together with an appropriate estimate and uncertainty interval. The margin, the specific contrasts, and the required interval-based result are not reported in the registry record. A Kruskal-Wallis p-value alone does not establish either non-inferiority or equivalence.
What can be inferred from the sample counts?
The registry lists 8 participants for each treatment group for the primary outcome. These are the outcome group counts, not a statement about the total number randomized, enrolled, or completing treatment. The record lists enrollment of 46, but does not explain how that number relates to the outcome counts. Participant flow, exclusions, and missing outcome data are not reported in the registry record. The counts therefore describe the posted endpoint summaries but do not clarify how participants moved through the study.
In general, results from small groups can be sensitive to the values of individual observations, and estimates can be imprecise. This is a general consideration, not a measured precision assessment for these results. The registry does not give confidence intervals for the group medians or treatment contrasts, so the degree of precision cannot be quantified from the reported analysis.
Why does analysis choice matter?
Rank-based tests can be useful when a continuous outcome's distribution does not meet assumptions used by common mean-based methods. In general, the Kruskal-Wallis test evaluates ranked distributions; it should not automatically be interpreted as a test of medians alone unless additional assumptions about the group distributions are appropriate. The registry does not report diagnostic checks, distributional assumptions, or the rationale for selecting this method. It also does not report an adjusted analysis or a model accounting for other variables.
The registry lists three outcome measures and three analyses, while only the primary IT-T outcome and its analysis details are described in the posted results. It does not report how the testing of multiple outcomes or comparisons was handled. In general, when several hypotheses are tested, the chance of at least one false positive can increase unless the analysis plan addresses multiplicity. The impact of that issue cannot be determined from this record. No interim analyses, sample-size justification, or detailed statistical analysis plan are reported in the registry record.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Kruskal-Wallis | not reported | < 0.050 |
The registry reports the sponsor's analysis as a Kruskal-Wallis test across the five treatment groups, with p <0.05. That is an overall test of the group distributions. It is the principal inferential result reported for the primary IT-T outcome; the group medians and inter-quartile ranges provide descriptive context but do not replace it.
No recalculated pairwise contrast or confidence interval is reported for this endpoint. The registry entry also labels the analysis as non-inferiority or equivalence, but does not report the margin, a contrast estimate, or a confidence interval needed to evaluate such a claim. The overall Kruskal-Wallis result should therefore not be recast as evidence for a specific pairwise non-inferiority or equivalence conclusion.
The posted data do not identify a discrepancy between a sponsor analysis and a recalculation. The sponsor's reported overall analysis remains the available inferential result. Its scope is limited: it indicates an overall difference in distributions under the test, but does not state which groups differ, how large any specific difference is, or how precisely it is estimated.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures and three analyses, but the posted primary result is intratesticular testosterone. The study summary also states aims concerning intratesticular dihydrotestosterone and intratesticular estradiol. Results for those aims are not reported in the registry record. The record does not explain whether all listed outcomes were analyzed, how the primary outcome was distinguished from other outcomes for inference, or whether the testing plan changed.
Multiplicity is a general concern when several outcomes, treatment contrasts, or analyses are considered. Testing more than one hypothesis can increase the chance of finding at least one statistically significant result by chance. Statistical plans may address this through prespecification, adjusted significance thresholds, hierarchical testing, or other approaches. Which approach, if any, was used is not reported in the registry record. The p-value for the overall five-group test should therefore be read as the reported result for that test, without assuming an adjustment or an absence of other testing.
The record provides an enrollment figure and endpoint group counts, but does not report participant flow or explain the relationship between them. The numbers of participants screened, randomized, treated, withdrawn, or included in an intention-to-treat or per-protocol analysis are not reported in the registry record. The analysis population is not specified. Reasons for missing data, the amount of missing outcome data, and any imputation or sensitivity analyses are also not reported in the registry record.
These omissions matter because analysis populations and missing-data handling can affect what an estimate represents. In general, analyzing only participants with observed outcomes may yield a different result from analyzing all randomized participants, particularly if missingness is related to treatment or outcome. The record does not provide the information needed to assess whether that issue arose. A sample-size justification, interim-analysis plan, and detailed statistical analysis plan are not reported in the registry record, so the planned handling of these questions cannot be established from the posted information.
12. 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 |
|---|---|---|---|
| Acyline & T Gel & Ketoconazole 400 | 1 | 8 | 12.5% |
| Acyline & T Gel & Dutasteride | 0 | 8 | 0.0% |
| Acyline & T Gel & Placebo Ketoconazole | 0 | 8 | 0.0% |
| Acyline & T Gel & Ketoconazole 800 | 0 | 8 | 0.0% |
| Group 5: Anastrazole | 0 | 8 | 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 |
|---|---|
| Acyline & T Gel & Ketoconazole 400 | 3 of 8 |
| Acyline & T Gel & Dutasteride | 2 of 8 |
| Acyline & T Gel & Placebo Ketoconazole | 5 of 8 |
| Acyline & T Gel & Ketoconazole 800 | 6 of 8 |
| Group 5: Anastrazole | 5 of 8 |
Most frequent serious adverse event terms
| Event term | Organ system | Acyline & T Gel & Ketoconazole 400 | Acyline & T Gel & Dutasteride | Acyline & T Gel & Placebo Ketoconazole | Acyline & T Gel & Ketoconazole 800 | Group 5: Anastrazole |
|---|---|---|---|---|---|---|
| Testicular hematoma and hematocele | Endocrine disorders | 1 of 8 | 0 of 8 | 0 of 8 | 0 of 8 | 0 of 8 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Acyline & T Gel & Ketoconazole 400 | Acyline & T Gel & Dutasteride | Acyline & T Gel & Placebo Ketoconazole | Acyline & T Gel & Ketoconazole 800 | Group 5: Anastrazole |
|---|---|---|---|---|---|---|
| Headache | General disorders | 0 of 8 | 0 of 8 | 0 of 8 | 3 of 8 | 2 of 8 |
| Seasonal allergies | Respiratory, thoracic and mediastinal disorders | 1 of 8 | 0 of 8 | 2 of 8 | 1 of 8 | 0 of 8 |
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | 1 of 8 | 0 of 8 | 1 of 8 | 0 of 8 | 1 of 8 |
| Pain at spermatic cord/at scrotum | Endocrine disorders | 0 of 8 | 1 of 8 | 1 of 8 | 0 of 8 | 0 of 8 |
| abdomenal ecchymosis | Surgical and medical procedures | 0 of 8 | 0 of 8 | 0 of 8 | 1 of 8 | 0 of 8 |
| Change in mood/irritability | Psychiatric disorders | 0 of 8 | 1 of 8 | 0 of 8 | 0 of 8 | 0 of 8 |
| Decreased libido | Endocrine disorders | 0 of 8 | 0 of 8 | 0 of 8 | 0 of 8 | 1 of 8 |
| Finger laceration | Musculoskeletal and connective tissue disorders | 0 of 8 | 0 of 8 | 0 of 8 | 0 of 8 | 1 of 8 |
| platar fascitis | Immune system disorders | 0 of 8 | 0 of 8 | 1 of 8 | 0 of 8 | 0 of 8 |
| Prostatitis | Endocrine disorders | 1 of 8 | 0 of 8 | 0 of 8 | 0 of 8 | 0 of 8 |
Serious events with the highest arm-level rate: testicular hematoma and hematocele (12.5%).
The adverse-event record lists serious adverse events and other adverse events separately for the treatment groups. For serious adverse events, the recorded affected-participant counts are 1 in the ketoconazole 400 group and 0 in each of the dutasteride, placebo ketoconazole, ketoconazole 800, and anastrazole groups. Each group lists 8 participants at risk. The record identifies “Testicular hematoma and hematocele” as a top serious adverse-event term, with 12.5% reported. It does not assign that term to a particular treatment group in the information reported.
For other adverse events, the affected-participant counts are 3 in the ketoconazole 400 group, 2 in the dutasteride group, 5 in the placebo ketoconazole group, 6 in the ketoconazole 800 group, and 5 in the anastrazole group. Each group lists 8 participants at risk. These are registry counts of affected participants, not a comparison adjusted for exposure, timing, or other factors. The record does not provide event-level descriptions for these other adverse events in the information reported.
Death counts are not reported in the registry record. The counts should be read descriptively: they do not establish that a treatment caused or prevented an event, and they do not provide a precise estimate of comparative safety. The registry record does not report a formal statistical comparison of adverse events.
13. What the Result Does, and Does Not, Mean
The posted primary outcome shows that the five groups had different observed distributions of intratesticular testosterone at 10 days, with a reported overall Kruskal-Wallis p-value of <0.05. Their reported medians range from 1.7 ng/mL in the ketoconazole 800mg group to 24.0 ng/mL in the anastrazole 1mg group. The inter-quartile ranges describe the spread of observations within each group. The result is a comparison of this endpoint in the listed treatment groups; it is not a complete account of the study's hormonal aims.
The result does not establish which individual groups differ statistically from one another. No pairwise estimates or confidence intervals are reported. It also does not quantify the precision of the medians, demonstrate a non-inferiority or equivalence conclusion, or show that the observed pattern is clinically important. Although the analysis is labeled non-inferiority or equivalence, the relevant margin and contrast results are not reported in the registry record.
The result is limited to intratesticular testosterone at the stated 10-day time point. It does not provide posted results for intratesticular dihydrotestosterone or estradiol, despite the study summary's stated aims concerning those hormones. Nor does it report sperm-production outcomes in the results presented for the primary endpoint. The research rationale mentions sperm production and possible relevance to male hormonal contraception; that rationale should not be confused with evidence on contraceptive effectiveness or safety.
The trial is listed as randomized, but details needed to judge allocation, masking, missing data, analysis population, and participant flow are not reported in the registry record. The endpoint group counts are small, and uncertainty estimates for comparisons are absent. The findings therefore describe the posted group summaries and overall test, while leaving important questions about comparison-specific precision and generalizability unanswered.
14. Why This Trial Matters Statistically
This trial illustrates how a multi-group study can present several treatment combinations while reporting only an overall statistical test for its primary endpoint. The Kruskal-Wallis result provides an omnibus assessment across five groups, and the medians and inter-quartile ranges show the observed group summaries. These answer related but different questions: the test addresses evidence against a common distribution, while the summaries describe the outcomes within each group. Neither provides a precise estimate for a specific treatment contrast.
It also illustrates why the label attached to an analysis cannot replace the information needed to interpret it. The registry labels the analysis non-inferiority or equivalence, but does not report a margin, a contrast, or a confidence interval. Those details are central to interpreting whether a result supports either type of claim. An overall p-value below the registry's threshold does not supply them.
The study's scientific aims span several intratesticular hormones, but the posted primary result is IT-T. Separating the stated aims from the outcomes with available results helps prevent a reported endpoint from being treated as if it answered every biological question. The record also highlights the importance of reporting analysis populations, participant flow, missing-data handling, and multiplicity plans alongside outcome summaries.
For clinical researchers, the key statistical lesson is to distinguish an observed pattern, an overall test, and a treatment-specific estimate. Each has a different interpretation. Reporting group-level summaries and an omnibus test can signal that further comparison is relevant, but without planned contrasts and uncertainty estimates, the magnitude and precision of individual differences remain unclear.
15. 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 registry's primary result is a 10-day group summary, with no baseline IT-T values, change-from-baseline results, or follow-up beyond that endpoint reported. No individual participant observations are reported. The inter-quartile ranges describe within-group spread, but they do not provide confidence intervals for the group medians or for differences between groups.
The inferential result is an overall Kruskal-Wallis test across five groups. Pairwise comparisons, effect estimates, and confidence intervals are not reported. Although the analysis is labeled non-inferiority or equivalence, the relevant margin and contrast-specific results are absent. The registry does not report the rationale for the test, checks of assumptions, or a detailed statistical analysis plan.
The registry lists enrollment of 46, while 8 participants are listed for each group in the primary outcome. The relationship between the enrollment and endpoint counts, and details on screening, randomization, withdrawal, exclusion, or missing outcomes, are not reported in the registry record. The analysis population and missing-data approach are also not reported. This limits assessment of how representative the analyzed outcomes are of the enrolled or randomized participants.
Only the primary IT-T results are described, although the study summary gives aims concerning intratesticular dihydrotestosterone and estradiol. Their results are not reported in the registry record. The record also does not report multiplicity handling, a sample-size justification, or interim analyses. The study population is described as healthy males; broader applicability to other populations is not established by these results. Finally, the registry provides adverse-event counts but not a formal comparative safety analysis or death counts.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: ITT4 Intratesticular Hormonal Milieu in Man (ITT4) — NCT01215292.
- Registry record last updated 2014-03-31; status last verified 2014-02.
- Results first posted 2014-01-29.
- 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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19. Record Summary
ITT4 is listed as a completed, randomized, single-masked, parallel-group phase 1/phase 2 study of healthy males, sponsored by the University of Washington. The registry lists enrollment of 46. Its stated research purpose concerns the intratesticular hormonal environment and its relationship to sperm production.
The posted primary outcome is intratesticular testosterone in ng/mL at 10 days, reported as a median and inter-quartile range for five groups receiving acyline and testosterone gel with different oral treatments. Each group has 8 participants listed for the outcome. The registry reports an overall Kruskal-Wallis result of p <0.05. Pairwise estimates and confidence intervals are not reported. The results for the other stated hormonal aims, analysis-population details, missing-data handling, and multiplicity plan are not reported in the registry record.