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 Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism (NCT02504541), a na phase 3 study. The primary outcome is Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02504541 |
| Phase | Phase 3 |
| Condition | Hypogonadism |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 133 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Antares Pharma Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Adult males with hypogonadism. The registry record lists an enrollment of 133 participants. The primary safety outcome concerns events arising after the first dose, as well as events present before dosing that worsened in severity or relatedness to the study treatment.
Intervention
Testosterone enanthate delivered subcutaneously once each week using an auto-injector. The stated regimen included 50 mg, 75 mg, or 100 mg, with possible titration to a higher or lower dose at scheduled intervals during the study.
Comparator
There was no comparator group in the single-group study. Allocation is listed as not applicable and masking as none. The registry record therefore does not describe a randomized, like-for-like treatment comparison.
Primary question
Among adult males with hypogonadism who received the weekly regimen, how many participants experienced adverse events meeting the registry’s stated timing and worsening criteria during the 26-week outcome timeframe? This is a descriptive safety question, not a comparison of treatment effects against another group.
The central statistical feature is that the outcome counts participants with adverse events rather than comparing event rates between assigned treatments. A participant may experience more than one event, but the outcome description explains that a participant was counted only once within a system-organ category. The same participant could contribute to multiple preferred-term categories.
This distinction matters because a count of affected participants does not convey the total burden or timing of all events. The record also notes that four patients had a total of 9 serious adverse events during the study. Those figures describe both affected people and event episodes; they are not interchangeable measures.
3. Trial Design
The registry describes a Phase 3, completed, single-group study sponsored by Antares Pharma Inc. It lists a start in 2015-07 and primary completion in 2016-06. The official title characterizes the study as a 6-month safety study, while the primary outcome timeframe is specified as 26 weeks.
Participants received testosterone enanthate through a subcutaneous auto-injector once each week. The dose options were 50 mg, 75 mg, or 100 mg, with possible titration to a higher or lower dose at scheduled intervals. The registry does not state how many participants received each dose, how often dose changes occurred, or what criteria guided titration; these details are not reported in the registry record.
The design is listed as single group, with allocation not applicable and masking none. There is no concurrent control arm described. Consequently, the study’s participant counts can describe adverse events observed during treatment, but they do not establish how those counts compare with an untreated group or another regimen. Changes over time, background event rates, and differences between dose levels cannot be evaluated from the posted results.
The record lists an enrollment of 133. This is a study enrollment figure, not by itself a complete description of the number contributing to every outcome or of missing observations. Outcome-specific analysis populations and missing-data handling are not reported in the registry record. The record lists one outcome measure and no analyses.
The design is therefore best read as a safety-focused observation of a regimen in a defined population and timeframe. Its structure supports a description of the recorded participant counts. It does not support a randomized causal comparison, and no protocol-level rationale for the enrollment target or detailed statistical analysis plan is 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: Although 21 sites participated in the study, only 19 sites enrolled patients in the United States. This study was intended to collect additional safety and exposure data, to ensure compliance and accuracy.
Overall Study
| Stage | Testosterone Enanthate Auto-injector |
|---|---|
| STARTED | 133 |
| COMPLETED | 113 |
| NOT COMPLETED | 20 |
Reasons for not completing this period:
| Reason | Testosterone Enanthate Auto-injector |
|---|---|
| Adverse Event | 4 |
| Withdrawal by Subject | 4 |
| Lost to Follow-up | 1 |
| Met Stopping Criteria | 1 |
| Protocol Violation | 2 |
| Termination by Sponsor | 1 |
| Other | 2 |
| Multiple | 5 |
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: Masked dose assignment based upon Testosterone levels; Individual patients may receive all three dose levels.
| Characteristic | Unit | Testosterone Enanthate Auto-injector |
|---|---|---|
| Participants analysed | 133 | |
| Age, Continuous | years | 54.5 (SD 10.30) |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 133 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 17 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 116 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 18 |
| Race (NIH/OMB): White | Participants | 113 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Region of Enrollment: United States | participants | 133 |
6. Primary Endpoint
The registry lists the primary outcome as Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism, measured over 26 weeks.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants experiencing adverse events during the 26-week timeframe. The registry defines qualifying events as those that started on or after the first dose of QuickShot testosterone, or events that existed before the first dose and worsened in severity or relatedness to the treatment after dosing.
This participant-count measure is useful in safety reporting because it indicates how many people had at least one qualifying event, rather than counting every occurrence as a separate affected participant. The outcome description says a participant with two or more treatment-emergent adverse events or serious adverse events was counted only once within a system-organ category. The same participant could nevertheless appear in more than one preferred-term category.
That counting rule helps prevent repeated events in one person from being mistaken for the same number of affected people. It also means the endpoint does not show the total number of non-serious events, their duration, severity distribution, or timing. The record’s description of four patients having 9 serious adverse events illustrates the distinction between the number of people affected and the number of event episodes.
The endpoint is used to characterize safety during exposure, not to measure clinical benefit or compare treatments. A count alone does not establish that treatment caused an event. The registry’s timing and worsening criteria define which events were considered, but causal attribution beyond those criteria is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety results describe a single group exposed to weekly subcutaneous testosterone enanthate. Among 133 participants listed at risk, 4 were recorded as having serious adverse events, and 68 were recorded in the other adverse-event tally. The registry also records 0 deaths. These are descriptive counts in the study group, not estimates of a treatment difference.
The serious-event description states that four patients had a total of 9 serious adverse events during the study. The number of affected participants and the number of serious events answer different questions: the first concerns how many people experienced an event, while the second counts episodes. A person could have multiple events. The record’s counting rules also allow one person to contribute to more than one preferred-term category.
The serious-event terms listed include Visual Impairment, APPENDICITIS, DEEP VEIN THROMBOSIS, HYPOXIC RESPIRATORY FAILURE, CORONARY ARTERY DISEASE, and RIGHT KNEE SEPTIC ARTHRITIS. Each is listed as 0.8%. The posted term percentages should be read as registry-reported figures, not as evidence that each term occurred in a distinct participant. The outcome description explicitly allows a person to contribute to multiple preferred-term categories.
No confidence intervals, hypothesis tests, adjusted estimates, or analysis results are listed in the registry record. The observed counts therefore have no accompanying registry-reported measure of statistical precision. In general, an interval estimate can communicate uncertainty around an observed quantity, but an interval is not reported for these counts in the record.
Because there is no comparator group, the results cannot show whether the observed counts were higher or lower than they would have been without treatment or under another regimen. They also cannot isolate the contribution of dose level, because dose-specific counts are not reported. The findings describe events recorded in this study over its stated timeframe; they do not by themselves establish causation, comparative safety, or what would occur in a different population or over a different duration.
Any sample-size planning illustration based on the observed effect is retrospective and is not the trial’s original design justification. It should not be interpreted as observed power or as a substitute for the missing statistical analysis plan.
9. Statistical Methods Explained
General: A binary participant-level outcome classifies each person according to whether the defined event occurred. For a safety endpoint, this makes the number of affected participants straightforward to interpret, but it does not preserve how many times an event occurred in an affected person. The registry’s endpoint is a participant count, and its description separately acknowledges multiple events in some patients.
What do participant counts represent?
A count of participants with an event answers how many people met the endpoint definition during the stated observation period. It is not the same as a count of all event episodes. For serious adverse events, the record states that four patients had a total of 9 events. That distinction is particularly important when a single participant has more than one event or when a participant appears in more than one preferred-term category.
The registry notes that participants were counted once within a system-organ category, while the same person could contribute to two or more preferred-term categories. Thus, category counts should not be treated as mutually exclusive categories that can be added to recover a total number of people. No such addition is needed to interpret the overall participant count.
What does the denominator tell the reader?
The serious and other adverse-event results each list 133 participants at risk. A denominator identifies the group against which the corresponding affected-participant count is reported. It does not, on its own, establish that every enrolled participant completed the full observation period or contributed complete outcome data. The number included in each analysis and the handling of incomplete follow-up are not reported in the registry record.
General: In safety studies, denominators should match the population and timeframe relevant to the event count. If follow-up varies or some participants have missing outcome data, the interpretation of a simple count can depend on how those circumstances are handled. The record does not describe such handling, so no assumptions about complete follow-up or missing outcomes should be made.
How should uncertainty be understood?
General: An observed count is one realization from the participants followed in a study. An interval estimate can express the statistical uncertainty around an estimated event frequency; a hypothesis test can assess a prespecified comparison. Neither is listed for the primary outcome in the registry record. Without an interval, the reader cannot use the posted result to assess its statistical precision in that way. The count remains useful as a description of what was recorded in this study, but it should not be mistaken for a precise prediction of event frequency in other settings.
The record does not list a comparative estimate, and the single-group design has no control arm. Recalculating a treatment contrast from the posted summaries is therefore not applicable. No sponsor analysis or recalculated inferential result is listed in the registry record.
Why do repeated events require different methods?
General: Methods for counts of repeated events answer questions about the number of episodes per person, whereas a binary participant endpoint asks whether a person had at least one qualifying event. Repeated-event analyses may need to account for variation between people and for over-dispersion, which occurs when event counts vary more than a simple model expects. That concern cannot be assessed from a participant-level yes-or-no count alone. The posted primary outcome is not a detailed repeated-event analysis, and the registry does not report event-level statistical modeling.
The serious-event description gives a total event count in addition to the number of affected patients, but it does not provide individual event histories, timing, or a model for recurrent events. The record therefore supports reporting the stated count, not reconstructing a repeated-event analysis.
What can sample-size illustrations establish?
General: A sample-size calculation asks how many participants might be needed under stated assumptions to detect a specified effect with a chosen statistical procedure. A planning illustration based on an observed effect is retrospective: it uses an effect seen in the data rather than documenting the original rationale for the trial’s enrollment. Such an illustration is not observed power and does not demonstrate that the study was adequately powered for every safety outcome.
The stated planning assumptions refer to a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Those assumptions describe an illustration and do not match the single-group design as a randomized two-arm comparison. The original sample-size justification and detailed statistical plan are not reported in the registry record.
Overall, the available statistical information is descriptive. The posted results identify participant counts and serious-event terms, but do not provide uncertainty intervals, comparative tests, adjusted analyses, or details needed to reproduce a broader statistical analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists one outcome measure and no analyses. It does not report a multiplicity strategy, such as how statistical testing across multiple outcomes or subgroups would be controlled. Because no hypothesis tests are listed, there is no reported adjustment for multiple comparisons to interpret. The absence of a reported strategy should not be taken to mean that a particular strategy was or was not used outside the registry record.
Missing-data procedures are not reported in the registry record. It does not specify how incomplete follow-up, missed visits, withdrawal, or unavailable event information was handled. The listed enrollment and the number at risk for the adverse-event tallies do not establish that every participant contributed complete observations over the full timeframe.
Analysis populations are also not described in detail. The record does not state whether the primary outcome used all enrolled participants, participants who received at least one dose, or another defined set. The event definition refers to events following the first dose, but the exact population rule for the posted count is not reported in the registry record.
In general, prespecifying outcomes, analysis populations, missing-data rules, and multiplicity procedures helps clarify which results were planned and how uncertainty should be interpreted. Without those details, the posted counts remain interpretable as reported descriptive safety findings, but the record does not support conclusions about unreported analyses or the handling of unavailable data.
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 Enanthate Auto-injector | 4 | 133 | 3.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Testosterone Enanthate Auto-injector | 0 of 133 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Testosterone Enanthate Auto-injector | 68 of 133 |
Most frequent serious adverse event terms
| Event term | Organ system | Testosterone Enanthate Auto-injector |
|---|---|---|
| Visual Impairment | Eye disorders | 1 of 133 |
| APPENDICITIS | Infections and infestations | 1 of 133 |
| DEEP VEIN THROMBOSIS | Vascular disorders | 1 of 133 |
| HYPOXIC RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | 1 of 133 |
| CORONARY ARTERY DISEASE | Cardiac disorders | 1 of 133 |
| RIGHT KNEE SEPTIC ARTHRITIS | Infections and infestations | 1 of 133 |
| PRINZMETAL ANGINA | Cardiac disorders | 1 of 133 |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | 1 of 133 |
| VENTRICULAR TACHYCARDIA | Cardiac disorders | 1 of 133 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Testosterone Enanthate Auto-injector |
|---|---|---|
| Hematocrit increased | Investigations | 11 of 133 |
| Upper respiratory tract infection | Infections and infestations | 10 of 133 |
| Injection site hemorrhage | General disorders | 8 of 133 |
| Nasopharyngitis | Infections and infestations | 5 of 133 |
| Blood creatine phosphokinase increased | Investigations | 5 of 133 |
| Injection site bruising | General disorders | 5 of 133 |
| Urinary tract infection | Infections and infestations | 4 of 133 |
| PSA increased | Investigations | 4 of 133 |
| Prostatitis | Reproductive system and breast disorders | 4 of 133 |
| Fatigue | General disorders | 3 of 133 |
Serious events with the highest arm-level rate: visual impairment (0.8%), appendicitis (0.8%), deep vein thrombosis (0.8%), hypoxic respiratory failure (0.8%), coronary artery disease (0.8%).
The registry reports 4 participants with serious adverse events among 133 at risk, and states that these patients had a total of 9 serious adverse events during the study. These figures describe affected people and event episodes, respectively. A participant could experience multiple serious events, so the two counts should not be treated as equivalent.
The listed serious-event terms are Visual Impairment, APPENDICITIS, DEEP VEIN THROMBOSIS, HYPOXIC RESPIRATORY FAILURE, CORONARY ARTERY DISEASE, and RIGHT KNEE SEPTIC ARTHRITIS. Each term is reported as 0.8%. The registry’s counting explanation allows the same participant to appear in more than one preferred-term category, so the term list does not establish a one-to-one correspondence between terms and people.
The record lists 0 deaths. It also reports 68 participants in the other adverse-event tally among 133 at risk. These results describe what was recorded in the study; they do not establish that treatment caused a particular event or permit comparison with another regimen. No event-specific analysis or confidence interval is reported in the registry record.
12. What the Result Does, and Does Not, Mean
The results show that adverse events were recorded during the 26-week safety study, with the registry reporting participant counts for serious and other adverse events. The serious-event information includes both the number of affected patients and the total number of serious events. The record also lists serious-event terms and reports 0 deaths.
These observations are descriptive. A single-group study has no concurrent comparator, and the registry lists allocation as not applicable and masking as none. As a result, the counts do not estimate a difference between treatments. They cannot establish what the event counts would have been in the absence of treatment or with a different regimen, and they do not isolate an effect of any particular dose.
The endpoint definition makes clear which events were included: events beginning on or after the first dose, as well as pre-existing events that worsened in severity or relatedness after dosing. However, the registry record does not report a detailed causal assessment for individual events. The timing and worsening criteria define the endpoint; they do not independently prove that the treatment caused an event.
The counts also do not summarize every aspect of safety. They do not give the duration of events, a full account of severity, event timing, or participant-level histories. The serious-event term percentages should not be treated as distinct-person counts because the record allows participants to contribute to multiple preferred-term categories.
Finally, no confidence intervals, hypothesis tests, or adjusted analyses are listed. The findings can be read as the reported experience of participants in this study, but their statistical precision and comparative meaning are not quantified in the registry record. They should not be extended automatically to other populations, doses, observation periods, or clinical settings.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the difference between describing safety events and estimating comparative treatment effects. Its single-group design can report what adverse events were recorded among participants receiving a specified weekly regimen. It cannot, by itself, distinguish events associated with treatment from events that might also occur without that treatment or under another regimen.
The endpoint also illustrates why the unit of analysis matters. The primary safety outcome counts participants, while the serious-event description separately reports event episodes. Four patients had a total of 9 serious adverse events. Treating those figures as interchangeable would confuse the number of people affected with the number of events experienced.
Another statistical lesson is the importance of category overlap. The registry states that a participant could be counted in multiple preferred-term categories. Consequently, term-level percentages do not necessarily correspond to separate people, and categories should not be interpreted as mutually exclusive. The stated participant-level counting rule within a system-organ category adds context to those reports.
The record’s limitations also show why outcome counts are strongest when accompanied by prespecified analysis populations, missing-data procedures, and measures of uncertainty. Those details, as well as confidence intervals and inferential analyses, are not reported in the registry record. Their absence does not erase the descriptive value of the reported counts, but it limits what can be concluded about precision and generalizability.
Finally, planning illustrations based on an observed effect are not a substitute for the original design rationale. They are retrospective illustrations, not observed power. Keeping that distinction clear prevents a descriptive safety study from being interpreted as a randomized comparative trial or as a definitive estimate for other settings.
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 limitation is the absence of a comparator group. With a single group, the registry can describe events observed during exposure but cannot estimate a between-group difference or determine what would have occurred under another treatment or without treatment. No causal conclusion follows from the participant counts alone.
Masking is listed as none, and allocation is listed as not applicable. The record does not describe a randomized allocation process or a blinded outcome assessment. How event reports were collected and adjudicated is not reported in the registry record, so those procedures cannot be evaluated from the posted information.
The regimen allowed 50 mg, 75 mg, or 100 mg dosing and possible titration. Dose-specific participant counts, titration patterns, and dose-level safety results are not reported in the registry record. The overall findings therefore cannot be used to compare doses. The registry also does not provide participant-level event timing, duration, or a full distribution of event severity.
The primary endpoint counts participants meeting the event definition, not every event episode. The record reports a total of 9 serious adverse events among four patients, but does not provide detailed event histories or analyses of recurrence. In addition, a participant may appear in multiple preferred-term categories, which limits how category-specific percentages can be interpreted as counts of unique people.
Confidence intervals, hypothesis tests, adjusted estimates, missing-data rules, analysis populations, and a detailed statistical plan are not reported in the registry record. These omissions limit assessment of statistical precision, potential bias from incomplete follow-up, and reproducibility. The stated 26-week timeframe also bounds the findings to the period described; outcomes beyond that timeframe are not characterized by this endpoint.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism — NCT02504541.
- Registry record last updated 2018-03-30; status last verified 2018-03.
- Results first posted 2018-03-30.
- 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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18. Record Summary
The registry describes a completed Phase 3, single-group study sponsored by Antares Pharma Inc., with an enrollment of 133 adult males with hypogonadism. Participants received testosterone enanthate by subcutaneous auto-injector once each week, with stated doses of 50 mg, 75 mg, or 100 mg and possible titration. The primary safety outcome covers 26 weeks.
The posted results report 4 participants with serious adverse events among 133 at risk, with a total of 9 serious adverse events, and 68 participants in the other adverse-event tally among 133 at risk. The record lists 0 deaths and reports six serious-event terms, each at 0.8%.
There is no comparator group, and the registry lists no analyses. Comparative estimates, confidence intervals, missing-data procedures, and detailed analysis populations are not reported in the registry record. The counts are therefore descriptive findings from the study rather than estimates of comparative treatment effects.