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 Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men (NCT00695110), a na phase 2 study. The primary outcome is Serum Testosterone Average Concentration (Cavg) (ng/dL).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00695110 |
| Phase | Phase 2 |
| Condition | Hypogonadism |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 29 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Clarus Therapeutics, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns men with hypogonadism. The registry record lists an enrollment of 29 and describes all study participants as the analysis group. It says that available individual serum concentrations and pharmacokinetic parameter estimates were reported, with missing data not imputed. It also notes that data were insufficient to calculate all pharmacokinetic parameters for one subject in Treatment Period 1 and one subject in Treatment Period 4.
Intervention
The study examines oral testosterone undecanoate, alone and combined with testosterone enanthate. Listed formulations include testosterone undecanoate at 300 mg T equivalents per dose; a combination at 400 mg T equivalents per dose; testosterone undecanoate at 200 mg T equivalents per dose, with and without food; and a combination at 300 mg T equivalents per dose. The treatment-period description specifies twice-daily dosing for 7 days in Periods 1 and 2; the full period description is not reported in the registry record.
Comparator
This was a single-group study with allocation listed as not applicable and no masking. It was not a randomized comparison, and the registry record cautions that the arms are not a like-for-like control comparison. The described treatment periods include different formulations and food conditions, but the record does not establish a randomized concurrent control group.
Primary question
The primary outcome is serum testosterone average concentration, or Cavg, measured in ng/dL. The study asks about the concentration profile associated with the oral formulations across the specified sampling times and treatment periods. Numerical Cavg results, estimates of differences between formulations, and uncertainty estimates are not reported in the registry record, so the comparative magnitude and precision cannot be assessed from the record.
3. Trial Design
The registry identifies this as a Phase II, repeat-dose pharmacokinetic study in men with hypogonadism. It was completed, with enrollment recorded as 29. The study model is single group; allocation is listed as not applicable, and masking is listed as none. These features distinguish it from a masked randomized trial in which participants are assigned to parallel intervention and control groups.
The listed interventions cover oral testosterone undecanoate (TU), alone or combined with testosterone enanthate (TE), at several T-equivalent doses, including a TU condition with and without food. The arm description begins by specifying Treatment Period 1 as three capsules, each containing 100 mg testosterone as TU, taken twice daily for 7 days. Treatment Period 2 is described as two capsules, each containing 200 mg T as TU and TE, taken twice daily for 7 days. The posted period description ends partway through the next period, so the full sequence, all dosing details, and the complete description of Treatment Period 4 are not reported in the registry record.
Sampling was planned around morning and evening doses in some treatment periods, with the primary outcome description specifying measurements before dosing and at post-dose times. Treatment Period 3 included sampling after a morning dose with food on Day 7 and fasting on Day 8. These details indicate that the endpoint concerns measured concentration over time, not a clinical event endpoint.
The record describes a single-group structure and cautions that the arms are not a like-for-like control comparison. It does not report a randomized allocation method, masking, a concurrent control group, or the statistical plan for comparisons across periods. The registry record lists two outcome measures and no analyses. Consequently, the design can be described, but numerical efficacy or pharmacokinetic findings cannot be reconstructed 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: After signing an informed consent form, subjects underwent a screening evaluation up to 28 days prior to the first dose of study drug. 29 subjects meeting the admission criteria, began Treatment Period 1 intervention (7 days) followed by a 7-14 day washout period and then proceeded to Treatment Periods 2-4. A 7-14 day washout period occurred between successive Treatment Periods. Treatment Periods 1, 2, and 4 had intervention for 7 days and Treatment Period 3 had intervention for 8 days.
Treatment Period 1
| Stage | All Study Participants |
|---|---|
| STARTED | 29 |
| COMPLETED | 26 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | All Study Participants |
|---|---|
| Adverse Event | 1 |
| Withdrawal by Subject | 2 |
Treatment Period 2
| Stage | All Study Participants |
|---|---|
| STARTED | 26 |
| COMPLETED | 26 |
| NOT COMPLETED | 0 |
Treatment Period 3
| Stage | All Study Participants |
|---|---|
| STARTED | 26 |
| COMPLETED | 25 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | All Study Participants |
|---|---|
| Withdrawal by Subject | 1 |
Treatment Period 4
| Stage | All Study Participants |
|---|---|
| STARTED | 25 |
| COMPLETED | 24 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | All Study Participants |
|---|---|
| Adverse Event | 1 |
Analysis population for the primary outcome, as defined in the registry: All available individual serum concentrations and pharmacokinetic parameter estimates were reported; missing data were not imputed. For 1 subject in Treatment Period 1 and 1 subject in Treatment Period 4 there were insufficient data to calculate all pharmacokinetic parameters.
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: Data for all 29 subjects enrolled in this single group, four period study are included in the baseline measures at Treatment Period 1. No additional baseline measures were analyzed for successive Treatment Periods 2-4.
| Characteristic | Unit | All Study Participants |
|---|---|---|
| Participants analysed | 29 | |
| Age, Continuous | years | 48.6 (SD 10.23) |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 29 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 6 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 23 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 27 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Total Testosterone (ng/dL) | ng/dL | 169.0 (SD 82.80) |
| Body Mass Index (BMI) (kg/m^2) | kg/m^2 | 30.4 (SD 3.43) |
| Height | inches | 69.9 (SD 4.0) |
| Weight | pounds | 212.2 (SD 38.68) |
6. Primary Endpoint
The registry lists the primary outcome as Serum Testosterone Average Concentration (Cavg) (ng/dL), measured over 30 minutes pre-dose and 0, 1, 2, 4, 8, 12 hours and 0,1, 2, 4, 8, and 12 hours post respective AM/PM doses.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | ng/dL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is serum testosterone average concentration (Cavg), expressed in ng/dL. The record describes sampling before dosing and at post-dose times, including observations around morning and evening doses in specified treatment periods. For Treatment Period 3, sampling is described after the morning dose with food on Day 7 and fasting on Day 8. The stated purpose is to determine Cavg after the relevant doses and, in some periods, over 24 hours.
As a general pharmacokinetic concept, an average concentration condenses measurements taken over time into a summary of circulating drug concentration across a defined sampling interval. It can help describe exposure patterns that a single measurement might not capture. Its interpretation depends on the sampling schedule and the interval to which the average refers. The registry record supplies timing details but does not report the numerical Cavg values or the method used to calculate the average.
The outcome is reported as a mean with standard deviation. A mean describes the central value of the measured concentrations, while a standard deviation describes their spread across observations. Neither statistic is numerically reported for the primary outcome in the registry record. The record also does not report confidence intervals or numerical comparisons between formulations. Therefore, the endpoint’s intended measurement is clear, but the size and precision of the observed concentrations cannot be evaluated from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies serum testosterone Cavg as the primary outcome and states the unit as ng/dL. It describes when blood samples were taken and says that available individual serum concentrations and pharmacokinetic parameter estimates were reported. However, numerical primary-outcome results are not reported in the registry record. No Cavg means, standard deviations, confidence intervals, or formulation contrasts are included in the recorded information. As a result, the direction, magnitude, and precision of any differences between treatment conditions cannot be interpreted.
The design also shapes what the study can establish. The record classifies the study as single group, with allocation not applicable and no masking. It explicitly cautions that this is not a randomized comparison and that the arms are not like-for-like control comparisons. The listed formulations differ in dose and composition, and one condition concerns food status. Without a reported randomized control comparison or a full analysis description, apparent differences across conditions would not automatically represent isolated effects of a specific ingredient, dose, or food condition.
The record notes that one subject in Treatment Period 1 and one subject in Treatment Period 4 had insufficient data to calculate all pharmacokinetic parameters. That statement concerns the ability to calculate all parameters; it does not establish which specific values were unavailable or how the primary Cavg endpoint was affected. The record says missing data were not imputed. It does not report an analysis population for each treatment period or a sensitivity analysis of missing observations.
For safety, the adverse-event record lists one serious adverse event among 29 at risk, 19 other adverse events among 29 at risk, and zero deaths. Osteomyelitis is listed as a top serious term at 3.4%. These are descriptive registry entries; the record does not provide enough detail to infer causation, compare event rates across formulations, or determine the circumstances of each event.
A planning illustration is described as based on the observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation. It treats the effect to detect as a stated fraction of the observed effect. Because the observed primary outcome effect and the illustration’s resulting sample-size values are not reported in the registry record, those planning assumptions cannot support a numerical assessment of precision or power for the completed study. Such illustrations are planning aids, not observed power.
9. Statistical Methods Explained
The statistical information recorded for this study is limited. The registry identifies a continuous primary outcome, specifies that it is a mean with standard deviation, and gives the endpoint unit and sampling schedule. It does not report numerical primary outcome summaries or an analysis plan. The explanations below describe general statistical concepts relevant to the recorded endpoint; they do not imply that a particular unreported method was used.
What does a mean summarize?
As a general statistical concept, a mean is a measure of the central level of a set of observations. For this study, the stated outcome is mean serum testosterone average concentration. It is intended to summarize measured concentrations for a defined treatment condition and sampling interval. The registry record does not include the actual mean values. Without those values, it is not possible to describe which condition had a higher or lower average, or the size of any difference.
The record pairs the mean with a standard deviation. In general, standard deviation describes the spread of individual observations around their mean. It is not the same as a confidence interval: a standard deviation characterizes variability in the observed values, while a confidence interval describes uncertainty around an estimate under a specified statistical model. The registry record does not report numerical standard deviations or confidence intervals for Cavg, and it does not describe a model for estimating uncertainty.
Why does the sampling schedule matter?
As a general pharmacokinetic concept, concentrations change over time after dosing. A summary average therefore depends on which time points are sampled and the interval being summarized. The record specifies pre-dose and post-dose sampling, describes morning and evening sampling in some periods, and describes food and fasting conditions in Treatment Period 3. This information helps define the measurement context, but it does not reveal the observed concentration curve or the numerical average.
The record describes the purpose as determining Cavg following doses and, for specified periods, over 24 hours. It does not state the calculation method used to derive Cavg from the individual measurements. For example, it does not report whether the average was calculated using a particular area-under-the-curve method or another rule. No such method should be inferred from the endpoint label alone.
What can be concluded from the study structure?
The registry classifies the model as single group, lists allocation as not applicable, and lists masking as none. It also cautions that the arms are not a like-for-like control comparison. As a general design principle, randomized concurrent comparisons can help separate intervention effects from other influences. Comparisons across treatment periods may be affected by period, sequence, or other factors; whether those concerns apply and how they were handled cannot be determined because the protocol details and analysis plan are not reported in the registry record.
The interventions involve multiple formulations and doses, with a food-condition contrast listed for one TU dose. A comparison among these conditions would need to account for the specific treatment sequence and measurement conditions to support a clear interpretation. The registry record does not give a complete description of all periods, a prespecified contrast hierarchy, or a model for comparing repeated measurements. It would therefore be inappropriate to claim that a particular statistical adjustment or crossover analysis was used.
How should uncertainty be understood?
As a general concept, an estimate is more informative when accompanied by an interval expressing its uncertainty. A confidence interval gives a range of values compatible with the data and model at a stated confidence level; its width reflects both variability and information available. No confidence interval for Cavg is reported in the registry record. Accordingly, the precision of any treatment-specific estimate or comparison is unknown from this record.
The study’s enrollment is recorded as 29, but enrollment alone does not identify the number of usable measurements for every period or endpoint. The record states that data were insufficient to calculate all pharmacokinetic parameters for one subject in Treatment Period 1 and one subject in Treatment Period 4. It does not state whether those observations were included in the primary Cavg summary, which parameters were unavailable, or whether other missing observations occurred. These details matter because the amount and pattern of available data can affect estimates and their uncertainty.
What do the planning assumptions mean?
The record describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. In general, a sample-size calculation estimates the amount of information needed to detect a chosen effect under specified assumptions. It does not describe the actual precision achieved in a completed study, and it is not observed power. The record’s observed-effect values and resulting sample-size values are not reported in the registry record, so the illustration cannot be interpreted numerically.
The record lists no analyses. It does not report whether hypothesis tests were performed, which statistical test or model was used, how estimates were adjusted, or whether interim analyses took place. Those matters are not reported in the registry record. The absence of recorded methods should not be replaced by assumptions based on the study’s pharmacokinetic purpose or the endpoint name.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists two outcome measures but does not describe a multiplicity strategy. Multiplicity arises when several outcomes, treatment conditions, or statistical comparisons are examined: the chance of at least one misleading finding can increase as the number of tests grows. As a general statistical principle, prespecifying a primary comparison or using an appropriate adjustment can help address that issue. The record does not say whether comparisons among formulations or food conditions were planned as separate tests, whether an adjustment was used, or which result was intended to control interpretation.
Missing-data handling is described in one respect: available individual serum concentrations and pharmacokinetic parameter estimates were reported, and missing data were not imputed. The record also notes that one subject in Treatment Period 1 and one subject in Treatment Period 4 had insufficient data to calculate all pharmacokinetic parameters. It does not identify all missing measurements, say which parameters were affected, or clarify whether the primary Cavg endpoint was available for those subjects. The analysis population for each outcome and period is not reported in the registry record.
As a general concept, not imputing missing values means that absent observations are not filled in with model-based substitutes. This does not by itself explain why data are missing or establish that the remaining observations are representative. The record does not report an assessment of missingness, a sensitivity analysis, or a comparison of results under alternative assumptions.
The registry lists no analyses. It does not report a statistical analysis plan, adjustment methods, interim analyses, or rules for handling repeated measurements. These details are not reported in the registry record, so the degree to which multiplicity and missing-data concerns were addressed cannot be assessed.
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 |
|---|---|---|---|
| All Study Participants | 1 | 29 | 3.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| All Study Participants | 0 of 29 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| All Study Participants | 19 of 29 |
Most frequent serious adverse event terms
| Event term | Organ system | All Study Participants |
|---|---|---|
| Osteomyelitis | Infections and infestations | 1 of 29 |
Most frequent non-serious adverse event terms
| Event term | Organ system | All Study Participants |
|---|---|---|
| Headache | Nervous system disorders | 7 of 29 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 3 of 29 |
| Back pain | Musculoskeletal and connective tissue disorders | 2 of 29 |
| Constipation | Gastrointestinal disorders | 2 of 29 |
| Cough | Respiratory, thoracic and mediastinal disorders | 2 of 29 |
| Fatigue | General disorders | 2 of 29 |
| Gastrointestinal reflux | Gastrointestinal disorders | 2 of 29 |
| Nausea | Gastrointestinal disorders | 2 of 29 |
| Pharyngitis | Infections and infestations | 2 of 29 |
| Upper respiratory infection | Infections and infestations | 2 of 29 |
Serious events with the highest arm-level rate: osteomyelitis (3.4%).
The registry lists one serious adverse event among 29 participants at risk and 19 other adverse events among 29 participants at risk. It also reports zero deaths. Osteomyelitis is the top serious term listed, with a recorded value of 3.4%. These figures describe the registry entries; they do not establish whether an event was caused by a study formulation.
As a general reading principle, serious adverse events and other adverse events are separate categories in the record. They should not be combined or treated as interchangeable. The registry does not explain whether participants could appear in both categories, give event-level narratives, or report the timing of each event in relation to a treatment period. The record also does not provide a formulation-specific safety comparison, so these entries cannot be used to compare risk across the listed conditions.
The 3.4% value is reported for the top serious term, osteomyelitis. It is not a numerical estimate of the causal risk attributable to treatment. The record does not provide additional information on severity, duration, outcome, or attribution for that term. The safety results should therefore be read as descriptive counts and a listed term, with limited context for interpreting their relationship to exposure.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed Phase II, repeat-dose pharmacokinetic study enrolled 29 men with hypogonadism and examined oral testosterone ester formulations. Its primary endpoint was serum testosterone Cavg in ng/dL, with sampling described around doses and across treatment periods. The interventions included TU alone and in combination with TE, as well as a TU condition with and without food.
What the record does not establish is the numerical Cavg achieved under each condition. It does not report the primary endpoint means, standard deviations, confidence intervals, or comparisons. Without these results, the magnitude and precision of the measured concentrations cannot be evaluated, and no conclusion about differences among formulations can be drawn from the registry record.
The study’s single-group structure and the explicit warning that the arms are not like-for-like control comparisons also limit interpretation. The listed treatment conditions vary in dose, composition, or food status. The registry record does not describe a randomized control comparison or a complete analysis plan. A measured difference across conditions, if one were reported elsewhere, would require interpretation in light of these design features and the sequence and timing of treatment.
The safety entries report one serious adverse event, 19 other adverse events, and zero deaths; osteomyelitis is listed as a top serious term at 3.4%. These descriptive entries do not establish cause or permit a safety comparison among formulations.
Thus, the registry record identifies the pharmacokinetic question and the measurement approach, but it does not contain the numerical primary results needed to quantify exposure or assess uncertainty. It also does not provide enough detail to resolve how missing data, multiple comparisons, or period effects were handled. Any stronger interpretation would require information not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of why a clear endpoint and a complete results record are both needed. The registry identifies a continuous pharmacokinetic endpoint, defines its unit, and describes a sampling schedule around morning and evening dosing as well as a food-condition comparison. These details indicate what was intended to be measured and the timing relevant to interpretation.
At the same time, a defined endpoint is not sufficient to assess a result. The record does not report numerical Cavg means, standard deviations, confidence intervals, or contrasts. Readers therefore cannot determine the size of the measured concentrations or the precision of estimates. The record lists no analyses, leaving the statistical approach to repeated measurements or between-condition comparisons undocumented.
The single-group design makes the distinction between treatment conditions and a conventional randomized control comparison especially important. The registry explicitly cautions that the arms are not like-for-like control comparisons. Formulation, dose, and food status differ across listed conditions, while the full treatment-period description and analysis plan are unavailable. These features limit how specifically any observed contrast could be attributed, even if numerical outcomes were present.
The missing-data statement also illustrates the importance of reporting endpoint-specific availability. The record says missing data were not imputed and flags insufficient data for all pharmacokinetic parameters for subjects in Treatment Periods 1 and 4. It does not explain which endpoint values were affected or how missing observations were reflected in each summary.
Finally, a planning illustration based on an observed effect should not be mistaken for evidence of achieved precision or observed power. The assumptions are described, but the observed effect and resulting planning values are not reported in the registry record. Transparent numerical outcomes and analysis details are necessary to make the study’s statistical findings interpretable.
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 registry record does not report numerical results for the primary endpoint. The mean and standard deviation are identified as the intended summary statistics, but their values are absent, as are confidence intervals and comparisons among treatment conditions. This prevents assessment of the magnitude and precision of the pharmacokinetic findings.
Important design details are incomplete. The study is listed as single group, with allocation not applicable and masking none; the record also warns that the arms are not like-for-like control comparisons. The treatment-period description is truncated after the beginning of Treatment Period 3, and a complete account of the order and dosing for all periods is not reported in the registry record. Statistical methods for comparing periods or conditions are also not reported.
Missing-data information is limited. The record says missing data were not imputed and flags insufficient data to calculate all pharmacokinetic parameters for one subject in Treatment Period 1 and one subject in Treatment Period 4. It does not state which measures were unavailable, whether primary Cavg values were affected, or what analysis population applied to each period.
The record lists two outcome measures but no analyses and does not describe multiplicity control, confidence-interval methods, interim analyses, or an analysis plan. The adverse-event entries are not broken down by formulation or treatment period and do not include event narratives or attribution details. These limitations are specific to the information recorded and leave both efficacy interpretation and safety context incomplete.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men — NCT00695110.
- Registry record last updated 2021-06-25; status last verified 2021-06.
- Results first posted 2021-06-24.
- 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 II, repeat-dose pharmacokinetic study of oral testosterone ester formulations in men with hypogonadism. Enrollment was 29. The study was single group, with allocation listed as not applicable and masking listed as none. The interventions included TU alone or combined with TE at listed T-equivalent doses, including a TU condition with and without food.
The primary outcome was serum testosterone average concentration (Cavg), measured in ng/dL and summarized as a mean with standard deviation. The record describes sampling before and after doses across treatment periods. Numerical Cavg results and statistical analyses are not reported in the registry record. Missing data were not imputed; insufficient data to calculate all pharmacokinetic parameters were noted for one subject in Treatment Period 1 and one subject in Treatment Period 4.
The safety record lists one serious adverse event, 19 other adverse events, zero deaths, and osteomyelitis as a top serious term at 3.4%. The registry cautions that this was not a randomized comparison and that the arms are not like-for-like control comparisons.