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 HOP-3 Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone (NCT00839319), a randomized phase 1, phase 2 study. The primary outcome is Serum Testosterone (T).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00839319 |
| Phase | Phase 1, Phase 2 |
| Condition | Healthy Males |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 59 |
| Arms in the primary outcome | 5 |
| Lead sponsor | University of Washington |
| Results posted | Yes |
2. Clinical Question
Population
Healthy males were eligible for this study. The registry lists an enrollment of 59, while the primary outcome description says the analysis used participants who completed all study procedures and met a serum LH suppression criterion. The record does not report the full eligibility criteria or the number screened.
Intervention
All listed regimens included Acyline 300 ug/kg by subcutaneous injection on Day 1. The study compared placebo hCG, three hCG doses—15 IU, 60 IU, and 125 IU—or testosterone gel at 75 mg/day. The injections or gel were given over 10 days as described for each group.
Comparator
The Acyline plus placebo hCG group is the reference group in the registry record. The reported ANOVA analysis included this group and the Acyline plus 15 IU, 60 IU, and 125 IU hCG groups. The testosterone gel group was not listed in that reported test.
Primary question
The primary outcome asks what serum testosterone concentrations were at the end of the 10-day treatment period under the different regimens. The broader study purpose was to investigate how much testosterone is needed to maintain sperm production in the testis, as background for development of male hormonal contraception. The posted primary outcome measures serum testosterone, not sperm production itself.
3. Trial Design
This was a randomized, unmasked, parallel-group Phase 1 and Phase 2 study in healthy males. The registry lists enrollment of 59 and status as completed. The listed study start was 2009-03, and primary completion was 2010-09. The sponsor was the University of Washington.
The groups received Acyline plus placebo hCG, Acyline plus 15 IU hCG, Acyline plus 60 IU hCG, Acyline plus 125 IU hCG, or Acyline plus testosterone gel. Each regimen included Acyline 300 ug/kg by subcutaneous injection on Day 1. The hCG regimens used subcutaneous injections every other day for 5 doses over 10 days. The placebo group received placebo hCG on that schedule. The testosterone group received testosterone gel 75 mg/day daily for 10 days.
Randomization means the study assigned participants to treatment groups by chance, but the registry record does not report the allocation procedure, allocation ratio, or any stratification factors. Unmasked means masking was listed as none; further details about who knew the assigned regimen are not reported in the registry record. The parallel model means the listed regimens were assigned as separate groups rather than described as a sequence of treatments within each participant.
The primary outcome was serum testosterone measured over a 10-day timeframe. Its analysis was described as per protocol and restricted to participants who completed all study procedures and suppressed serum LH below the lower limit of normal. The full selection process, the number excluded from this analysis, and reasons for exclusion are not reported in the registry record. The record does not report a sample-size justification or further details of the protocol.
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: 2 of 61 men decided not to enroll. 19 failed inclusion criteria, 1 withdrew consent before study procedures, 1 dropped out after Day 1, and 1 was withdrawn by the investigator for syncopal reaction. 6 did not suppress serum luteinizing hormone(affecting intratesticular testosterone)and were excluded from analysis. 31 completed the study.
Overall Study
| Stage | Acyline Plus Placebo | Acyline Plus 15 IU hCG | Acyline Plus 60 IU hCG | Acyline Plus 125 IU hCG | Acyline Plus Testosterone Gel |
|---|---|---|---|---|---|
| STARTED | 8 | 8 | 8 | 8 | 8 |
| COMPLETED | 6 | 7 | 5 | 5 | 8 |
| NOT COMPLETED | 2 | 1 | 3 | 3 | 0 |
Analysis population for the primary outcome, as defined in the registry: Analysis per protocol. Due to nonnormality, the data were expressed as medians and 25th and 75 percentiles. Analysis of both baseline and end of treatment hormone concentrations performed on 31 subjects who completed all study procedures and who suppressed serum LH below the lower limit of normal at end of treatment.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Acyline Plus Placebo | Acyline Plus 15 IU hCG | Acyline Plus 60 IU hCG | Acyline Plus 125 IU hCG | Acyline Plus Testosterone Gel | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 6 | 7 | 5 | 5 | 8 | 31 | |
| Age, Customized | years | 21 (20 to 26) | 25 (20 to 29) | 22 (20 to 24) | 22 (21 to 26) | 22 (20 to 24) | 22 (20 to 26) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 6 | 7 | 5 | 5 | 8 | 31 |
| Body Mass Index (BMI) | kg/m^2 | 24.8 (23.6 to 26.3) | 24.1 (23.2 to 26.7) | 24.9 (21.2 to 26.3) | 25.8 (22.9 to 26) | 23.7 (21.1 to 25.4) | 24.1 (22.9 to 26.3) |
| Serum Luteinizing Hormone (LH) | IU/L | 3.5 (3.1 to 4.8) | 3.0 (2.6 to 4.9) | 3.4 (3.4 to 4.9) | 2.9 (2.3 to 3.7) | 3.8 (2.6 to 4.6) | 3.4 (2.6 to 4.9) |
| Serum Follicle Simulating Hormone (FSH) | IU/L | 2.7 (1.2 to 3.4) | 2.4 (2 to 2.8) | 2.6 (2.2 to 3.2) | 2.2 (1.9 to 2.5) | 1.9 (1.3 to 2.8) | 2.4 (1.5 to 3.0) |
| Serum Testosterone (T) | nmol/L | 13.0 (11.3 to 16.9) | 15.0 (11.4 to 20.9) | 14.2 (12.7 to 14.9) | 16.8 (14.4 to 18.6) | 15.0 (13.7 to 18.3) | 14.6 (12 to 17.3) |
| Serum Dihydrotestosterone (DHT) | nmol/L | 1.0 (0.7 to 1.5) | 1.3 (0.9 to 1.7) | 1.2 (1 to 1.3) | 0.9 (0.7 to 1.5) | 1.1 (1.1 to 1.2) | 1.1 (0.9 to 1.4) |
| Serum Estradiol | pmol/L | 89 (47 to 150) | 65 (34 to 125) | 62 (48 to 78) | 77 (44 to 95) | 86 (54 to 95) | 77 (46 to 104) |
| Serum 17-Hydroxyprogesterone | nmol/L | 4.7 (3.8 to 7.8) | 4.9 (4.2 to 6.5) | 5.9 (5.1 to 7.6) | 4.3 (4 to 4.5) | 4.6 (3.7 to 5.4) | 4.9 (3.9 to 6.5) |
| Intratesticular Testosterone (ITT-T) | nmol/L | 3467 (2508 to 3839) | 2425 (1700 to 3380) | 1821 (1753 to 2412) | 3502 (2305 to 3959) | 2933 (1527 to 3390) | 2508 (1753 to 3502) |
| Intratesticular Dihydrotestosterone (ITT-DHT) | nmol/L | 18.0 (11.9 to 24.5) | 5.0 (4.5 to 11) | 7.6 (7.1 to 21.3) | 18.8 (11.1 to 22.2) | 12.9 (7.9 to 15.5) | 11.9 (7.3 to 21.3) |
6. Primary Endpoint
The registry lists the primary outcome as Serum Testosterone (T), measured over 10 days.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | nmol/liter |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was serum testosterone, reported in nmol/liter, at the end of a 10-day treatment period. Serum testosterone is a circulating hormone concentration. In this study it provided a measurable indicator of the hormonal milieu under each assigned regimen. It is not a direct measure of sperm production, despite the broader research purpose described in the study summary.
The registry describes the outcome values as medians because the data were considered nonnormally distributed. It also identifies the 25th and 75th percentiles, which together define the interquartile range (IQR). In general, the median is the middle value after observations are ordered. The IQR describes the range containing the central half of observations and is less sensitive to extreme values than the full range. It conveys variability but does not, by itself, show uncertainty in the estimated median.
The registry reports an end-of-treatment median and quartile limits for each group. It does not provide a baseline-to-end change estimate or a confidence interval for the primary outcome. The outcome description refers to analysis of both baseline and end-of-treatment hormone concentrations, but the posted group summaries concern the reported serum testosterone outcome. No further detail about how baseline values entered the analysis is reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome summaries show a median serum testosterone concentration of 0.43 nmol/liter in the Acyline plus placebo group, with the 25th and 75th percentiles at 0.35 and 0.76. The corresponding summaries were 1.5 nmol/liter, with percentiles 0.79 and 4.9, for Acyline plus 15 IU hCG; 3.7 nmol/liter, with percentiles 1.0 and 8.5, for Acyline plus 60 IU hCG; and 8.4 nmol/liter, with percentiles 4.9 and 11.0, for Acyline plus 125 IU hCG. The Acyline plus testosterone gel group had a median of 16.0 nmol/liter, with percentiles 13.0 and 20.0.
These are group summaries, not individual participant values. The group sizes reported for the primary outcome were 6, 7, 5, 5, and 8, respectively. The quartile intervals differ in width across groups, indicating that the spread of observed values was not the same in each group. Because the record reports medians and quartiles rather than means and standard deviations, interpretations based on normal-distribution summaries would not match the displayed analysis.
The registry reports an ANOVA with p < 0.05 for the comparison involving the placebo hCG group and the three hCG dose groups. That result is evidence, under the assumptions of the reported test, against all four group means being equal. However, the registry also describes the outcome as nonnormally distributed and does not report the ANOVA details or a test statistic. It does not establish which specific pairs of groups differ, nor does it report a formal test of a dose-response trend. The testosterone gel group was not included in the stated ANOVA comparison.
The reported analysis is per protocol, so its summaries apply to participants meeting the stated completion and LH suppression conditions rather than necessarily to everyone randomized. That distinction matters: group comparisons in a selected analysis population may not have the same interpretation as comparisons among all randomized participants. The record does not report enough information to assess how selection into the per-protocol population affected group comparability.
The result is descriptive of short-term serum testosterone under the assigned regimens in this study. It does not quantify the effect on sperm production, establish longer-term hormonal outcomes, or address clinical contraception outcomes. No confidence interval for a treatment contrast is reported in the registry record, so the precision of between-group differences cannot be judged from a contrast interval.
9. Statistical Methods Explained
What do the group summaries convey?
The primary outcome is reported as medians with 25th and 75th percentiles because the registry describes the data as nonnormally distributed. In general, a median summarizes the center of an ordered set of observations without relying on a symmetric distribution. The two percentile limits give a sense of how dispersed the central observations are. They are not a confidence interval for the median, and they do not describe every observation or the full range.
For example, the listed group values give a median and two percentile limits, not an estimate of a treatment difference. A contrast between groups would require a defined comparison and an associated analysis. The registry record does not post a confidence interval for a difference in serum testosterone between any pair of groups. Without such an interval, the uncertainty around a particular contrast cannot be read directly from the quartile limits.
What does the reported ANOVA test?
The registry reports an analysis of variance (ANOVA) for the placebo hCG group and the three hCG dose groups, with p < 0.05. In general, an omnibus ANOVA tests whether there is evidence that at least one group mean differs from the others. It does not, by itself, identify which groups differ or establish a graded dose-response pattern. Follow-up comparisons or a prespecified trend test would be needed to answer those more specific questions; such details are not reported in the registry record.
ANOVA is commonly explained using a comparison of variation between groups with variation within groups. In general, its usual forms rely on assumptions about the outcome distribution and variance structure. The registry says the data were nonnormal and expressed as medians and percentiles, but does not identify a transformation, robust approach, or other adaptation used for the reported ANOVA. The exact model specification, test statistic, degrees of freedom, and diagnostic checks are not reported in the registry record. This limits assessment of how the reported analysis handled the stated nonnormality.
Why does over-dispersion matter?
In general, over-dispersion means that observed variation is greater than a model expects. When a method assumes less variation than is present, standard errors can be too small and uncertainty can be understated. That concern is especially relevant when outcomes are highly variable or group sizes are limited. The registry gives percentile limits that show substantial spread within some groups, but it does not report a formal assessment of over-dispersion or an alternative variance model. These general considerations do not establish that the analysis was biased; they explain why details of the method and its assumptions are useful.
What is the role of randomization and masking?
In general, random assignment is intended to reduce systematic differences between treatment groups at the time of assignment. It does not ensure that every observed group is identical, particularly in a small study or after restricting analysis to a selected subset. The registry lists randomization but does not describe sequence generation or concealment. It lists masking as none. Lack of masking can affect care, outcome assessment, or participant reporting depending on the outcome and study procedures; the record does not describe safeguards or whether serum measurement was performed without knowledge of group assignment.
The study used a parallel-group model, so each participant was assigned to a listed regimen. A parallel design compares outcomes across groups, but the interpretation depends on retaining the randomized groups and on handling missing outcomes and exclusions appropriately. The primary analysis is described as per protocol rather than as an analysis of all randomized participants. Details of the allocation-to-analysis flow and missing outcome handling are not reported in the registry record.
How should the p-value be read?
In general, a p-value describes how compatible the observed data are with a specified statistical null model, assuming the model and analysis assumptions are appropriate. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of a difference. The registry gives p < 0.05, not an exact p-value, confidence interval, or effect estimate for the reported omnibus test. Its result therefore conveys a thresholded significance statement, not the magnitude or precision of any pairwise contrast.
The group medians and percentile limits remain important alongside the p-value because they describe the observed outcome distribution. They should not be treated as proof that every pair of regimens differs. Nor should the p-value be read as a test of the testosterone gel group, which was not included in the reported analysis.
What can sample-size illustrations establish?
In general, a sample-size calculation estimates the number of participants needed under stated assumptions about an effect, significance level, allocation, and statistical model. A calculation based on an observed effect is a planning illustration, not observed power and not evidence that a trial was adequately designed. The registry record does not report the trial's own sample-size justification. No specific planning estimate is stated in the registry record, so no participant requirement can be inferred from the reported study results.
Overall, the registry describes a small-group, short-term analysis using medians and percentile summaries, alongside an ANOVA p-value for a subset of groups. The lack of contrast estimates, confidence intervals, and fuller model details restricts how specifically the inferential result can be interpreted.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| ANOVA | not reported | < 0.050 |
The registry reports the sponsor's analysis as an ANOVA across the Acyline plus placebo hCG, 15 IU hCG, 60 IU hCG, and 125 IU hCG groups, with p < 0.05. The testosterone gel group is not part of that stated analysis. The record does not give an effect estimate or confidence interval for the comparison, nor does it report which specific groups differ.
The posted outcome summaries are medians and percentile limits, while ANOVA is generally framed as a comparison of means. The registry does not explain the model specification or how the reported ANOVA accommodated the stated nonnormality. The p-value should therefore be read as the sponsor-reported omnibus result, not as a pairwise treatment effect or a quantified dose-response estimate.
No conflicting sponsor and recalculated result is identified in the registry record. The sponsor's reported analysis remains the relevant inferential result in the record; a separate recalculated contrast, if considered, would need to be distinguished from that analysis and interpreted according to its own assumptions. No such contrast estimate or interval is reported in the registry record.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists four outcome measures and reports no posted secondary outcomes. The primary outcome described in detail is serum testosterone. It reports one inferential analysis, an ANOVA involving four groups, but does not report whether other outcomes or comparisons were tested outside the posted results. The record does not state whether a multiplicity adjustment was planned or applied.
Multiplicity arises when several outcomes, time points, groups, or pairwise comparisons are tested. In general, conducting more tests can increase the chance of at least one statistically significant result under a setting where no effects exist. Whether and how this concern applies depends on the analysis plan and the family of tests considered. The registry record does not report a prespecified testing hierarchy, adjustment procedure, or complete list of analyses, so the overall multiplicity strategy cannot be assessed.
The primary outcome analysis was per protocol. Its described population consisted of participants who completed all study procedures and suppressed serum LH below the lower limit of normal. The registry does not report how many randomized participants failed those criteria, why they were excluded, or whether exclusions differed by group. It also does not report an intention-to-treat analysis or a comparison of results across analysis populations.
Missing data handling is not reported in the registry record. There is no description of whether any outcome values were missing, how missing values were treated, or whether sensitivity analyses were conducted. These omissions matter because a per-protocol analysis can be affected by who completes procedures and meets post-assignment criteria. The available summaries do not establish the direction or size of any resulting bias.
The protocol's sample-size justification, interim analyses, and fuller statistical analysis plan are not reported in the registry record. Without these details, it is not possible to determine what comparisons were prespecified, how the study planned to manage multiple analyses, or how its target enrollment related to the precision required for the primary question.
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 Plus Placebo | 0 | 6 | 0.0% |
| Acyline Plus 15 IU hCG | 0 | 7 | 0.0% |
| Acyline Plus 60 IU hCG | 0 | 5 | 0.0% |
| Acyline Plus 125 IU hCG | 0 | 5 | 0.0% |
| Acyline Plus Testosterone Gel | 0 | 8 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Acyline Plus Placebo | 1 of 6 |
| Acyline Plus 15 IU hCG | 1 of 7 |
| Acyline Plus 60 IU hCG | 3 of 5 |
| Acyline Plus 125 IU hCG | 2 of 5 |
| Acyline Plus Testosterone Gel | 1 of 8 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Acyline Plus Placebo | Acyline Plus 15 IU hCG | Acyline Plus 60 IU hCG | Acyline Plus 125 IU hCG | Acyline Plus Testosterone Gel |
|---|---|---|---|---|---|---|
| hot flashes | Endocrine disorders | 1 of 6 | 1 of 7 | 0 of 5 | 0 of 5 | 0 of 8 |
| dry itchy skin | Skin and subcutaneous tissue disorders | 0 of 6 | 0 of 7 | 0 of 5 | 0 of 5 | 1 of 8 |
| fatigue | General disorders | 0 of 6 | 0 of 7 | 1 of 5 | 0 of 5 | 0 of 8 |
| decreased libido | Endocrine disorders | 0 of 6 | 0 of 7 | 1 of 5 | 0 of 5 | 0 of 8 |
| testicular soreness | Reproductive system and breast disorders | 0 of 6 | 0 of 7 | 0 of 5 | 1 of 5 | 0 of 8 |
| syncope | Nervous system disorders | 0 of 6 | 0 of 7 | 1 of 5 | 0 of 5 | 0 of 8 |
| slight dizziness | Nervous system disorders | 0 of 6 | 0 of 7 | 0 of 5 | 1 of 5 | 0 of 8 |
The registry reports no serious adverse events in any of the listed groups. The numbers at risk for serious adverse events were 6 in the Acyline plus placebo group, 7 in the 15 IU hCG group, 5 in the 60 IU hCG group, 5 in the 125 IU hCG group, and 8 in the testosterone gel group. Each group's serious-event count was 0. No serious adverse event terms are listed.
These are counts from the study record, not evidence that the regimens have no serious risks. The study groups were small, and the registry record does not report further details about event definitions, monitoring duration, or how events were collected. It also does not give a death count; deaths are not reported in the registry record, which is different from a reported count of zero.
The registry separately reports other adverse events affecting 1 participant in the placebo group, 1 in the 15 IU hCG group, 3 in the 60 IU hCG group, 2 in the 125 IU hCG group, and 1 in the testosterone gel group. The record does not provide event terms or further detail for these counts. Serious and other adverse-event counts should not be combined, and the other-event counts do not indicate severity beyond the category used in the registry.
13. What the Result Does, and Does Not, Mean
The findings describe serum testosterone concentrations after 10 days in participants included in the per-protocol analysis. The posted medians differ across the listed regimens, and the registry reports an ANOVA result of p < 0.05 for the placebo hCG group and the three hCG dose groups. Those summaries and that test describe a short-term hormone outcome in this study population.
They do not establish how much testosterone is necessary to maintain sperm production. Sperm production is part of the study's broader purpose, but the posted primary outcome is serum testosterone. The result also does not establish contraceptive effectiveness, duration of hormonal effects, or longer-term safety. Those outcomes are not reported in the primary endpoint record.
The ANOVA p-value is an omnibus result and does not identify specific pairs with differences. The record does not report a formal dose-response test, a contrast estimate, or a confidence interval for the primary outcome comparison. The group medians and percentile limits describe the observed values, but they do not replace an estimate of the uncertainty in a between-group effect.
The reported analysis is restricted to participants who completed all study procedures and met a serum LH suppression condition. Thus, the result does not necessarily describe all randomized participants. The registry does not report the selection flow, missing data handling, or an intention-to-treat analysis, so the impact of those features cannot be determined from the record.
As a Phase 1 and Phase 2 randomized, unmasked study with small reported analysis groups and a 10-day outcome timeframe, it provides a focused short-term comparison. It should not be generalized beyond the measured outcome, study population, assigned regimens, and analysis population without additional evidence.
14. Why This Trial Matters Statistically
This trial illustrates how a statistical question can be narrower than a study's broader scientific motivation. The study summary describes interest in testosterone needed to maintain sperm production, while the primary outcome reported is serum testosterone over a 10-day period. Keeping those outcomes distinct prevents a hormone concentration from being mistaken for direct evidence about sperm production or contraception.
It also shows why a p-value and descriptive summaries answer different questions. The medians and percentile limits characterize observed group distributions. The reported ANOVA p-value addresses an overall comparison among four specified groups, but it does not give the size or precision of any pairwise difference. Reading both types of information together gives a more complete account of what the registry reports, while leaving the limitations of the analysis visible.
The per-protocol population is another important statistical feature. Restricting an analysis to participants who complete procedures and meet a post-assignment hormone criterion may change the population to which results apply. That does not establish that the reported analysis is invalid, but it makes details about exclusions, missing data, and the randomized population especially relevant.
Finally, the registry illustrates the value of transparent reporting. The listed group summaries and omnibus result provide useful information, but the record does not report a confidence interval for a contrast, a full model description, sample-size justification, or multiplicity plan. Such details help readers judge precision, assumptions, and the scope of inference without treating statistical significance as a measure of effect size.
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 primary analysis includes participants who completed all study procedures and suppressed serum LH below the lower limit of normal. The registry does not report the number screened, randomized, excluded, or missing from the analysis, or the reasons for any exclusions. This makes it difficult to assess how the per-protocol selection relates to the randomized groups.
Group sizes for the reported primary outcome were limited: 6, 7, 5, 5, and 8 across the five regimens. The record does not report confidence intervals for the group medians or for treatment contrasts. Consequently, the precision of individual group estimates and between-group differences is not quantified in the posted result.
The outcome is described as nonnormally distributed and summarized by medians and quartiles, but the reported inferential test is ANOVA. The registry does not explain the model specification, any transformation or robust method, or diagnostic assessment. It gives only the threshold p < 0.05, without a test statistic or further analysis details. The stated ANOVA covers the placebo hCG and three hCG dose groups, not the testosterone gel group.
The registry does not report baseline-adjusted contrasts, a formal dose-response analysis, multiplicity procedures, interim analyses, or a sample-size justification. Missing-data methods and an intention-to-treat analysis are also not reported. Because the outcome timeframe was 10 days, these results do not address longer-term hormone levels or outcomes outside the posted primary endpoint.
Safety reporting is limited to event counts. Serious adverse events are reported as zero in the listed groups, but deaths are not reported in the registry record, and event definitions and monitoring details are not provided. The other adverse-event counts have no event terms in the record. These reporting limitations do not establish that unreported events occurred; they constrain what can be concluded from the available information.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: HOP-3 Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone — NCT00839319.
- Registry record last updated 2016-01-11; status last verified 2015-12.
- Results first posted 2010-11-16.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
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19. Record Summary
The completed Phase 1 and Phase 2 study was randomized, unmasked, and parallel-group, with an enrollment of 59 healthy males. It compared Acyline plus placebo hCG, three Acyline plus hCG regimens, and Acyline plus testosterone gel. The primary outcome was serum testosterone in nmol/liter over 10 days, reported as medians and 25th and 75th percentiles.
The primary analysis was per protocol among participants who completed all procedures and suppressed serum LH below the lower limit of normal. The registry reports an ANOVA result of p < 0.05 for the placebo hCG and three hCG dose groups. It reports no serious adverse events in the listed groups and gives counts for other adverse events. Confidence intervals for contrasts, detailed missing-data methods, multiplicity procedures, and the study's sample-size justification are not reported in the registry record.