Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males (NCT02994602), a na phase 1 study. The primary outcome is Changes From Baseline (Cavg) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel.

2. Clinical Question

3. Trial Design

This completed phase 1 study is described as a two-center, open-label investigation in healthy male and female volunteers. Its focus was secondary exposure: male participants applied a combined Nestorone and testosterone gel to the shoulders or upper arms, and non-dosed female participants had supervised skin contact with the application site two hours later. The brief summary describes three single applications, on days 1, 8, and 15.

The study assessed whether washing or a clothing barrier altered exposure. The primary-outcome timeframe associates the T-shirt condition with day 1, the shower-and-dried condition with day 8, and the no-shower-or-T-shirt condition with day 15. These descriptions identify the conditions assessed, but the record does not describe a randomized order or a separate control group. Allocation is listed as not applicable, and the study model is single group.

Enrollment is listed as 26. The record separately identifies male and female subjects in its safety entries, while the primary endpoint population is female participants who completed the skin-contact types. It does not report the number of female participants contributing to each primary outcome measurement or give participant flow by condition.

The study began in 2017-01, had primary completion in 2017-06, and is marked completed. Its stated primary outcome is change from baseline in female serum testosterone levels, summarized as Cavg. The registry record lists additional outcomes concerning pharmacokinetics in males, hormone levels after application, adverse events, and hematology safety labs. It does not report the primary endpoint estimates, statistical analysis results, or a detailed statistical plan.

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: 13 partners were enrolled (13 females and 13 males); Planned enrollment was 24 but study enrolled 26 participants.

Overall Study

Analysis population for the primary outcome, as defined in the registry: includes female participants that completed the skin contact types

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: The analysis population includes 13 couples - 13 males and 13 females.

6. Primary Endpoint

The registry lists the primary outcome as Changes From Baseline (Cavg) for Serum Testosterone Levels in Females After Secondary Exposure to Nestorone + Testosterone Combination Gel, measured over Baseline and 48 hours after each intervention (day 1 for t-shirt, day 8 for shower and dried, and day 15 for no shower or t-shirt).

The primary endpoint is change from baseline in female participants’ serum testosterone levels, summarized as Cavg after secondary exposure to the combined gel. Cavg is described in the registry record as a mean of a continuous measure. The unit is ng/dL, and the stated dispersion measure is the standard deviation. The timeframe is baseline and 48 hours after each intervention.

Repeated hormone measurements can describe the level of a substance over a specified observation period rather than relying on a single reading. In general, a mean provides a summary of the measured values, while a standard deviation describes their spread around that mean. A change-from-baseline measure expresses the follow-up result relative to each participant’s baseline; interpretation depends on the actual values and on how the measure was calculated.

For this endpoint, the registry record says results were to be summarized for each of the three skin-contact types and that the population included female participants who completed those types. The record does not report the observed means, standard deviations, changes, confidence intervals, or other inferential results. It also does not provide further detail on the operational calculation of Cavg. Consequently, the endpoint’s definition can be described, but the size and precision of any observed change cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record describes a continuous primary outcome: changes from baseline in serum testosterone levels, summarized as Cavg and measured in ng/dL. A continuous outcome can take a range of values rather than being limited to categories. The record identifies the mean as the summary parameter and the standard deviation as the dispersion measure. The mean describes the central level of observed measurements; the standard deviation describes how dispersed individual measurements are around that mean. Neither summary is reported numerically for the primary endpoint.

What does change from baseline describe?

In general, a change-from-baseline analysis compares a follow-up measurement with a participant’s baseline measurement. It can help describe whether the measured quantity tends to be higher or lower after an exposure, while accounting for where measurements began. The precise interpretation depends on the calculation used, the timing of measurements, and the analysis population. The registry record states that changes were to be assessed through 48 hours after each intervention, but does not give the observed changes or further computational detail for Cavg.

The stated measurement schedule associates baseline and 48-hour follow-up with each intervention. The contact conditions were a T-shirt on day 1, showering and drying on day 8, and no shower or T-shirt on day 15. This repeated schedule makes timing and the relation between conditions important when interpreting any estimates. The registry record does not describe the order as randomized, nor does it report an analysis that accounts for repeated measurements or possible period effects.

How should uncertainty be understood?

In general, an estimate describes the observed data, while a confidence interval communicates the precision of an estimate under the assumptions of the statistical method. A narrower interval indicates greater precision than a wider interval, but neither interval width nor a p-value alone establishes whether a result is important in a clinical or practical sense. The registry record does not report a confidence interval or p-value for the primary endpoint, so its precision and inferential evidence cannot be assessed.

The standard deviation and a confidence interval answer different questions. The standard deviation describes variation among measurements; a confidence interval describes uncertainty around an estimated quantity. The record names standard deviation as the dispersion statistic, but does not state a confidence-interval method for the primary endpoint. No unadjusted or adjusted recalculation is reported, and there is no sponsor analysis result in the registry record to compare with a recalculation.

What does the design imply for comparisons?

The study model is single group, masking is listed as none, and allocation is not applicable. These features mean the record does not present the study as a randomized comparison. The three skin-contact conditions are relevant exposure circumstances, but the record does not identify a separate control arm or report a between-group treatment estimate. Open-label conduct means participants and study personnel were not masked according to the registry entry; the record does not explain whether or how that could affect outcome measurement.

In general, comparisons across repeated conditions may be affected by differences in timing, participant completion, and measurement availability. A within-participant analysis can account for some stable participant characteristics, but whether that approach was used is not reported in the registry record. The outcome population is defined as female participants who completed the skin-contact types; the record does not give the number contributing to each condition, exclusions, or a missing-data method.

What can the planning assumptions tell readers?

The record describes a sample-size planning illustration based on the observed effect. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. These are assumptions for an illustration, not a reported statistical plan for this single-group study. The numerical planning results and the effect used in the illustration are not reported in the registry record. Such illustrations are not observed power and do not show what the trial demonstrated.

More generally, over-dispersion means that variability is greater than a model assumes. When that occurs, standard errors from the simpler model can understate uncertainty, and inference may be unreliable. The registry record does not report an over-dispersion assessment or say that such a model was used. It would be inappropriate to infer a specific distributional issue or model choice from the endpoint definition alone.

The record lists 24 outcome measures and zero analyses. It does not report the statistical tests, model specifications, adjustment variables, analysis software, missing-data procedures, or multiplicity strategy. As a result, the endpoint description allows readers to understand what was intended to be measured, but not to reconstruct the analysis or judge its assumptions from the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 24 outcome measures, including the primary serum testosterone endpoint and secondary outcomes related to male pharmacokinetics, hormone levels after application, adverse events, and hematology safety labs. When a study evaluates multiple outcomes or comparisons, the chance of at least one apparently unusual result can increase. Statistical methods for handling multiplicity can help address that issue, but the record does not report a multiplicity procedure, a hierarchy among secondary outcomes, or which comparisons were designated for confirmatory inference.

The record lists zero analyses. It gives no primary endpoint estimate, p-value, confidence interval, or analysis model. Accordingly, no adjustment or unadjusted analysis can be evaluated, and no conclusion about statistical significance is available from the registry record.

The primary outcome population is described as female participants who completed the skin-contact types. The record does not report how many participants had complete measurements for each condition, whether all enrolled participants were included in the primary analysis, or how participants with missing measurements were handled. It does not report reasons for missing data, imputation methods, or sensitivity analyses. The distinction between an intended population and the participants contributing observed measurements therefore cannot be examined.

The registry record also does not report a detailed statistical analysis plan, interim analyses, or sample-size justification. The planning illustration’s assumptions do not establish that they were used to design or analyze this study. Without outcome-level results and analysis details, readers cannot assess multiplicity control, missing-data sensitivity, or the robustness of the primary endpoint analysis.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 3% reporting threshold.

Most frequent non-serious adverse event terms

The safety entries distinguish serious adverse events from other adverse events. For the overall Nestorone and testosterone combined-gel group, the record lists 0 serious adverse events among 26 at risk and 6 other adverse events among 26 at risk. The male-subject entry lists 0 serious adverse events among 13 at risk and 1 other adverse event among 13 at risk. The female-subject entry lists 0 serious adverse events among 13 at risk and 5 other adverse events among 13 at risk. No deaths are listed in these entries.

The overall group and the sex-specific entries are separate registry entries, so their counts should not be added together. The record does not provide event descriptions for the other adverse events in this summary or report event timing, severity, relatedness, or participant-level overlap. The count of zero serious adverse events is a descriptive observation in the listed groups, not proof that serious events could not occur or a comparison against another treatment. Safety interpretation is limited to the information recorded.

12. What the Result Does, and Does Not, Mean

This study addresses a focused exposure question: whether serum testosterone levels in female participants changed after skin contact with sites where male participants had applied a combined Nestorone and testosterone gel. The registry record describes contact under a T-shirt condition, after showering and drying, and without showering or a T-shirt. It specifies a baseline and follow-up timeframe through 48 hours after each intervention.

What the record does not provide is the observed primary endpoint result. There are no reported condition-specific changes, means, standard deviations, or uncertainty estimates. Readers therefore cannot determine from the registry record whether values rose, fell, or remained similar, nor how precisely any estimate was measured. The descriptions of the intended measurements should not be mistaken for evidence of a particular outcome.

The study’s open-label, single-group design also limits the kinds of comparisons represented. Allocation is listed as not applicable, and no separate control group is described. The contact conditions do not constitute a randomized comparison in the registry record. A measured difference between conditions, if available, would need to be interpreted in light of timing, participant completion, and the analysis used; those results and details are not reported.

The safety entries report no serious adverse events in the listed groups, alongside counts of other adverse events. These descriptive figures do not establish a comparative safety profile. The registry record does not provide the clinical detail needed to interpret the other events or determine how outcomes differed by exposure condition.

In general, a registry record can describe a study’s purpose, design, and planned outcomes without providing enough results for a statistical conclusion. Here, the endpoint definition is informative about what investigators intended to measure, but the absence of reported primary outcome estimates prevents assessment of effect size, precision, or statistical evidence. No claim that the gel does or does not produce a particular effect follows from the information recorded.

13. Why This Trial Matters Statistically

The study is statistically notable for separating the question of primary exposure in male users from secondary skin exposure in female contacts. Its primary endpoint is framed around female serum testosterone after contact with an application site, while the record also lists pharmacokinetic and safety outcomes in male and female participants. This makes the endpoint population and exposure timing central to interpretation.

The three described contact circumstances are practically distinct: a T-shirt condition, showering and drying, and no shower or T-shirt. Statistically, however, distinct conditions do not automatically create a controlled comparison. The record identifies a single-group, open-label study and does not describe randomized allocation or a separate control group. Readers need to distinguish the study’s exposure conditions from a randomized treatment contrast.

The registry record also illustrates why endpoint definitions and endpoint results are different kinds of information. It specifies Cavg, the unit, dispersion measure, follow-up timeframe, and population, but does not report the observed primary values or analyses. Without estimates and uncertainty, neither the magnitude nor precision of the primary outcome can be evaluated. The presence of a detailed measurement definition does not resolve that gap.

Finally, this record includes a planning illustration whose assumptions refer to equal allocation between two arms, while the registered design is single group. Such an illustration should not be treated as the study’s own design justification or as a measure of observed power. The distinction highlights the importance of interpreting planning calculations in the context of the actual design. The posted information is useful for understanding the research question, but does not support a quantitative conclusion about the primary outcome.

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 primary limitation for interpretation is that the registry record does not report the primary outcome results. It provides no numerical changes from baseline, condition-specific means, standard deviations, confidence intervals, or p-values. The record lists 24 outcome measures and zero analyses, leaving no reported inferential analysis to assess.

The design is described as open-label and single group, with allocation not applicable. The registry record does not identify a separate control group or describe randomized ordering of contact conditions. Consequently, it does not support a randomized between-group interpretation. The listed conditions also occur on different days, but the record does not explain how timing or order was handled analytically.

The primary endpoint population includes female participants who completed the skin-contact types. The record does not report the number with usable outcome measurements for each condition, participant flow, reasons for non-completion, or methods for handling missing data. It also does not provide enough detail to assess whether all scheduled measurements were collected or how Cavg was calculated.

Other unreported analysis details include the statistical model, inferential procedure, multiplicity strategy, adjustment variables, and sensitivity analyses. The registry record does not report an interim analysis or a detailed statistical analysis plan. The sample-size assumptions are described as a planning illustration, not as the trial’s own design justification, and the numerical illustration is not reported.

Safety interpretation is also limited: the record gives counts for serious and other adverse events, but does not report event descriptions, timing, severity, relatedness, or participant-level overlap. These omissions prevent a fuller assessment of the results and their precision.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males — NCT02994602.
• Registry record last updated 2026-02-09; status last verified 2018-02.
• Results first posted 2026-02-09.
• 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.

18. Record Summary

NCT02994602 is a completed phase 1, open-label, single-group study of secondary exposure to a combined Nestorone and testosterone gel. Male participants applied the gel to the shoulders or upper arms, followed by supervised skin contact by non-dosed female participants two hours later. The study assessed contact conditions involving a T-shirt, showering and drying, and no shower or T-shirt.

The primary endpoint was change from baseline in female serum testosterone Cavg, measured in ng/dL through 48 hours after each intervention. Enrollment is listed as 26; the primary population is described as female participants who completed the contact types. The registry record lists 24 outcome measures and zero analyses, but does not report the primary endpoint results. Safety entries list no serious adverse events in the overall or sex-specific groups and also report other adverse events.