Safety Study of a Sensitive Sensual Touch and Personal Lubricant: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety Study of a Sensitive Sensual Touch and Personal Lubricant (NCT01271036), a na na study. The primary outcome is Number of Participants With Physical Irritation Scores.

2. Clinical Question

3. Trial Design

This was a completed, single-center safety evaluation of Formula PD-F-7716. The official title describes medical supervision and couples, while the study summary says the lubricant was used in-home for one week by subjects who perceived themselves as having sensitive skin. Enrollment is listed as 124. The intervention description specifies applying a dime-size amount at each application site as instructed during the study period.

The registry record identifies a single-group model, no masking, and allocation as not applicable. It does not describe a randomized comparison or a separate control arm. The male and female categories in the safety data are not like-for-like treatment arms; the record presents both within this single-group safety study. Accordingly, those categories should not be interpreted as randomized groups or as a treatment-versus-control contrast.

The primary outcome was assessed after one week and measured the number of participants with physical irritation scores. A score of 0 at baseline was required for inclusion, so the investigators treated any later score as a change from baseline. The population for the endpoint is called the Full Analysis Set, but its membership and rules are not reported in the registry record.

The registry lists the study as completed, with a start date of 2010-12 and primary completion in 2011-01. The phase is recorded as NA. The record does not report a protocol rationale for the enrollment target, a sample-size justification, or a detailed statistical analysis plan. It lists 0 analyses. As a result, design features such as planned handling of missing observations, analysis sets beyond the named endpoint population, and any prespecified statistical comparisons cannot be established from this 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: Only one IP was used per couple in this single-arm study. At baseline (visit 1), all qualified subjects received the IP for use per protocol.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Full Analysis Set

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: Full Analysis Set

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Physical Irritation Scores, measured over One week.

The primary endpoint is the number of participants with physical irritation scores after one week. An Investigator rated physical irritation on a scale from 0, no irritation, to 6, presence of lesions. The registry record also says categorical severity was recorded. It does not provide the categories’ definitions or the observed endpoint count.

Requiring a baseline score of 0 means that a nonzero score at follow-up represents a change from the eligible baseline state. This makes the outcome useful for describing whether physical irritation was recorded after product use among participants who began with no physical irritation score. It does not, by itself, establish that the product caused any later finding: without a concurrent control group, changes over time cannot be separated from other possible explanations.

Counting participants with an event is a straightforward way to report how often an outcome was observed. The count should be interpreted together with its denominator and the way the event is defined. Here, the endpoint description names the Full Analysis Set, but the registry record does not report the number analyzed, missing-outcome handling, or the primary result. Therefore, the endpoint’s intended meaning can be described, but its observed frequency and precision cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record identifies a single-group study with allocation recorded as not applicable and masking recorded as none. These design labels describe the absence of a randomized, masked comparison in the registry. In general, random allocation can help make comparison groups similar with respect to both measured and unmeasured factors. A single-group design does not offer that protection through a concurrent comparator. Consequently, observed changes can be described, but a causal comparison with an alternative treatment or no treatment is not available from this design.

What does the baseline requirement contribute?

Eligibility required a baseline physical irritation score of 0. The primary outcome description treats any score after one week as a change from baseline. This is a baseline-controlled feature in the limited sense that the endpoint is anchored to a recorded starting state. It clarifies what counts as a new finding for the eligible participants. It is not equivalent to a control group: all participants received the same intervention, and the registry does not identify a parallel group that did not receive it.

In general, baseline measurements help define change and may provide context for follow-up observations. Their usefulness depends on consistent measurement and on knowing which participants contributed each measurement. The record does not describe the scoring procedures in detail, assessor training, blinding of the Investigator, or rules for resolving uncertain scores. Since masking is recorded as none, the record does not indicate that treatment knowledge was concealed from assessors.

How should the primary endpoint be understood?

The endpoint is a participant count: the number of people with physical irritation scores after one week. The underlying severity scale runs from 0, no irritation, to 6, presence of lesions. The record says categorical severity was also recorded, but does not report the category definitions or the observed values. A count endpoint answers how many participants met the event definition within the analyzed population. It does not communicate severity distribution unless those categories are also reported.

For a binary event outcome, the event definition should be explicit and applied consistently. Here, the description indicates that any post-baseline score above the required baseline score of 0 represents a change. However, the record does not state whether the endpoint count includes every nonzero score, how incomplete assessments were treated, or whether the count is based on the worst score or another summary across application sites. Those details are not reported in the registry record and should not be inferred.

What does uncertainty mean for these results?

In general, a confidence interval describes a range of values compatible with the observed data under a specified statistical method. It helps readers assess estimation precision rather than relying on a point estimate alone. The registry record does not report a primary endpoint estimate or confidence interval, so precision cannot be judged. A p-value tests a specified statistical hypothesis under stated assumptions; without a reported analysis or comparison, there is no primary p-value to interpret.

For count outcomes, the denominator and analysis population are essential context. The endpoint names the Full Analysis Set, but the registry record does not define this population or state how many participants contributed to the primary outcome. The enrollment figure does not establish the number analyzed. General statistical practice distinguishes enrollment from the analysis denominator because participants can have incomplete follow-up or unavailable measurements. The record does not report participant flow or missing-outcome handling.

What does over-dispersion mean in general?

For count data, a statistical model may assume a particular degree of variability. Over-dispersion means the observed variability is greater than that assumed by a model, which can make standard errors too small and confidence intervals too narrow if it is ignored. This is a general consideration for count analyses, not a claim about this trial: the registry record does not report a count model, dispersion estimate, or model-based analysis. The primary measure is a number of participants with an event, and no analysis method is listed.

How should planning illustrations be read?

Sample-size illustrations are planning calculations, not observed results and not observed power. The record describes the illustrations as based on the observed effect and specified assumptions, rather than as the study’s own design justification. It does not report a prospective sample-size rationale. Because the trial is single-group and does not provide a like-for-like control comparison, a planning illustration that assumes two arms should not be mistaken for evidence that the trial made such a comparison. General sample-size calculations depend on assumptions about the effect to detect, allocation, significance level, and analysis method; their interpretation is limited when those assumptions do not match the study design.

The registry lists 0 analyses. Thus, the statistical methods actually used for the primary endpoint, secondary outcomes, and safety counts are not reported in the registry record. No adjustment strategy, model diagnostics, or sensitivity analysis can be attributed to the investigators based on this record.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary endpoint and four secondary outcomes: subjective irritation at two genital application sites and two neck application sites. The record does not state whether these outcomes were tested as a family, whether a hierarchy was prespecified, or whether any multiplicity adjustment was used. In general, testing multiple outcomes can increase the chance that at least one result appears noteworthy by chance. An adjustment or a prespecified outcome hierarchy can help address that issue, but neither is reported.

The record names the Full Analysis Set for the primary endpoint, but does not define how participants entered that set. It also does not report whether the secondary outcomes used the same analysis population. The number enrolled is not necessarily the number with complete outcome measurements, so enrollment should not be substituted for an analysis denominator.

Missing-data procedures, reasons for missingness, participant flow, and any imputation or sensitivity analyses are not reported in the registry record. In general, missing observations can affect both the estimate and its uncertainty, particularly if the likelihood of missingness is related to participants’ outcomes. Without a description of missingness and its handling, the effect of incomplete data cannot be assessed.

The registry lists 0 analyses and does not report a statistical analysis plan. It is therefore not possible to determine whether outcome definitions, analysis populations, multiplicity handling, and missing-data procedures were specified before results were examined.

11. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry’s safety fields list male and female categories, with 62 at risk in each. The recorded serious-event count is 0 for male participants and 0 for female participants. The other adverse-event counts are 7 for male participants and 17 for female participants. These are counts, not comparative estimates, and should be read within the single-group study design.

The categories do not represent randomized treatment arms. The counts alone do not show whether events were considered related to the product, how long participants were observed for each event, or how the events were defined and collected. The registry record does not report those details. Nor does it provide additional descriptions of the listed other events, so their nature and clinical importance cannot be determined from the counts.

Deaths are not reported in the registry record. This is different from a reported death count of 0, and the record should not be interpreted as establishing that no deaths occurred. The safety figures provide limited descriptive information; they do not establish comparative safety or support a causal conclusion.

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

The record establishes that Formula PD-F-7716 was evaluated in a completed, single-center, one-week safety study. The study summary describes in-home use among people who perceived themselves as having sensitive skin, and the primary endpoint concerns physical irritation scores after one week. A score of 0 was required at baseline, and the primary description treats any later score as a change from baseline.

The record does not report the primary outcome count, its severity distribution, or an uncertainty estimate. As a result, the central endpoint cannot be quantitatively interpreted from the registry record. The safety fields do report serious-event counts of 0 in both sex categories, and other adverse-event counts of 7 for male participants and 17 for female participants. Those counts are descriptive and lack the event detail needed to judge attribution, timing, or clinical significance. They also do not constitute a randomized comparison.

A before-and-after observation without a concurrent control can describe what was recorded during use, but cannot isolate the product’s effect from other possible causes of change. The baseline score requirement helps define a new irritation finding among eligible participants; it does not solve the absence of a comparator. In general, causal interpretation relies on a design and analysis capable of distinguishing treatment effects from other explanations.

The registry record also does not describe the analysis methods, missing-data handling, or multiplicity strategy. These omissions limit assessment of robustness and precision. Sample-size planning illustrations should be understood as planning calculations under their stated assumptions, not as observed power or as trial results. The record does not provide a prospective sample-size justification.

Thus, the available information supports a restrained account of the study design and the reported safety counts. It does not establish the frequency of the primary physical irritation outcome, a treatment effect, a comparison with an alternative, or a definitive safety conclusion.

13. Why This Trial Matters Statistically

This trial illustrates the difference between a defined outcome and a reported result. The registry provides a clear broad description of the primary measure: the number of participants with physical irritation scores after one week, with a baseline score of 0 required. Yet it does not report the observed primary count or severity categories. A careful statistical reading must keep endpoint definition separate from evidence about what occurred.

It also demonstrates why design determines the questions that can be answered. A single-group, unmasked study can describe observations during product use, but it cannot offer the same controlled treatment contrast as a randomized comparison. The baseline requirement clarifies what constitutes a change for eligible participants, but does not supply a counterfactual. This distinction is especially important when a safety study is read as evidence about causation rather than as a description of recorded events.

The safety counts show another important principle: counts need context. The registry lists male and female categories, but those categories are not treatment arms. Differences between the reported other-event counts should not be treated as comparative effects. Denominators, event definitions, observation procedures, and attribution are all relevant to interpretation, and several of those details are not reported in the registry record.

Finally, the record lists no analyses and leaves key methods undocumented, including missing-data and multiplicity handling. These omissions are not a reason to invent methods or conclusions. They are a reason to distinguish what the registry documents from what cannot be assessed. That discipline is central to transparent clinical biostatistics.

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 endpoint result is not reported in the registry record. Although the endpoint definition and timeframe are described, the observed number of participants with physical irritation scores and the categorical severity results are absent. No confidence interval or other measure of uncertainty is reported, so the precision of the primary finding cannot be assessed.

The single-group design offers no concurrent control comparison. The required baseline score of 0 makes later nonzero scores interpretable as a change from baseline for eligible participants, but cannot establish that product use caused a change. Masking is recorded as none, and the registry does not describe whether outcome assessors were otherwise shielded from treatment knowledge.

The record does not define the Full Analysis Set or report the number contributing to the primary endpoint. Participant flow, incomplete assessments, reasons for missing data, and missing-data methods are not reported. The endpoint description also does not clarify how repeated assessments or application sites were combined into the participant count.

Methods for analyzing the primary and secondary outcomes are not reported, and the record lists 0 analyses. It also does not state how the four secondary irritation outcomes were handled for multiplicity. The safety fields give limited counts without event descriptions, timing, attribution, or collection details. Deaths are not reported in the registry record. These limitations constrain both quantitative interpretation and assessment of the completeness of safety reporting.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Safety Study of a Sensitive Sensual Touch and Personal Lubricant — NCT01271036.
• Registry record last updated 2014-03-04; status last verified 2013-09.
• Results first posted 2014-03-04.
• 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

The registry record describes a completed, single-center, medically supervised, single-group safety evaluation of Formula PD-F-7716. The study summary describes one-week in-home use among people who perceived themselves as having sensitive skin. Enrollment is listed as 124, and the primary endpoint population is identified as the Full Analysis Set.

The primary outcome was the number of participants with physical irritation scores after one week, measured on a scale from 0 to 6. A baseline score of 0 was required. The registry record does not report the primary outcome result, severity categories, or statistical analysis. It lists four secondary subjective-irritation outcomes and 0 analyses.

Safety fields report 0 serious events in each of the male and female categories, and other adverse-event counts of 7 and 17, respectively. These categories are not randomized arms. The record does not report deaths, event attribution, missing-data methods, or a multiplicity strategy.