Safety Study for an All-in-One Body and Personal Lubricant: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety Study for an All-in-One Body and Personal Lubricant (NCT01189617), a na na study. The primary outcome is Number of Subjects With Irritation Score of "0" at Baseline and One Week.

2. Clinical Question

The study asked whether participants had an irritation score of 0 at baseline and one week after using Formula PD-F-7619. The registry describes the study as a one-week safety evaluation during in-home use, rather than a comparison of the product with another treatment or a control product.

The clinical question is therefore narrow: it concerns a recorded irritation score after a brief period of instructed product use. It does not, by itself, address comparative effects, longer-term use, or outcomes beyond the listed irritation measure and safety counts. Those questions require information not reported in the registry record.

3. Trial Design

The registry lists NCT01189617 as a completed, single-center, medically supervised safety evaluation. Enrollment was 70. The study began in 2010-06, and primary completion was also recorded as 2010-06. Its stated purpose was to examine safety during one week of in-home use of an all-in-one body and personal lubricant product.

The design is listed as single group, with allocation NA and no masking. These entries describe a study without a randomized parallel-group comparison. The product intervention is Formula PD-F-7619. The instructions specify use at least twice per week for one week, applying about a dime-sized amount to the application site as directed.

The primary outcome is a participant count, not a continuous measurement or time-to-event outcome. It concerns participants with an irritation score of 0 at baseline and one week. Irritation severity is described on a scale from 0, meaning no irritation, to 6, meaning presence of lesions. The registry states that score 0 at baseline was required for inclusion and calls the endpoint baseline-controlled.

The primary outcome population is named as the Full Analysis Set. How that set was defined, and how participants with incomplete outcome data were handled, are not reported in the registry record. The record lists one outcome measure and no analyses. It does not report a protocol-specific sample-size justification, a statistical analysis plan, or details of any interim analysis. The sponsor is Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

Because there is no concurrent control group, outcomes should be read as observations from participants who used the product under the stated instructions, not as a head-to-head treatment contrast. A baseline score of 0 provides a reference condition for the endpoint, but does not supply the information that a randomized control group would provide.

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.

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 Subjects With Irritation Score of "0" at Baseline and One Week, measured over Baseline and One Week.

The primary endpoint is the number of participants with an irritation score of 0 at both baseline and one week. The irritation scale ranges from 0, no irritation, to 6, presence of lesions. The registry states that a baseline score of 0 was required for inclusion. Thus the recorded endpoint is intended to describe whether participants who entered with no irritation retained a score of 0 at the one-week assessment.

A participant count is a binary-outcome summary: each participant either meets the stated score criterion or does not. Counts can be useful for a safety evaluation because they express the number of people meeting a defined condition, rather than averaging scores in a way that could obscure how many participants experienced a change. The registry names the Full Analysis Set as the endpoint population, but its membership rules are not reported in the registry record.

The registry describes this endpoint as a change-from-baseline measure and calls the trial baseline-controlled. That wording indicates a baseline reference, not a separate untreated or active comparator group. No endpoint count, proportion, confidence interval, or statistical test result is reported in the registry record. Consequently, the endpoint definition can be described, but the observed one-week irritation outcome cannot be quantified from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a participant count represent?

General: A binary outcome assigns each participant to one of two categories according to a defined criterion. A count reports how many participants meet that criterion. For the primary outcome in this study, the criterion is an irritation score of 0 at baseline and one week. The registry labels the outcome parameter as a number of participants. It does not report the observed count, so neither the number meeting the criterion nor the number not meeting it can be stated.

General: A count is most informative when its denominator and analysis population are clear. The registry names the Full Analysis Set for the primary outcome, but does not define which enrolled participants belong to that set. The enrollment count is 70, while the outcome denominator is not reported in the registry record. Enrollment and analysis-population size should not be treated as interchangeable unless the analysis population is explicitly described.

What does baseline control mean in this record?

General: A baseline measure records status before or at the start of an intervention period. When participants are selected based on a baseline criterion, a subsequent measurement can describe whether that status is retained or changes. This is different from a concurrent control group, in which outcomes under another assigned condition provide a comparison. In this study, baseline score 0 was required for inclusion, and the registry calls the endpoint baseline-controlled. The listed design remains single group, with allocation NA and no masking.

General: Baseline referencing can make an outcome easier to interpret for a selected population, but it does not remove all uncertainty about why a later observation occurred. A single-group result is descriptive of the participants and study conditions. Without a concurrent comparator, the design does not estimate a between-group difference.

How should uncertainty be assessed?

General: A confidence interval expresses the range of values compatible with an estimate under a statistical model and its assumptions. For a participant count or an event proportion, the interval helps convey how precisely the underlying event frequency has been estimated. A small study can yield imprecise estimates even when the observed count appears straightforward; the degree of precision depends on the data and method used.

No confidence interval for the primary endpoint is reported in the registry record. Without the endpoint count and denominator, no interval can be interpreted or reconstructed from the registry information. The record also lists no analyses, so no test statistic or p-value for the primary outcome is reported.

What role would a statistical test have?

General: A hypothesis test evaluates data relative to a stated null hypothesis and assumptions. A p-value describes how unusual data at least as incompatible with that null hypothesis would be if the null model held. It does not measure the probability that a treatment works, and it does not communicate the size or practical importance of an effect. Interpretation requires the test, hypothesis, estimate, and uncertainty to be considered together.

The registry record does not report a primary-outcome test or a statistical analysis plan. It is not possible to determine which null hypothesis, if any, was used, or whether an adjusted or unadjusted analysis was planned. No test should be inferred from the outcome title or study design.

How do the planning assumptions differ from trial results?

General: Sample-size calculations are planning exercises based on assumptions about an effect, variability or event frequency, significance level, power, and design. They are not evidence that a study observed the assumed effect, and a retrospective calculation is not observed power. Planning illustrations can be useful for showing how assumptions affect a hypothetical design, but they do not replace the trial’s actual analysis.

The registry describes planning-illustration assumptions based on a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect defined as a stated fraction of the observed effect. It also distinguishes event totals for time-to-event calculations from participants per arm for other calculations. These are described as planning illustrations, not as the study’s own design. The actual study is listed as single group, and the primary outcome result needed to anchor an observed-effect illustration is not reported in the registry record. No numerical planning result or sample-size justification for the trial is reported in the registry record.

Why can over-dispersion matter?

General: Over-dispersion occurs when outcome variability is greater than a statistical model assumes. If a model understates variability, standard errors may be too small and confidence intervals too narrow. The relevance of over-dispersion depends on the outcome type and analysis model. This registry describes a binary participant-count endpoint, but does not report an analysis model or variance estimate. There is therefore no basis to claim that over-dispersion was assessed or affected an analysis.

For this study, the most important methodological distinction is between an endpoint definition and an endpoint result. The definition specifies what would be counted; the result would report the observed count and, where analyzed, its uncertainty. The registry supplies the former but does not report the latter. Statistical interpretation must remain within that boundary.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure, identified as the primary irritation endpoint, and lists no analyses. It does not report whether the study had additional planned endpoints outside the posted outcome record, whether multiple time points or subgroups were tested, or whether any multiplicity adjustment was planned. A multiplicity strategy is therefore not reported in the registry record. No claim can be made that testing was adjusted, or that adjustment was unnecessary.

The registry names the Full Analysis Set as the primary endpoint population, but does not define it. The record does not state how many participants contributed endpoint data, whether all enrolled participants were included, or how missing one-week assessments were handled. It does not describe imputation, exclusion rules, sensitivity analyses, or a missing-data assumption. These details are not reported in the registry record.

Missingness can affect interpretation when participants without follow-up differ from those with observed outcomes. General: Complete-case summaries describe participants with available measurements, while imputation or other approaches rely on assumptions about unobserved outcomes. The choice should be specified and assessed in relation to the design and endpoint. No such approach can be attributed to this study from the registry entry.

Because the primary result itself is not reported in the registry record, the impact of missing data and the population represented by any estimate cannot be evaluated. The named analysis population and the absence of reported analysis details should be kept distinct: naming a population does not explain its definition or establish how missing observations were treated.

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 safety summary separates serious adverse events from other adverse events and lists male and female groups. For the male group, 35 participants were at risk for serious adverse events and 0 were affected; 35 were at risk for other adverse events and 2 were affected. For the female group, 35 were at risk for serious adverse events and 0 were affected; 35 were at risk for other adverse events and 2 were affected.

These are descriptive counts within the study groups. The study is listed as single group, so the sex categories are not product and control arms. The counts do not provide a randomized comparison, and the registry summary does not describe the two other adverse events in each group. The top serious-event terms list is empty. Death counts are not reported in the registry record.

General: A zero count means that no affected participants are recorded in that category in the posted summary; it does not establish that an event is impossible or that risk is absent. Safety interpretation also depends on follow-up duration, event definitions, completeness of ascertainment, and the number of participants observed. The registry describes one week of use, but does not report further detail on event collection or adjudication. The serious-event figures should therefore be read as reported counts, not as proof of no safety risk.

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

The registry record documents a completed, single-group safety evaluation of Formula PD-F-7619 during one week of in-home use. It defines a primary irritation outcome based on a score of 0 at baseline and one week and reports serious and other adverse-event counts for male and female groups. Those features describe what the study was designed to observe and what safety counts were posted.

The record does not report the primary outcome count, an estimate of its precision, or an inferential analysis. It therefore does not establish how many participants maintained a score of 0 at one week or how variable that outcome was. The adverse-event entries show 0 affected participants for serious events in each listed group and 2 affected participants for other events in each group. These counts are limited to the registry summary and its stated study context.

General: A single-group study can describe observed outcomes among participants who used an intervention under specified conditions. It cannot, by itself, separate an intervention-associated change from other influences over time. A baseline reference is informative about participants’ starting status but is not equivalent to a concurrent control group. This distinction is particularly important when the outcome is a change from a required baseline condition.

The study record does not provide enough information to assess longer-term outcomes, comparative effects, or results for populations beyond the enrolled participants. It also does not report the endpoint analysis denominator, missing-data handling, or the rationale for the chosen enrollment. Those omissions limit assessment of precision and generalizability.

Accordingly, the posted information supports a description of the study design, endpoint definition, and reported safety counts. It does not support a quantitative interpretation of the primary irritation result or a causal comparison with another condition. The absence of a reported result is not itself evidence of a particular outcome.

13. Why This Trial Matters Statistically

This study illustrates a useful distinction in clinical biostatistics: an outcome can be precisely defined in a registry even when its observed result is not reported. Here, the endpoint specifies a participant count tied to an irritation score of 0 at baseline and one week. That definition tells readers what was intended to be measured, but it does not reveal the count, its denominator, or the uncertainty around it.

The design also makes clear why baseline control and a control group are not interchangeable ideas. Requiring score 0 at baseline creates a common starting criterion for the primary endpoint. It does not create a parallel group that represents what would have happened under a different condition. Statistical descriptions of within-group outcomes and causal comparisons answer different questions.

The registry’s safety entries offer another practical lesson. Counts should be read with their at-risk group and event category in view. A recorded zero for serious adverse events is a statement about the posted count, not a general guarantee about safety. Likewise, counts for other adverse events need event descriptions and ascertainment context to support deeper interpretation; those details are not reported in the registry record.

Finally, the record demonstrates why analysis-population definitions and missing-data procedures matter. The Full Analysis Set is named, but its rules and the handling of missing endpoint observations are not reported. Without those details, readers cannot fully assess who contributed to an estimate—even if an estimate were available. Clear reporting of outcomes, denominators, uncertainty, and analysis decisions is essential for evaluating a clinical study statistically.

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 has several limitations specific to interpreting this study. Most importantly, it does not report the primary endpoint result. The number of participants with an irritation score of 0 at baseline and one week, the analysis denominator, and any uncertainty measure are not reported in the registry record. This prevents quantitative evaluation of the primary question.

The study is listed as single group, with allocation NA and no masking. There is no concurrent comparator arm described, so the posted design does not support a direct comparison with another product or condition. The baseline criterion helps define the population and endpoint but does not resolve the absence of a parallel comparator.

The registry names the Full Analysis Set but does not define it. The number of participants with follow-up data, reasons for missing assessments, and methods for handling missing data are not reported in the registry record. The statistical analysis plan, endpoint analysis method, and any multiplicity approach are also not reported.

The study period is described as one week, and the instructions specify use at least twice per week. The registry does not provide evidence about outcomes beyond that period. It also does not provide further participant characteristics or detailed descriptions of the other adverse events listed in the safety summary. Death counts are not reported in the registry record.

Finally, the record does not report the trial’s sample-size justification or a primary-outcome analysis. Planning assumptions described for illustrations should not be mistaken for a protocol-specific design rationale or observed result. These limits mean the available record supports a narrow account of design and posted safety counts, rather than a complete statistical assessment of the primary endpoint.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Safety Study for an All-in-One Body and Personal Lubricant — NCT01189617.
• Registry record last updated 2017-02-27; status last verified 2017-01.
• Results first posted 2014-01-10.
• 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

NCT01189617 is listed as a completed, single-center safety evaluation of Formula PD-F-7619, an all-in-one body and personal lubricant product. Enrollment was 70, with in-home use directed at least twice per week for one week. The design is single group, allocation is NA, and masking is none.

The primary endpoint is the number of participants with an irritation score of 0 at baseline and one week; a score of 0 at baseline was required for inclusion. The Full Analysis Set is named, but its definition is not reported. The primary result and analysis are not reported in the registry record.

The male and female safety groups each list 35 participants at risk for serious adverse events and 0 affected, and 35 at risk for other adverse events and 2 affected. Further event descriptions and death counts are not reported in the registry record.