A Single-Center, Clinical Study to Evaluate the Safety of a New Personal Lubricant in Healthy Female Subjects: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Single-Center, Clinical Study to Evaluate the Safety of a New Personal Lubricant in Healthy Female Subjects (NCT02737852), a na na study. The primary outcome is Number of Subjects With Observed Local Erythema Based on the 5 Point Scoring Scale.

2. Clinical Question

The registry frames the study as an evaluation of safety in healthy female participants after use of a new personal lubricant. Its primary endpoint focuses on a local examination finding, erythema, rather than on a comparison between treatments or on a reported measure of effectiveness. The stated endpoint is a participant count: the number with observed local erythema after two weeks.

The study description sets out a use regimen, but the registry record does not report whether every participant followed it, how use was recorded, or whether participants had the same exposure. The description’s additional instruction for participants with monogamous male partners does not establish how many participants met that condition or how those participants’ observations were handled.

With one study group and no comparator, the record can describe observations among participants in that group, but it cannot estimate a treatment-versus-control contrast. The primary endpoint count itself is not reported, so the record does not give the number of participants who met the erythema definition. That missing result limits interpretation of the principal safety question. The posted adverse-event counts are a separate kind of result and should not be substituted for the primary examination endpoint.

3. Trial Design

The registry identifies this as a completed, single-center clinical study sponsored by Church & Dwight Company, Inc. It lists the phase as not applicable, allocation as not applicable, and masking as none. The study model is single group. Those design features describe a study in which participants were exposed to the lubricant without a separate randomized comparison group and without masking.

The registry lists enrollment of 32. The intervention is Trojan “Chameleon” Personal Lubricant, categorized as a device. The arm description refers to healthy subjects exposed to the lubricant at least four times weekly for two weeks. The brief description adds that participants with monogamous male partners were to use it at least twice weekly during sexual intercourse. These statements describe the intended regimen; the record does not report individual adherence or exposure duration.

The primary outcome is the number of participants with observed local erythema based on an obstetrician/gynecologist examination and a five-point clinical scale. Its stated timeframe is two weeks. The registry also lists edema as a condition, but the primary endpoint named in the record is erythema. The record lists two outcome measures overall, while a primary numerical result and analysis are not reported.

The registry marks the study completed and gives start and primary-completion months of 2016-03 and 2016-05. It does not report details of recruitment, eligibility criteria beyond the description of healthy female participants, the number completing follow-up, or reasons participants may not have contributed to the safety counts. Although the registry lists 32 enrolled, its adverse-event group reports 30 participants at risk. The reason for this denominator difference is not reported in the registry record.

Because there is no control arm, the study design supports a descriptive account of the observed group, subject to the reporting limitations. It does not provide a direct comparative estimate, and absence of masking means the record does not describe blinded assessment. The registry does not report further details of the examination procedures, assessor training, or any analysis 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.

Overall Study

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Number of Subjects With Observed Local Erythema Based on the 5 Point Scoring Scale, measured over 2 weeks.

The primary endpoint is the number of participants with observed local erythema at the two-week timeframe. The registry describes an obstetrician/gynecologist examination and a clinical scale with categories from normal appearance through slight, mild, moderate, and severe erythema. The scale’s listed values are 0 for normal appearance with no irritation, 0.5 for slight irregular erythema, 1 for mild erythema, 2 for moderate erythema, and 3 for severe erythema.

The endpoint is expressed as a count of participants, not as an average severity score or a change from a baseline value. Its intended role is to record how many participants met the endpoint based on the examination. The scale gives clinical context for grading the finding, while the endpoint title focuses on the number of participants with observed erythema.

As a general statistical point, a count can be useful for describing how often a defined event was observed in a study group. To interpret such a count, readers need both the number meeting the endpoint and the relevant denominator, as well as information about missing examinations and how the endpoint was applied. The registry record does not report the primary endpoint count, its denominator, or an analysis of the result. It therefore does not permit a numerical estimate of the observed frequency of erythema from the primary endpoint.

The endpoint is a local examination finding and should not be conflated with the separately recorded adverse-event counts. The registry’s posted safety figures do not replace the missing primary outcome result; they refer to serious and other adverse events, not specifically to the primary clinical-scale endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

These methods points explain how the design and outcome types affect interpretation. They are general statistical explanations, not claims about analyses performed in this study. The registry does not report an analysis plan or any analysis results.

What does a single-group design estimate?

A single-group study observes participants exposed to an intervention without a separate comparison group. Its direct descriptive target is the experience recorded in that group during the study. A count of participants with an event can describe the observed number, provided the event definition and denominator are clear. It does not, on its own, estimate what would have happened to those same participants without exposure.

In a randomized comparison, the groups can be compared to estimate a difference under the study’s design and assumptions. No such between-group estimate is available in this record because it describes a single group and no comparator. A before-and-after comparison could be another design feature, but baseline outcome measurements are not reported in the registry record and should not be presumed.

How should a binary outcome be understood?

A binary outcome classifies each participant into one of two analysis categories, such as meeting or not meeting a specified event definition. The primary endpoint is described as a count of participants with observed erythema. To interpret that count as a frequency, readers would also need to know the number assessed for the endpoint and how participants with missing examinations were handled. Those details and the numerical endpoint count are not reported in the registry record.

As a general statistical concept, an estimate based on a small group can be uncertain even when the observed count is clear. A confidence interval conveys a range of values compatible with the data under the method’s assumptions; it is not a guarantee that the true value lies within that range. No confidence interval for the primary endpoint or adverse-event counts is reported. Without a reported interval, precision cannot be judged from the record using interval estimates.

What does a zero adverse-event count say?

The registry records zero serious adverse events and zero other adverse events among 30 participants at risk. The observed counts are straightforward descriptions of what the record reports. As a general statistical point, observing no events in a finite group does not establish that the event rate in a broader population is exactly zero. An uncertainty interval, if calculated using an appropriate method and clearly defined denominator, could show how imprecise an estimate may be. No such interval is reported.

The adverse-event categories also need to remain distinct from the primary clinical examination outcome. A participant could, in principle, have an examination finding that is not recorded in an adverse-event category, or the categories could be defined in ways not described in the registry. The record does not explain how erythema findings were related to adverse-event reporting. Therefore, the zero adverse-event counts cannot be treated as the primary erythema result.

Why does the denominator matter?

A count is interpreted in relation to the number of participants who could have contributed to it. The registry lists enrollment of 32, while the adverse-event group has 30 participants at risk. The difference is not explained. It is not appropriate to assume that the 30 were the only participants exposed, that the other participants withdrew, or that any particular participants were excluded. A participant flow account and endpoint-specific denominators would clarify who contributed to each result, but those details are not reported.

Missing observations can affect descriptive estimates and comparisons. As a general matter, missingness may be related to participant characteristics, events, or study procedures, and the appropriate approach depends on why data are missing and the planned analysis. The registry does not report missing outcome counts, reasons for missingness, imputation, or other handling methods. No assumptions about these matters can be recovered from the posted record.

What can masking and allocation contribute?

Masking can reduce the chance that knowledge of treatment assignment influences participant reports, assessor judgments, or other study processes. The registry records masking as none. It does not report whether the examination assessor was independent or whether any other steps were used to reduce assessment bias. Allocation is listed as not applicable and the design is single group, so there is no randomized allocation between treatment arms to evaluate.

These design features do not invalidate a descriptive observation, but they limit what can be concluded from it. Without a control group, the record cannot separate findings that occurred during exposure from the background occurrence of similar findings. Without reported masking, the record does not establish that outcome assessment was insulated from knowledge of exposure.

How should planning illustrations be read?

General sample-size calculations are planning tools, not results about the participants observed in a trial. The stated planning convention uses a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and a target effect defined as a fraction of an observed effect. The convention specifies participants per arm for most outcomes and total events for time-to-event calculations. Those assumptions describe a hypothetical planning exercise and do not match this single-group study’s design as recorded.

Any sample-size illustration should not be read as the trial’s actual enrollment, as evidence that the study achieved a particular power, or as a result observed in participants. The registry does not report a sample-size justification for this study. Specific planning values and a numerical primary effect are not reported in the registry record, so the illustrations cannot resolve the missing primary endpoint result.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Healthy Subject")
n      <- c(30)
events <- c(0)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Healthy Subject  30  0  0.0  0.0  11.6  0.0  11.4  0.1  11.2

11. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures, but it does not report the names and results of both measures in the available record, an analysis plan, or any analyses. The primary endpoint is named as a count of participants with observed local erythema at two weeks. Its result is not reported. No statistical analysis is listed. The record therefore does not show which outcomes were tested, whether any formal hypotheses were specified, or whether results were adjusted for examining multiple outcomes.

As a general statistical point, when several outcomes or hypotheses are tested, the chance of at least one apparently unusual result can increase if each is assessed separately without accounting for multiplicity. Methods to address multiplicity depend on the intended questions and analysis plan. No multiplicity strategy is reported in the registry record, so it is not possible to determine whether any such approach was planned or used. With no analyses reported, there are no p-values to assess for multiplicity in any case.

Missing-data handling is also not reported. The registry does not give the number of participants assessed for the primary endpoint, the number with missing examinations, reasons for missingness, or any method used to address missing observations. The difference between enrollment of 32 and the 30 listed at risk for adverse-event counts is not explained and should not be taken as evidence of a particular missing-data pattern.

The analysis population is not reported in the registry record. It is therefore unclear which participants contributed to any outcome analysis, whether all enrolled participants were included, or how incomplete exposure or follow-up would have been treated. These omissions matter because denominators and analysis populations determine the scope of a result. They also prevent assessment of whether the reported adverse-event counts and the primary endpoint would refer to the same participants.

12. 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.

The registry reports zero serious adverse events among 30 participants at risk and zero other adverse events among 30 participants at risk. These are adverse-event counts for the healthy-subject group. They are not the reported result for the primary endpoint, which concerns observed local erythema on examination. That primary numerical result is not reported in the registry record.

A zero count means that no events in the relevant category are recorded for the stated group in the registry. As a general statistical point, it does not establish that the event is impossible or that the underlying frequency is exactly zero beyond the observed group. The record does not report confidence intervals or other uncertainty estimates for these counts, so their statistical precision cannot be assessed from the posted results.

The listed enrollment is 32, while the adverse-event counts use 30 participants at risk. The reason for that difference is not reported. The registry also does not give details about how adverse events were collected, their definitions, or the period of monitoring beyond the study’s stated two-week use context. Deaths are not reported in the registry record; a blank or unreported value should not be interpreted as a zero count.

These figures are descriptive safety information. They do not establish the absence of all unwanted findings, and they do not answer the separate question of how many participants had erythema on examination.

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

The record describes a completed, single-group study of a personal lubricant in healthy female participants. Its primary question concerns the number of participants with local erythema observed on examination at two weeks. The registry gives the clinical scale used to grade erythema, but does not report the numerical primary endpoint result. Consequently, the record does not establish how many participants met that endpoint or how precisely the result was estimated.

The safety data that are reported show zero serious adverse events and zero other adverse events among 30 participants at risk. These counts describe the adverse-event categories in the registry. They should not be substituted for the missing erythema result, and they do not establish that no examination findings occurred. Deaths are not reported in the registry record.

The design also shapes what the data can mean. There was one group, no separate comparator, and no masking. A descriptive result in the exposed group could not by itself show what would have happened without exposure, nor isolate the effect of the lubricant from other influences. The record does not report a randomized comparison, baseline outcome values, or a blinded assessment process.

The registry lists 32 enrolled participants but reports 30 at risk for the adverse-event counts. It does not explain the difference, identify the endpoint-specific denominator, or describe missing observations and analysis populations. These gaps limit the ability to establish who contributed to the reported counts and whether those counts represent the full enrolled group.

These data therefore support a narrow reading: the registry records no serious or other adverse events in the stated group of 30, while the primary examination outcome is not numerically reported. The record does not provide an inferential analysis, confidence intervals, or a statistical plan. It should not be read as proving either the presence or absence of local erythema, or as a comparison of this lubricant with another product or with no exposure.

14. Why This Trial Matters Statistically

This study illustrates why the reporting of an endpoint result and its denominator is essential to statistical interpretation. The primary outcome is clearly described: a participant count based on an examination for local erythema at two weeks, with a specified clinical grading scale. Yet the numerical count is not reported. A well-defined measure without its observed result cannot answer the main descriptive question the endpoint was designed to address.

It also illustrates the distinction between different kinds of safety information. The registry includes adverse-event counts, but those counts are not the same as the primary examination endpoint. Readers need to know whether an examination finding was classified as an adverse event and how each outcome was collected. The record does not report that relationship, so the two result types must remain separate in interpretation.

Denominators are another central issue. Enrollment is listed as 32, while 30 participants are listed as at risk for adverse-event counts. Without participant flow or an explanation, the scope of the safety figures is less clear. This shows why reporting the number enrolled, exposed, assessed, and included in each outcome can be as important as reporting a count.

The single-group design also makes the distinction between description and comparison visible. Observations in an exposed group can be described, but they do not provide a direct contrast with an unexposed or alternative-treatment group. Statistical interpretation must follow the structure of the design rather than treating an observed count as a comparative effect.

Finally, the record does not report analyses, uncertainty estimates, multiplicity handling, or missing-data methods. These are not details that can be reconstructed from a study title or endpoint definition. Their absence underscores a basic lesson for clinical research: clear numerical results, denominators, and methods are necessary for readers to judge what the data show and how precisely they show it.

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 principal limitation for interpreting this trial record is that the numerical result for the primary endpoint is not reported. The endpoint definition and timeframe are available, but the number of participants with observed erythema and the denominator assessed are not. The scale description alone cannot establish the observed frequency or the distribution of severity grades.

The single-group design has no concurrent control comparison. Accordingly, any finding in the group could not be contrasted directly with observations under another condition. The registry records no masking, and it does not describe blinded examination, assessor independence, or other measures to limit assessment bias. The study is also described as single-center, which limits how broadly its observations might apply to settings or populations not represented in the record.

The registry lists 32 enrolled participants, but the adverse-event group reports 30 at risk. The reason for this difference is not reported. The record does not give participant flow, completion counts, exposure adherence, endpoint-specific denominators, or reasons for missing observations. It is therefore not possible to determine whether the adverse-event group represents everyone enrolled or how incomplete data may have affected results.

The record lists two outcome measures but does not report all outcome results or analyses. Statistical methods, confidence intervals, p-values, multiplicity procedures, analysis populations, and missing-data methods are not reported in the registry record. Deaths are also not reported, rather than recorded as a numerical zero.

The adverse-event counts are limited to the categories and group as registered: zero serious adverse events and zero other adverse events among 30 participants at risk. The record does not explain event definitions or the relation of those categories to the primary erythema examination. These limitations mean that the posted safety counts provide only a narrow descriptive account and cannot fill the gap in the primary endpoint reporting.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Single-Center, Clinical Study to Evaluate the Safety of a New Personal Lubricant in Healthy Female Subjects — NCT02737852.
• Registry record last updated 2017-09-01; status last verified 2017-08.
• Results first posted 2017-08-02.
• 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.

19. Record Summary

The registry record describes a completed, single-center, single-group study sponsored by Church & Dwight Company, Inc. It lists enrollment of 32 and evaluates Trojan “Chameleon” Personal Lubricant in healthy female participants. The described regimen is use at least four times weekly for two weeks, with additional use during sexual intercourse specified for participants with monogamous male partners.

The primary endpoint is the number of participants with observed local erythema at two weeks, assessed by an obstetrician/gynecologist using a five-point clinical scale. The numerical primary result is not reported in the registry record. The record lists no analyses.

For the healthy-subject group, the registry reports zero serious adverse events and zero other adverse events among 30 participants at risk. It does not explain why this denominator differs from enrollment of 32. Deaths are not reported. With no comparator group and no masking, the record provides limited descriptive safety information and no direct treatment comparison.