Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy (NCT02085980), a na na study. The primary outcome is The Main Outcome of the Study is the Efficacy of the Laser Procedure, Intended as the Amelioration of 50% of the Severity of the Vaginal Dryness at 12 Months, Compared With Baseline.

2. Clinical Question

3. Trial Design

This completed clinical investigation evaluated laser treatment for vulvovaginal atrophy. The registry lists the study as single-group, with 30 participants enrolled. Its allocation is recorded as NA, and it is identified as not being a randomized comparison. The intervention is listed as a device, and the only arm described is Laser Treatment. Masking is recorded as none. The phase is listed as NA.

The study began in 2014-03, and primary completion is recorded as 2015-08. Its status is completed. The registry lists one outcome measure, the primary outcome concerning improvement in vaginal dryness severity. The assessment compares the symptom at baseline with follow-up at 12 months after the last treatment. The symptom was measured with a 10 cm visual analog scale.

The design can describe change over time in the treated group if the outcome measurements and analysis are reported. It does not provide a randomized control group for distinguishing treatment-associated change from other influences on symptoms over time. Details about eligibility criteria, recruitment, treatment delivery, follow-up procedures, and the planned statistical analysis are not reported in the registry record. A sample-size justification is also not reported in the registry 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.

Overall Study

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 The Main Outcome of the Study is the Efficacy of the Laser Procedure, Intended as the Amelioration of 50% of the Severity of the Vaginal Dryness at 12 Months, Compared With Baseline, measured over Baseline and at follow up visit at 12 months post last treatment.

The primary endpoint is defined around a threshold: improvement of 50% in vaginal dryness severity at 12 months after the last treatment, compared with baseline. Severity was assessed using a 10 cm visual analog scale. The registry describes the outcome as a count of participants, so its intended interpretation is the number meeting the stated improvement criterion, rather than the average symptom change alone.

A threshold outcome can make a clinical question easier to state: it identifies participants whose measured change meets a specified level. It also discards information about how far each participant’s change lies above or below that threshold. The scale measurement and the rule for determining whether the threshold was met therefore matter to interpretation. Additional details on the calculation of the 50% improvement criterion are not reported in the registry record.

Using baseline as a reference allows within-participant change to be assessed. A follow-up measurement at 12 months after the last treatment places the outcome at a defined time point. However, the endpoint definition alone does not establish how many participants met the criterion. That count, along with any analysis or uncertainty estimate, is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the endpoint count represent?

The primary outcome is defined as a count of participants who meet the improvement threshold. The threshold is a 50% amelioration of vaginal dryness severity at 12 months after the last treatment, compared with baseline. The symptom assessment uses a 10 cm visual analog scale. In general, a count endpoint turns each participant’s measurement into a category: the participant either meets the stated criterion or does not. That can make the target result straightforward to communicate, but it loses detail about the size of changes within each category. The registry record does not explain the calculation used to classify participants at the threshold.

How does a within-group comparison differ from a controlled comparison?

The study is recorded as single-group, not as a randomized comparison. In general, measurements at baseline and follow-up can describe how outcomes changed among participants in the group being studied. Random assignment to a comparator group can help distinguish treatment-associated change from changes that might also occur without the intervention. This record lists no comparator arm, so a treatment-versus-control contrast is not available. Potential influences on symptoms over time are general limitations of a single-group design, not reported events in this study.

For paired measurements, each participant’s follow-up value is considered in relation to that participant’s baseline value. This can account for the fact that measurements from the same participant are related. The registry specifies a comparison with baseline but does not report the statistical method used to analyze paired observations, whether the analysis used the underlying scale values, or how the threshold outcome was tested.

What can a confidence interval add?

In general, a confidence interval expresses the precision of an estimated quantity under the assumptions of the method used. A narrow interval indicates greater precision than a wide interval, while neither interval alone resolves design limitations such as lack of a comparator. No confidence interval is reported for this primary outcome in the registry record. Without a reported endpoint count and analysis, there is no posted estimate whose precision can be assessed.

Why does the analysis population matter?

In general, an analysis population is the set of participants whose data are included in a particular analysis. The enrolled group, the group that completes follow-up, and the group with usable measurements may differ. Reporting these counts and the rules for including participants helps readers understand what population the result describes. The number assessed at follow-up, the analysis population, and any inclusion or exclusion rules for the primary analysis are not reported in the registry record.

What do the planning assumptions mean?

The registry’s planning illustration is described as separate from the trial’s own design. It uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; its target effect is a stated fraction of the observed effect. The description specifies participants per arm for outcomes other than time-to-event outcomes, and total events for time-to-event calculations using the Schoenfeld method. These are general planning conventions, not characteristics of this single-group study, which has no recorded comparator arm. The registry record does not report a sample-size justification for the trial itself. Nor does it report a primary outcome analysis from which the observed effect could be assessed. Planning illustrations are not observed power and cannot substitute for a reported endpoint result or its uncertainty.

Over-dispersion is a general issue when count data vary more than a model assumes; if ignored, uncertainty can be understated. The primary endpoint is a participant count, but the registry does not report a model, a dispersion assessment, or an inferential analysis. It would therefore be inappropriate to attribute any particular statistical method or adjustment to this investigation.

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("Laser Treatment")
n      <- c(30)
events <- c(27)
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  Laser Treatment  30  27  90.0  73.5  97.9  74.4  96.5  74.2  96.4

11. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure, and its stated primary measure concerns the 50% improvement threshold for vaginal dryness. This limited listing does not establish that the protocol had no additional outcomes or analyses; any broader outcome plan is not reported in the registry record. A multiplicity adjustment or other strategy for handling multiple comparisons is also not reported.

In general, testing multiple outcomes or multiple analyses can increase the chance of finding an apparently notable result by chance. A prespecified primary outcome and a transparent analysis plan help readers understand which result was intended to answer the main question. The record identifies a primary outcome definition but does not provide the statistical plan, planned contrasts, or any multiplicity procedure.

The registry does not report the number of participants with follow-up measurements, the number missing, reasons for missingness, or how missing measurements were handled. These details matter because an analysis limited to participants with observed follow-up can describe a different group from the one originally enrolled. The record also does not identify the primary analysis population or explain whether participants were included according to any prespecified analysis rule.

Because no primary endpoint count or analysis is reported, the possible influence of missing data and the handling of multiple analyses cannot be evaluated from the registry record. These omissions do not show that missing data or multiplicity affected the findings; they leave those aspects of the evidence unclear.

12. 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 0% reporting threshold.

For the Laser Treatment group, the registry records 30 participants at risk for serious adverse events and zero affected. It also records 30 at risk for other adverse events and zero affected. Deaths are recorded as zero. These are the reported counts for the categories shown in the registry record.

A zero count means that no event in the relevant category was recorded among the participants listed as at risk. It does not establish that the risk of an event is absent. In general, uncommon events can remain undetected in a study even when none are observed, and event counts alone do not describe severity, timing, or cause. The registry lists no serious adverse-event terms.

The record does not provide further detail about adverse-event collection, definitions, duration of safety follow-up, or whether participants discontinued because of an event. These details are not reported in the registry record. The safety counts should therefore be read as the posted event totals, not as a complete account of every aspect of safety monitoring or as evidence about comparative risk.

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

The record identifies a completed investigation of laser treatment for vulvovaginal atrophy and defines a primary outcome based on improvement in vaginal dryness severity. It also records 30 participants enrolled and gives zero counts for serious adverse events, other adverse events, and deaths in the listed categories. Those are the principal result-related details available in the registry record.

The key efficacy outcome is not accompanied by a participant count, score summary, or analysis. Accordingly, the record does not establish how many participants met the improvement criterion, what the average or distribution of symptom change was, or how precisely any change was estimated. It is not possible to infer an efficacy result from the outcome definition alone. The absence of a posted endpoint result should not be interpreted as either success or failure.

The single-group design also limits what a change from baseline could establish. In general, an observed change after treatment does not by itself show what would have happened over the same period without treatment. A control group and a suitable comparison would be needed to address that distinction more directly. This is a design consideration, not a claim about what happened to participants in this study.

The zero adverse-event counts are limited to the categories and participants recorded. They do not establish that risk is absent, and the record does not provide enough detail to evaluate all aspects of safety monitoring. The registry does not report the analysis plan, missing-data handling, or endpoint uncertainty. Overall, the posted information describes the question and design more fully than it reports the outcome. Conclusions about the magnitude, precision, or comparative meaning of the primary result cannot be drawn from the registry record.

14. Why This Trial Matters Statistically

This study illustrates why an outcome definition and an outcome result are different kinds of information. The registry describes a participant-count endpoint tied to a stated improvement threshold and a follow-up time. That helps clarify what investigators intended to measure. But without the count of participants meeting the criterion, readers cannot estimate how frequently the threshold was reached or assess the result’s precision.

It also highlights the role of design in interpretation. A single-group study can describe change over time in the treated group, but it does not include a concurrent control group for comparison. This matters because changes in symptoms over time can have explanations other than the intervention. That is a general methodological limitation, not evidence that any particular alternative explanation occurred in this investigation.

The registry also distinguishes a completed study from a fully reported analysis. It records completion and enrollment, along with safety counts, while the primary efficacy result and statistical analysis are not reported. Knowing which details are absent helps prevent an endpoint definition from being mistaken for a finding, or enrollment from being mistaken for complete follow-up.

Finally, the planning assumptions described for sample-size illustrations should not be confused with the design or analysis of this trial. The record is single-group, while the illustration describes equal allocation between two arms. This distinction is important when interpreting any planning material alongside the study’s actual design. Transparent reporting of outcomes, analysis methods, and participant flow is necessary for readers to understand what the data can support.

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 limitation for interpreting efficacy is that the registry record does not report the primary outcome count or a statistical analysis. It therefore does not permit estimation of the frequency of participants meeting the 50% improvement criterion, the degree of symptom change, or the precision of an estimate. The outcome description gives the assessment time and threshold but does not report how the threshold was operationalized from the visual analog scale.

The single-group design has no randomized comparator, so a within-group change, if available, would not by itself separate treatment-associated change from other influences over time. The record lists no masking. It does not report details of eligibility, participant characteristics, treatment delivery, adherence, or use of other care, limiting assessment of who was studied and how the intervention was implemented.

Enrollment is recorded as 30, but the number with endpoint data and the number included in any analysis are not reported. The registry also does not describe missing-data handling, the analysis population, confidence intervals, or the statistical plan. These omissions prevent evaluation of attrition, analysis choices, and uncertainty. The basis for the trial’s sample size is not reported in the registry record.

Safety information is limited to the posted event counts. Definitions, follow-up coverage, event timing, and details about collection are not reported. The zero counts should not be taken to show that adverse events were impossible or that all safety questions were resolved. These limitations concern what can be learned from the registry record; they do not establish that unreported procedures or analyses were not performed.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy — NCT02085980.
• Registry record last updated 2021-06-04; status last verified 2017-02.
• Results first posted 2021-06-04.
• 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.

19. Record Summary

NCT02085980 is a completed single-group clinical investigation of laser treatment for vulvovaginal atrophy, sponsored by El. En. SpA. The registry records 30 participants enrolled, no masking, and no randomized comparison. The study began in 2014-03, with primary completion in 2015-08.

The primary outcome concerns the number of participants with 50% improvement in vaginal dryness severity at 12 months after the last treatment compared with baseline, measured using a 10 cm visual analog scale. The endpoint count and statistical analysis are not reported in the registry record. The record lists zero serious adverse events, zero other adverse events, and zero deaths in the Laser Treatment group.

The registry lists one outcome measure and no analysis entry. Further details about the statistical plan, missing data, analysis population, and the trial’s sample-size justification are not reported.