Use of J3 Bioscience Lubricating Intravaginal Ring VR101 to Relieve the Symptoms of Vaginal Dryness: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Use of J3 Bioscience Lubricating Intravaginal Ring VR101 to Relieve the Symptoms of Vaginal Dryness (NCT03150407), a randomized na study. The primary outcome is Efficacy of VR101 Treatments at 28 Days Assessed by Change in VHI (Vaginal Health Index) Scores Assigned by Clinicians.

2. Clinical Question

3. Trial Design

The study was registered as a randomized, triple-masked, crossover investigation of the VR101 lubricating intravaginal ring. Its stated purpose was to evaluate safety and efficacy for relieving symptoms of vaginal dryness. The registry lists enrollment as 72 and status as completed. The study start is recorded as 2017-05-01, with primary completion on 2017-08-31. The phase is listed as not applicable.

In a crossover design, participants receive more than one intervention in sequence, so comparisons can be made within the same participant as well as across treatment periods. The registry describes consecutive use of VR101 devices and sham rings. Each device was to be used for 7 consecutive days and then replaced. The descriptions specify four VR101 devices and four sham rings during the crossover investigation. The order was described as randomized, but details of sequence generation, concealment, and any washout between periods are not reported in the registry record.

The record labels the study triple-masked but does not identify which people or roles were masked, or how masking was maintained. Those details are not reported in the registry record. The presence of a sham comparator supports a controlled comparison, but the record does not explain the sham’s physical or sensory characteristics.

A separate long-term safety evaluation was described as an option for participants who successfully completed the crossover study. It was intended to involve 13 consecutive weeks of VR101 use. The registry record does not report how many participants entered or completed that evaluation, or its safety results. Enrollment, completion, and analysis populations should therefore not be treated as interchangeable.

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.

Period 1

Washout

Period 2

Long-Term Safety Extension

Analysis population for the primary outcome, as defined in the registry: "Completers Only": Participants that completed both study periods. "Worst-Case, Non-Statistical, Per-Protocol": Subjects who didn't complete a study period were assigned the last available score for Day 28. Subjects who missed an entire study period were assigned the worst-performing change score from the remaining population for Day 28. LOCF: Same as the per-protocol group, except participants missing an entire study period were assigned a change score of 0 (no efficacy) for that 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 Efficacy of VR101 Treatments at 28 Days Assessed by Change in VHI (Vaginal Health Index) Scores Assigned by Clinicians, measured over Baseline, 28 Days.

The primary endpoint was efficacy assessed by clinician-assigned change in Vaginal Health Index scores at 28 days. The index ranges from 5 to 20 and is calculated by adding clinician ratings for vaginal elasticity, fluid volume, epithelial integrity, moisture, and pH. Each component ranges from 1 to 5, with 5 described as the best rating. The score is therefore a composite measure: it combines several aspects of vaginal health into a single summary.

Change from baseline is used to describe how a participant’s score changes over the assessment period, rather than relying only on the score at the end. A treatment comparison would need to relate changes observed during the VR101 and sham periods. The registry record gives the endpoint definition and timeframe but does not report baseline values, 28-day values, change estimates, or a numerical comparison between the interventions. It is consequently not possible to describe the observed direction or size of the primary outcome from the record.

As a general measurement consideration, a composite can be useful when a condition has several clinically relevant dimensions. It can also conceal differences among its components: a total score alone does not show whether each component changed in the same way. Component-level results and information about measurement variability are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, triple-masked crossover study and a continuous primary measure summarized as a mean with standard deviation. Those labels identify broad design and reporting choices, but they do not specify the full analysis. The model, exact estimand, handling of repeated observations, and inferential procedure are not reported in the registry record.

What does randomization contribute?

In general, random assignment is intended to reduce systematic differences in how participants receive study sequences. In a crossover investigation, it can help determine the order in which participants use the study interventions. This does not guarantee that every relevant influence is balanced, and it does not by itself address missing outcome data or effects that persist from one period into another. The registry says assignment was randomized, but the sequence-generation method and allocation concealment are not reported in the registry record.

What does a crossover comparison require?

In general, crossover data contain repeated observations from the same participant. Such observations are related, rather than independent, because they come from the same person. An analysis can use this within-participant structure to compare responses across interventions, but it should also consider period and sequence. A period effect is a difference associated with when an observation occurs; a sequence effect can arise when the order of interventions matters. Carryover is a lingering effect of an earlier intervention that could influence observations in a later period. The registry record does not report which effects were included in the analysis or whether washout was used.

The description says participants used VR101 devices and sham rings in consecutive periods, with each device used for 7 consecutive days. It specifies four devices of each type. Those schedule details do not establish the statistical unit of analysis or how observations across days and periods were combined. The analytic handling of repeated measurements is not reported in the registry record.

What do means and standard deviations describe?

As a general explanation, a mean describes the average value in a group or analysis population. A standard deviation describes how spread out individual values are around that mean. They provide different information: the mean characterizes location, while the standard deviation characterizes variability among observations. Neither alone gives the precision of a treatment comparison. A confidence interval, when reported, describes the uncertainty around an estimate under the assumptions of the analysis. No numerical means, standard deviations, treatment estimate, or confidence interval for the primary outcome is reported in the registry record.

What is the role of the endpoint scale?

The Vaginal Health Index combines clinician ratings for vaginal elasticity, fluid volume, epithelial integrity, moisture, and pH. Its stated range is 5 to 20, and each component ranges from 1 to 5, with 5 described as best. The primary outcome is change from baseline assessed at 28 days. In general, a change score summarizes movement from a starting value, but its interpretation depends on the scale, measurement consistency, and the analysis used. The record does not give a threshold for a clinically meaningful change, measurement reliability, or component-specific results.

How should significance testing be interpreted?

As a general statistical concept, a p-value assesses compatibility between observed data and a specified null model; it does not measure the probability that a treatment works, nor does it convey the size of an effect. An effect estimate and its confidence interval are needed to discuss magnitude and precision. The registry record has no listed analysis entries, and it does not report a primary-outcome p-value, confidence interval, or statistical model. It is therefore not possible to assess statistical significance or precision from the record.

The record includes general planning assumptions for a sample-size illustration: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. These are described as planning assumptions, not as the trial’s own design justification. Numerical sample-size illustrations and the observed effect used for them are not reported in the registry record. Such illustrations are planning exercises, not observed power, and cannot replace a reported analysis of the trial data.

Why can variability affect an analysis?

In general, greater variation in outcome measurements makes an estimate less precise when other features of the data are unchanged. A standard deviation is one way to describe variability for a continuous measure. The registry does not provide primary-outcome variability estimates, so the amount of dispersion in the observed scores cannot be assessed. For count outcomes, over-dispersion means that variability exceeds what a chosen model expects; a model that ignores this can misstate uncertainty. No count-outcome model or over-dispersion assessment is reported for this trial.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 8 outcome measures and indicates that the primary outcome has several categories or time points, so it is not reduced to a single comparison in the posted results. This makes it important to distinguish the endpoint definition from a specific reported contrast. The registry record does not identify which categories or time points were selected for a primary statistical test, nor does it report an adjustment for multiple comparisons.

As a general matter, examining multiple outcomes, time points, or subgroup contrasts can increase the chance of finding an apparently notable result by chance. Multiplicity procedures can address that issue, but the appropriate method depends on the prespecified analysis plan. Whether any multiplicity adjustment was planned or used is not reported in the registry record. A protocol or statistical analysis plan is also not reported there.

Missing data are especially relevant to the crossover design because a participant may not complete both treatment periods. The registry describes a “Completers Only” population and a “Worst-Case, Non-Statistical, Per-Protocol” population. For the latter, the record says that participants who did not complete a period were assigned the last available score for Day 28, and those who missed an entire period were assigned the worst-performing change score; the description is incomplete. The numbers included in either population, reasons for missingness, and sensitivity analyses are not reported in the registry record.

These population labels do not reveal whether missingness was related to symptoms, treatment, or other factors. In general, assumptions used to replace missing values can affect estimates and should be interpreted alongside sensitivity analyses. Neither the assumptions in full nor sensitivity-analysis results are reported in the registry record. No analysis entries are listed, so the record does not establish how the primary outcome was ultimately analyzed.

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 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports zero serious adverse events among 69 participants at risk in the VR101 group and zero among 67 at risk in the sham control group. It also reports zero deaths in each group. These are the serious-event and death counts recorded for the groups; the registry record does not provide event descriptions or further timing details.

For other adverse events, the record reports 46 affected among 69 at risk in the VR101 group and 31 affected among 67 at risk in the sham control group. These are counts of participants affected, not a description of the number or type of individual events. The record does not report the event terms, severity, duration, relatedness assessments, or how events were collected. No serious adverse event terms are listed.

As a general interpretation point, a count of zero serious events in a group does not establish that risk is absent. Adverse-event counts also do not by themselves establish that an event was caused by an intervention. The crossover design and the reported group denominators should be considered when interpreting the safety summaries, but the record does not explain how exposure across periods was handled. These figures describe recorded events; they do not provide a complete safety profile or the results of the optional long-term evaluation.

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

The registry record establishes that this was a randomized, triple-masked crossover investigation of VR101 and a sham control ring, with clinician-assessed change in Vaginal Health Index scores at 28 days designated as the primary outcome. It also records selected adverse-event counts. These registry entries describe the study’s intent and some posted safety information.

The record does not report the primary outcome values or the direct comparison between interventions. It therefore does not show the observed size or direction of any difference, and it does not show how precisely that difference was estimated. No efficacy conclusion can be drawn from the endpoint definition, the enrollment figure, or the study design alone. The posted record also does not provide the analysis methods needed to assess whether the within-participant structure of the crossover study was handled appropriately.

Likewise, the serious adverse-event counts should be read narrowly. The registry reports zero serious adverse events and zero deaths in both groups, along with counts of other affected participants. It does not provide event-level details or the outcomes of the optional long-term safety evaluation. Those summaries cannot establish that there were no harms or determine whether reported events were attributable to a device.

As a general principle, a trial’s findings are interpreted through its estimates, uncertainty, outcome definitions, analysis population, and data completeness. Here, key numerical efficacy results and analytical details are not reported in the registry record. A reader can describe the design and the recorded counts, but cannot use this record alone to determine the magnitude, precision, or clinical importance of a treatment difference.

13. Why This Trial Matters Statistically

This trial is statistically notable for its crossover structure. In general, crossover designs allow participants to receive multiple interventions, making within-participant comparisons possible. That can be useful when outcomes vary substantially between people. It also creates analytic responsibilities: observations from the same participant are related, and period, sequence, and carryover effects may matter. The registry record describes the design but does not report how these features were handled in the analysis.

The primary outcome is a clinician-assessed composite index rather than a single symptom rating. It combines vaginal elasticity, fluid volume, epithelial integrity, moisture, and pH. Composite measures can bring several dimensions into a concise summary, but the total can obscure which component drives a change. Component-level results, measurement properties, and a threshold for clinically meaningful change are not reported in the registry record.

The registry also makes the distinction between an efficacy crossover and an optional long-term safety evaluation visible. These are different questions and populations: the long-term evaluation was described for participants who successfully completed the crossover study, and it was intended to last 13 consecutive weeks. Its enrollment and findings are not reported in the registry record.

Finally, the record illustrates why design and outcome definitions cannot substitute for results. Enrollment is listed as 72, and adverse-event counts are available, but the primary comparison’s estimate and uncertainty are not reported. Without those results, statistical interpretation is limited to describing what was intended and what information the registry records—not estimating the effect or its precision.

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 main limitation for interpreting efficacy is that numerical results for the primary endpoint are not reported in the registry record. The record defines change in clinician-assessed Vaginal Health Index scores from baseline to 28 days, but does not provide the values, comparison estimate, uncertainty, or inferential result. It also does not report the clinical threshold used to judge whether a change would be meaningful.

The analysis details are limited. Although the trial is described as randomized, triple-masked, and crossover, the registry does not identify who was masked, detail the randomization procedure, or describe allocation concealment. It does not report the statistical model, handling of period and sequence effects, a washout procedure, or evaluation of carryover. These omissions limit assessment of whether the analysis matched the design.

The registry lists a completers-only population and a worst-case, non-statistical, per-protocol population, but the latter description is incomplete. The number of participants analyzed, reasons for missing observations, and sensitivity analyses are not reported. Enrollment should not be interpreted as the number included in the primary analysis.

Eight outcome measures are listed, and the primary outcome is not reduced to a single comparison in the posted results. The registry does not report how multiple categories or time points were handled, whether comparisons were prespecified, or whether multiplicity was addressed. The optional long-term safety evaluation is described, but its results are not reported. Safety event descriptions, severity, timing, and attribution are also not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Use of J3 Bioscience Lubricating Intravaginal Ring VR101 to Relieve the Symptoms of Vaginal Dryness — NCT03150407.
• Registry record last updated 2022-11-07; status last verified 2022-10.
• Results first posted 2022-11-07.
• 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, randomized, triple-masked crossover investigation of VR101 and sham control rings for symptoms of vaginal dryness. Enrollment is listed as 72. The study started on 2017-05-01, and primary completion is recorded as 2017-08-31.

The primary outcome was clinician-assessed change in Vaginal Health Index score from baseline to 28 days. The index combines five clinician-rated dimensions and ranges from 5 to 20. The record also describes an optional 13-week long-term safety evaluation for participants who completed the crossover study.

The registry reports zero serious adverse events and zero deaths in both groups, with other adverse events affecting 46 of 69 at risk in the VR101 group and 31 of 67 at risk in the sham control group. Numerical primary-outcome results, analysis methods, and long-term safety results are not reported in the registry record.