A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis (NCT01867164), a randomized phase 3 study. The primary outcome is Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment.

2. Clinical Question

These regimens differ in active agents and in treatment duration. Consequently, the study's comparison concerns the two treatment packages as described, not the isolated contribution of any single ingredient. The registry identifies the study as a Phase 3, randomized, parallel-group comparison and states an enrollment of 160. It was open-label, so masking was not used. These design features frame the question, but they do not substitute for outcome results. The primary endpoint is described, yet the record does not provide the category-level results needed to judge symptom status in the groups or a quantitative comparison between them.

3. Trial Design

The registry record describes a prospective, randomized, open-label, comparative study with a parallel, double-arm structure. It lists the phase as Phase 3, the allocation as randomized, and the masking as none. The stated enrollment is 160. The study was multicentric, and the record identifies Janssen-Cilag, S.A. as sponsor. Its status is completed. The record gives a start of 2007-12 and a primary completion of 2008-12.

The two groups received different vaginal ovule regimens. Gynoclin V combined terconazole, clindamycin, and fluocinolone acetonide and was administered once per day at night for 3 days. Vagitrol V combined metronidazole, fluocinolone acetonide, and nystatin and was administered once per day at night for 10 days. The registry names vaginitis and infectious vaginosis as conditions and describes symptoms associated with infectious vaginitis or vaginosis, including bacterial, mycotic, or parasitic causes.

Random allocation is intended, in general, to make treatment groups comparable with respect to factors that could affect outcomes, although chance imbalances can remain. Open-label conduct means the record reports no masking. In general, awareness of assigned treatment can influence participant reports or clinical assessments; the record does not say whether particular safeguards were used to address this possibility. The study's parallel structure means the comparison is between groups assigned to different regimens, rather than a stated sequence in which each participant receives both.

The primary outcome was the presence or absence of itching, burning, and sudden vulvar pain at the stated post-treatment assessment. The timing was described as 3 days after treatment, with assessment at Day 7 for Gynoclin V and Day 13 for Vagitrol V. This means the scheduled calendar day differs by group because the treatment courses differ in duration. The registry also lists participant-assessed and physician-assessed response as secondary outcomes. Their results are not reported in the registry record.

The registry does not report the randomization procedure, allocation concealment, site locations, detailed eligibility criteria, or the planned statistical analysis. It also does not report the rationale for the enrollment target. Those omissions limit assessment of how assignment was implemented and how the planned analysis related to the design. The record lists no outcome analyses, and it does not provide a usable numerical result for the primary symptom comparison. Thus, the design can be described, but the reported information is insufficient to evaluate the comparative primary outcome.

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: Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in Intent-to-treat (ITT) population. Here 'N' specifies participants who were evaluated for this outcome measure.

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: Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in Intent-to-treat (ITT) population.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment, measured over 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V).

The primary endpoint concerns whether symptoms were present or absent after treatment. The symptoms named in the registry are itching, burning, and sudden vulvar pain. This is a binary form of assessment at the participant level: the outcome description focuses on symptom presence or absence rather than a continuous measurement such as a score. The endpoint title describes a percentage of participants, while its parameter is listed as NUMBER. The record says that N represents the participants evaluated for this outcome.

The scheduled assessment is described as 3 days after treatment, at Day 7 for Gynoclin V or Day 13 for Vagitrol V. Since treatment duration differs between regimens, these calendar days are not the same, even though the endpoint description uses the same interval after treatment. The record does not describe how symptom responses were combined into a participant-level result when symptoms might differ, nor does it report the criteria for determining response beyond presence or absence.

A symptom endpoint is used to capture whether the symptoms named as relevant to the condition remain present at the assessment. In general, a binary endpoint can be straightforward to interpret, but it does not convey how severe a symptom was, how much it changed, or when it changed between assessments unless such information is separately collected and reported. The registry record does not report those details. It also does not provide the category counts or a comparative estimate for the primary outcome, so the endpoint definition alone cannot show the observed symptom response in either group or the precision of a between-group contrast.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The available information describes a randomized, open-label, parallel comparison, but does not report a statistical analysis plan or outcome analysis. The following discussion explains general statistical ideas relevant to interpreting such a design; it does not describe analyses that the registry confirms were performed.

What does randomization contribute?

In general, randomization assigns participants to groups by a chance-based process. Its purpose is to reduce systematic differences between groups at the point of assignment, including differences in measured and unmeasured characteristics. Randomization does not guarantee that groups will be identical, especially in a particular study, and it does not protect against biases arising after assignment. The record labels allocation randomized but does not report the method used to generate the assignment sequence, how assignments were concealed before enrollment, or whether randomization was stratified. Those implementation details are not reported in the registry record, so the adequacy of the process cannot be assessed from this information.

Why does the open-label design matter?

The registry lists masking as none. In general, open-label conduct means that treatment assignment is known rather than hidden from participants and study personnel. For outcomes based on symptoms, awareness can influence how participants notice, recall, or report experiences. It may also influence clinical assessment. These are possible sources of measurement bias, not proof that bias occurred. The record does not report blinding of outcome assessors or other procedures intended to reduce these risks.

Randomization and masking address different concerns. Randomization aims to balance characteristics at assignment. Masking can limit knowledge-related effects after assignment. An open-label randomized trial can still provide a randomized comparison, but interpretation should account for the possibility that outcome measurement is affected by knowledge of treatment. The registry does not provide enough detail to assess the magnitude or direction of any such influence.

How should a binary symptom endpoint be understood?

The primary outcome is described as presence or absence of symptoms, and its unit is a percentage of participants. In general, a binary outcome classifies each evaluated participant into categories, such as symptom present or absent under the study's definition. A percentage communicates the share in a category, but it does not show symptom severity or the timing of changes unless those are measured and reported separately. Here, the record names itching, burning, and sudden vulvar pain but does not report how those components were combined or how each was counted.

For a comparison of binary outcomes, analysts may report group-specific proportions and a contrast between them. Common contrasts include a difference in proportions or a ratio of proportions, but the registry does not report which contrast was planned or used. No effect estimate is available in the registry record, so there is no basis to describe the size or direction of a primary-outcome difference. No new contrast can be calculated from the information recorded because the outcome category counts are not reported.

What does a confidence interval add?

In general, a confidence interval expresses uncertainty around an estimated effect under the assumptions of the analysis. It gives readers a range of values that are reasonably compatible with the data and method, rather than a single estimate alone. Its width reflects precision: wider intervals indicate less precision, while narrower intervals indicate more precision. A confidence interval is not a guarantee that the true effect lies within its limits, and it does not by itself establish clinical importance. The registry record does not report a confidence interval for the primary outcome.

A p-value, in general, measures how unusual data at least as inconsistent with a specified null hypothesis would be if that hypothesis and the statistical model were correct. It does not measure the probability that the null hypothesis is true, nor does it quantify the size or importance of an effect. The registry record does not report a primary-outcome p-value or identify the statistical test used. Without an estimate and uncertainty measure, the strength and precision of the comparison cannot be evaluated.

Why does the timing need careful reading?

The primary assessment is described as 3 days after treatment, with Day 7 for Gynoclin V and Day 13 for Vagitrol V. In general, outcome timing matters because the measured status may depend on when it is assessed. The regimens also have different stated durations, so the calendar-day assessments are not identical. The registry describes the intended assessment timing but does not report whether additional measurements were collected or how any deviations from the scheduled assessment were handled.

What can planning calculations tell readers?

In general, a sample-size calculation is a planning exercise based on assumptions about the effect to detect, variability or event frequency, significance level, power, and allocation. It does not report what the trial observed. The registry includes assumptions for a planning illustration: a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect expressed as a fraction of the observed effect. The registry record does not state that these were the trial's design assumptions, and the illustration is not the trial's observed power. No calculated planning values are included in the record.

The distinction is important: a planning illustration may explore what future study sizes would correspond to specified assumptions, but it cannot replace the actual outcome estimate or its uncertainty. It should not be interpreted as evidence that the trial had adequate power or that a particular effect was demonstrated. The record does not report the original sample-size justification or the assumptions used by the trial designers.

What is not established by the recorded methods?

The registry record does not report the statistical analysis plan, adjustment methods, handling of missing outcomes, interim analyses, or whether the primary analysis followed randomized assignment. It identifies an intent-to-treat population as participants who received at least one dose and were evaluated for efficacy parameters. That description is not the same as an analysis of all randomized participants, and the number excluded or missing is not reported in the registry record. The record also lists no outcome analyses. Therefore, readers can understand the stated design and endpoint but cannot verify the analysis choices or reproduce the primary comparison.

10. Multiplicity, Missing Data and Analysis Populations

The registry names a primary outcome and two secondary outcomes: response assessed by the participant and response assessed by the physician. It also states that there are five outcome measures overall. The record does not report the results for the named secondary outcomes, nor does it report the remaining outcome details needed to understand the full set of measures. It lists no outcome analyses.

Multiplicity arises in general when several outcomes, time points, subgroups, or statistical tests are examined. If many tests are considered without adjustment, the chance of at least one apparently noteworthy result can increase. Some analysis plans address this by prioritizing outcomes, adjusting significance thresholds, or treating secondary findings as exploratory. The registry record does not report whether any multiplicity procedure was planned or used. It also does not report an analysis hierarchy or the prespecified statistical plan, so the handling of multiple outcomes cannot be assessed.

Missing data can affect both the estimated outcome and its uncertainty. In general, the consequences depend on why observations are missing and on the assumptions and methods used to address them. The registry record does not report the amount or pattern of missing primary-outcome data, reasons for missingness, or imputation or sensitivity methods. It also does not report the number evaluated for the primary endpoint. The stated intent-to-treat population includes participants who received at least one dose and were evaluated for efficacy parameters; the record does not clarify how participants without an efficacy evaluation were treated in the analysis.

Thus, neither multiplicity control nor missing-data handling can be evaluated from the registry record. These omissions do not establish that no such methods were used; they mean the registry does not report them. The absence of a recorded primary analysis further limits assessment of how the analysis population, endpoint categories, and any missing observations contributed to the reported findings.

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 reports serious adverse event counts of 0 among 81 participants at risk in the Gynoclin V group and 0 among 79 participants at risk in the Vagitrol V group. For other adverse events, it reports 1 among 81 participants at risk for Gynoclin V and 1 among 79 participants at risk for Vagitrol V. The record does not report death counts.

These are counts within the safety categories shown in the registry. The serious adverse event figures indicate that no serious events were recorded in the listed at-risk groups; they do not establish that the regimens have no risk. The other adverse event counts are separate from the serious-event counts and should not be combined with them. The record does not provide event descriptions for the other adverse events, details about severity, timing, relatedness, or the method used to collect events. It lists no serious adverse event terms.

Safety counts are not a substitute for the primary symptom outcome. The at-risk numbers are specific to the safety summaries and should not be treated as the numbers evaluated for efficacy. Because the registry does not report additional safety detail or death counts, interpretation should remain limited to the reported categories and counts.

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

The record establishes that a randomized, open-label, parallel-group study compared two vaginal ovule regimens for secondary vulvar or vaginal symptoms associated with infectious vaginitis or vaginosis. It identifies the primary symptom outcome, the assessment timing, the treatment descriptions, and limited safety counts. These registry entries describe what the study set out to compare and some of what was recorded.

The registry record does not report the primary outcome results in a form that permits a comparative interpretation. It gives no group-specific symptom counts or percentages, no effect estimate, no confidence interval, and no p-value for that outcome. Therefore, the posted information does not show the direction, size, or precision of a difference between the regimens. It also does not support a conclusion that either regimen produced a better symptom outcome.

In general, a study design and an endpoint definition do not themselves demonstrate an outcome. A result requires observed data and an analysis that links those observations to the study question. Even a reported estimate would need to be interpreted in light of uncertainty, the assessment process, the analysis population, missing data, and the open-label design. Those details are not reported in the registry record for this comparison.

The safety summaries report zero serious adverse events in each listed group and one other adverse event in each. This is a limited description, not a complete characterization of safety. Death counts and detailed event information are not reported in the registry record. The absence of a listed serious event in these summaries should not be extended into a claim that no serious risk exists.

The registry's planning assumptions are also not evidence of an observed result or of observed power. Planning calculations depend on assumed effects and design choices, and the record explicitly describes its illustration as based on the observed effect rather than the trial's own design. The original design rationale is not reported. Overall, the record provides a description of the trial and selected counts, but not enough outcome analysis to determine comparative efficacy or fully assess safety.

13. Why This Trial Matters Statistically

This trial is statistically relevant because it illustrates the difference between a detailed study description and a reportable result. The registry specifies randomized allocation, an open-label parallel design, two distinct regimens, and a symptom-based primary endpoint. Yet the primary outcome comparison is not reported in a form that supports estimation or inference. Without the outcome counts and analysis, readers cannot assess the observed group contrast or how precise it is.

The comparison also highlights the importance of defining the endpoint and its timing. The primary outcome concerns presence or absence of itching, burning, and sudden vulvar pain, with assessment at Day 7 for Gynoclin V and Day 13 for Vagitrol V. The description says that both assessments occur 3 days after treatment, but the calendar days differ because the treatment durations differ. Clear reporting of timing helps readers understand what the outcome represents and whether the intended assessment was applied consistently.

The open-label design is another reason statistical interpretation depends on more than a significance test. In general, outcomes that involve participant report or physician assessment can be affected by knowledge of assigned treatment. Randomization addresses allocation, while masking can address some knowledge-related influences; the registry records no masking. The record does not describe how assessment bias was addressed.

Finally, the record shows why completeness of reporting matters for multiplicity, missing data, and safety interpretation. Secondary outcomes are named, but their results are not reported. The analysis plan, missing-data approach, and primary comparison are not reported in the registry record. Limited adverse-event counts are present, but they do not provide a full safety profile. These gaps leave important questions about precision and analytic choices unresolved, regardless of the study's phase or enrollment.

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.

Several trial-specific limitations affect interpretation of the registry record. First, the primary endpoint is described but its category-level results and comparative analysis are not reported. No effect estimate, confidence interval, or p-value is reported, preventing assessment of the magnitude, direction, and precision of the symptom outcome.

Second, the trial was open-label, with masking listed as none. The primary outcome includes symptoms assessed by presence or absence, and secondary outcomes include participant- and physician-assessed response. In general, knowledge of assigned treatment can influence subjective reporting or assessment. The record does not describe safeguards to limit this possibility.

Third, the scheduled primary assessment is stated as 3 days after treatment, at Day 7 for Gynoclin V or Day 13 for Vagitrol V. The regimens differ in duration, and the record does not provide further detail about assessment procedures, deviations from scheduled timing, or additional symptom assessments. It also does not explain how the listed symptoms were combined into the primary result.

Fourth, the primary-outcome analysis population and missingness are not fully characterized. The record defines the intent-to-treat population as participants who received at least one dose and were evaluated for efficacy parameters, but it does not report the number evaluated for the primary outcome or the handling of participants without an evaluation. Missing-data reasons and methods are not reported in the registry record.

Finally, the analysis plan, randomization implementation details, multiplicity procedures, and original sample-size rationale are not reported. The safety summaries provide limited counts, while death counts and detailed adverse-event descriptions are not reported in the registry record. These limitations concern the information recorded and do not establish what may have been documented elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis — NCT01867164.
• Registry record last updated 2013-12-24; status last verified 2013-11.
• Results first posted 2013-12-24.
• 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 describes a completed, Phase 3, randomized, open-label, parallel-group, multicentric comparison sponsored by Janssen-Cilag, S.A. It lists an enrollment of 160 and compares Gynoclin V, given once nightly for 3 days, with Vagitrol V, given once nightly for 10 days. The study concerns secondary vulvar or vaginal symptoms of vaginitis or infectious vaginosis.

The primary outcome is presence or absence of itching, burning, and sudden vulvar pain 3 days after treatment, assessed at Day 7 for Gynoclin V or Day 13 for Vagitrol V. Participant-assessed and physician-assessed response are listed as secondary outcomes. The primary comparative results, secondary results, statistical analysis plan, and missing-data methods are not reported in the registry record.

The safety summaries record no serious adverse events among the listed at-risk participants and one other adverse event in each group. Death counts are not reported in the registry record. Overall, the study design and selected safety counts are described, but the registry does not provide the outcome analysis required to judge the comparative symptom findings.