Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis (NCT05507333), a na na study. The primary outcome is Clinical Cure Rate at Day 7-14.

2. Clinical Question

The study was intended to evaluate clinical performance and safety in women with confirmed vulvovaginal candidiasis. Because there is no control group, the primary endpoint describes outcomes among participants treated in this study; it does not by itself estimate how those outcomes compare with another treatment or with no treatment. Open-label conduct also means participants and study personnel were not masked to the intervention, as recorded in the registry. The registry lists additional outcomes concerning clinical response, combined clinical and mycological cure, mycological cure, wet-smear findings, and changes in symptoms and signs over time. Their result values are not reported in the registry record.

3. Trial Design

The record describes a completed, open-label, multi-centre, multi-national, single-group study sponsored by Gedea Biotech AB. Allocation is recorded as NA and masking as none. The listed enrollment is 26; the study summary says that 26 patients were planned for inclusion. No randomized comparator arm is listed, so this design provides no concurrent control group for a like-for-like comparison.

The study population was described as post-menarchal, pre-menopausal females aged 18 years or older who sought care for vulvovaginal candidiasis symptoms and had confirmed infection. On Day 0, participants were to undergo screening and a gynaecological examination, with collection of composite vulvovaginal signs-and-symptoms data and vaginal samples. The summary describes self-administration of six daily doses from Day 0 to Day 5.

A clinic visit was scheduled on Day 7, with a permitted window of +2 days, for examination and assessment of clinical cure, as well as reporting of adverse events and concomitant medications. Participants without clinical and mycological cure at Day 7 were described as returning on Day 14, with a permitted window of ±2 days, for further examination and clinical-cure assessment. Rescue treatment was to be offered at visits 2 and 3 if necessary. The summary also describes a telephone follow-up on Day 25, with a permitted window of ±3 days, for adverse-event, concomitant-medication, and potential menstruation reporting.

The record lists a start date of 2023-03-16, a primary completion date of 2024-02-22, and status COMPLETED. The listed phase is NA. The registry record does not report further details of the allocation process, a comparator regimen, or the statistical 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:

Analysis population for the primary outcome, as defined in the registry: Full Analysis Set

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Clinical Cure Rate at Day 7-14, measured over Day 7-14.

The primary endpoint is the clinical cure rate at Day 7–14, with the outcome unit specified as participants and the primary population identified as the Full Analysis Set. Clinical cure required a composite vulvovaginal signs-and-symptoms score equal to or below 3, along with no specified intercurrent event before endpoint assessment. The listed intercurrent events include concomitant antifungal therapy or other treatment related to vulvovaginal candidiasis due to lack of clinical performance, discontinuation due to lack of clinical performance, or rescue medication before assessment.

The composite score combines six individually scored features: erythema, edema, and excoriation as signs, and itching, burning, and irritation as symptoms. Each feature was scored from 0, meaning absent, through 3, meaning severe. The total is the sum of the six individual scores. The endpoint therefore captures both signs and symptoms rather than relying on a single symptom or a laboratory result alone.

As a general statistical concept, a binary clinical-cure endpoint gives a clear count of participants meeting a prespecified definition and can be expressed as a proportion of the relevant analysis population. In a single-group study, that proportion describes the observed outcome in the treated group; it does not establish a comparative treatment effect. The registry record gives the endpoint definition but does not report the number meeting it, the denominator used for the result, or an uncertainty interval. The clinical-cure result itself is therefore not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record describes the trial as single group, open label, and without masking. It does not report a statistical analysis plan. The endpoint and analysis population are defined, but the record does not specify the statistical model, confidence-interval method, hypothesis test, missing-data procedure, or adjustments for multiple outcomes. These omissions limit what can be concluded about the analysis beyond the stated outcome definition.

What does a binary endpoint represent?

As a general statistical explanation, a binary endpoint classifies each participant into one of two outcome categories, such as meeting or not meeting a clinical-cure definition. A count and proportion can describe how often the defined outcome occurred in the analysis population. For this study, clinical cure is defined using the composite vulvovaginal signs-and-symptoms score and the listed intercurrent-event rules. The result count, denominator, and rate are not reported in the registry record, so no estimate can be interpreted.

For a binary outcome, the denominator matters as much as the number meeting the endpoint. A denominator can be smaller than enrollment if some participants are not included in the analysis or do not have an evaluable assessment. The record names the Full Analysis Set for the primary endpoint, but the size of that set and the handling of participants without endpoint data are not reported in the registry record. It would therefore be inappropriate to assume that all 26 enrolled participants contributed to the primary result.

Why does the single-group design matter?

As a general explanation, an outcome proportion in a single group is a descriptive measure of observed outcomes in that group. A comparison between treatment strategies requires a comparator and a method that accounts for how the groups were formed. Here, no comparator group is listed, and allocation is recorded as NA. The primary endpoint can therefore describe clinical cure among assessed participants, but it cannot provide a randomized between-group treatment contrast. This does not make the endpoint meaningless; it defines the scope of the inference that the design can support.

Open-label conduct is also relevant. Because masking is recorded as none, participants and study personnel were not blinded to treatment assignment. In general, knowledge of treatment can influence reporting, assessment, additional care, or decisions to discontinue treatment. The endpoint includes objective examination findings and reported symptoms, but the registry record does not give enough detail to determine how individual assessments were made or whether any independent review was used.

How should uncertainty be assessed?

As a general statistical explanation, a confidence interval describes a range of values compatible with the observed data under a specified statistical method. Its width reflects statistical precision: wider intervals indicate greater uncertainty about the underlying outcome rate. A p-value, when used, addresses compatibility with a specified null hypothesis under model assumptions; it does not measure the size or clinical importance of an effect. Neither an interval nor a p-value is reported for the primary endpoint in the registry record.

The record’s sample-size description concerns a planning illustration, not the actual study design. It specifies a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of an observed effect. The trial itself is listed as single group, so the two-arm allocation assumption is not a description of its design. The record also states that such sample-size values are planning illustrations, not observed power. No numerical planning values are reported in the record details. The original sample-size justification is not reported in the registry record.

What do the outcome listings tell us?

The registry lists a primary clinical-cure outcome and secondary outcomes involving clinical response, mycological cure, combined cure, wet-smear findings, and change in the composite score. These outcome definitions and titles describe the questions of interest, but do not show the analysis results. The record lists 11 outcome measures and 8 analyses. It does not explain the mapping between these counts and individual outcome analyses, nor does it give reported estimates for the secondary outcomes.

As a general statistical consideration, analyses of repeated measurements or several outcomes may require attention to correlation, outcome selection, and the risk of chance findings when many comparisons are made. The registry record does not report whether any adjustment for multiplicity was planned or applied. The names of multiple outcomes alone are not enough to conclude that a particular multiplicity method was used.

Because this is a count-based clinical-cure endpoint, over-dispersion is not the central issue suggested by the listed primary outcome. In general, over-dispersion concerns variability greater than expected under a model such as a Poisson count model. The primary outcome is specified as participants meeting a binary cure definition, not as a count of recurrent events or an event rate over person-time. The registry record does not report a model, so no claim can be made about the model actually used.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary clinical-cure endpoint and a range of secondary outcomes. The secondary outcome titles include continued clinical response at Day 25, combined clinical and mycological cure at Day 7–14, mycological cure at different assessment times, absence of Candida hyphae in a wet smear, changes in the composite signs-and-symptoms score, and reductions in symptom scores. The record lists 11 outcome measures and 8 analyses. It does not report how the analyses map to the listed outcomes or how the outcomes were prioritized beyond identifying clinical cure at Day 7–14 as primary.

As a general statistical consideration, evaluating multiple outcomes can increase the chance of observing apparently notable results by chance, particularly if results are selected after inspection. A prespecified primary endpoint helps identify the principal question, but does not alone explain how secondary outcomes were interpreted. Whether multiplicity adjustments, testing hierarchies, or other safeguards were planned or used is not reported in the registry record. No unreported adjustment should be assumed.

The primary analysis population is named as the Full Analysis Set, but its size and operational definition are not reported in the registry record. The listed enrollment is 26; it does not establish how many participants had evaluable primary endpoint data. The record also does not describe how missing Day 7–14 assessments, discontinuations, rescue treatment, or other intercurrent events were handled in the analysis, beyond including specified events in the endpoint definition. The extent of missing data and any imputation or sensitivity analyses are not reported in the registry record.

These omissions matter because outcome estimates depend on who is included and how participants without an observed endpoint are treated. Without the analysis denominator, missing-data methods, multiplicity approach, and outcome results, neither the robustness of the primary result nor the interpretation of secondary findings can be assessed from the registry record.

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 record lists 26 participants at risk for serious adverse events and 0 participants affected. It lists 26 participants at risk for other adverse events and 16 participants affected. The death count is 0. These are descriptive counts for the Gedea Pessary group; the record lists no serious adverse-event terms.

As a general statistical explanation, a count of participants affected is not the same as a count of all events, since a participant may experience more than one event. The registry record does not clarify whether the other-adverse-event figure represents participants with at least one event or provides event-level detail beyond the count shown. It also does not report the specific other adverse events, their severity, timing, duration, or relatedness to the intervention. The number of participants with serious events and the death count should be read as recorded, not as evidence that no other safety issues occurred.

These figures do not support a comparison with another treatment because no comparator group is listed. They also do not, on their own, establish the absence of risk: the study has a listed enrollment of 26, and the registry record does not provide a detailed exposure or follow-up account for safety outcomes. The safety counts should therefore be interpreted as the registry’s reported observations for this group, with the detail and precision limited by the information recorded.

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

The registry record defines a clinically focused endpoint: absence of vulvovaginal candidiasis signs and symptoms at Day 7–14 according to a composite score threshold, with specified intercurrent events taken into account. It also describes a treatment course and follow-up assessments. These details clarify what the study intended to measure and when it intended to assess it.

However, the registry record does not report the primary endpoint result. Without the number of participants who met the clinical-cure definition, the analysis denominator, and an estimate of uncertainty, the observed clinical-cure outcome cannot be described or judged for precision. The listed enrollment of 26 is not a substitute for the primary analysis result. The secondary outcome titles likewise do not establish whether the outcomes occurred or how often.

Even if the cure result were available, the single-group, open-label design would limit its interpretation. A rate in the treated group would describe observed outcomes in the study population, not the difference between the pessary and another intervention. Without a concurrent comparator, changes over the assessment period could not be attributed solely to treatment based on this design. This is a general limitation of uncontrolled studies rather than a conclusion about individual participants.

The safety record lists 0 participants with serious adverse events, 16 participants with other adverse events, and 0 deaths. Those counts are useful descriptive information, but the registry record does not provide event details, and the absence of a control group prevents comparative safety interpretation. No clinical recommendation follows from these registry entries alone.

In short, the record establishes the study question, intervention, endpoint definition, and selected safety counts. It does not supply the outcome data or analysis details needed to determine the size, uncertainty, or comparative meaning of the clinical findings. The distinction between a prespecified question and a reported result is essential when interpreting this study.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of how a clearly specified endpoint and a limited design answer different parts of a clinical question. The primary endpoint combines signs and symptoms into a composite score and defines a threshold for clinical cure. It also specifies events that preclude classification as a cure before assessment. That level of definition makes the intended outcome more interpretable than an unspecified statement of improvement.

At the same time, the single-group structure establishes the limits of the comparison. The registry record describes a multi-centre, multi-national study and lists enrollment of 26, but no control group or randomized allocation is listed. Statistical description of outcomes in a treated group and causal comparison of treatments are distinct tasks. A single-group design can report the former if outcome data are available, but it cannot supply a randomized treatment contrast.

The record also highlights why analysis populations and missing data matter. The Full Analysis Set is named, but its size is not reported, and the handling of missing endpoint observations is not described. For a binary endpoint, a rate depends on both the number meeting the definition and the number included in the denominator. Without those values and an uncertainty interval, even a clearly defined endpoint cannot be statistically appraised.

Finally, the entry lists multiple secondary outcomes and a planning illustration based on a two-arm framework, while the study itself is single group. This emphasizes the need to distinguish planned outcome questions, analysis choices, and design assumptions from actual results. The registry record supplies useful design and endpoint information, but does not report enough results to support a statistical estimate of clinical performance.

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 limitations specific to this study are apparent from the registry record. The design is single group and open label, with no listed comparator. This limits the interpretation of any outcome rate to the study participants and prevents a direct comparison with another treatment. Open-label conduct may also affect symptom reporting, clinical assessment, care decisions, and discontinuation, although the record does not report whether or how these possibilities were addressed.

The listed enrollment is 26, and the primary analysis population is identified as the Full Analysis Set. The size of that set is not reported in the registry record, nor is the number of participants with a Day 7–14 assessment. The record does not explain missing-data handling, endpoint imputation, or sensitivity analyses. As a result, the denominator and the influence of unavailable assessments cannot be evaluated.

The primary endpoint combines six signs and symptoms and includes rules for intercurrent events. This composite definition is specific, but the registry record does not give the individual component results or counts of participants affected by the listed intercurrent events. It also does not report the clinical-cure result, its uncertainty, or the values for the secondary outcomes.

The record lists multiple outcomes and analyses without describing the analysis methods or a multiplicity strategy. It also does not report the original sample-size justification. The sample-size assumptions described are a planning illustration based on a two-arm framework, not the single-group design. Details about the study’s actual statistical plan, assessment procedures, and safety-event characteristics are not reported in the registry record. Together, these gaps constrain assessment of precision, robustness, and the meaning of any intended treatment-performance claim.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis — NCT05507333.
• Registry record last updated 2025-10-06; status last verified 2025-09.
• Results first posted 2025-10-06.
• 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

NCT05507333 is a completed, open-label, single-group study sponsored by Gedea Biotech AB. It evaluated the Gedea pessary, identified as pHyph generation II, in adult women with vulvovaginal candidiasis. The registry lists enrollment of 26 and identifies the primary outcome as clinical cure at Day 7–14 in the Full Analysis Set.

Clinical cure was defined using a composite score of vulvovaginal signs and symptoms equal to or below 3, subject to specified intercurrent-event rules. The registry record lists secondary clinical and mycological outcomes, but their results are not reported in the registry record. The primary result, analysis denominator, confidence interval, p-value, and detailed statistical methods are also not reported.

The safety figures list 0 participants with serious adverse events, 16 with other adverse events, and 0 deaths. With no comparator group, these are descriptive counts rather than comparative estimates.