Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction (NCT04984993), a randomized phase 3 study. The primary outcome is Change From Baseline in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire, in Patients Randomised to MED3000, at Week 24.

2. Clinical Question

The registry record frames the primary endpoint around change in erectile function in the MED3000 group. It describes two co-primary objectives: assess improvement from baseline and assess whether the mean change meets or exceeds the stated threshold. The endpoint is therefore not, as recorded, a direct primary comparison of change between MED3000 and tadalafil. A comparative treatment effect on this measure is not reported in the primary outcome information.

The investigation also includes secondary outcomes concerning the percentage of uses per patient associated with onset of erection or onset of action within a specified period for patients randomized to MED3000. The registry record does not report those outcome results in the information available. Consequently, the clinical question can be described, but its answers cannot be inferred from the endpoint definition or from the study design alone.

3. Trial Design

NCT04984993 is recorded as a completed Phase 3 clinical investigation sponsored by Futura Medical Developments Ltd. It is described as multicentre, randomized, open-label, home use, and parallel group. The registry lists enrollment as 116. The brief summary states that eligible patients were randomized in a 1:1 ratio to MED3000 gel or tadalafil (5 mg) tablets. No masking was used.

MED3000 is described as a gel formulation applied topically to the glans penis; tadalafil is described as an oral tablet. The official title gives a 24-week treatment period. The brief summary says each patient was expected to participate for up to 30 weeks. The recorded study start is 2021-09-14 and primary completion is 2022-07-13. These dates and design features describe the conduct planned or recorded, but they do not establish what happened to each participant or the completeness of follow-up.

The primary outcome is change from baseline at Week 24 in the IIEF erectile-function domain for patients randomized to MED3000. The registry identifies the measure as a mean with standard error. Its outcome description also states that Week 24 values for patients who discontinued early for reasons adversely related to randomized treatment were imputed as their baseline value, resulting in zero change. The available description ends after a reference to Week 2, so further details of the outcome population or assessment schedule are not reported in the registry record.

The record lists three outcome measures and seven analyses, but does not give the full analysis plan, the allocation-generation procedure, or details about concealment of assignment. Sample-size justification, interim analyses, and the statistical plan are not reported in the registry record. The study design alone cannot show whether the treatment groups were comparable at baseline or whether the planned analyses were carried out as intended.

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.

Before assignment: Of 232 screened patients (males and females enrolled for eligibility assessment), 192 patients and their partners were randomised to treatment. Of the 40 patients and partners that failed screening, 36 did not satisfy inclusion criteria and 2 were excluded for other reasons.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: MED3000 randomised patients (the only group considered for this outcome). Week 24 values for patients who do not have a Week 24 IIEF-EF value due to early treatment discontinuation adversely related to randomised treatment were imputed as baseline value resulting in zero change from baseline. Week 24 values for patients with early termination discontinuation not adversely related to randomised treatment were imputed via multiple imputation method.

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: Regional enrolment details are combined for both the male participants and their female partners.

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire, in Patients Randomised to MED3000, at Week 24, measured over Baseline and Week 24.

The primary endpoint is change from baseline to Week 24 in the erectile-function domain of the International Index of Erectile Function questionnaire among patients randomized to MED3000. The IIEF is described as a validated questionnaire with 15 questions. The erectile-function domain is derived from questions 1, 2, 3, 4, 5, and 15. Higher scores indicate better sexual function, and the domain score is calculated by summing the scores for those questions.

The record states that the minimum and maximum possible domain scores are 1 and 30, and that patients with a score of 21 or less are considered to have erectile dysfunction. Change is defined as the Week 24 score minus the baseline score. The primary outcome is a continuous measure, reported as a mean with standard error. The description sets out the aim of assessing improvement from baseline and whether mean change reaches the stated minimal clinically important difference of 4.

In general, a change score puts the follow-up measurement in relation to a participant's starting score. This can make the direction and size of within-group change easier to interpret. It does not, by itself, estimate the difference in change between randomized groups. The registry record does not report the observed mean change, its standard error, or a confidence interval for this endpoint, so the amount and precision of observed change cannot be assessed from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a continuous change score, and the registry identifies its summary as a mean with standard error. In general, a mean combines individual measurements into an average on the outcome scale. A change score is calculated by subtracting the baseline score from the Week 24 score, as the endpoint description specifies. Positive change corresponds to a higher follow-up score; the questionnaire description says higher scores indicate better sexual function. These definitions explain how a result would be interpreted, but the record does not report the observed mean change.

What does the standard error describe?

In general, the standard error characterizes the uncertainty of an estimated mean due to sampling variability under the analysis assumptions. It is not the spread of individual participants' scores; a measure of participant-to-participant variability would describe a different feature of the data. A smaller standard error indicates a more precisely estimated mean, all else equal. Since the registry record does not report the primary standard error or an interval estimate, the precision of the primary result cannot be assessed.

How would a confidence interval help?

In general, a confidence interval pairs an estimate with a range expressing its statistical uncertainty under a specified method. For a mean change, it would help readers judge which values are reasonably compatible with the data and how precisely the mean is estimated. Comparing an interval with a clinically meaningful benchmark can be informative, but interpretation depends on the analysis and the endpoint. The registry record does not report a confidence interval for the primary endpoint, so no interval-based conclusion is available.

What does the clinical benchmark mean?

The outcome description identifies a minimal clinically important difference of 4 and states that one objective was to observe a mean change greater than or equal to that value. This is a benchmark named in the record, not a reported finding. In general, a benchmark gives context for judging the magnitude of an estimate; it does not replace uncertainty estimates or a prespecified analysis plan. Whether the observed mean reached the benchmark cannot be determined because the mean result is not reported in the registry record.

What does randomization contribute?

In general, random assignment is intended to make treatment groups comparable, on average, with respect to measured and unmeasured baseline characteristics. This supports causal comparisons when outcomes are analyzed according to an appropriate plan and follow-up and measurement are handled adequately. Randomization does not guarantee that groups will be identical, nor does it resolve missing data or open-label measurement concerns. The record identifies randomized allocation and a 1:1 ratio, but does not report baseline balance or the details of allocation generation and concealment.

Why does the open-label design matter?

In general, when participants and study personnel know the assigned treatment, expectations or behavior can influence reporting, adherence, follow-up, and outcome assessment. This is particularly relevant to a patient-reported questionnaire, even when its scoring rules are specified. Randomization can address some sources of confounding in treatment assignment, but it does not remove possible effects of awareness on measurement or participation. The record reports no masking; it does not quantify any resulting bias.

Why can over-dispersion matter?

In general, over-dispersion occurs when outcome variability is greater than a statistical model assumes. If a model understates variability, its standard errors and confidence intervals can be too optimistic. This concept is especially relevant to some count or rate outcomes; the primary endpoint is described as a continuous score summarized by a mean and standard error. The record does not report a model or diagnostic analysis, so it is not possible to say whether over-dispersion was assessed or relevant to any secondary analysis.

The registry record also lists sample-size assumptions for a planning illustration based on an observed effect, including a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such an illustration is not the trial's own design justification and does not establish the study's achieved power. The design's sample-size justification is not reported in the registry record. Any sample-size illustration is a planning aid, not a result about the probability that this completed investigation detected an effect.

The record states the primary summary type and describes a specific imputation rule for some early treatment discontinuations. It does not report a complete statistical analysis plan, the exact test or model used for the primary outcome, covariate adjustment, diagnostic checks, or the construction of any confidence interval. Those details should not be inferred from a mean and standard error label alone. Nor does the listing of analyses reveal whether they were prespecified or how they were interpreted.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("MED3000")
n   <- c(48)
m   <- c(5.73)
sp  <- c(1)
sd  <- sp * sqrt(n)      # standard errors converted to SDs
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  MED3000  48  5.730  6.928  3.718  7.742

11. Multiplicity, Missing Data and Analysis Populations

The record lists three outcome measures and seven analyses. It identifies co-primary objectives within the MED3000 endpoint description: improvement from baseline and assessment against the stated minimal clinically important difference of 4. How multiplicity was handled across objectives, outcomes, or analyses is not reported in the registry record. In general, testing multiple hypotheses can increase the chance of a false-positive finding if no adjustment or testing hierarchy is used. The record does not allow readers to determine whether an adjustment, hierarchy, or other strategy was planned.

The primary outcome population is described as patients randomized to MED3000. For Week 24 values missing because of early treatment discontinuation adversely related to randomized treatment, the record says baseline was imputed, yielding zero change. This is a specific missing-data rule, not evidence that all missing observations were handled in the same way. The available population description is incomplete, ending with a reference to Week 2. Other missing-data methods, the amount of missingness, and sensitivity analyses are not reported in the registry record.

In general, imputation choices rely on assumptions about the unobserved outcomes. Assigning zero change for the specified cases treats those missing Week 24 scores as unchanged from baseline in the endpoint calculation. The consequences depend on how many such cases there were and on the true outcomes that were not observed; those details are not reported. The record does not describe analyses testing how conclusions might change under alternative assumptions.

The analysis populations, treatment of deviations from assigned treatment, and relationship between the registered plan and the reported analyses are not fully described. No statistical plan or interim-analysis details are reported in the registry record. These gaps limit assessment of how missing data and multiple analyses may affect the reliability of any efficacy interpretation.

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 2% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: appendicitis (1.1%).

The registry lists serious adverse event counts for MED3000 and tadalafil, with 94 at risk in each group. Serious adverse events affected 0 in the MED3000 group and 1 in the tadalafil group. The record also lists other adverse events, with 47 at risk in each group; other adverse events affected 10 in the MED3000 group and 16 in the tadalafil group. Deaths are recorded as 0 in each group.

Appendicitis is listed among the serious adverse event terms, at 1.1%. The registry entry does not link that term explicitly to a treatment group in the information, so it should not be assigned to either group based on the term listing alone.

In general, counts describe the events recorded under the registry's definitions; they are not, by themselves, measures of comparative risk. The at-risk figures and affected counts should be read as separate registry entries, without converting them into percentages or assuming that the listed term information fully explains the group counts. The record does not report further detail on event timing, duration, severity beyond the serious classification, causal assessment, or exposure-adjusted comparisons. These entries are therefore a limited safety description, not a complete comparative safety analysis.

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

The registry record establishes that a randomized, open-label, parallel-group investigation compared topical MED3000 gel with oral tadalafil for erectile dysfunction. It identifies a primary endpoint based on change from baseline to Week 24 in the IIEF erectile-function domain among patients randomized to MED3000. It also describes a benchmark of 4 and a rule for handling a specified form of missing Week 24 data.

These details explain what the investigation sought to measure and some aspects of how the measure was defined. They do not reveal the observed primary mean change, its standard error, or its confidence interval. The record therefore does not show whether the MED3000 group improved on average, how precisely its change was estimated, or whether the stated benchmark was reached. The primary endpoint description alone also does not provide a direct comparison with tadalafil.

In general, evidence about a treatment comparison requires estimates for the relevant groups or a direct between-group effect, together with uncertainty and an analysis appropriate to the design. Even an observed change within a treatment group would not on its own establish a comparative treatment effect. The registry record does not report the relevant primary comparative estimate or sufficient results to make that assessment.

The listed safety counts give a limited account of serious and other adverse events and deaths. They do not replace a full safety analysis and cannot establish comparative safety without fuller information on definitions, follow-up, and the analysis. The record also leaves important statistical details unreported, including multiplicity handling and broader missing-data methods.

Accordingly, the registry supports a careful description of the trial's question, design, endpoint, and selected safety entries. It does not support a conclusion about the efficacy or comparative performance of MED3000 and tadalafil. That absence of a reported endpoint result should not be mistaken for evidence of no effect; it means the primary result is not reported in the registry record.

14. Why This Trial Matters Statistically

This investigation is statistically notable because it combines randomized treatment assignment with a primary endpoint described as a within-group change among patients randomized to MED3000. The distinction matters: a randomized comparison is designed to support contrasts between assigned groups, whereas a change from baseline in one group describes that group's trajectory. A within-group change and a between-group treatment effect answer different questions.

The endpoint is based on a patient-reported questionnaire, and the investigation is open-label. In general, patient-reported measures can capture aspects of experience that may not be represented by other measures, while awareness of assignment can influence reporting or follow-up. This makes transparent reporting of measurement procedures, missing-data handling, and uncertainty especially important. The registry identifies the instrument and its scoring framework but does not report the primary result or all analysis details.

The stated minimal clinically important difference gives the endpoint a clinical benchmark alongside statistical estimation. A benchmark helps readers interpret the size of an estimate, but cannot substitute for the estimate itself or its uncertainty. Because the registry record does not report the observed change, readers cannot assess either its magnitude or its precision relative to that benchmark.

The record's explicit imputation rule also illustrates why missing-data assumptions matter. Treating certain missing Week 24 values as baseline values yields zero change for those observations. Without the number affected or sensitivity analyses, the influence of that choice cannot be assessed. More broadly, the absence of reported multiplicity and analysis-plan details makes it harder to evaluate how the listed analyses relate to the stated objectives.

The statistical importance of the record lies in these distinctions between design, endpoint definition, and evidence. Randomization and a clinically framed endpoint establish a structure for asking a question; they do not supply the results needed to answer 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 primary limitation for interpreting efficacy is that the registry record does not report the observed primary outcome result. The mean change, standard error, confidence interval, and any test result are not reported. Without these, neither the size nor precision of the within-group change can be evaluated, and the stated benchmark cannot be assessed.

The endpoint is specified for patients randomized to MED3000, while the study also includes a tadalafil group. The record does not report a primary between-group contrast for this outcome. It therefore does not provide the information needed to compare changes between treatments on the primary measure. Comparative results for the secondary outcomes are not reported in the registry record either.

The design is open-label and the primary endpoint is patient-reported. In general, awareness of assigned treatment can affect reporting and study participation. The record does not report procedures that might address this concern or quantify its possible impact. Randomization does not eliminate potential measurement effects associated with an unmasked design.

Missing-data information is partial. The record describes baseline-value imputation for Week 24 values missing after early discontinuation adversely related to randomized treatment, but does not report how many observations this affected, the handling of other missing outcomes, or sensitivity analyses. The population description is incomplete in the available record.

Multiplicity handling, the full statistical analysis plan, interim analyses, sample-size justification, and details of the primary analysis are not reported in the registry record. The safety entries also lack further information on event timing, causal assessment, and follow-up. These reporting gaps constrain interpretation; they do not establish that particular methods were or were not used.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction — NCT04984993.
• Registry record last updated 2023-09-21; status last verified 2021-07.
• Results first posted 2023-09-21.
• 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

NCT04984993 is a completed Phase 3, randomized, open-label, parallel-group investigation of MED3000 gel and oral tadalafil (5 mg) for erectile dysfunction. The registry lists enrollment as 116 and describes a 1:1 allocation. The official title gives a 24-week treatment period, and the brief summary describes participation for up to 30 weeks.

The primary endpoint is change from baseline to Week 24 in the IIEF erectile-function domain among patients randomized to MED3000. The record describes a mean with standard error and an imputation rule for certain missing Week 24 values. It does not report the observed primary result or a comparative estimate against tadalafil.

Serious and other adverse event counts and deaths are listed by group. The record does not report the full statistical plan, multiplicity handling, or broader missing-data analyses. The study's question and design are identifiable, but its primary efficacy finding cannot be interpreted from the registry record.