Clitoral Location in Relation to Sexual Function Using Pelvic Imaging: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clitoral Location in Relation to Sexual Function Using Pelvic Imaging (NCT01195701), a registered phase not stated study. The primary outcome is Clitoral Measurements Using Pelvic MRI.

2. Clinical Question

3. Trial Design

The registry describes a case-control study, not a randomized clinical trial. Its central comparison is between women with anorgasmia, classified as cases, and women who report normal orgasmic function, classified as controls. The study is listed as completed, with enrollment of 35. The record lists a start of 2010-07 and primary completion of 2012-09. It identifies TriHealth Inc. as the sponsor.

Both groups were to undergo pelvic MRI without contrast to assess the clitoral complex. The primary outcome description specifies measurements in millimeters, reported as a mean and standard deviation, during day 1-14 (follicular phase) of the menstrual cycle. The record does not provide the measurement results or clarify which individual anatomical dimensions comprise the clitoral measurement outcome.

The registry also lists free testosterone, total testosterone, free androgen index, and Female Sexual Function Index (FSFI) total and domain scores among secondary outcomes. The stated hypothesis concerns possible differences in anatomy and hormone levels between the groups. These are questions being investigated, not findings reported by the registry.

Allocation is not stated, and the record explicitly cautions that the arms are not a like-for-like control comparison. The record does not report the participant selection process, eligibility details beyond the group descriptions, or procedures used to ensure comparability. It lists 11 outcome measures and zero analyses. Thus, although the study is marked completed, the registry entry does not contain a statistical result that would allow readers to assess the observed group differences.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

5. Baseline Characteristics

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

Population: A sample size calculation determined that with an alpha level of 0.05 a sample size of 13 participants in each arm (N=26) would yield 90% power to detect a mean difference of 5.6 between groups on the FSFI Orgasm subscale. We planned to enroll 40 patients (20 in each arm) to accommodate a predicted dropout rate of approximately 40%.

6. Primary Endpoint

The registry lists the primary outcome as Clitoral Measurements Using Pelvic MRI, measured over Between day 1-14 (follicular phase) of menstrual cycle.

The primary endpoint is described as clitoral measurements obtained using pelvic MRI. The MRI was to be performed without contrast in both cases and controls, and measurements are expressed in millimeters. The registry specifies the mean and standard deviation as the intended summary, with assessment during day 1-14 (follicular phase) of the menstrual cycle. The record does not identify the individual anatomical dimensions in more detail or report their values.

The endpoint addresses the study’s anatomical question: whether measurements of the clitoral complex differ between women classified as having anorgasmia and women reporting normal orgasmic function. A continuous measurement can describe the magnitude and variation of an anatomical feature across participants. Comparing group summaries can therefore help characterize whether the recorded measurements tend to differ between these case and control groups. That comparison alone, however, cannot establish that anatomy caused a difference in orgasmic function.

In general, collecting measurements at a specified phase of the menstrual cycle can make timing more consistent across participants. The registry describes this timing as part of the outcome timeframe, but does not report how consistently it was achieved or whether timing was included in any analysis. No endpoint estimates, uncertainty intervals, or group comparison results are reported in the registry record. The endpoint’s intended role is clear, but its observed values and the precision of any estimated difference cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

For the primary outcome, the registry specifies a mean and standard deviation for continuous clitoral measurements in millimeters. A mean describes the center of a set of measurements, while a standard deviation describes their spread around that center. These summaries can characterize each group, but they do not by themselves show how precisely a between-group difference has been estimated. The registry record does not report either group’s summary values.

General statistical explanation: a confidence interval gives a range of values compatible with the data and the analysis assumptions, and conveys uncertainty around an estimate. A narrow interval indicates greater precision than a wide interval, all else being equal. Here, no confidence interval or effect estimate for the primary outcome is reported, so neither the direction nor precision of a difference can be assessed. A p-value, if reported, would address compatibility with a specified null model; it would not measure the size or importance of a difference. No p-values are reported.

The case-control structure matters for interpretation. The comparison is between groups defined by orgasmic-function status rather than groups assigned to different treatments. In general, an observed difference between such groups can be associated with other differences between participants. Randomization is not stated, and the registry specifically cautions that the arms are not a like-for-like control comparison. The record does not report a statistical adjustment strategy, matching procedure, or other method intended to address group differences.

The registry lists an overall set of outcome measures that includes the MRI measurements, hormone-related measures, and FSFI total and domain scores. It reports zero analyses. Thus, the record does not identify which outcome-specific statistical tests or models were used, whether estimates were adjusted, or what analytic assumptions were checked. Those methods are not reported in the registry record. The primary outcome description’s use of means and standard deviations indicates the planned descriptive summaries, but it does not establish the inferential method for comparing groups.

General statistical explanation: continuous outcomes can be compared using methods that estimate a difference in group means, provided their assumptions are suitable for the data and design. Those assumptions can concern the distribution of measurements, the independence of observations, and whether variability is similar across groups. The registry does not report diagnostic checks or an alternative method for situations in which assumptions may not hold. No particular comparison test should therefore be attributed to this study based on the available record.

The registry’s planning description refers to a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect defined as a stated fraction of an observed effect. It also distinguishes planning illustrations for continuous outcomes from those for time-to-event outcomes. These are planning assumptions, not evidence that the study used those assumptions in its own design or analysis. The registry does not report its own sample-size justification, and no numerical planning outputs or observed effect estimates are reported in the registry record. Any sample-size illustration based on an observed effect is hypothetical in the absence of a reported estimate. It must not be interpreted as observed power.

In general, over-dispersion means that data vary more than a model assumes; ignoring it can make uncertainty appear smaller than it is. This concept may matter for some outcome types, but the registry does not describe a model or report evidence of over-dispersion for these measurements. There is no basis in this record for claiming that over-dispersion was present or that a particular correction was applied.

The listed safety counts are descriptive. Zero serious events and zero other events are recorded for the stated at-risk counts, but the entry does not describe a safety analysis method. The deaths fields are null rather than numerical counts. The registry does not report whether missing safety or outcome information was assessed, nor does it describe an analysis population. These omissions limit both the statistical and clinical interpretation of the reported record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 11 outcome measures, including the primary MRI measurement and secondary hormone and FSFI measures. Considering multiple outcomes can raise a multiplicity issue: when many statistical comparisons are made, the chance of at least one apparently unusual result can increase. General statistical practice may address this through a prespecified hierarchy or adjustment, depending on the purpose of the analyses. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or any outcome-specific analysis. It also reports zero analyses, so no set of results is available for assessing how multiple comparisons were handled.

The record does not report missing-data counts, reasons for missingness, or procedures for handling missing measurements or questionnaire responses. It does not describe whether any imputation or sensitivity analysis was planned or performed. These details are not reported in the registry record, so the completeness and robustness of the outcome data cannot be assessed.

Similarly, the registry does not define an analysis population or state how participants were included in each outcome analysis. The record lists enrollment of 35, while its safety groups list at-risk counts of 10 and 20; it does not explain how those figures relate. No conclusion about the number analyzed for the primary endpoint can be drawn from these entries. The listed safety denominators should not be treated as analysis sample sizes for the MRI outcome.

These reporting gaps leave unresolved how the study addressed outcome multiplicity, incomplete data, and participant inclusion. They do not establish that an inappropriate method was used; rather, the relevant methods and results are not reported in the registry record.

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.

The safety listing records zero serious events and zero other events for the Anorgasmia (Cases) group, among 10 participants at risk. For the Normal Orgasmic Function group, it records zero serious events and zero other events among 20 participants at risk. These are the safety counts recorded in the registry; they are not results for the MRI or sexual-function outcomes.

The registry separately lists enrollment of 35, but does not explain how that enrollment figure relates to the group-specific at-risk counts. The counts should therefore be read as the safety denominators stated for those groups, not as a complete account of enrollment or the number assessed for the primary endpoint. The deaths fields are null, not numerical zeroes; deaths are not reported in those fields.

In general, a record of zero events does not prove that an event could not occur. The amount of information in a safety count depends on the number of people observed, the period and completeness of monitoring, and how events were defined and collected. The registry entry does not report those details. It also does not describe adverse-event attribution or a safety analysis plan. The listed zero counts are therefore limited descriptive entries, not a basis for broader conclusions about safety.

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

The record identifies a research question about the relationship between clitoral anatomy and orgasmic function. It describes comparing MRI measurements in women classified as cases with measurements in women reporting normal orgasmic function. It also identifies hormone measures and FSFI scores as secondary outcomes. These details describe what the study set out to examine, not what it found.

No outcome estimates or analyses are reported. As a result, the registry entry does not show whether the groups differed in clitoral measurements, testosterone-related measures, or sexual-function scores. It also does not show how large or precise any difference might have been. The completed status and enrollment of 35 do not substitute for reported results. There is no basis in this record to conclude that the proposed anatomical or hormonal differences were present or absent.

Even if group differences were available, this case-control design would describe associations rather than establish that an anatomical feature or hormone level caused orgasmic difficulty. The registry does not state allocation and cautions that the groups are not a like-for-like control comparison. The record also does not report participant characteristics, an adjustment strategy, or analysis populations that would help readers evaluate potential group differences beyond the case-control classification.

The safety counts are separate from the primary question. The registry lists zero serious events and zero other events for the stated at-risk counts, while deaths are not reported numerically. Those entries do not resolve the unanswered outcome question, and the record does not explain the relationship between the safety denominators and listed enrollment.

In practical statistical terms, the registry record is informative about the planned comparison and its stated measures, but not about the empirical result. Its limitations are reporting limitations: estimates, uncertainty, missing-data handling, and analysis methods are not reported in the registry record. The findings therefore cannot be characterized from this entry.

13. Why This Trial Matters Statistically

This study illustrates the distinction between a clearly framed research question and a statistically interpretable result. The registry describes a comparison of MRI-based clitoral measurements between women with anorgasmia and women reporting normal orgasmic function. It also identifies hormone measures and FSFI scores as secondary outcomes. Those design details help readers understand the intended scope of the investigation.

For biostatistical interpretation, however, a completed study needs reported estimates and uncertainty, along with enough information about the analysis to understand how those estimates were obtained. This registry record reports zero analyses and no outcome estimates. Readers therefore cannot evaluate the magnitude, direction, or precision of any differences. It is not possible to distinguish a small, uncertain difference from a larger, more precisely estimated one using this record.

The case-control structure is also important. The groups are defined by orgasmic-function status, and the record says allocation was not stated and the arms are not a like-for-like control comparison. In general, this design can investigate associations, but it does not by itself establish a causal pathway. Reporting participant selection, group characteristics, and analytic methods would help readers assess how group comparability affects interpretation; these details are not reported in the registry record.

The listing of multiple measures raises another general statistical consideration: readers need to know which outcomes were prespecified as primary and how multiple comparisons were handled. Although the record identifies the primary MRI outcome and lists secondary measures, it does not report an analysis plan or results. This is a useful reminder that endpoint names and study completion do not convey the evidential strength of a finding. Transparent reporting of estimates, uncertainty, analysis populations, and missing-data handling is necessary for meaningful statistical appraisal.

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 of the registry entry for interpreting this study is the absence of outcome results. It does not report the actual clitoral MRI measurements, their group-specific means or standard deviations, or a comparison estimate. It also provides no confidence intervals or p-values. The direction and precision of the primary comparison therefore cannot be evaluated.

The record gives limited detail about what the MRI outcome comprises. It refers to clitoral measurements of the clitoral complex in millimeters, but does not specify the individual anatomical dimensions in the outcome description. It does not report measurement procedures, reader reliability, or whether assessment was blinded to case-control status. These details are not reported in the registry record.

Further information about participant selection and baseline characteristics is absent. The record does not describe recruitment, eligibility criteria in detail, or methods to make the groups comparable. It states that allocation was not stated and that the arms are not a like-for-like control comparison. Consequently, the potential influence of differences between the groups cannot be assessed from this entry.

The registry lists enrollment of 35 but does not report the number contributing data to each outcome. Its safety entries use at-risk counts of 10 and 20, without explaining their relation to enrollment. The deaths fields are null. Missing outcome data, analysis populations, and safety follow-up details are not reported in the registry record.

Finally, the record lists multiple outcomes but reports zero analyses. It does not describe the statistical comparison method, covariate adjustment, multiplicity handling, or the study’s own sample-size justification. These omissions prevent assessment of the analytic choices and uncertainty. They are limitations of what the registry record reports and do not establish what was or was not done outside the record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Clitoral Location in Relation to Sexual Function Using Pelvic Imaging — NCT01195701.
• Registry record last updated 2014-12-03; status last verified 2014-11.
• Results first posted 2014-12-03.
• 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

This completed case-control study, sponsored by TriHealth Inc., concerns clitoral location and sexual function using pelvic imaging. The registry lists enrollment of 35, a start of 2010-07, and primary completion of 2012-09. Cases were women with difficulty or inability to reach sexual climax; controls reported that they usually or always achieved sexual climax.

The primary outcome is described as clitoral measurements using pelvic MRI, in millimeters, summarized by means and standard deviations, with assessment during day 1-14 (follicular phase) of the menstrual cycle. Secondary outcomes include testosterone-related measures and FSFI scores. The registry lists 11 outcome measures and zero analyses.

No outcome estimates or statistical comparison results are reported in the registry record. Safety entries list zero serious events and zero other events for at-risk counts of 10 and 20, respectively; deaths are not reported numerically. The record does not explain the relationship between those safety denominators and enrollment.