Recall by Genotype: Neuropeptide Stimulation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Recall by Genotype: Neuropeptide Stimulation (NCT05901467), a na phase 1 study. The primary outcome is Endogenous LH Pulse Amplitude.

2. Clinical Question

This is therefore a question about the study’s intended physiological measurements, not a comparison of treatment outcomes. The planned tests were intended to characterize responses to stimulation in people carrying relevant gene variants. Separately, the primary endpoint description refers to average amplitude of LH pulses at baseline. The registry record does not report an estimate of that average or its variability, and it does not provide results for stimulation responses.

Because there is no comparator, the study could not directly estimate a contrast between the planned stimulation regimen and a control condition. The design also does not support a randomized comparison. The record describes the study objective and planned measures, but its termination and the absence of intervention mean that the intended stimulation question was not answered by observed intervention data in the posted record.

3. Trial Design

This was a Phase 1, single-group study with no masking. Allocation is recorded as not applicable. The registry lists 16 participants as the enrollment, but its primary endpoint description states that no participants underwent the intervention. These statements describe different aspects of the record: the enrollment entry does not establish that participants received the planned study drugs or contributed intervention data.

The planned intervention consisted of intravenous kisspeptin 112-121 and intravenous GnRH, each described as one bolus in the arm description. The study objective was to assess stimulation responses and baseline LH secretion patterns among individuals carrying variants in genes related to infertility. The primary outcome measure was endogenous LH pulse amplitude at baseline, with a timeframe of Hours 0-8.

The study started on 2023-10-20 and its primary completion date is listed as 2024-05-29. Its status is terminated. The registry record attributes termination to the study team no longer having access to the study drugs. It does not report further operational details about why drug access ended or whether any data collection occurred before termination.

The listed design does not include a like-for-like control arm, and the record explicitly indicates that the arms are not a control comparison. Consequently, the posted record cannot support a between-group treatment-effect interpretation. The study has two outcome measures listed, but no analyses are recorded. Details such as a protocol-level statistical analysis plan, recruitment flow, the number completing assessments, and any analysis population are not reported in the registry record.

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: There was no washout or run-in period. 4 individuals were found to be ineligible by criteria.

Overall Study

Analysis population for the primary outcome, as defined in the registry: No participants underwent the intervention. This trial was terminated because the study team no longer had access to the study drugs.

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 Endogenous LH Pulse Amplitude, measured over Hours 0-8.

The primary endpoint is endogenous LH pulse amplitude, described as the average amplitude of LH pulses at baseline. It is a continuous measure, expressed in mIU/mL, and summarized as a mean with standard deviation. The recorded timeframe is Hours 0-8. In general, pulse amplitude describes the size of a measured hormonal pulse; summarizing amplitudes can help characterize baseline secretion patterns in a study focused on reproductive hormone physiology.

The endpoint complements the study’s broader objective of examining baseline LH secretion as well as responses to kisspeptin and GnRH stimulation. A baseline measure and a post-stimulation response address related but distinct questions: one describes secretion before the planned stimulation, while the other concerns response to the test drugs. The registry record identifies the baseline pulse-amplitude measure as primary, but it does not report an observed mean or standard deviation.

The record states that no participants underwent the intervention, and no primary endpoint result is reported in the registry record. It therefore offers no posted estimate from which to judge the magnitude or precision of the baseline endpoint. The reason for choosing this endpoint, its measurement procedures, and any rules for identifying or summarizing individual pulses are not reported in the registry record. Without those details and the endpoint results, the measure can be described, but its observed distribution cannot be evaluated.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies the primary measure as continuous and describes it using a mean and standard deviation. The study was single-group, was not masked, and has no recorded analyses. The statistical interpretation is therefore limited: there are no posted endpoint estimates or inferential results to explain. The concepts below provide general context for reading the measures and the planning assumptions, rather than describing analyses confirmed to have been performed.

What a mean and standard deviation describe

In general, a mean summarizes the central level of a continuous measurement, while a standard deviation describes how dispersed individual measurements are around that mean. For LH pulse amplitude, the intended summary would describe the average baseline pulse amplitude and the variability among measurements included in the summary. Neither value is reported for the primary endpoint, so the registry record does not allow the reader to assess the central level or spread of the observed measurements.

A mean is not a complete description of a distribution. Different patterns of individual measurements can share the same mean and standard deviation. For pulse-based data, the way pulses are detected and the way repeated measurements are combined can also matter. The registry record does not report the pulse-identification procedure, the number of observations contributing to a participant-level summary, or the rule for combining observations across participants. Those details should not be inferred from the endpoint name alone.

Why variability matters

In general, variability affects the precision of an estimate. A standard deviation describes dispersion among observations; a confidence interval, when reported, would express uncertainty around an estimated quantity under a statistical model. These are different ideas. A standard deviation is not itself a confidence interval, and it does not by itself show how precisely a study estimates a population mean. The primary endpoint’s standard deviation and any confidence interval are not reported in the registry record.

Measurements of biological secretion can sometimes show greater variability than a simple model assumes. In general, over-dispersion means that observed variation exceeds what a chosen model expects. If over-dispersion is present, standard errors from a model that assumes less variation may be too small, making uncertainty look narrower than it should. The registry record does not report a model for pulse data or an assessment of over-dispersion; it would be inappropriate to claim that either was used or observed.

What the design can support

In general, a single-group design can summarize measurements collected in that group, but it does not create a randomized comparison with a control group. This study has allocation listed as not applicable and no masking. Its registry entry also identifies the design as single-group and notes that the arms are not a like-for-like control comparison. There is therefore no posted controlled contrast to interpret. More importantly, the record says no participants underwent the intervention and provides no primary outcome analysis.

The absence of a comparator is distinct from the absence of an outcome result. A single-group study could, in principle, report descriptive baseline measurements, but the primary result is not reported. The record does not state whether baseline measurements were collected, whether any were included in an analysis, or how missing measurements were handled. The reason for termination is access to the study drugs; the registry does not state whether any other study procedures took place.

How to read the planning assumptions

The sample-size assumptions describe a planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They state that the target effect is a specified fraction of the observed effect. In general, such an illustration estimates the participants per arm that a hypothetical design might require under its assumptions. It is not a count of participants actually treated, an analysis of this trial, or a measure of observed power.

Those assumptions should be kept separate from the actual registry design. The record describes a single-group study, not equal allocation between two arms, and states that no participants underwent the intervention. Thus, the planning framework is hypothetical and does not describe what happened in this study. Sample-size planning depends on the effect used as its reference and on modeling assumptions; a different assumed effect or variability can yield a different planning requirement. The underlying numerical planning outputs are not restated here, and the registry record does not report a trial-specific sample-size justification.

In general, statistical significance and practical or biological importance are also distinct. A significance threshold is one part of a decision rule for a specified analysis, while an effect estimate and its uncertainty describe the magnitude and precision of the data. Here there is no posted primary estimate, interval, test statistic, or p-value. The stated planning threshold cannot be read as a test result. It does not indicate that a hypothesis was tested or that the study reached a conclusion.

The record lists two outcome measures but zero analyses. It does not report the statistical model, treatment of repeated measurements, handling of missing data, covariate adjustment, or a prespecified multiplicity approach. These omissions prevent reconstruction of an analysis strategy. General statistical principles can explain what those choices would mean, but cannot establish which choices investigators made.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and identifies endogenous LH pulse amplitude as the primary endpoint. It records zero analyses. No secondary outcome results, analysis populations, or multiplicity strategy are reported in the registry record. The presence of multiple measures can raise a general issue of multiplicity: when several outcomes or tests are examined, the chance of at least one apparently unusual result can increase unless the analysis plan accounts for that process. That general concern does not establish that multiple tests were performed.

The record does not report whether any interim analyses were planned or conducted, or how the primary outcome was to be analyzed alongside the other measure. It also does not report a statistical analysis plan, any hierarchy of outcomes, or an adjustment procedure. These details should not be inferred from the number of listed measures.

Missing-data handling is not reported in the registry record. The statement that no participants underwent the intervention does not establish whether baseline observations or other study data were collected. The record does not say whether measurements were missing, whether any observations were excluded, or what rules would have governed incomplete records.

Likewise, the analysis populations are not reported. The enrollment entry of 16 does not by itself establish how many participants were assessed, eligible for an analysis, or included in a particular endpoint summary. No participant flow or endpoint-specific denominator is posted in the registry record. With no analyses listed and no endpoint results, there is no basis to assess the impact of missing data, exclusions, or population definitions.

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 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists 16 participants at risk for serious adverse events and zero serious events. It also lists 16 at risk for other adverse events and one other event. These are counts as entered in the record; the event term for the other event and the timing and circumstances of the event are not reported in the registry record. No serious adverse-event terms are listed.

The denominator entries should be read cautiously alongside the primary endpoint description, which states that no participants underwent the intervention. The registry record does not explain how the at-risk counts relate to exposure to the planned drugs, whether they reflect a broader study population, or how adverse events were collected. It would be unsupported to treat the counts as proof that all 16 participants received kisspeptin or GnRH.

These figures describe recorded event counts, not a comparative safety analysis. The study had no control group, and no causal assessment or event-level detail is reported. A zero count in the serious-event field does not establish the absence of all possible harms, nor does the one other event establish a relationship to either planned drug. The record does not provide enough context to interpret incidence or attribute events to the interventions.

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

The record documents a planned Phase 1 investigation of baseline LH secretion and responses to kisspeptin and GnRH among people carrying variants in genes related to infertility. It identifies baseline endogenous LH pulse amplitude as the primary endpoint and specifies a mean and standard deviation over Hours 0-8. It also gives the planned administration route and bolus description for the two study drugs.

What the record does not show is an observed primary endpoint result or a stimulation-response result. It says that no participants underwent the intervention and records zero analyses. The trial status is terminated, with the stated reason that the study team no longer had access to the study drugs. Accordingly, the posted results do not establish a baseline mean, the variability of that measure, or the size of any response to either stimulation test.

The enrollment entry of 16 should not be interpreted as the number treated or as the number contributing outcome measurements. The record does not explain what data, if any, were collected from those listed under enrollment. Similarly, the adverse-event counts do not clarify drug exposure or establish causation. They are registry entries that require the context the record does not provide.

These limitations mean the study record cannot be used to claim that the planned stimulation tests did or did not produce a particular response. It also cannot support a treatment comparison, because the design was single-group and did not include a like-for-like control. The record is informative about the intended question, design, endpoint, termination, and reported event counts, but it does not provide results that answer the physiological question.

The distinction is important: an unreported result is not evidence of no effect, just as a planned endpoint is not evidence that it was measured successfully. The registry record leaves the outcome magnitude and precision unknown. Any numerical planning illustration should be understood as hypothetical design information, not as observed evidence from this terminated study.

13. Why This Trial Matters Statistically

This study illustrates why trial design information, enrollment, intervention exposure, and outcome analysis must be read as separate elements. The record lists an enrollment of 16, but also says that no participants underwent the intervention. Treating the enrollment entry as a treated sample would misstate what the record says. Distinguishing these concepts is essential when assessing whether an endpoint estimate represents collected outcome data.

It also illustrates the limits of interpreting a planned primary endpoint without a posted estimate. The endpoint is clearly named and its summary format is specified, yet the record gives no mean, standard deviation, or analysis. Naming a measure does not demonstrate that it was observed or analyzed. Without an estimate and an uncertainty measure, statistical precision cannot be assessed.

The study’s single-group design and lack of masking are also relevant to the scope of any possible inference. The record does not define a control comparison, and it explicitly notes that the arms are not a like-for-like comparison. A planning illustration based on equal allocation between two arms should not be confused with the actual study design. Hypothetical calculations and observed trial results answer different questions.

Finally, the termination reason provides important context for the absence of intervention data. The record attributes termination to loss of access to study drugs, rather than reporting a completed test of the biological question. The statistical lesson is to separate a study’s objective from what its posted data can establish. Here, the objective and endpoint are described, but no intervention-based outcome analysis is reported.

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 most consequential limitation is that the registry record states that no participants underwent the intervention. Although enrollment is listed as 16, the record does not explain whether any participants contributed baseline measurements or other data. It therefore cannot be assumed that the enrolled group posted observations for the primary endpoint, or that the listed enrollment is an analysis denominator.

No primary endpoint estimate or analysis is reported. The record provides no mean LH pulse amplitude, standard deviation, confidence interval, or test result. No results are reported for responses to kisspeptin or GnRH stimulation. The record lists two outcome measures, but their results and any secondary outcome analyses are not reported in the registry record.

The design was single-group, with no masking and allocation not applicable. There is no like-for-like control comparison, so the record cannot support an estimate of a randomized contrast. In addition, the statistical analysis plan, sample-size justification, missing-data approach, analysis populations, and any interim-analysis plan are not reported in the registry record.

The endpoint description does not specify how LH pulses were identified or how individual observations were summarized. The registry does not report whether baseline measurements were collected or how the Hours 0-8 timeframe was operationalized. These gaps limit assessment of measurement methods as well as statistical methods.

The adverse-event entries include at-risk counts and event counts, but the record does not report event details, exposure context, or causal assessments. The study’s termination is attributed to lack of access to study drugs, but further details are not reported. Taken together, the record supports a description of the intended study and its status, but offers little outcome evidence for the stated physiological objectives.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Recall by Genotype: Neuropeptide Stimulation — NCT05901467.
• Registry record last updated 2026-03-06; status last verified 2025-11.
• Results first posted 2025-11-18.
• 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 Phase 1, single-group study planned intravenous kisspeptin 112-121 and GnRH stimulation testing in individuals carrying variants in genes related to infertility. Its primary endpoint was mean endogenous LH pulse amplitude at baseline, summarized with a standard deviation over Hours 0-8. The registry lists enrollment of 16, but states that no participants underwent the intervention.

The study started on 2023-10-20, has a primary completion date of 2024-05-29, and is recorded as terminated because the team no longer had access to the study drugs. Zero analyses are listed, and no primary endpoint estimate is reported in the registry record. The record lists zero serious adverse events and one other adverse event, with 16 at risk in each category, but does not provide event details or exposure context.

The intended questions and measures are described, but the posted record does not provide intervention results or a controlled comparison.