A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer (NCT02499497), a randomized phase 2 study. The primary outcome is Change in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4).

2. Clinical Question

The study addresses symptom management and quality of life after prostatectomy, rather than a cancer-control outcome. The registry describes the questionnaire as covering sexual desire, enjoyment and performance; sexual activity; and mood, while identifying the sexual activity score as the primary outcome. The primary endpoint therefore represents one defined domain of sexual function, not every aspect of sexual health or overall quality of life.

The posted arm summaries and comparisons describe changes at the stated time point among participants with available data. They do not by themselves establish how participants’ experiences changed outside the measured questionnaire, or whether any observed difference was meaningful to participants. A minimally important difference and a threshold for clinically meaningful change are not reported in the registry record.

3. Trial Design

The registry describes a randomized, double-masked, parallel phase 2 study sponsored by Dana-Farber Cancer Institute. The condition listed is prostate cancer, and the study summary concerns participants who had undergone radical prostatectomy. Enrollment was 114, and the study status is completed. The registry lists a start date of 2016-02-29 and primary completion on 2020-10-31.

Four arms are reported: placebo and three LY2452473 dose groups. The arm descriptions state that eligible participants were randomized to one of these groups and describe daily oral treatment per cycle. Specific dose amounts, cycle duration, treatment duration, and the identities of those masked are not reported in the registry record. The record identifies the study as double-masked but does not provide further masking details.

The primary outcome is change in the sexual activity score of the Psychosexual Daily Questionnaire at 12 weeks from baseline. Its stated analysis population is randomized and treated participants with data available at the given time point. The numbers contributing to the primary outcome summaries differ among arms, and the registry does not explain the reasons for those differences.

The registry lists 34 outcome measures and 33 posted secondary outcomes. These include sexual function, fatigue, energy, and urinary symptoms. The original sample-size justification, the planned statistical analysis, handling of missing outcome data, and any interim analyses are not reported in the registry record. The posted sample-size illustrations are separate calculations based on observed effects, not documentation of the study’s original design assumptions.

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: All randomized and treated participants with data available at the given time-point.

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 Change in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4), measured over 12 weeks from baseline.

The primary endpoint is change from baseline in the sexual activity score of the Psychosexual Daily Questionnaire, measured 12 weeks from baseline. The registry describes the questionnaire as covering three domains: sexual desire, enjoyment and performance; sexual activity; and mood. The primary outcome uses the sexual activity domain, assessed with a 12-item checklist.

The score ranges from 0 to 12, and higher scores represent better sexual activity. Measuring change focuses the comparison on how scores shifted from baseline by the stated assessment time, rather than on a single follow-up score alone. This can be useful when the question concerns symptom change during a treatment period. The registry does not report the individual baseline scores or explain how any baseline adjustment was handled in the trial’s own analysis.

Sexual activity is relevant to the study’s stated symptom-management and quality-of-life rationale following prostatectomy. It is nevertheless a specific questionnaire outcome. It does not directly summarize every component of sexual function, general well-being, cancer status, or treatment burden. Other sexual-health measures are listed among the secondary outcomes, but their presence does not change which outcome the registry identifies as primary.

The outcome summaries apply to randomized and treated participants who had data available at the time point. The registry does not report how missing questionnaire responses were handled or whether the score was considered meaningful to participants at particular levels of change. Interpretation should therefore keep the endpoint’s scope, measurement time, and available-data population in view.

7. Results Posted in the Registry

• LY2452473 Dose 1: mean 0.45 versus 0.04 on control; difference 0.41 (95% CI -0.22 to 1.04), standardized effect d = 0.37; z-test p = 0.203.
• LY2452473 Dose 2: mean -0.02 versus 0.04 on control; difference -0.06 (95% CI -0.63 to 0.51), standardized effect d = -0.05; z-test p = 0.836.
• LY2452473 Dose 3: mean 0.12 versus 0.04 on control; difference 0.08 (95% CI -0.57 to 0.73), standardized effect d = 0.08; z-test p = 0.809.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Change in Sexual Activity, Interest, and Desire Scale (SAID)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • LY2452473 Dose 1: mean 4.25 versus -0.67 on control; difference 4.92 (95% CI -2.33 to 12.17), standardized effect d = 0.36; z-test p = 0.184.
  • LY2452473 Dose 2: mean -3.00 versus -0.67 on control; difference -2.33 (95% CI -10.23 to 5.57), standardized effect d = -0.14; z-test p = 0.563.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between LY2452473 Dose 1 and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between LY2452473 Dose 2 and the control. The interval gives the range of effects that remain compatible with the data.

Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • LY2452473 Dose 1: mean 2.29 versus 0.31 on control; difference 1.98 (95% CI -1.71 to 5.67), standardized effect d = 0.28; z-test p = 0.293.
  • LY2452473 Dose 2: mean -0.36 versus 0.31 on control; difference -0.67 (95% CI -4.25 to 2.91), standardized effect d = -0.09; z-test p = 0.713.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between LY2452473 Dose 1 and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between LY2452473 Dose 2 and the control. The interval gives the range of effects that remain compatible with the data.

Change in Hypogonadism Energy Diary (HED)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • LY2452473 Dose 1: mean 2.71 versus -0.45 on control; difference 3.16 (95% CI -4.60 to 10.92), standardized effect d = 0.21; z-test p = 0.425.
  • LY2452473 Dose 2: mean 2.64 versus -0.45 on control; difference 3.09 (95% CI -5.55 to 11.73), standardized effect d = 0.17; z-test p = 0.483.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between LY2452473 Dose 1 and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between LY2452473 Dose 2 and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists a broad group of secondary outcomes spanning sexual function, fatigue, energy, and urinary symptoms. The numerical secondary comparisons posted for selected measures show variation in direction and precision rather than a uniform pattern across domains. Their intervals include zero, and their unadjusted p-values do not establish clear differences from placebo. These findings are best read as exploratory context around the primary outcome, not as a separate set of definitive conclusions.

The secondary outcomes relate to the primary question by assessing other aspects of sexual health and symptom experience. They may help describe whether a pattern in sexual activity appears alongside changes in related measures, but they do not substitute for the primary endpoint. Nor does the absence of a clear result on one measure establish that all related experiences were unchanged.

Unadjusted secondary results carry less weight because multiple outcomes and comparisons create more opportunities for apparently notable results to arise through chance. The registry does not report a multiplicity adjustment, a hierarchy for secondary hypotheses, or a complete analysis plan. The posted secondary results therefore do not support treating isolated estimates as confirmatory evidence. Their role is descriptive and hypothesis-generating unless a prespecified testing strategy is documented elsewhere; such a strategy is not reported in the registry record.

The numerical summaries are also incomplete for assessing the full secondary-outcome program. Although 33 secondary outcomes are posted, detailed numerical comparisons are not available in the registry record described for every listed measure. The overall pattern should consequently be stated cautiously: the available summaries show uncertainty and variation, while the registry’s broad outcome list indicates that the study evaluated more than the primary sexual activity score.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Change in All Domains of International Index of Erectile Function (IIEF)
• Change in Sexual Activity, Interest, and Desire Scale (SAID)
• Change in Derogatis Index of Sexual Function Male II (DISF-M-II)
• Change in Three Domains of Men's Sexual Health Questionnaire (MSHQ)
• Change in Two Domains of Expanded Prostate Cancer Index Composite (EPIC)
• Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
• Change in Hypogonadism Energy Diary (HED)
• Change in International Prostate Symptom Score (IPSS)

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: it is a score measured on a numerical scale. The registry reports mean changes for each arm and standard errors, followed by mean differences between each LY2452473 dose group and placebo. These summaries address the question of average change, not the proportion of individuals who improved or worsened.

What does a mean change describe?

A mean is the arithmetic average of the observed changes among participants contributing data. It condenses individual results into one arm-level summary. That is useful for comparing average outcomes, but it does not show how responses vary across participants. Two groups can have similar means while individual experiences differ widely. The registry does not provide a distribution of individual changes for this endpoint.

The reported arm values are mean changes from baseline at 12 weeks. For placebo the value is 0.04; for LY2452473 Dose 1 it is 0.45; for Dose 2 it is -0.02; and for Dose 3 it is 0.12. A positive value indicates an increase in the score as defined, while a negative value indicates a decrease. Because higher scores represent better sexual activity, the direction of a change can be described on the scale, but the registry does not identify a threshold that would make a change important to participants.

What does the standard error tell the reader?

A standard error describes uncertainty in an estimated mean. It is not the standard deviation of participant outcomes and does not describe the range of individual responses. Smaller standard errors generally indicate a more precisely estimated mean, while larger ones indicate less precision. The primary arm summaries report standard errors of 0.19 for placebo, 0.26 for Dose 1, 0.22 for Dose 2, and 0.27 for Dose 3.

Uncertainty in a comparison depends on the estimates in both groups and the information available in each. The posted comparisons report mean differences and confidence intervals. A confidence interval gives a range of values compatible with the data under the statistical procedure used. General interpretation: a wide interval indicates that the data do not pin down the effect very precisely; an interval that includes zero is compatible with no mean difference as well as with differences on either side of zero. The confidence level and the procedure used for the trial’s own interval calculations are not reported in the registry record.

How should the p-values be read?

The registry posts unadjusted p-values for the primary comparisons: 0.203 for Dose 1, 0.836 for Dose 2, and 0.809 for Dose 3. A p-value describes how unusual data at least as incompatible with a specified null model would be if that model and the test assumptions held. It is not the probability that the null hypothesis is true, nor the probability that a result happened by chance. These values do not describe the size or practical importance of a difference; the estimated difference and its interval are needed for that.

The registry does not state the trial’s original significance threshold or full testing procedure. The p-values are explicitly unadjusted, so they do not account for testing multiple comparisons or outcomes. A reader should not treat them as a complete confirmatory analysis of all trial outcomes.

Why can over-dispersion matter?

General explanation: over-dispersion occurs when observed variation is greater than a statistical model assumes. If a model underestimates variation, standard errors can be too small and intervals too narrow, making results appear more precise than they are. This is a general issue in statistical modeling, not a reported feature of this trial. The posted primary outcome is a continuous score, and the registry does not report an over-dispersion assessment or a model-based analysis for it.

The comparison summaries include pooled standard deviations and standardized effect estimates, but they do not replace the outcome-scale mean differences. Standardized estimates express a difference relative to variability and can assist comparisons across scales; they are less directly interpretable in the original questionnaire units. The registry’s primary question is most readily understood through the mean difference on the sexual activity score and its confidence interval.

What can be inferred from the design information?

Randomization and masking are design features intended to limit systematic differences and bias, but the registry’s design labels do not show whether those protections were maintained in practice. The record identifies a randomized, double-masked, parallel study; details about sequence generation, allocation concealment, masking procedures, and the trial’s statistical analysis plan are not reported in the registry record.

The primary outcome population includes participants with available data at the time point. This is not enough information to determine how missing observations were treated, whether all randomized participants were included in the trial’s own analysis, or whether an imputation method was used. The original sample-size rationale and the trial’s own power assumptions are also not reported. Those omissions limit how fully the posted summaries can be connected to a prespecified inferential plan.

11. Confidence Intervals and Precision

The primary mean-difference estimates are accompanied by intervals that show substantial uncertainty around each comparison. For Dose 1 versus placebo, the estimate is 0.41, with an interval from -0.221 to 1.041. For Dose 2, the estimate is -0.06, with an interval from -0.630 to 0.510. For Dose 3, the estimate is 0.08, with an interval from -0.567 to 0.727. All three intervals include zero and extend to values on both sides of it.

General explanation: a confidence interval represents a range of effect values compatible with the observed data and the method used to calculate the interval. Its width conveys precision: a wider interval leaves more uncertainty about the size and direction of the underlying difference. The confidence level and interval method are not reported in the registry record, so the intervals should be interpreted as posted rather than assigned an unreported coverage level.

The number of participants contributing to the primary outcome varies by arm: 28 for placebo, 23 for Dose 1, 35 for Dose 2, and 13 for Dose 3. The arm-specific standard errors are also reported. Limited information in an arm tends to make its mean less precise, although precision also depends on outcome variability. The smaller Dose 3 group is especially important context when considering its estimate and interval.

These intervals do not establish that the effects are exactly zero, and they do not establish that an effect of a particular practical size is ruled out. The registry does not report a minimally important difference for this scale. Without such a threshold, precision can be discussed statistically, but the interval cannot be classified as excluding or including a known clinically meaningful effect.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size illustrations relate hypothetical future planning to the observed comparisons; they are not the enrollment targets for this trial. For these continuous outcomes, the listed numbers are participants per arm, not total events. The planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is set as a stated fraction of the observed effect. The trial’s own original sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the estimated participants per arm for a planned study to have an 80% chance of detecting the specified effect under the stated assumptions, if that effect and assumptions hold. The 90% power column gives the corresponding planning estimate for a 90% chance. Power is a property of a proposed design under assumed conditions; it does not indicate the probability that the observed result is true.

Each comparison has planning rows based on 100%, 75%, and 50% of the observed effect. Planning for 75% of the observed effect requires more participants per arm than planning for 100% of the observed effect; planning for 50% requires more again. This illustrates the general principle that smaller effects are harder to distinguish from random variation and therefore require more participants for a given power target.

The observed effects are uncertain, especially when estimated from limited groups. These planning figures inherit that uncertainty and depend on the assumptions used. They are not observed power and should not be read as a retrospective judgment about whether the completed study was adequately designed.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 0.410; pooled standard deviation σ = 1.120.
2. n = 2 × (1.96 + 0.842)² × 1.120² / 0.410² = 117.2, rounded up to 118 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.41                      # observed difference in means
sigma <- 1.12028786388106                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2499497)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 118 (80% power), 157 (90% power)
 75% of observed effect: n per arm = 209 (80% power), 279 (90% power)
 50% of observed effect: n per arm = 469 (80% power), 628 (90% power)
power.t.test: 118.2 
Simulated power at n = 118 per arm: 0.797 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists 34 outcome measures, including 33 posted secondary outcomes, and reports unadjusted primary comparison p-values. It does not report a multiplicity adjustment, a hierarchy of hypotheses, or a complete statistical analysis plan. Without those details, the intended control of false-positive findings across outcomes and comparisons is not reported in the registry record. This is relevant because interpreting many separate tests as though each were the only test can overstate the strength of evidence.

The registry gives a primary-outcome population definition: randomized and treated participants with data available at the given time point. That definition makes clear that the posted endpoint summaries are based on available outcome data, but it does not explain what happened to participants without measurements. Missing-data methods, reasons for missingness, imputation, sensitivity analyses, and the number of missing primary assessments by arm are not reported in the registry record.

The record does not state whether the trial’s own analysis followed an intention-to-treat approach, used another analysis population, or adjusted comparisons for baseline variables. It also does not report interim analyses, stopping rules, or the original sample-size justification. These should not be inferred from the posted arm summaries or from the separate planning illustrations.

These gaps do not invalidate the posted descriptive values, but they constrain assessment of how closely the reported comparisons reflect a prespecified analysis and how sensitive they may be to missing data or multiple testing. The reported results can be described as posted, while stronger claims about confirmatory inference require details that are not reported in the registry record.

15. 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 serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: renal cancer (7.1%), coronary artery bypass (3.6%), myocardial infarction (3.6%), metastatic ocular melanoma (2.8%), pain in extremity (2.8%).

The safety summaries report serious adverse events among 36 participants at risk in the placebo group, 28 in Dose 1, 36 in Dose 2, and 14 in Dose 3. The numbers affected by serious adverse events were 2, 2, 1, and 1, respectively. The registry also reports other adverse events among the same at-risk group sizes: 33 for placebo, 22 for Dose 1, 33 for Dose 2, and 10 for Dose 3. Deaths are reported as 0 in every group.

These are counts, not comparative risk estimates. They should be read with the at-risk group sizes and should not be interpreted as evidence that an event was caused by treatment. The registry does not provide event-level timing, severity details beyond the serious-event category, or a causal assessment for each event in these summaries.

The record lists serious-event terms and percentages, including Renal Cancer at 7.1%, Coronary artery bypass at 3.6%, Myocardial infarction at 3.6%, Metastatic ocular melanoma at 2.8%, and Pain in extremity at 2.8%. These are presented as top serious-event terms; the registry entries do not give the denominators or group attribution for each term. Counts and listed terms therefore provide a limited safety description, not a complete assessment of comparative safety.

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

The posted primary results describe mean change in a specific sexual activity score at 12 weeks among participants with available data. The estimates for the three LY2452473 dose groups are close to zero or positive, and the placebo estimate is also close to zero. The comparison intervals include zero and allow differences in either direction. This means the posted data do not sharply distinguish any dose group from placebo on the primary endpoint.

That interpretation is not the same as concluding that LY2452473 has no effect. The intervals are compatible with a range of effects, and the registry does not report a threshold for a meaningful change on the scale. Conversely, a positive point estimate for a dose group is not enough to conclude that participants experienced a meaningful improvement. The estimate, interval, outcome definition, and available-data population all matter.

The endpoint captures sexual activity using a questionnaire score; it is not a direct measure of every aspect of sexual function, overall quality of life, or cancer outcomes. The study summary provides a symptom-management rationale after radical prostatectomy, but the posted primary comparison alone cannot establish broader effects beyond the measured score and time point.

The trial is described as randomized and double-masked, which are design features relevant to reducing bias. The registry does not report enough detail to assess implementation of those features, missing-data handling, or the full analysis plan. The secondary measures broaden the clinical context, but their unadjusted results and the absence of documented multiplicity procedures limit confirmatory interpretation.

Accordingly, the posted evidence is best understood as uncertain estimates from a completed phase 2 study, not as a definitive ranking of doses or a firm conclusion about treatment effects. Neither treatment advice nor a conclusion about an individual participant follows from these group-level summaries.

17. Why This Trial Matters Statistically

This trial is statistically informative because its central question concerns a patient-relevant symptom domain after prostatectomy, while the primary outcome reduces that domain to a defined questionnaire score. The distinction between the measured score and broader quality of life is important: an endpoint can be relevant without representing every experience the study aims to address.

The four-arm design compares placebo with three dose groups, while the primary outcome summaries include different numbers of participants across arms. This makes precision essential to interpretation. The point estimates alone might suggest different directions across doses, but the confidence intervals show that the comparisons remain uncertain and include zero.

The record also illustrates why a non-significant or uncertain comparison should not be translated into proof of no effect. The posted intervals encompass both negative and positive differences, and no minimally important difference is reported. Statistical uncertainty and clinical importance are related questions, but they are not interchangeable.

Finally, the trial’s broad set of outcome measures makes multiplicity and analysis transparency relevant. Unadjusted results across many outcomes can be useful for generating questions, but without a documented hierarchy or adjustment they carry less confirmatory weight. The record allows readers to examine the reported estimates while also showing which details are not available for a complete assessment of the study’s inferential plan.

18. 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 outcome is a self-reported questionnaire score for sexual activity, a specific domain rather than a comprehensive measure of sexual health or quality of life. The registry provides the scale range and direction but does not report a minimally important difference or explain what magnitude of change participants would consider meaningful.

The primary outcome summaries include only participants described as randomized and treated with data available at the time point. The registry does not report missingness by arm, reasons for missing assessments, or methods for handling missing data. The number of participants contributing to the endpoint differs by group, and the record does not explain why.

The registry identifies the trial as randomized and double-masked, but does not report details of allocation procedures, who was masked, or how masking was maintained. Dose amounts and treatment duration are also not reported in the registry record. These omissions limit assessment of the intervention contrast and design implementation.

Primary comparisons have broad intervals that include zero, and the registry does not document the confidence-interval method or the trial’s full statistical analysis plan. Multiple outcomes are listed, while multiplicity handling and a secondary-outcome hierarchy are not reported. The secondary numerical results are unadjusted and should be considered cautiously.

Finally, the study’s original sample-size justification and interim-analysis plans are not reported. The separate planning illustrations rely on observed effects and stated planning assumptions; they cannot recover the trial’s original design rationale. These limitations call for restraint when interpreting the posted estimates, rather than a claim that the results are invalid.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer — NCT02499497.
• Registry record last updated 2021-09-28; status last verified 2021-09.
• Results first posted 2021-09-28.
• 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.

22. Record Summary

The registry describes a completed randomized, double-masked, parallel phase 2 study of placebo and three LY2452473 dose groups in participants with prostate cancer who had undergone radical prostatectomy. Enrollment was 114. The primary outcome was change in the Psychosexual Daily Questionnaire sexual activity score at 12 weeks from baseline.

Mean differences versus placebo were 0.41 for Dose 1, -0.06 for Dose 2, and 0.08 for Dose 3. Each reported interval includes zero, and the unadjusted p-values do not show a clear separation from placebo. The estimates are uncertain and do not establish either equivalence or a clinically meaningful effect.

The registry lists numerous secondary outcomes and reports safety counts, including zero deaths in each group. Details about the trial’s original sample-size rationale, missing-data methods, multiplicity handling, and complete analysis plan are not reported in the registry record.