Safety and Efficacy Study of MT-2990 in Women With Endometriosis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety and Efficacy Study of MT-2990 in Women With Endometriosis (NCT03840993), a randomized phase 2 study. The primary outcome is Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe).

2. Clinical Question

3. Trial Design

This was a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study with quadruple masking. The registry describes the study as completed and lists enrollment as 76. MT-2990 and placebo were each administered over 16 weeks. The trial’s purpose was to assess safety and efficacy for moderate to severe endometriosis-related pain in women with surgically diagnosed endometriosis.

The primary endpoint used data from participants in the Intent To Treat population who had outcome data available. The reported analyzed groups were 32 for placebo and 29 for MT-2990. These analysis counts are distinct from the registry’s enrollment figure; the reasons that participants did not contribute to this endpoint are not reported in the registry record.

The primary completion date was 2021-05-13, and the listed start date was 2019-01-15. The record lists 30 outcome measures and posts results for 29 secondary outcomes, but it does not describe the full hierarchy or testing sequence for those outcomes. Detailed original sample-size assumptions, the statistical model specification, and any interim analyses are not reported in the registry record. The randomized and masked design supports a controlled comparison, but the posted summary does not give enough methodological detail to reconstruct every aspect of the sponsor’s analysis.

4. Participant Flow and Accounting

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

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.

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 Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe), measured over Baseline to Week 16.

The primary endpoint was mean change from baseline to Week 16 in nonmenstrual pelvic pain, measured on a scale whose stated range is 0 (None) to 3 (Severe). It is a continuous summary of a pain measure: a change captures how the recorded score at follow-up differs from the baseline score. Negative mean changes in both groups indicate that the group average moved downward on the scale over the study period. The endpoint is focused on nonmenstrual pelvic pain rather than pain confined to menstruation or intercourse.

A change-from-baseline measure is used to describe symptom movement over a defined follow-up period while accounting for each participant’s starting measurement in the outcome definition. A group mean gives an overall estimate, but it does not show the range of individual experiences or how many participants improved, stayed the same, or worsened. The registry reports least-squares means, which are model-based mean estimates, and standard errors for the arm estimates. The detailed model used to obtain those least-squares means is not reported in the registry record.

The registry describes the analysis population as participants in the Intent To Treat population with data available. That qualification matters: the result summarizes participants contributing endpoint data, rather than necessarily every person enrolled. The endpoint alone does not measure all aspects of endometriosis-related pain, functioning, medication use, or safety.

7. Results Posted in the Registry

• MT-2990: mean -0.63 versus -0.28 on control; difference -0.35 (95% CI -0.68 to -0.02), standardized effect d = -0.53; z-test p = 0.039.

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.

Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (None) to 3 (Severe)

• 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:
  • MT-2990: mean -0.68 versus -0.47 on control; difference -0.21 (95% CI -0.64 to 0.22), standardized effect d = -0.25; z-test p = 0.338.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between MT-2990 and the control. The interval gives the range of effects that remain compatible with the data.

Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranges From 0 (None) to 3 (Severe)

• 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:
  • MT-2990: mean -0.57 versus -0.38 on control; difference -0.19 (95% CI -0.70 to 0.32), standardized effect d = -0.21; z-test p = 0.468.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between MT-2990 and the control. The interval gives the range of effects that remain compatible with the data.

Mean Change From Baseline to Week 16 in Non-Menstrual Pelvic Pain (NMPP) Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain)

• 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:
  • MT-2990: mean -2.33 versus -1.05 on control; difference -1.28 (95% CI -2.33 to -0.23), standardized effect d = -0.61; z-test p = 0.017.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for MT-2990 than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The posted secondary results cover additional pain measures, including dysmenorrhea, dyspareunia, and nonmenstrual pelvic pain assessed on a different scale. The registry also lists outcomes involving analgesic use and time to rescue medication, among other measures, but detailed numerical results for all listed outcomes are not included in the results. The scale and symptom being measured matter: changes on different scales should not be compared as though they were the same quantity.

Across the three secondary pain comparisons with posted arm estimates, the direction of the estimated mean differences favors a larger decrease in the MT-2990 group, but the uncertainty differs across endpoints. The unadjusted comparisons for dysmenorrhea and dyspareunia have confidence intervals that include zero, whereas the nonmenstrual pelvic pain comparison on the 0-to-10 scale has an interval that excludes zero. The primary endpoint is also nonmenstrual pelvic pain, but it uses a 0-to-3 scale; the distinct scale and endpoint definitions prevent direct comparison of raw difference magnitudes.

Secondary outcomes can help describe whether patterns extend beyond the primary measure, but their results generally carry less confirmatory weight when many outcomes are examined and no multiplicity procedure is reported. The registry does not report a testing hierarchy or adjustment for multiple comparisons. Therefore, unadjusted secondary p-values should be read as exploratory evidence about those individual comparisons, not as a set of independent confirmations of the primary result. The record also does not report analyses for all secondary measures, which limits conclusions about the broader outcome pattern.

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

• Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (None) to 3 (Severe)
• Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranges From 0 (None) to 3 (Severe)
• Mean Change From Baseline to Week 16 in Non-Menstrual Pelvic Pain (NMPP) Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain)
• Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain)
• Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranging From 0 (no Pain) to 10 (Worst Pain)
• Mean Change From Baseline Through Week 16 in the Number of Any Analgesic Pills Used
• Mean Change From Baseline Through Week 16 in the Number of Opioid Pills Used
• Time to Use of Rescue Medication (Analgesic)

9. Statistical Interpretation

10. Statistical Methods Explained

The registry reports the primary endpoint as a continuous measure and gives least-squares mean changes for the two randomized groups. It also reports a standard error for each arm estimate. A least-squares mean is generally a model-based estimate of a group mean; unlike a raw arithmetic mean, it can reflect terms included in the statistical model. The specific model, covariates, and handling of repeated measurements are not reported in the registry record, so the exact meaning of the adjustment cannot be reconstructed from the posted summary.

What does the standard error describe?

In general, a standard error describes the statistical uncertainty around an estimated quantity, such as a group mean. It is not the spread of individual participant scores. A smaller standard error generally indicates a more precise estimate under the model and assumptions used. For the primary endpoint, the registry reports standard errors of 0.12 in both groups. Those values describe uncertainty in the arm estimates; they should not be read as the range of changes experienced by individual participants.

How is the between-group contrast read?

The comparison is expressed as MT-2990 minus placebo. The recalculated mean difference is -0.35 units. Because lower scores represent less severe pain on the stated scale, a negative contrast means the estimated average change was more negative in the MT-2990 group. The contrast is not the same thing as either arm’s mean change: it summarizes the difference between the two group estimates. It is an unadjusted recalculation from the posted summary statistics and does not include model details that are not reported in the registry record.

What does the confidence interval add?

A confidence interval expresses uncertainty around an estimate. In general, a 95% confidence interval is generated by a method that, under repeated use and its assumptions, would contain the fixed quantity of interest in 95% of such intervals. It does not assign a 95% probability to this particular interval containing the true value. The primary comparison’s interval ranges from -0.683 to -0.017 units. Its position relative to zero is relevant to the unadjusted comparison, while its width conveys that more than one magnitude of difference remains compatible with the summary data and method.

What does the p-value tell the reader?

The unadjusted p-value for the primary recalculation is 0.039. In general, a p-value measures the compatibility of data with a specified null model, assuming the analysis conditions hold. It is not an effect-size measure and does not indicate clinical importance. It does not account for multiple testing unless a multiplicity adjustment is explicitly incorporated. The registry record does not report the multiplicity procedure or a detailed statistical analysis plan, so this p-value should be interpreted as an unadjusted statistic rather than as evidence that a particular family-wise testing rule was met.

Why can over-dispersion matter?

General statistical explanation: over-dispersion occurs when observed variability exceeds what a model assumes. If a model understates variability, standard errors can be too small and confidence intervals too narrow; if it overstates variability, estimates can be less precise than necessary. This is a general consideration, not a finding about this trial. The posted summary does not report a diagnostic assessment of over-dispersion, and the primary endpoint is described as a continuous measure rather than a count outcome. No claim about over-dispersion in this analysis can be made from the registry summary.

What can be inferred from the group sizes?

The reported primary analysis counts are 32 for placebo and 29 for MT-2990. Sample size affects precision: fewer observations generally provide less information about a group mean, all else equal. The arm counts do not reveal the full pattern of missingness, the reasons participants lacked endpoint data, or whether missingness was related to outcomes. The registry’s description says the analyzed population includes participants with available data in the Intent To Treat population; further missing-data methods are not reported in the registry record.

What is not specified?

The posted record does not report the detailed model formula, covariate adjustment, assumptions used for the sponsor’s primary test, a detailed analysis population flow, or a multiplicity adjustment. It also does not report interim analyses or the original sample-size justification. These absences limit how far an independent reader can reproduce or audit the formal analysis. The estimates and uncertainty can still be described as posted, while the recalculated contrast remains a simple unadjusted comparison rather than a replacement for the sponsor’s full analysis.

11. Confidence Intervals and Precision

The primary comparison’s recalculated mean difference is -0.35 units, with a 95% confidence interval from -0.683 to -0.017. This interval gives a range of estimates compatible with the posted summary statistics under the method used for the unadjusted recalculation. Every value in the interval is negative, but the upper endpoint is close to zero. Thus, the interval supports a direction for the estimated contrast while leaving uncertainty about its magnitude.

The arm-level standard errors are 0.12 for placebo and 0.12 for MT-2990. Standard errors describe uncertainty in the estimated means, not participant-to-participant variability. Because no confidence intervals are posted for the arm means themselves, the reported comparison interval is the more direct summary of uncertainty for the between-group contrast. The underlying detailed model and its assumptions are not reported in the registry record.

Precision is also limited by the number of participants contributing data: 32 in the placebo group and 29 in the MT-2990 group. The point estimate should not be treated as an exact or stable value simply because it is reported to two decimal places. The interval allows readers to see that estimates with different magnitudes remain plausible under the recalculation. The interval and p-value are unadjusted; no multiplicity procedure is reported in the registry record, so they should not be interpreted as reflecting any adjustment across endpoints or analyses.

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 displayed planning figures are participants per arm, not total participants or total events. The planning illustration assumes a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It considers detecting the stated fraction of the observed effect: 100%, 75%, or 50%. The trial’s own original sample-size assumptions and justification are not reported in the registry record, so these figures should not be read as the design target used by the investigators.

The 80% power column means the number of participants per arm in a hypothetical design that would have an 80% chance of detecting the specified effect under the illustration’s assumptions. The 90% power column gives the corresponding per-arm planning count for a 90% chance. These are planning probabilities under a model, not guarantees about a future study and not estimates of what happened in this completed trial. The listed calculations are based on the observed effect, so they depend on an estimate from the current study that is itself uncertain.

As the effect to be detected gets smaller, more participants are needed to distinguish it from random variation under the same planning assumptions. The planning values and curve illustrate that relationship; they do not establish an optimal design or show that the observed trial had a particular probability of success. These values are not observed power.

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 = -0.350; pooled standard deviation σ = 0.664.
2. n = 2 × (1.96 + 0.842)² × 0.664² / -0.350² = 56.4, rounded up to 57 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 <- -0.35                      # observed difference in means
sigma <- 0.663549775890811                     # 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(3840993)
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 = 57 (80% power), 76 (90% power)
 75% of observed effect: n per arm = 101 (80% power), 135 (90% power)
 50% of observed effect: n per arm = 226 (80% power), 303 (90% power)
power.t.test: 57.4 
Simulated power at n = 57 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 multiple outcome measures, including the primary endpoint and many secondary outcomes. When several statistical tests are conducted, the chance of obtaining at least one apparently notable result by chance can increase. In general, multiplicity procedures manage that issue by defining which tests are confirmatory, adjusting significance thresholds, or controlling an error rate across a family of outcomes. The registry record does not report a multiplicity plan, a testing hierarchy, or whether the posted p-values were adjusted. The primary and secondary p-values discussed in this analysis are therefore described as unadjusted recalculations where applicable.

The registry identifies the primary analysis population as participants in the Intent To Treat population with data available. This wording does not establish that every randomized participant contributed primary endpoint data. The registry enrollment is 76, while the primary endpoint analysis counts are 32 for placebo and 29 for MT-2990. Reasons for unavailable outcome data, timing of withdrawal, and the distribution of missing data are not reported in the registry record.

Missing data can affect interpretation if the participants with available measurements differ systematically from those without them. General statistical explanation: methods such as imputation or likelihood-based analysis can address missing observations under explicit assumptions, but different assumptions can produce different results. The registry does not report the missing-data method, sensitivity analyses, or assumptions about why endpoint data were unavailable. It is therefore not possible to assess the robustness of the result to alternative missing-data assumptions from the posted summary alone.

The record reports zero analyses in its analysis listing and does not provide a detailed statistical analysis plan. This does not prove that no analysis was performed; it means that formal analysis details are not reported in the registry record. In particular, the analysis model, handling of missing data, multiplicity control, and any interim analyses are not specified. These omissions constrain independent verification and make the unadjusted recalculations descriptive rather than a substitute for a complete sponsor analysis.

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: abortion induced (2.7%).

The registry reports serious adverse events among 39 participants at risk in the placebo group and 37 at risk in the MT-2990 group. There were 0 serious adverse events reported for placebo and 1 for MT-2990. Deaths were 0 in each group. For other adverse events, 22 participants were affected in the placebo group and 23 in the MT-2990 group, with 39 and 37 participants at risk, respectively.

The serious adverse event term listed as a top serious term is “Abortion induced,” reported as 2.7%. The registry summary does not provide enough context to infer circumstances, causality, or whether the event was considered related to treatment. Counts and percentages describe events recorded in the trial; they do not establish that an intervention caused an event. The at-risk counts differ between groups, and the posted figures alone do not provide a comparative safety analysis or account for event timing and severity beyond the serious-event classification.

These data describe the reported safety counts during the study and should be read alongside the limited size and 16-week duration of the trial. The record does not report further detail in the summarized results about individual event narratives or an adjusted comparison of safety outcomes.

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

The posted primary endpoint estimates show negative mean changes from baseline in both groups, with a more negative group estimate for MT-2990 than for placebo. The unadjusted recalculation gives a between-group difference of -0.35 units and a 95% confidence interval from -0.683 to -0.017. These statistics describe the observed summary data for the defined Week 16 pain measure and the participants with available endpoint data in the stated analysis population.

They do not show what every participant experienced. A group average can conceal variation in individual changes, and the registry does not provide individual-level results in the information summarized. The endpoint also captures one aspect of endometriosis-related pain on a particular scale and at a particular follow-up time. It does not by itself establish effects on other symptoms, daily functioning, longer-term outcomes, or outcomes not reported in the registry.

The confidence interval and unadjusted p-value describe statistical uncertainty under the methods used for the recalculation. They do not establish clinical importance. A judgment about whether a difference matters to patients would require context about the scale, meaningful change thresholds, and patient experience; those thresholds are not reported in the registry record. The result is also not a substitute for a complete analysis accounting for the reported design, missing data, and the set of outcomes examined.

The record describes a randomized, masked, placebo-controlled Phase 2 study, but the posted summary does not include the detailed statistical plan or all analysis results. The findings should therefore be kept within their scope: one trial, a 16-week period, the reported population and endpoint, and unadjusted summary statistics. They do not by themselves establish a general conclusion about treatment or provide medical advice.

17. Why This Trial Matters Statistically

This trial illustrates why a reported treatment contrast should be read together with its uncertainty, analysis population, and endpoint definition. The primary estimate is a group-level difference on a 0-to-3 nonmenstrual pelvic pain scale, not a direct description of individual responses. The confidence interval shows the range of magnitudes compatible with the unadjusted recalculation, while the standard errors describe uncertainty in the reported arm means.

It also demonstrates the distinction between a trial’s enrollment and the number of participants contributing to a particular endpoint. The registry lists enrollment of 76, while 32 placebo participants and 29 MT-2990 participants were analyzed for the primary endpoint. The available-data description makes missingness relevant, but reasons and methods for handling missing values are not reported. Those details can shape how confidently an endpoint estimate represents the randomized groups.

Multiplicity matters because the record includes numerous outcomes. An unadjusted comparison can be informative, but it does not answer whether a result remains compelling after accounting for the full set of tests. Without a reported testing hierarchy or adjustment, primary and secondary results need to be distinguished carefully. The planning illustration also serves a separate role: it describes hypothetical per-arm sample sizes under stated assumptions rather than the original trial’s rationale or its observed performance.

Together, these features show why numerical results are most useful when read with design details and reporting limits. The posted estimate has a clear direction, but its precision, population scope, unreported analysis choices, and multiplicity context remain important to interpretation.

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.

Several limitations are specific to the information reported for this trial. The primary outcome analysis includes 32 participants assigned to placebo and 29 assigned to MT-2990, while registry enrollment is 76. The record describes the analyzed population as participants with available data in the Intent To Treat population, but does not report why data were unavailable or how missingness was handled. This limits assessment of how representative the endpoint analysis is of all randomized participants.

The registry reports least-squares means and standard errors but does not provide the detailed statistical model, covariate set, assumptions, or analysis plan. The between-group comparison and its interval discussed in this analysis are unadjusted recalculations from posted summary statistics. They may not reproduce the sponsor’s full analysis if it used additional modeling details not included in the registry record.

Multiple outcome measures are listed, but no multiplicity adjustment or testing hierarchy is reported. The secondary results therefore cannot be treated as independent confirmatory tests. The registry also does not include reported analyses for all listed outcomes, limiting a comprehensive account of the outcome pattern.

The trial is described as Phase 2, and the intervention period was 16 weeks. The posted data do not establish longer-term outcomes. The primary measure is one pain scale and one symptom domain; its group mean does not describe individual response patterns or all aspects of endometriosis-related pain. Safety counts are also limited by the number at risk and the trial duration, and the summarized record does not establish causality for reported events. These limits should inform how broadly the result is interpreted.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Safety and Efficacy Study of MT-2990 in Women With Endometriosis — NCT03840993.
• Registry record last updated 2025-12-31; status last verified 2025-12.
• Results first posted 2024-07-10.
• 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 record describes NCT03840993, “Safety and Efficacy Study of MT-2990 in Women With Endometriosis,” as a completed, randomized, double-blind, placebo-controlled Phase 2 study with quadruple masking and a parallel-group design. Enrollment was 76. MT-2990 and placebo were given over 16 weeks to women with surgically diagnosed endometriosis experiencing moderate to severe endometriosis-related pain.

The primary outcome was mean change from baseline to Week 16 in nonmenstrual pelvic pain on a 0-to-3 scale. The registry reports least-squares mean changes of -0.28 for placebo and -0.63 for MT-2990, with 32 and 29 participants analyzed, respectively. An unadjusted recalculation gives a difference of -0.35 and a 95% confidence interval from -0.683 to -0.017.

The record lists multiple secondary outcomes and reports serious adverse event counts, but does not report a detailed statistical analysis plan, multiplicity procedure, or missing-data methods. These reporting limits constrain interpretation beyond the posted summary results.