A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain (NCT00196313), a randomized phase 2 study. The primary outcome is Mean Change in Average Severity for Abdominal/Pelvic Pain.

2. Clinical Question

3. Trial Design

The registry identifies this as a completed Phase 2 study with randomized allocation, double masking, and a parallel-group model. The listed enrollment is 95. The sponsor was Duramed Research. The recorded study start is 2005-05 and the primary completion is 2008-10. These registry dates identify the recorded study timeline; they do not describe how long any individual participant was followed.

The planned treatment period was 13 weeks, with an option to extend blinded therapy for an additional 13 weeks. The overall study duration was described as 6-9 months. Participants were required to record menstrual pain in a daily diary. The primary outcome timeframe nevertheless ends at the end of the 13-week treatment period, so it should not be treated as an outcome measured across the optional extension.

The treatment groups listed for the primary result are Seasonique and placebo. The reported primary outcome values use 36 participants for Seasonique and 40 for placebo. These outcome counts differ from the registry’s overall enrollment figure; the registry defines the primary analysis population as the Complete Cohort, consisting of randomized subjects who completed the full 13 weeks and had no recorded protocol violations that would exclude them from analysis. Reasons that participants were not included in those outcome counts are not reported in the registry record.

The registry lists five outcome measures and four posted secondary outcomes in addition to the primary measure. It reports no analyses for the secondary outcomes. Detailed information about the randomization sequence, allocation concealment, masking procedures, and the trial’s original statistical analysis plan is not reported in the registry record. The registry record also does not report the original sample-size justification or the assumptions used to plan enrollment.

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: A total of 123 subjects were screened, of which 95 subjects were randomized. Of those randomized, 95 subjects took at lease 1 dose of study medication.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.

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 in Average Severity for Abdominal/Pelvic Pain, measured over Baseline to end of 13-week treatment period.

The primary endpoint is the mean change from baseline in average abdominal or pelvic pain severity, measured through the end of the 13-week treatment period. The registry defines the average by summing pain scores and dividing by the number of days on which the participant experienced abdominal or pelvic pain. Scores were recorded on a 4-point scale: 0 for “None,” 1 for “Mild,” 2 for “Moderate,” and 3 for “Severe.”

A change score describes how the reported outcome shifted relative to baseline. A negative change indicates a lower score at the endpoint than at baseline on this scale. The posted values are least-squares means, with standard errors reported for each group. Least-squares means are model-based group summaries; the registry record does not provide the model specification or enough detail to reproduce the sponsor’s analysis.

Using an average severity score makes the endpoint a summary of pain intensity on days with pain. It does not directly represent the number of pain days, the maximum pain score, or the effect of pain on daily activities. Those are distinct questions, reflected in the separate secondary outcomes for maximum severity and days missed. The Complete Cohort definition also means the primary result pertains to participants who met the registry’s completion and protocol-violation criteria, rather than automatically representing every randomized participant.

7. Results Posted in the Registry

• Seasonique: mean -0.45 versus -0.19 on control; difference -0.26 (95% CI -0.42 to -0.10), standardized effect d = -0.72; z-test p = 0.002.

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 From Baseline in Maximum Severity of Abdominal/Pelvic 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:
  • Seasonique: mean -0.62 versus -0.17 on control; difference -0.45 (95% CI -0.78 to -0.12), standardized effect d = -0.62; z-test p = 0.007.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Seasonique than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Incidence of Menstrual Bleeding and /or Spotting

• 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 deviations.
• Result:
  • Seasonique: mean 28.39 versus 18.00 on control; difference 10.39 (95% CI 5.24 to 15.54), standardized effect d = 0.94; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Seasonique than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Number of Days Missed From School/Work or Other Activities

• 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 deviations.
• Result:
  • Seasonique: mean 0.83 versus 2.75 on control; difference -1.92 (95% CI -3.14 to -0.70), standardized effect d = -0.69; z-test p = 0.002.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Seasonique than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary outcomes cover several related but distinct aspects of cyclic pelvic pain and its consequences: maximum pain severity, menstrual bleeding or spotting, days missed from school, work, or other activities, and analgesic use. Together, they extend the question beyond average pain severity by addressing peak intensity, bleeding patterns, daily activity, and medication use. They do not measure the same construct as the primary endpoint, so agreement or disagreement across them would not be a direct replication of the primary comparison.

The posted numerical results indicate a pattern of group differences across the reported continuous secondary measures, but each outcome has its own scale, timeframe, and meaning. The secondary results should be interpreted using their individual estimates and uncertainty rather than collapsed into a single overall claim. The registry does not post an analysis for analgesic use, despite listing it as a secondary outcome.

These results relate to the primary finding by adding descriptive context about other recorded outcomes during or through the 13-week period. They cannot establish that changes in one outcome caused changes in another, and the registry record does not report analyses of relationships among endpoints. Differences in the way outcomes were measured and summarized also limit direct comparison of their effect sizes.

The secondary p-values are unadjusted, and the registry does not report a multiplicity plan. When several outcomes are tested, the chance of at least one apparently unusual result can increase, even if there are no real differences. This is why unadjusted secondary results generally carry less evidential weight than a designated primary result, particularly when the trial’s testing hierarchy is not reported. The secondary findings are best treated as supportive or exploratory context rather than independent confirmation of the primary comparison.

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

• Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain
• Incidence of Menstrual Bleeding and /or Spotting
• Number of Days Missed From School/Work or Other Activities
• Analgesic Use

9. Statistical Interpretation

10. Statistical Methods Explained

What does a mean change summarize?

A mean change combines participant-level changes into a group average. In this study, the scale runs from 0, “None,” to 3, “Severe,” and the pain average is calculated over days when abdominal or pelvic pain was experienced. A group mean can describe the direction and average size of change, but it can conceal variation in individual responses. The registry does not report the distribution of participant-level changes, so the group averages alone cannot show how consistently participants changed.

The primary results are reported as least-squares means. In general, a least-squares mean is a model-based estimate of a group average, potentially adjusted for terms in a statistical model. Which terms were included, how missing observations were handled, and how the model was fitted are not reported in the registry record. The posted estimates should therefore be read as the reported summaries, without assuming a particular adjustment or model structure.

What is the mean difference?

The comparison estimate is the Seasonique group mean minus the placebo group mean for change from baseline. The posted group estimates are -0.45 and -0.19, respectively, and the recalculated unadjusted contrast is -0.26. A negative value means the average change was more negative in the Seasonique group on this scale. The estimate is expressed in scale units; it is not a percentage or a count of participants.

This recalculation uses posted group summaries. It is not a substitute for a trial-specific model-based contrast if that analysis used additional covariates, assumptions, or data not represented by the summaries. The registry does not report a sponsor contrast for this endpoint or a detailed analysis specification. The discrepancy flag is false, so the posted comparison does not carry a flagged disagreement with the recalculated summary.

How should the confidence interval be read?

A confidence interval describes the uncertainty around an estimated effect under the statistical method used to construct it. In general, a 95% confidence interval is produced by a procedure that, under its assumptions, would cover the underlying effect in 95% of repeated samples. It is not a statement that there is a 95% probability that this particular interval contains the true effect. For the primary comparison, the interval is -0.424 to -0.096. Its location below zero indicates that the entire displayed interval corresponds to a negative difference.

The interval’s width matters as well as its position. A narrow interval indicates greater precision than a wide interval, while both the sample information and variability affect precision. The posted interval is based on an unadjusted recalculation from summary statistics; details of any sponsor-side interval method are not reported in the registry record. The group standard errors are 0.06 for Seasonique and 0.058 for placebo. Those are measures of uncertainty in the group mean estimates, not measures of the spread of individual pain scores.

What does a p-value contribute?

The unadjusted p-value for the primary comparison is 0.002. In general, a p-value measures how unusual data at least as incompatible with a null hypothesis of no difference would be, if that null and the test assumptions held. It does not measure the probability that the null is true, the probability that the result is due to chance, or the clinical value of the estimated difference. It should be considered alongside the estimate and interval, rather than used as a stand-alone measure.

The p-value is identified as unadjusted. The registry does not report whether a broader multiplicity procedure was planned or applied. If several outcomes or comparisons are assessed, unadjusted p-values do not account for the increased chance of obtaining small values across multiple tests. The primary outcome has a designated role in the record, but the full statistical analysis plan is not reported.

Why does over-dispersion matter in general?

For count outcomes, a simple model may assume that the variance is related to the mean in a particular way. Over-dispersion means the observed variability is greater than that assumed by the model. Ignoring it can make standard errors too small and confidence intervals too narrow. This general issue is relevant to some count-data analyses, but the primary endpoint is a continuous pain-severity summary, and the registry does not report an over-dispersion analysis for it. It would not be appropriate to assume that a particular count model was used for the primary comparison.

What can the reported dispersion tell readers?

For the primary least-squares means, the registry reports standard errors rather than standard deviations. A standard error describes the precision of an estimated mean; a standard deviation describes variation among observations. They answer different questions and should not be substituted for each other. The posted recalculation uses an approximate pooled standard deviation derived from the reported standard errors and group sizes. Because it is approximate, it is a descriptive aid rather than a reported participant-level dispersion measure.

The secondary continuous outcomes use different summaries: the severity change outcome is also reported as least-squares means with standard errors, while bleeding or spotting days and missed days are reported as means with standard deviations. Those differing measures of dispersion should be interpreted according to their definitions. The registry does not report individual-level data or additional distributional summaries.

11. Confidence Intervals and Precision

The primary mean difference is -0.26 units, with a 95% confidence interval from -0.424 to -0.096. This interval conveys both direction and uncertainty: the displayed range is below zero, but the exact size of the difference is not pinpointed. The endpoint is measured in units on a scale, so the interval is expressed in the same units rather than as a proportion or percentage.

Precision depends on the amount of information and the variability in the observations. The primary result reports standard errors of 0.06 for Seasonique and 0.058 for placebo. These quantify uncertainty in the reported group means, not the range of individual participants’ pain scores. The primary outcome counts are 36 for Seasonique and 40 for placebo, and the analysis population is limited by the Complete Cohort definition.

The interval and p-value are based on an unadjusted recalculation from posted summary statistics. The registry record does not report a sponsor analysis specification, covariate adjustment, or interval-construction method. The reported figures therefore should not be read as if they document all details of the trial’s original analysis. Participant-level data are also not reported, limiting assessment of the distribution and consistency of changes.

Statistical precision is not the same as clinical importance. The registry record does not report a threshold for a clinically meaningful change on the scale, nor does it provide enough information to establish how participants valued changes of this size. The interval helps characterize uncertainty in the average comparison; it does not resolve those separate questions.

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 figures are planning illustrations based on the observed effect, not the trial’s original design calculations. They assume a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The assumed effect to detect is stated as 100%, 75%, or 50% of the observed effect. For these continuous outcomes, the figures are participants per arm, not total participants or total events.

The 80% power column gives the number of participants per arm that the planning calculation estimates would be needed to have an 80% chance of detecting the stated effect under those assumptions, if that effect were the true effect and the assumptions held. The 90% power column gives the corresponding per-arm planning figure for a 90% chance. These are design calculations, not descriptions of the study’s observed probability of detecting an effect.

Across the listed scenarios, planning for a smaller fraction of the observed effect requires more participants per arm. That pattern is expected: smaller differences are harder to distinguish from random variation when other assumptions stay the same. The illustration is not observed power. It does not determine whether the study was adequately planned, because the trial’s own sample-size justification and original design assumptions are not reported in the registry record.

The figures depend on the estimated effect used as their starting point. Since that effect was observed in this study, it is uncertain and may not represent the effect that would be expected in a future study. The planning figures should therefore be read as conditional illustrations under the stated assumptions, not as guarantees about a future study’s results. The assumptions also do not establish that the original trial used equal allocation or the same significance level or approximation.

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 = -0.260; pooled standard deviation σ = 0.364.
2. n = 2 × (1.96 + 0.842)² × 0.364² / -0.260² = 30.7, rounded up to 31 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 <- -0.26                      # observed difference in means
sigma <- 0.363612505359832                     # 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(196313)
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 = 31 (80% power), 42 (90% power)
 75% of observed effect: n per arm = 55 (80% power), 74 (90% power)
 50% of observed effect: n per arm = 123 (80% power), 165 (90% power)
power.t.test: 31.7 
Simulated power at n = 31 per arm: 0.790 (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 identifies a primary outcome and lists secondary outcomes, but it does not report a detailed statistical analysis plan or a multiplicity adjustment. Multiplicity arises when several outcomes, time points, groups, or statistical comparisons are examined. In general, the more tests considered, the greater the chance that at least one will produce a small p-value by chance alone. Adjustments or prespecified testing hierarchies can address that issue, but their use in this study is not reported in the registry record.

The primary p-value is explicitly unadjusted, as are the recalculated secondary comparisons. The primary outcome remains the central comparison because it is designated as primary in the record, but the absence of documented testing procedures means the statistical evidence should not be treated as if a family-wise error strategy were known. The listed secondary outcomes provide context; they do not all carry the same inferential status as the primary endpoint.

Missing-data handling is also not reported in the registry record. The primary population is defined as the Complete Cohort: randomized subjects who completed the full 13 weeks and had no recorded protocol violations that would exclude them from analysis. This is not described as an analysis of all randomized participants. The record does not report how many randomized participants were excluded from the primary analysis for each reason, how missing diary entries were handled, or whether any imputation method was used.

Restricting analysis to participants who completed the study and met protocol criteria can affect interpretation if completion or protocol adherence is related to outcome. The registry does not provide information to assess whether that occurred. It also does not report a sensitivity analysis using a broader population or alternative missing-data assumptions. Consequently, the posted Complete Cohort estimate should be read as an outcome among the defined analysis population, with the possible influence of exclusions and missing observations unresolved.

15. 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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: excruciating pain rlated to menstruation (2.1%), exacerbation of stress (2.1%).

The registry reports serious adverse events among 2 participants at risk in the Seasonique group and 0 participants at risk in the placebo group. The at-risk counts were 47 for Seasonique and 48 for placebo. These are serious-event figures, not counts of all adverse events. The listed serious-event terms are “Excruciating pain rlated to menstruation” and “Exacerbation of Stress,” each reported as 2.1%. The registry does not provide a term-by-group breakdown for those terms, so their group attribution should not be inferred from the aggregate counts.

Other adverse events are reported for 47 participants at risk in the Seasonique group and 17 at risk in the placebo group; the respective at-risk counts are 47 and 48. These figures describe the registry’s adverse-event reporting categories and should not be combined with the serious-event counts. Deaths are not reported in the registry record.

Adverse-event counts alone do not establish whether an event was caused by treatment. The record does not provide detailed event narratives, severity grading beyond the serious-event category, timing, exposure-adjusted rates, or a causal assessment. These data are a limited description of events recorded in the registry and do not by themselves support a broad safety conclusion.

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

The posted primary comparison describes the average change in pain severity during the 13-week treatment period among participants in the defined Complete Cohort. The group estimates and recalculated contrast favor a more negative change for Seasonique than placebo on the recorded severity scale. The confidence interval is entirely below zero, while still leaving uncertainty about the exact size of the mean difference.

This result does not describe every participant’s response. A group mean can coexist with a range of individual experiences, and participant-level distributions are not reported. It also does not directly measure the number of days with pain, maximum severity, or broader quality of life. Although related outcomes were listed, the primary endpoint is specifically an average severity measure over days on which pain occurred.

The estimate pertains to the reported Complete Cohort, not automatically to every randomized participant. The registry does not report details of missing-data handling, the sponsor’s statistical model, or the original analysis plan. Nor does it report a threshold for a clinically meaningful change on the scale. Those omissions make it difficult to determine how the average difference should be translated into a judgment about practical importance.

The posted data also do not establish outcomes beyond the recorded primary timeframe, including whether any group difference persisted during or after the optional extension. The registry description indicates an option to extend blinded therapy for an additional 13 weeks, but the primary result is for the end of the initial 13-week treatment period. Results should not be generalized beyond the study population and period without further evidence.

In statistical terms, the record presents evidence of a group-average difference under the reported comparison, with uncertainty summarized by the interval. That is narrower than a claim about individual benefit, long-term outcomes, or overall treatment value. The result should be considered alongside the analysis-population definition, missing information, secondary outcomes, and adverse-event reporting.

17. Why This Trial Matters Statistically

This study illustrates why reading the endpoint definition is essential. “Pain severity” here is not a single pain score at a single moment: it is an average based on pain scores on days when abdominal or pelvic pain was experienced, assessed over the period from baseline through Week 13. A different outcome, such as maximum severity or number of pain days, answers a different question. Understanding that distinction prevents the mean-change result from being interpreted as a complete measure of the experience of cyclic pelvic pain.

The record also illustrates the importance of distinguishing analysis populations. The primary result is for a Complete Cohort with completion and protocol criteria, while the registry reports an overall enrollment figure separately. Without details on exclusions and missing data, readers cannot assume that the analyzed group represents all randomized participants in the same way an intention-to-treat analysis would.

Finally, the record provides estimates and uncertainty but limited documentation of the underlying analysis plan. The primary comparison can be interpreted from the posted group summaries, yet the model specification, multiplicity procedures, and original design assumptions are not reported. The sample-size illustrations are based on observed effects and stated assumptions, not evidence of the trial’s original planning. These distinctions show why statistical interpretation depends not only on an estimate and p-value, but also on knowing what was measured, who was analyzed, and how decisions about testing and missing data were made.

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 registry record gives limited detail about eligibility, so the population cannot be characterized beyond the adolescent description in the official title and the listed condition of dysmenorrhea. Age range, diagnostic criteria, baseline severity requirements, and other eligibility features are not reported in the registry record. That limits assessment of how closely the study population corresponds to other groups with cyclic pelvic pain.

The primary analysis population is restricted to participants who completed the full 13-week study participation and had no recorded protocol violations that would exclude them. The registry does not explain the number or reasons for exclusions, or report how missing diary observations were handled. A complete-case or protocol-restricted result can be sensitive to who remains in the analysis, and the record does not include sensitivity analyses to assess this.

The posted primary endpoint is a least-squares mean, but the model terms and analysis method are not reported. The comparison is an unadjusted recalculation from summary statistics, and participant-level distributions are unavailable. The registry also does not report a clinically meaningful difference threshold, a multiplicity strategy, or the original sample-size justification. These gaps limit interpretation of the practical importance and the robustness of the statistical findings.

The primary timeframe is the end of 13 weeks. Although blinded therapy could be extended for an additional 13 weeks, outcomes from that extension are not described in the posted primary results. The record therefore does not establish whether the observed pattern continued over longer follow-up. Safety reporting is also limited: event attribution by term, detailed narratives, and deaths are not reported in the registry record. These constraints make the registry results informative about the posted short-term comparison, but incomplete for broader conclusions.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain — NCT00196313.
• Registry record last updated 2016-09-22; status last verified 2016-08.
• Results first posted 2012-05-25.
• 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

NCT00196313 is a completed randomized, double-masked, parallel-group Phase 2 study comparing Seasonique with placebo for cyclic pelvic pain. The registry lists enrollment of 95 and identifies adolescents in the official title. The primary endpoint was mean change in average abdominal or pelvic pain severity from baseline to the end of the 13-week treatment period, measured on a 4-point scale.

The posted primary group estimates were -0.45 for Seasonique and -0.19 for placebo. The recalculated unadjusted mean difference was -0.26, with a 95% confidence interval from -0.424 to -0.096 and an unadjusted p-value of 0.002. The primary population was the Complete Cohort defined in the registry. Important details—including the statistical model, missing-data methods, multiplicity plan, and original sample-size justification—are not reported in the registry record.