This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Efficacy and Safety of S-equol on Vasomotor Symptoms in Menopausal Patients (NCT00962585), a randomized phase 2 study. The primary outcome is Mean Change in Frequency of Moderate to Severe Vasomotor Symptoms (MSVS) Baseline at Week 4 (2-week Period).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00962585 |
| Phase | Phase 2 |
| Condition | Menopause |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 169 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Ausio Pharmaceuticals, LLC |
| Results posted | Yes |
2. Clinical Question
Population
Menopausal patients with hot flushes and night sweats were studied. The trial enrolled 169 participants. The primary efficacy analysis population was narrower: randomized patients who received at least 1 dose of study drug starting at visit 3 and had at least 1 post-dose efficacy assessment. The record does not report the number included in that analysis.
Intervention
Participants were assigned to S-equol at one of three dose levels: 10 mg BID, 50 mg BID, or 150 mg BID. The arm descriptions give the corresponding total daily doses as 20 mg, 100 mg, and 300 mg.
Comparator
The comparator was placebo. The record identifies placebo and the three S-equol dose groups but does not report a single reduced comparison of an S-equol dose against placebo for the primary endpoint.
Primary question
The primary question concerned the mean change in the frequency of moderate to severe vasomotor symptoms from baseline to Week 4. Frequency was assessed over a 2-week baseline run-in period and a Week 4 period. The registry record does not report the primary endpoint estimates or confidence intervals, so the size and precision of any group differences are not available in the posted results.
Vasomotor symptoms in this trial were moderate or severe hot-flush symptoms. Moderate symptoms were defined as a sensation of heat with sweating while the participant could continue activity; severe symptoms involved a sensation of heat with sweating that caused cessation of activity. Participants used a daily take-home diary to record symptoms during the run-in and treatment periods. The clinical question therefore focused on diary-recorded symptom frequency over specified periods, rather than on a single symptom assessment. The record also lists secondary outcomes concerning symptom frequency and severity, vaginal measures, hormone concentrations, and the Menopause Rating Scale. Those additional measures broadened the outcomes collected, but their presence does not substitute for the missing primary endpoint estimates.
3. Trial Design
This was a randomized, double-blind, multicenter, placebo-controlled Phase 2 proof-of-concept trial with a parallel-group design. The registry record lists an enrollment of 169 and identifies four arms: placebo and three S-equol dose groups. It gives the S-equol total daily doses as 20 mg, 100 mg, and 300 mg. The record does not describe the randomization procedure, allocation ratio, concealment method, or which trial roles were masked.
The official title describes 4 weeks of treatment. The primary outcome timeframe is 4 weeks from baseline, with a 2-week run-in period. Baseline symptom frequency was captured over a 14 ± 2 day period; the endpoint compared that baseline period with the Week 4 assessment period. This schedule makes the run-in relevant to interpretation: the endpoint was a change from a diary-based baseline, not a comparison of an isolated Week 4 assessment with no prior observation.
The study status is completed. Its listed start was 2010-06 and its primary completion was 2011-11. The sponsor was Ausio Pharmaceuticals, LLC. The registry describes the study purpose as assessing the safety and effectiveness of S-equol in menopausal patients with hot flushes and night sweats. The record does not report a planned sample-size justification, the intended allocation ratio, or a detailed protocol for handling the several dose-group comparisons. A planning illustration based on an observed effect, where available, should not be mistaken for the trial's original design rationale or for evidence about the precision of these results.
The primary efficacy analysis was defined for randomized participants who received at least 1 dose of randomized study drug starting at visit 3 and had at least 1 post-dose efficacy assessment. This is not an all-randomized analysis population, because receipt of study drug and a post-dose assessment were required. The number of participants meeting these criteria is not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: After completing screening visit assessments, subjects were instructed to refrain from taking prohibited medications throughout the study. Patients who were taking prohibited medications at the time of the screening visit discontinued their use and completed a suitable washout period before progressing to the next visit.
Overall Study
| Stage | S-equol 10 mg BID | S-equol 50 mg BID | S-equol 150 mg BID | Placebo |
|---|---|---|---|---|
| STARTED | 43 | 42 | 42 | 42 |
| COMPLETED | 37 | 40 | 39 | 42 |
| NOT COMPLETED | 6 | 2 | 3 | 0 |
Reasons for not completing this period:
| Reason | S-equol 10 mg BID | S-equol 50 mg BID | S-equol 150 mg BID | Placebo |
|---|---|---|---|---|
| Adverse Event | 0 | 2 | 1 | 0 |
| Lost to Follow-up | 3 | 0 | 1 | 0 |
| Protocol Violation | 0 | 0 | 1 | 0 |
| Withdrawal by Subject | 1 | 0 | 0 | 0 |
| Withdrew Consent | 2 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.
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.
| Characteristic | Unit | S-equol 10 mg BID | S-equol 50 mg BID | S-equol 150 mg BID | Placebo | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 43 | 42 | 42 | 42 | 169 | |
| Age, Customized | years | 53.8 (SD 7.9) | 53.1 (SD 6.9) | 54.9 (SD 5.8) | 56.2 (SD 6.7) | 54.5 (SD 6.9) |
| Sex: Female, Male: Female | Participants | 43 | 42 | 42 | 42 | 169 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Asian | participants | 0 | 0 | 0 | 1 | 1 |
| Race/Ethnicity, Customized: Black or African American | participants | 4 | 7 | 10 | 5 | 26 |
| Race/Ethnicity, Customized: White | participants | 39 | 35 | 32 | 34 | 140 |
| Race/Ethnicity, Customized: Unknown or Not Reported | participants | 0 | 0 | 0 | 2 | 2 |
| Height | centimeters | 165.3 (SD 5.1) | 164.1 (SD 4.6) | 165.4 (SD 6.7) | 163.3 (SD 5.9) | 164.5 (SD 5.6) |
| Weight | kilograms | 74.1 (SD 11.6) | 73.0 (SD 10.7) | 74.4 (SD 10.1) | 73.2 (SD 12.8) | 73.7 (SD 11.3) |
| Body Mass Index | kilogram/meter^2 | 27.1 (SD 3.9) | 27.1 (SD 4.1) | 27.2 (SD 3.5) | 27.4 (SD 4.1) | 27.2 (SD 3.9) |
6. Primary Endpoint
The registry lists the primary outcome as Mean Change in Frequency of Moderate to Severe Vasomotor Symptoms (MSVS) Baseline at Week 4 (2-week Period), measured over 4 weeks from Baseline (2-week run-in period).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Number of MSVS/2 weeks |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was the mean change in the frequency of moderate to severe vasomotor symptoms from baseline to Week 4, expressed as number of MSVS per 2 weeks. Baseline frequency was collected during a 2-week run-in, with the description specifying a 14 ± 2 day period. Participants recorded symptoms in a daily diary during both the run-in and treatment period.
The endpoint uses symptom frequency as a continuous measure. A mean change can describe the average movement in diary-recorded frequency over the assessment period, while a group contrast can estimate how that change differs between assigned groups. The registry describes the primary group estimates as least-squares means and their 95% confidence intervals from an ANCOVA. It does not report the actual estimates or intervals, so the direction, size, and precision of the primary group differences cannot be read from the posted results.
Frequency was selected as the primary efficacy measure, while symptom severity and other clinical or biological measures were secondary outcomes. The moderate and severe categories had operational definitions based on the sensation of heat, sweating, and whether activity could continue. This gives the diary endpoint a specified symptom scope, though the record does not report diary-completion rates or the number of observations contributing to each participant's endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison of three S-equol dose groups with placebo and defines a primary endpoint based on change in moderate to severe vasomotor symptom frequency. It also specifies how the primary group estimates were intended to be expressed: adjusted least-squares means with 95% confidence intervals from an ANCOVA. However, the record does not report a reduced primary-outcome comparison, its estimated effect, or its confidence interval. The posted results therefore do not permit a numerical assessment of the primary endpoint's direction, magnitude, or precision.
This absence matters for interpretation. A trial design and a stated endpoint tell readers what investigators intended to evaluate, but they do not tell readers what the observed group differences were. Without the estimates and confidence intervals, it is not possible to judge whether the observed data were compatible with little difference, a more substantial difference, or a range of possibilities. No p-value for the primary comparison is reported in the record, either. The record's designation of the study as a proof-of-concept trial does not fill that evidential gap.
The trial included 169 participants across placebo and three dose groups. That enrollment figure alone does not establish how many participants contributed data to the primary analysis. The analysis population required randomized participants to receive at least 1 dose starting at visit 3 and to have at least 1 post-dose efficacy assessment; the analysis count is not reported. Missing efficacy data were not imputed. Thus, the number and pattern of participants with usable endpoint observations are important context that cannot be evaluated from the posted information.
The record lists 14 outcome measures and 56 analyses, including multiple secondary measures and time points. That breadth makes it important to distinguish a prespecified primary question from additional analyses. The multiplicity strategy, including any adjustment or hierarchy for interpreting multiple comparisons, is not reported in the registry record. The available record also does not describe the model covariates or provide the analysis outputs needed to assess model fit or robustness.
Safety information is presented separately by group. The registry lists serious and other adverse-event counts among participants at risk, along with several serious adverse-event terms and percentages. These counts are descriptive; without fuller event definitions, follow-up detail, or a formal comparative analysis, they should not be read as establishing that one group was safer than another. Death counts are not reported in the registry record.
In short, the record documents the trial question, design, endpoint definition, analysis population, and some adverse-event counts. It does not include the numerical primary efficacy findings needed to estimate a treatment-group contrast. The trial's posted information should therefore be read as an incomplete account of the evidence for the primary question, rather than as a basis for a conclusion about the size or reliability of an effect.
9. Statistical Methods Explained
The registry describes the primary endpoint as a continuous measure and says that treatment-group differences were estimated using least-squares means and 95% confidence intervals based on the mean square error from an ANCOVA. It does not report the model's covariates, the fitted group estimates, the confidence limits, or the accompanying test results. The concepts below explain the named methods generally; they do not add details to the trial's unreported analysis plan.
What does ANCOVA do?
General explanation: analysis of covariance (ANCOVA) compares group outcomes while accounting for one or more covariates included in the statistical model. Adjusting for covariates can improve the precision of a comparison when those variables explain some outcome variation. The record says ANCOVA was used, but the covariates and the exact model specification are not reported in the registry record. It is therefore not possible to determine which adjustments were made or how they affected the estimates.
What are least-squares means?
General explanation: least-squares means are model-based group means, adjusted for the covariates included in a fitted model. They are not necessarily identical to the raw arithmetic averages in each group. The trial description calls these estimates the overall adjusted mean frequency of MSVS. A group contrast based on adjusted means can summarize the modeled difference between groups, but the registry record does not provide the actual least-squares means or a contrast estimate for the primary endpoint.
How should a confidence interval be read?
General explanation: a confidence interval expresses the uncertainty around an estimated quantity under the assumptions of the statistical procedure. Its endpoints indicate a range of values compatible with the data and model at the stated confidence level. A narrower interval indicates greater precision than a wider interval, but neither width nor location can be assessed without the actual estimate and interval. The trial specifies 95% confidence intervals for its primary estimates, but the intervals themselves are not reported in the registry record. No conclusion about precision can be drawn from the confidence level alone.
What does the endpoint's mean represent?
General explanation: a mean summarizes the average value of a continuous measure across the participants contributing data. For this trial, the measure was change in diary-recorded frequency of moderate to severe vasomotor symptoms between baseline and Week 4. Group averages can conceal variation among individuals, so they do not describe every participant's experience. The record does not provide the distribution of individual changes, the group means, or measures of variability beyond stating that confidence intervals were used for the adjusted estimates.
Why do the analysis population and missing observations matter?
The primary analysis population included randomized participants who received at least 1 dose of study drug starting at visit 3 and had at least 1 post-dose efficacy assessment. This definition excludes people who did not meet either condition from that analysis, even though they may have been randomized. The registry says missing efficacy data were not imputed. General explanation: imputation is a method for representing missing values in an analysis; not imputing means the record does not describe replacing missing efficacy observations with modeled values. This does not, by itself, reveal how many observations were missing or whether missingness differed among groups. The number analyzed and the amount and pattern of missing data are not reported.
What cannot be inferred from the method description?
A method label does not provide the results. ANCOVA and a 95% confidence interval describe an approach to estimating and expressing uncertainty, but without the estimates, interval limits, and analysis details, they do not show the observed group differences. The registry record does not report the statistical analysis plan, the model covariates, any interim analyses, or a sample-size justification. It also does not state how comparisons across three S-equol doses, placebo, outcomes, or assessment times were handled as a family. These details should not be inferred from the number of listed analyses alone.
General explanation: when many outcomes, time points, or group comparisons are examined, the chance of at least one apparently unusual result can increase if each is interpreted independently. Multiplicity procedures can address this issue in different ways, but the appropriate approach depends on the planned questions and analysis strategy. Because the registry does not describe a multiplicity plan or report the primary estimates, the listed analysis count cannot establish which findings were confirmatory or how any statistical uncertainty was managed across analyses.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 14 outcome measures and 56 analyses. The outcomes cover symptom frequency and severity at several times, vaginal pH, vaginal maturation index, estradiol and progesterone concentrations, and the Menopause Rating Scale total score. Multiple doses, outcomes, and assessment times can create multiple opportunities for comparisons, but the number of listed analyses does not reveal how those comparisons were prioritized or interpreted.
The multiplicity strategy is not reported in the registry record. In particular, the record does not state whether comparisons across the three S-equol dose groups and placebo were adjusted, whether a hierarchy was used, or which secondary outcomes were intended to be confirmatory. General explanation: multiplicity adjustment is one way to account for the increased chance of a false-positive finding when several statistical tests are considered together. Without a reported plan, readers cannot determine how any individual test should be understood in relation to the full set of analyses.
The registry defines the primary efficacy analysis population as randomized participants who received at least 1 dose starting at visit 3 and had at least 1 post-dose efficacy assessment. It states that missing efficacy data were not imputed. The number of participants in this analysis population, the number with missing endpoint data, and the reasons for missingness are not reported in the registry record. It is also not reported whether the analysis population was used for every listed efficacy outcome.
These limitations constrain interpretation of both precision and potential selection effects. Without analysis counts and missing-data detail, readers cannot assess how much information contributed to the endpoint or whether availability of post-dose assessments differed across groups. The record does not report sensitivity analyses addressing missing data or a broader analysis of all randomized participants.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| S-equol 10 mg BID | 1 | 43 | 2.3% |
| S-equol 50 mg BID | 0 | 42 | 0.0% |
| S-equol 150 mg BID | 1 | 42 | 2.4% |
| Placebo | 0 | 42 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| S-equol 10 mg BID | 20 of 43 |
| S-equol 50 mg BID | 20 of 42 |
| S-equol 150 mg BID | 17 of 42 |
| Placebo | 15 of 42 |
Most frequent serious adverse event terms
| Event term | Organ system | S-equol 10 mg BID | S-equol 50 mg BID | S-equol 150 mg BID | Placebo |
|---|---|---|---|---|---|
| Ankle Fracture | Injury, poisoning and procedural complications | 0 of 43 | 0 of 42 | 1 of 42 | 0 of 42 |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | 1 of 43 | 0 of 42 | 0 of 42 | 0 of 42 |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | 0 of 43 | 0 of 42 | 1 of 42 | 0 of 42 |
Most frequent non-serious adverse event terms
| Event term | Organ system | S-equol 10 mg BID | S-equol 50 mg BID | S-equol 150 mg BID | Placebo |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 5 of 43 | 3 of 42 | 3 of 42 | 1 of 42 |
| Upper Respiratory Tract Infection | Infections and infestations | 2 of 43 | 2 of 42 | 6 of 42 | 2 of 42 |
| Urinary Tract Infection | Infections and infestations | 2 of 43 | 2 of 42 | 3 of 42 | 0 of 42 |
| Headache | Nervous system disorders | 1 of 43 | 3 of 42 | 1 of 42 | 2 of 42 |
| Constipation | Gastrointestinal disorders | 4 of 43 | 0 of 42 | 1 of 42 | 0 of 42 |
| Dyspepsia | Gastrointestinal disorders | 2 of 43 | 0 of 42 | 0 of 42 | 3 of 42 |
| Endometrial Hypertrophy | Reproductive system and breast disorders | 2 of 43 | 3 of 42 | 0 of 42 | 0 of 42 |
| Diarrhea | Gastrointestinal disorders | 3 of 43 | 0 of 42 | 0 of 42 | 1 of 42 |
| Vaginal Hemorrhage | Reproductive system and breast disorders | 1 of 43 | 1 of 42 | 0 of 42 | 1 of 42 |
| Fungal Infection | Infections and infestations | 0 of 43 | 1 of 42 | 1 of 42 | 0 of 42 |
Serious events with the highest arm-level rate: ankle fracture (2.4%), pulmonary embolism (2.4%), pleurisy (2.3%).
The registry lists serious and other adverse-event counts separately for each group. For S-equol 10 mg BID, 43 participants were at risk for serious adverse events and 1 was affected; 43 were at risk for other adverse events and 20 were affected. For S-equol 50 mg BID, the corresponding counts were 42 at risk and 0 affected for serious events, and 42 at risk and 20 affected for other events. For S-equol 150 mg BID, they were 42 at risk and 1 affected for serious events, and 42 at risk and 17 affected for other events. For placebo, they were 42 at risk and 0 affected for serious events, and 42 at risk and 15 affected for other events.
The record also lists Ankle Fracture at 2.4%, Pulmonary Embolism at 2.4%, and Pleurisy at 2.3% among the top serious adverse-event terms. It does not identify the group or denominator associated with these term percentages in the listed information, so they should not be assigned to a particular arm. The death counts are not reported in the registry record.
These figures are descriptive counts, not a formal comparison of safety between groups. The registry record does not provide event timing, exposure-adjusted rates, detailed event definitions, or statistical comparisons. Counts alone do not establish whether an observed difference reflects a reliable group difference. They also do not convey severity or clinical course beyond the serious-event classification and listed terms.
12. What the Result Does, and Does Not, Mean
The posted information establishes that a randomized, double-blind, placebo-controlled Phase 2 trial was conducted to assess S-equol for vasomotor symptoms in menopausal patients. It specifies three S-equol dose groups, a placebo group, a 4-week treatment period, and a diary-based primary endpoint comparing symptom frequency at baseline and Week 4. The primary analysis method is described as ANCOVA, with adjusted least-squares means and 95% confidence intervals.
Those design details do not establish the observed effect. The registry record does not report the primary endpoint estimates, confidence intervals, or a reduced comparison. Consequently, the direction and size of the primary group differences are unknown from the posted results, as is their statistical precision. The trial title and stated purpose are not outcome findings. No conclusion about whether S-equol changed symptom frequency can be drawn from the endpoint definition alone.
The same caution applies to secondary outcomes. The record identifies several symptom, vaginal, hormone, and rating-scale measures, but does not provide their numerical results in the listed information. Their inclusion does not show whether they changed, whether differences varied by dose, or whether any observed pattern was consistent across measures.
The adverse-event counts provide some descriptive information by group, but are not a full comparative safety analysis. The record does not report death counts, detailed event timing, or a formal statistical comparison. The serious-event terms and percentages are listed without a group or denominator in the available details. They should therefore be interpreted as reported terms, not as evidence that a particular dose group had a higher or lower risk.
General explanation: clinical trial results are best understood by considering the estimated effect and its uncertainty alongside the design, analysis population, missing data, and multiplicity. In this case, the design and endpoint are described, but the numerical efficacy findings and several supporting analysis details are absent. The posted information is insufficient to determine the magnitude or reliability of a primary treatment-group contrast.
13. Why This Trial Matters Statistically
This trial illustrates why a clearly defined endpoint and a reported endpoint estimate are both necessary for statistical interpretation. The registry defines symptom frequency as the primary measure, describes the baseline run-in and Week 4 assessment, and identifies ANCOVA-based adjusted estimates with 95% confidence intervals. Those details tell readers what was intended to be estimated and how the result was described statistically. They do not supply the estimate itself.
The multi-arm design also raises questions that matter when interpreting a proof-of-concept study. Three S-equol dose groups were compared within a trial that also included placebo, and the record lists numerous outcome measures and analyses. The registry does not report how comparisons were prioritized or how multiplicity was addressed. Without that information, the number of analyses cannot be translated into a clear hierarchy of confirmatory and exploratory findings.
The analysis population and missing-data rule are also statistically important. Eligibility for the primary efficacy analysis required treatment exposure and a post-dose assessment, and missing efficacy data were not imputed. Those statements clarify the analysis definition, but the record does not give the number analyzed or describe the amount and pattern of missing data. Readers therefore cannot assess how those features affect the available endpoint evidence.
Finally, safety counts and efficacy estimates answer different questions and require different context. Descriptive event counts can show what was recorded among participants at risk, but they do not by themselves quantify comparative safety. This record demonstrates the value of reporting estimates, uncertainty, analysis populations, and analytic decisions together: without the primary results and key methodological details, even a well-described trial question leaves substantial uncertainty about what the observed data show.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
A central limitation of the posted record is that it does not report the primary endpoint estimates or confidence intervals. Although the endpoint definition and intended analysis method are described, the actual group results are not available in the registry record. This prevents assessment of the observed direction, magnitude, and precision of the primary comparison.
The analysis population is defined, but its size is not reported. The record does not state how many participants in each group met the primary efficacy criteria, how many had complete diary data, or how many were excluded from the analysis. Missing efficacy data were not imputed, but the amount, timing, and reasons for missingness are not described. These omissions limit assessment of how the analysis population relates to all randomized participants.
The statistical model is described only at a broad level. ANCOVA and least-squares means are named, but the model covariates, exact specification, and diagnostic or sensitivity analyses are not reported in the registry record. The multiplicity strategy for the three dose groups and the numerous outcomes and time points is also not reported. Nor does the record provide a sample-size justification, interim-analysis details, or the statistical analysis plan.
Safety reporting is similarly limited. The registry lists participants at risk and affected counts for serious and other adverse events, as well as selected serious-event terms and percentages. The listed information does not specify the denominator for those term percentages or provide event timing and comparative analyses. Death counts are not reported in the registry record.
These are limitations of the information available in the registry record; they do not establish that the trial did or did not collect the missing details elsewhere. They do mean that the posted information cannot support a complete evaluation of efficacy, statistical precision, or comparative safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy and Safety of S-equol on Vasomotor Symptoms in Menopausal Patients — NCT00962585.
- Registry record last updated 2014-04-08; status last verified 2014-03.
- Results first posted 2014-04-08.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The record describes a completed, randomized, double-blind, parallel-group, multicenter, placebo-controlled Phase 2 trial of S-equol for vasomotor symptoms in menopausal patients. Enrollment was 169. The arms were placebo and S-equol at 10 mg BID, 50 mg BID, and 150 mg BID, corresponding to total daily doses of 20 mg, 100 mg, and 300 mg.
The primary endpoint was mean change in moderate to severe vasomotor symptom frequency from baseline to Week 4, measured over a 2-week period after a 2-week run-in. The stated analysis used ANCOVA least-squares means and 95% confidence intervals. The primary efficacy population required randomization, receipt of at least 1 dose starting at visit 3, and at least 1 post-dose efficacy assessment; missing efficacy data were not imputed.
The registry lists 14 outcome measures and 56 analyses, but the primary numerical estimates and confidence intervals are not reported in the registry record. It provides group-specific serious and other adverse-event counts and selected serious-event terms. A sample-size justification, multiplicity strategy, model covariates, and death counts are not reported in the registry record.