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 A Study of Evacetrapib in Healthy Female Participants (NCT01746732), a randomized phase 1 study. The primary outcome is Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01746732 |
| Phase | Phase 1 |
| Condition | Healthy Volunteers |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 23 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Healthy female participants were enrolled. The primary pharmacokinetic population included participants who received at least one dose of study drug and had evaluable pharmacokinetic data. The registry reports 23 participants enrolled; the numbers with evaluable primary-endpoint results were 16 for Ortho-Cyclen and 17 for Ortho-Cyclen plus evacetrapib.
Intervention
The combination treatment paired Ortho-Cyclen with evacetrapib. Ortho-Cyclen was taken orally once daily, with a 28-day lead-in and a 28-day treatment period. Evacetrapib was taken orally at 130 mg once daily for 21 days during the combination treatment period.
Comparator
The comparator was Ortho-Cyclen alone during a treatment period. The registry describes Ortho-Cyclen as containing 35 microgram ethinyl estradiol and 250 mcg norgestimate, taken orally once daily. Participants took part in two study periods, with treatment assignment randomized in a crossover design.
Primary question
Did the maximum concentration of ethinyl estradiol in blood differ between the Ortho-Cyclen-alone condition and the condition in which Ortho-Cyclen was taken with evacetrapib? The registry’s posted primary outcome is the geometric mean Cmax, measured in picogram per milliliter on Day 21 across the listed post-dose sampling times. The record reports a value for each condition but does not report a formal comparison, confidence interval, or p-value.
3. Trial Design
This was a Phase 1, randomized, open-label crossover study of evacetrapib and an oral contraceptive in healthy female participants. The registry lists 23 participants enrolled and marks the study completed. The study started in 2012-12, with primary completion in 2013-05. The sponsor was Eli Lilly and Company.
A crossover design means participants receive more than one treatment condition during separate treatment periods, rather than remaining in a single treatment group throughout. The brief summary says each woman participated in two study periods. The registry describes one condition as Ortho-Cyclen alone and the other as Ortho-Cyclen with evacetrapib. Treatment assignment was randomized. The record does not state the treatment sequence details, whether a washout period was used, or how any period or sequence effects were addressed in the analysis.
In both conditions, participants had an Ortho-Cyclen lead-in period of 28 days. During the treatment period, Ortho-Cyclen was taken once daily for 28 days. In the combination condition, evacetrapib was also taken once daily at 130 mg for 21 days. The listed Ortho-Cyclen formulation contained 35 microgram ethinyl estradiol and 250 mcg norgestimate. The registry does not describe additional protocol details beyond these treatment descriptions.
The primary pharmacokinetic outcome was the maximum concentration of ethinyl estradiol. The registry identifies the primary endpoint population as participants who received at least one dose of study drug and had evaluable pharmacokinetic data. The reported endpoint sample sizes were 16 in the Ortho-Cyclen condition and 17 in the combination condition. These endpoint counts are distinct from the overall enrollment count; the registry record does not explain the reasons for the difference.
The study was unmasked, so participants and study personnel were not described as blinded to treatment. The posted results include pharmacokinetic summaries and adverse-event participant counts. No separate analysis records are listed, and no secondary outcome results are posted. The registry does not report the sample-size justification, planned statistical analysis, or details of any interim analyses.
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.
Lead-In Period
| Stage | Ortho-Cyclen | Ortho-Cyclen Then Ortho-Cyclen + Evacetrapib; Sequence AB | Ortho-Cyclen + Evacetrapib Then Ortho-Cyclen; Sequence BA |
|---|---|---|---|
| STARTED | 23 | 0 | 0 |
| Participants Received at Least 1 Dose | 22 | 0 | 0 |
| COMPLETED | 22 | 0 | 0 |
| NOT COMPLETED | 1 | 0 | 0 |
Reasons for not completing this period:
| Reason | Ortho-Cyclen | Ortho-Cyclen Then Ortho-Cyclen + Evacetrapib; Sequence AB | Ortho-Cyclen + Evacetrapib Then Ortho-Cyclen; Sequence BA |
|---|---|---|---|
| Withdrawal by Subject | 1 | 0 | 0 |
Period 1
| Stage | Ortho-Cyclen | Ortho-Cyclen Then Ortho-Cyclen + Evacetrapib; Sequence AB | Ortho-Cyclen + Evacetrapib Then Ortho-Cyclen; Sequence BA |
|---|---|---|---|
| STARTED | 0 | 11 | 11 |
| COMPLETED | 0 | 10 | 11 |
| NOT COMPLETED | 0 | 1 | 0 |
Reasons for not completing this period:
| Reason | Ortho-Cyclen | Ortho-Cyclen Then Ortho-Cyclen + Evacetrapib; Sequence AB | Ortho-Cyclen + Evacetrapib Then Ortho-Cyclen; Sequence BA |
|---|---|---|---|
| Physician Decision | 0 | 1 | 0 |
Period 2
| Stage | Ortho-Cyclen | Ortho-Cyclen Then Ortho-Cyclen + Evacetrapib; Sequence AB | Ortho-Cyclen + Evacetrapib Then Ortho-Cyclen; Sequence BA |
|---|---|---|---|
| STARTED | 0 | 10 | 11 |
| COMPLETED | 0 | 10 | 7 |
| NOT COMPLETED | 0 | 0 | 4 |
Reasons for not completing this period:
| Reason | Ortho-Cyclen | Ortho-Cyclen Then Ortho-Cyclen + Evacetrapib; Sequence AB | Ortho-Cyclen + Evacetrapib Then Ortho-Cyclen; Sequence BA |
|---|---|---|---|
| Withdrawal by Subject | 0 | 0 | 2 |
| Adverse Event | 0 | 0 | 1 |
| Lost to Follow-up | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: All participants who received at least one dose of study drug and had evaluable PK data.
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.
Population: Twenty-two subjects received at least one dose of study drug and are included in the summary of subject demographics
| Characteristic | Unit | Ortho-Cyclen and Ortho-Cyclen + Evacetrapib |
|---|---|---|
| Participants analysed | 22 | |
| Age, Continuous | years | 33.0 (SD 6.8) |
| Sex/Gender, Customized: Females | Participants | 22 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 8 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 14 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 8 |
| Race (NIH/OMB): White | Participants | 11 |
| Race (NIH/OMB): More than one race | Participants | 2 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 22 |
6. Primary Endpoint
The registry lists the primary outcome as Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol, measured over Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | picogram per milliliter (pg/ml) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the maximum concentration, or Cmax, of ethinyl estradiol in blood. Cmax describes the highest measured concentration within a defined sampling period. It is a pharmacokinetic measure: it characterizes the concentration reached after dosing rather than describing a clinical health outcome. For this study, it helps assess whether the concentration profile of the ethinyl estradiol component of Ortho-Cyclen differed when the contraceptive was taken with evacetrapib rather than alone.
The registry reports this endpoint as a geometric mean in picogram per milliliter. A geometric mean is commonly used for positive measurements that vary multiplicatively or are skewed, because it represents the center of values on a multiplicative scale. The record also reports a geometric coefficient of variation, which describes relative variability on that scale. These summaries describe the observed concentrations; by themselves, they do not establish the precision of a treatment comparison.
Blood sampling was scheduled on Day 21 at predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose. Those repeated measurements support the characterization of the concentration profile and the identification of its maximum during the sampling window. The registry does not specify the exact calculation procedure used to derive Cmax from the measurements.
Cmax is useful for describing peak exposure, but it is only one aspect of pharmacokinetics. The posted primary endpoint does not by itself describe total exposure over time, other hormone concentrations, contraceptive efficacy, or clinical outcomes. The registry lists eight outcome measures overall, but it does not post secondary results in the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary result is a geometric mean ethinyl estradiol Cmax of 71.7 pg/ml for Ortho-Cyclen alone and 70.6 pg/ml for Ortho-Cyclen with evacetrapib. The reported geometric coefficients of variation are 35.0 and 37.0, respectively. These values describe the endpoint summaries for the participants with evaluable pharmacokinetic data in each condition. They do not, on their own, quantify uncertainty in the difference between conditions.
The study’s crossover structure is relevant to interpretation. In a crossover study, each participant receives more than one treatment condition, so a treatment contrast can be informed by within-participant observations. Such a design can account for stable differences between participants when the analysis uses paired data appropriately. However, the registry record does not report the statistical model, the paired treatment contrast, or whether period and sequence effects were evaluated. The arm-level summaries alone do not show how the participant-level pairing was used.
The posted values are close in magnitude, but the registry does not report a formal estimate of the treatment contrast. There is no confidence interval, standard error, or p-value for the comparison. Without an inferential estimate and its uncertainty, the summaries cannot determine how precisely the conditions differ or whether a difference is compatible with a range of effects. The geometric coefficients of variation describe variability in observations, not uncertainty around the contrast.
The sample sizes for the endpoint were 16 and 17. The enrolled count was 23. The registry does not explain the relationship between enrollment and endpoint availability, or report how missing or unevaluable pharmacokinetic measurements were handled. Consequently, the posted summaries should be read as applying to the reported evaluable endpoint samples, rather than as a complete account of outcomes for every enrolled participant.
The safety results are separately reported as participant counts by treatment phase or condition. No participants with a serious adverse event are listed in any of the three adverse-event groups. Other adverse events are reported for 9 participants in the Ortho-Cyclen lead-in group, 5 in the Ortho-Cyclen group, and 5 in the Ortho-Cyclen plus evacetrapib group. Those counts are not a formal comparative safety analysis. Death counts are not reported in the registry record.
The results are therefore descriptive. They document the posted concentration summaries and variability, but they do not provide the formal statistical comparison needed to assess the precision of a treatment effect. The registry also does not report a conclusion about equivalence or a prespecified margin for deciding whether the conditions are sufficiently similar.
9. Statistical Methods Explained
The central statistical issue is how to compare pharmacokinetic measurements collected under two treatment conditions when participants take both conditions in a crossover study. The primary results are presented as geometric means and geometric coefficients of variation. The registry does not describe the inferential method used for the treatment comparison, and it posts no separate analysis records. The explanations below describe the statistical concepts generally; they are not claims about unreported procedures in this trial.
What does a geometric mean represent?
A geometric mean summarizes positive measurements by treating proportional changes as central to the scale. In general, it is calculated by transforming values to a logarithmic scale, averaging there, and transforming back. This can be useful for concentration data, whose distributions may be right-skewed and whose variation may be more naturally described in relative rather than absolute terms. The registry identifies the primary endpoint parameter as a geometric mean, but does not state the precise computational procedure.
The reported geometric mean Cmax values are 71.7 pg/ml for Ortho-Cyclen and 70.6 pg/ml for Ortho-Cyclen plus evacetrapib. These are summaries of the observed concentration data in the endpoint population. A geometric mean is not the same as an arithmetic mean, and it does not reveal the full distribution of individual measurements. It also does not provide an estimate of the treatment contrast or its uncertainty.
What does the geometric coefficient of variation describe?
A coefficient of variation expresses dispersion relative to the scale of the measurements. The geometric coefficient of variation is used with multiplicative data and describes how spread out individual values are around a geometric mean. The reported values are 35.0 for Ortho-Cyclen and 37.0 for Ortho-Cyclen plus evacetrapib. These values indicate variability within each condition, but they are not confidence limits and should not be interpreted as the uncertainty of the difference between conditions.
Over-dispersion is a general concern when variability exceeds what a simple model assumes. If a model underestimates variability, standard errors can be too small and confidence intervals too narrow. Appropriate modeling should reflect the observed scale and distribution of the data. The registry does not report a variance model, transformation details, or a method for handling potential over-dispersion, so no claim can be made about which approach was used.
Why does crossover structure matter?
In a crossover design, observations from the same participant under different conditions are related. A direct treatment comparison can use this pairing, which may help separate treatment differences from stable participant characteristics. The statistical analysis should also consider whether measurements depend on the period in which a condition was received, and whether effects from an earlier treatment could persist into a later period. These are general design considerations, not statements that such effects occurred in this trial.
The registry says participants took part in two study periods and that allocation was randomized. It does not report treatment sequences, a washout procedure, or a model that accounts for participant, period, or sequence. The posted condition-level summaries do not preserve the information about which measurements belong to the same participant. For that reason, a reader cannot reconstruct a paired treatment estimate from these summaries alone.
What does uncertainty add?
A confidence interval is a range of values compatible with the observed data under a specified statistical procedure. It communicates the precision of an estimated contrast, not simply the spread of individual observations. A p-value addresses compatibility with a specified null hypothesis under an analysis model, but does not state the size or clinical importance of an effect. The registry reports neither a confidence interval nor a p-value for the primary comparison. It also does not report a treatment ratio or another contrast estimate.
The geometric coefficients of variation cannot substitute for these quantities. They describe within-condition variability; the precision of a paired contrast depends on the participant-level relationship between conditions as well as the amount of missing data and the analysis method. Since those details are not reported, the closeness of the two geometric means is descriptive rather than a complete inferential conclusion.
How should planning calculations be read?
Sample-size calculations are planning tools, not measurements of what happened in the trial. The registry’s planning description specifies a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such assumptions define an illustration, not the trial’s actual design rationale. The registry does not report the original sample-size justification. No specific planning estimates are stated in the registry record, and any planning illustration should not be described as observed power.
In general, power is a property of a study design under assumed conditions; it is not a measure of the probability that a reported result is correct. A calculation based on an observed effect is especially dependent on that effect estimate and should be treated as a planning illustration. It cannot replace a confidence interval for the observed treatment contrast or explain the precision of these posted endpoint summaries.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists eight outcome measures and identifies Cmax of ethinyl estradiol as the primary endpoint. It reports no secondary outcome results in the record. The registry does not describe a multiplicity strategy, such as a procedure for controlling error rates across multiple outcomes or comparisons. It is therefore not possible to determine from the record how multiple testing was handled or whether the primary endpoint was part of a broader prespecified testing hierarchy.
The primary endpoint population is described as participants who received at least one dose of study drug and had evaluable pharmacokinetic data. The posted endpoint sample sizes are 16 for Ortho-Cyclen and 17 for Ortho-Cyclen plus evacetrapib, while enrollment was 23. The registry does not report why participants or measurements were excluded from the endpoint summaries, whether any measurements were missing, or how missing or unevaluable data were treated. It also does not report whether an imputation method or sensitivity analysis was used.
The record describes the trial as randomized and crossover, but does not state the analysis population beyond the primary endpoint population description. It does not report whether the analysis followed a particular intention-to-treat or per-protocol approach, nor does it describe exclusions related to protocol deviations. A crossover analysis generally needs to preserve the pairing of participant observations and specify how incomplete pairs are handled; those details are not reported in the registry record.
No sample-size justification or interim-analysis plan is reported in the registry record. These omissions do not establish what was or was not done during the trial; they limit what can be verified from the posted information. The listed planning assumptions are not a substitute for a trial-specific design rationale or a missing-data analysis plan.
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 |
|---|---|---|---|
| Ortho-Cyclen (Lead-in Phase) | 0 | 22 | 0.0% |
| Ortho-Cyclen | 0 | 17 | 0.0% |
| Ortho-Cyclen + Evacetrapib | 0 | 21 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Ortho-Cyclen (Lead-in Phase) | 9 of 22 |
| Ortho-Cyclen | 5 of 17 |
| Ortho-Cyclen + Evacetrapib | 5 of 21 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ortho-Cyclen (Lead-in Phase) | Ortho-Cyclen | Ortho-Cyclen + Evacetrapib |
|---|---|---|---|---|
| Headache | Nervous system disorders | 8 of 22 | 1 of 17 | 5 of 21 |
| Nausea | Gastrointestinal disorders | 1 of 22 | 2 of 17 | 1 of 21 |
| Dizziness | Nervous system disorders | 2 of 22 | 0 of 17 | 0 of 21 |
| Menstruation irregular | Reproductive system and breast disorders | 1 of 22 | 1 of 17 | 0 of 21 |
| Procedural dizziness | Injury, poisoning and procedural complications | 0 of 22 | 1 of 17 | 0 of 21 |
The registry lists adverse-event participant counts for three groups: Ortho-Cyclen during the lead-in phase, Ortho-Cyclen, and Ortho-Cyclen plus evacetrapib. For serious adverse events, 0 affected participants are reported among 22 at risk in the lead-in group, 0 among 17 in the Ortho-Cyclen group, and 0 among 21 in the combination group. These are counts within the registry’s stated group denominators.
For other adverse events, the registry reports 9 affected participants among 22 at risk during the lead-in phase, 5 among 17 in the Ortho-Cyclen group, and 5 among 21 in the combination group. The record does not list top serious adverse-event terms. These figures describe participants reported as affected; they should not be treated as counts of all individual event episodes or as a formal comparison between conditions.
The adverse-event groups do not match the endpoint sample sizes, and the registry does not explain the difference between these populations. The record also does not report death figures. A zero serious-adverse-event count in a group describes the posted observations but does not establish that the risk is absent. In general, safety comparisons require careful attention to exposure, follow-up, event definitions, and uncertainty; the registry does not provide a comparative statistical analysis of these counts.
12. What the Result Does, and Does Not, Mean
The results answer a narrow pharmacokinetic question: the registry reports the geometric mean maximum concentration of ethinyl estradiol under Ortho-Cyclen alone and under Ortho-Cyclen with evacetrapib. The reported values are 71.7 pg/ml and 70.6 pg/ml, with geometric coefficients of variation of 35.0 and 37.0. These are descriptive summaries from the evaluable pharmacokinetic population.
The results do not provide a formal estimate of the treatment contrast or its uncertainty. No confidence interval or p-value is reported for the primary comparison. The registry also does not state a prespecified equivalence or non-inferiority margin. Consequently, similarity in the reported geometric means should not be taken as evidence that the conditions are equivalent, nor can the posted information establish the size of any treatment effect with a stated level of precision.
The endpoint concerns peak ethinyl estradiol concentration during the specified sampling window. It does not represent every feature of the concentration-time profile. The registry does not post a secondary endpoint result that would address other pharmacokinetic summaries, and the primary outcome is not itself a measure of clinical contraceptive outcomes. The study description says hormone amounts in blood were measured, but the posted primary result concerns ethinyl estradiol Cmax.
The study population was healthy female participants. The record does not support extending the posted summaries to other populations or circumstances. The open-label crossover design and the endpoint sample sizes are important context, while unreported analysis details limit assessment of how participant pairing, period effects, missing data, and variability were handled.
The safety counts are also descriptive. The registry reports no participants with serious adverse events in its listed groups and reports other adverse events in each group, but does not provide a formal comparative safety estimate or death figures. These posted data characterize what the record reports; they do not establish a general safety profile.
13. Why This Trial Matters Statistically
This study illustrates why pharmacokinetic trials often report concentration summaries alongside a clear account of the treatment contrast and its uncertainty. Cmax is a direct measure of peak concentration, and a geometric mean can be appropriate for positive concentration measurements with multiplicative variability. Reporting both a central summary and a dispersion measure helps describe the data. It does not replace an inferential comparison when the research question concerns differences between conditions.
The crossover design makes the analysis structure particularly important. Since each participant took part in two study periods, measurements under the conditions may be paired. A condition-level summary does not show the within-participant differences that can drive the treatment estimate in a crossover analysis. Without a reported paired contrast, confidence interval, and explanation of the model, readers cannot assess the precision or analytical handling of the comparison from the posted results alone.
The record also demonstrates a distinction between enrollment and endpoint availability. The registry reports 23 enrolled participants, while the endpoint summaries include 16 and 17 participants in the respective conditions. The record does not explain the difference. In clinical research, an explicit flow of participants and measurements helps readers judge how endpoint populations relate to the randomized study population and whether missingness could affect interpretation.
Finally, planning assumptions and observed results answer different questions. A planning calculation depends on assumptions about the effect, allocation, significance level, and statistical approximation. It is not observed power and cannot provide the uncertainty of the treatment comparison. The registry does not report the trial’s own sample-size justification. These distinctions are useful when evaluating a small pharmacokinetic study whose posted results are primarily descriptive.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation of the posted result is the absence of a formal treatment contrast and an uncertainty measure for the primary endpoint. Geometric mean Cmax values and geometric coefficients of variation are reported, but no confidence interval, standard error, or p-value is given. The reader therefore cannot assess the precision of the difference from the posted endpoint summaries alone.
Participant-level paired data and the analysis method are not reported in the registry record. This is especially relevant because the study used a crossover design. The record does not describe how within-participant measurements, treatment periods, treatment sequence, or possible carryover were handled. It also does not state whether the displayed condition-level values come from the same complete set of participants or how incomplete observations were addressed.
The endpoint counts are lower than the total enrollment count, and the registry does not report the reasons. No participant-flow explanation, missing-data method, or sensitivity analysis is provided. The analysis population is described as participants with at least one dose and evaluable pharmacokinetic data, but additional rules for inclusion or exclusion are not reported.
The study was open-label, and the registry does not describe blinding of those involved in data collection or analysis. The record also does not report a multiplicity plan despite listing eight outcome measures, or provide secondary outcome results. The protocol’s sample-size justification and any interim-analysis plan are not reported in the registry record.
Safety information is limited to participant counts by group. There is no formal comparative analysis, the registry lists no top serious adverse-event terms, and death figures are not reported. These limitations concern what can be established from the registry record; they do not establish that the unreported procedures or information were absent from the full study documentation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Evacetrapib in Healthy Female Participants — NCT01746732.
- Registry record last updated 2018-10-09; status last verified 2018-02.
- Results first posted 2018-10-09.
- 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 registry record describes a completed Phase 1 randomized, open-label crossover study of evacetrapib with Ortho-Cyclen in healthy female participants. It reports 23 participants enrolled, with study start in 2012-12 and primary completion in 2013-05.
The primary outcome was ethinyl estradiol maximum concentration on Day 21, summarized as a geometric mean and geometric coefficient of variation. The reported values were 71.7 pg/ml for Ortho-Cyclen and 70.6 pg/ml for Ortho-Cyclen plus evacetrapib. The endpoint sample sizes were 16 and 17, respectively. The registry does not report a formal comparison, confidence interval, or p-value.
Adverse-event results list no participants with serious adverse events in the three reported groups. Other adverse events were reported for 9, 5, and 5 participants in the lead-in, Ortho-Cyclen, and combination groups. The record does not report a trial-specific sample-size justification, analysis plan, multiplicity method, or explanation of missing endpoint data.