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 Pharmacokinetic Study Of AGILE AG200-15 After Weekly Application Under Various Conditions in Healthy Female Volunteers (NCT01375946), a na phase 1 study. The primary outcome is Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01375946 |
| Phase | Phase 1 |
| Condition | Healthy |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 24 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Agile Therapeutics |
| Results posted | Yes |
2. Clinical Question
Population
Healthy female volunteers were enrolled. The registry record lists an enrollment of 24 and identifies the primary pharmacokinetic population as the population for the main endpoint. It does not provide further eligibility details or a breakdown of participants by external condition.
Intervention
Participants wore AG200-15, a transdermal delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). The described wear period was 7 days. The study evaluated the patch’s pharmacokinetic profile, wearability and safety.
Comparator
This was a single-group study, not a randomized comparison. The registry description lists normal conditions, treadmill exercise, cold water, whirlpool and dry sauna as external conditions. It does not report a separate control treatment or enough detail to treat these conditions as like-for-like randomized arms.
Primary question
The primary endpoint was the mean area under the concentration-versus-time curve for LNG over 0–168 hours, assessed for each external condition. The question was how the LNG exposure profile was characterized across those conditions. Numerical AUC estimates are not reported in the registry record, so the direction or size of any differences cannot be assessed from the record.
3. Trial Design
This was a phase 1 pharmacokinetic and wearability study of AG200-15 in healthy female volunteers. The registry lists 24 participants enrolled and describes a single-group design. Allocation is listed as not applicable, masking as none, and the study status as completed. These features distinguish the study from a blinded randomized trial with a separate control group.
Participants wore AG200-15 for 7 days and were exposed to one of five external conditions: normal conditions, treadmill exercise, cold water, whirlpool or dry sauna. The registry record does not report how participants were assigned to conditions, the number included under each condition, or whether any participants experienced more than one condition. Those details should not be inferred from the listed condition names.
The study’s brief description identifies pharmacokinetics, wearability and safety as its areas of evaluation. Patch adhesion is listed as a secondary outcome. The record gives a 6-week timeframe for the primary outcome, while the described patch-wear period was 7 days. It does not explain the relationship between that overall outcome timeframe and the duration of patch application.
Blood samples for the pharmacokinetic evaluation were scheduled at 0 hour, immediately before dosing, and at 6, 12, 24, 48, 72, 120, 144 and 168 hours after patch application. The primary endpoint was the LNG area under the concentration-versus-time curve over 0–168 hours, with a mean and standard deviation specified as the summary measures. The registry record does not report numerical endpoint results or the statistical model used to compare conditions.
Because this is not a randomized comparison, differences between conditions, if reported elsewhere, would need to be interpreted in light of the study’s actual allocation and analysis details. Those details are not reported in the registry record. The listing therefore supports a description of the study’s aim, population and planned measurements, but not a causal conclusion about the effect of any external condition.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | AG200-15 Condition (NDC) | AG200-15 Condition (CNW) | AG200-15 Condition (WTN) | AG200-15 Condition (NCD) | AG200-15 Condition (DNT) | AG200-15 Condition (TWN) |
|---|---|---|---|---|---|---|
| STARTED | 4 | 4 | 4 | 4 | 4 | 4 |
| COMPLETED | 4 | 4 | 4 | 4 | 4 | 4 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Primary PK population
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Safety Population
| Characteristic | Unit | AG200-15 Condition |
|---|---|---|
| Participants analysed | 24 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 24 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 35.13 (SD 6.469) |
| Sex: Female, Male: Female | Participants | 24 |
| Sex: Female, Male: Male | Participants | 0 |
| Region of Enrollment: United States | Participants | 24 |
6. Primary Endpoint
The registry lists the primary outcome as Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG), measured over 6 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | ng*hr/mL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the area under the concentration-versus-time curve (AUC) for LNG from 0 to 168 hours after application of AG200-15. It is reported as a mean with standard deviation and is described for each external condition. The registry record names the primary pharmacokinetic population and gives a 6-week outcome timeframe.
AUC is a summary of drug concentration across a defined time interval. In general, it represents overall measured exposure during that interval, combining information from the concentration profile rather than relying on a single blood sample. AUC can therefore help characterize how exposure develops over time under different study conditions. Its interpretation depends on the measurement schedule, the interval covered and the analysis methods.
Here, the blood-sampling schedule runs from the pre-dose sample at 0 hour through 168 hours after patch application. This corresponds to the stated 0–168-hour AUC interval. The registry record does not provide the condition-specific AUC means, standard deviations, confidence intervals or other numerical endpoint results. It is therefore not possible to describe the observed exposure level, its variability, or the precision of any difference between conditions from the registry record.
AUC describes pharmacokinetic exposure; it is not itself a measure of patch adhesion or a safety outcome. Patch adhesion is listed separately as a secondary outcome. The record does not report the detailed method used to calculate AUC or how observations that were missing or incomplete were handled.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a pharmacokinetic study and identifies LNG AUC over 0–168 hours as the primary endpoint. It also names the external conditions under which that endpoint was to be assessed. However, the record does not report condition-specific mean AUC values, standard deviations or a numerical comparison between conditions. Consequently, the posted results in this record do not establish the size or direction of any observed exposure differences.
The mean is a measure of the central value of a continuous outcome. The standard deviation describes the spread of individual measurements around that mean. In general, these answer different questions: the mean characterizes the group’s average measured exposure, while the standard deviation conveys variability among measurements. Neither statistic alone gives the precision of an estimated mean or the uncertainty around a contrast between conditions. Confidence intervals or other inferential results would be needed to assess that uncertainty; these are not reported in the registry record.
The endpoint is described for each condition, but the study is listed as single group, with allocation not applicable and no masking. The record also states that participants were exposed to one of five conditions, without reporting condition-level enrollment or the method used to allocate participants. Without those details and without numerical condition results, the study cannot be read as a randomized head-to-head comparison. Even if condition summaries were available, an apparent difference would need to be interpreted according to the actual design and analysis.
The record lists enrollment of 24, but it does not report the number contributing endpoint data for each condition or whether all enrolled participants completed the sampling schedule. Enrollment should not be treated as equivalent to the number analyzed for every outcome. The stated primary pharmacokinetic population is not further defined in the registry record.
The safety record reports 0 serious adverse events among 24 participants at risk, and 23 participants with other adverse events among 24 at risk. These are descriptive safety counts. The registry record does not list serious adverse event terms, and it does not provide details about the nature, severity or timing of the other events. The counts should not be interpreted as a comparison with an untreated group, because no separate control group is listed.
Overall, the registry entry documents the study’s purpose, design features, primary measure and safety counts. It does not provide the numerical primary endpoint results needed to evaluate exposure estimates or their precision. Statistical conclusions about differences across external conditions are therefore not supported by the results recorded.
9. Statistical Methods Explained
The registry record identifies a continuous primary outcome: LNG AUC over 0–168 hours. It specifies the mean as the summary parameter and the standard deviation as the measure of dispersion. No numerical AUC summaries or analyses are reported in the registry record. The concepts below explain how such summaries are generally interpreted; they do not describe unreported analyses from this study.
What does the mean describe?
In general, a mean summarizes the central level of a continuous measurement across observations in a group. For a pharmacokinetic endpoint, the mean AUC would describe average measured exposure over the defined interval for the participants contributing data under a condition. It does not show whether individual values cluster closely around the average or vary substantially; that is why a measure of dispersion is also useful.
The registry specifies a mean for the primary outcome, but it does not give the condition-specific means. As a result, the endpoint definition is available while the numerical estimate itself is not. The record also does not state whether the reported mean was intended to be calculated from all enrolled participants or from a subset with evaluable pharmacokinetic measurements.
What does the standard deviation add?
In general, the standard deviation describes how spread out observed values are around their mean. A larger standard deviation indicates more variability in the measurements relative to the mean; a smaller one indicates less spread. It is not the same as a standard error or a confidence interval. Standard deviation describes variation among observations, whereas a confidence interval describes uncertainty around an estimated quantity under a statistical model.
No standard deviations for the primary endpoint are reported in the registry record. Even if a mean were available, a reader would need dispersion information to understand how representative that mean might be of the individual measurements. A standard deviation by itself would not establish whether condition means differ meaningfully or whether an estimate is precise.
Why does the sampling schedule matter?
General: AUC summarizes concentrations across a defined time interval, so interpretation depends on when samples are taken and how the curve between measured concentrations is handled. The registry lists samples at 0 hour, immediately before dosing, and at 6, 12, 24, 48, 72, 120, 144 and 168 hours after application. The endpoint covers 0–168 hours. The record does not state the computational method for deriving AUC from those measurements, or how any missing scheduled samples were handled.
Sampling at multiple times allows a concentration profile to be characterized over the wear interval rather than relying on a single measurement. In general, changes in sampling density can affect how well a profile is captured, particularly when concentrations change between observations. The registry listing does not report concentrations at individual time points, so no conclusions about the shape of the LNG profile can be drawn from it.
How should condition comparisons be understood?
The endpoint is described for normal conditions, treadmill exercise, cold water, whirlpool and dry sauna. In general, comparing group summaries can describe how measurements differ across settings, but a causal interpretation depends on design and analysis. This study is listed as single group, with no masking and allocation listed as not applicable. The registry does not describe a randomized allocation method, the number of participants per condition, or a statistical comparison model.
Without those details, it is not appropriate to treat the conditions as randomized treatment arms or to assume that groups were comparable in all relevant respects. A difference in group means, if one were reported, would need to be considered alongside how participants entered each condition and how the analysis accounted for the design. The registry record does not report an inferential test, confidence interval or adjusted comparison for the primary outcome.
What do planning assumptions mean?
The record describes sample-size planning illustrations using a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. It states that the effect to detect is a stated proportion of the observed effect. These are planning assumptions, not a description of the trial’s design: the trial itself is listed as single group, not a two-arm randomized comparison. The record does not report the numerical illustration values or the underlying effect estimate needed to interpret them.
In general, a planning calculation estimates the sample size that a hypothetical future design might require under specified assumptions. It does not show the probability that this completed study detected an effect, and it should not be described as observed power. The registry record does not report a sample-size justification for the trial’s own design. The planning assumptions should therefore remain separate from any account of the study’s observed results.
What can be inferred from the analysis listing?
The registry lists 0 analyses. That means the record does not contain listed inferential analyses to interpret. It does not establish that no analyses were conducted outside the registry record. No p-value, confidence interval, model specification or multiplicity procedure is reported for the primary endpoint. In general, a numerical estimate, a measure of uncertainty and a description of the analysis are complementary: the estimate describes the observed result, while uncertainty measures and methods indicate how precisely and under what assumptions it was estimated.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures and identifies LNG AUC over 0–168 hours as the primary outcome. Patch adhesion is listed as a secondary outcome. The record does not describe the status or definition of the other outcome measures, a hierarchy among outcomes, or a procedure for controlling the risk of false-positive findings across multiple statistical tests. No multiplicity adjustment is reported in the registry record.
In general, examining several outcomes or several comparisons can increase the chance that at least one result appears unusual by chance. A prespecified testing hierarchy or an adjustment method can address that issue, but the appropriate approach depends on the analysis plan. The registry record does not report such a plan or any inferential analyses; it would be inappropriate to assume either that adjustment was or was not performed outside the record.
Missing-data handling is also not reported in the registry record. The sampling schedule includes several post-application time points, but the listing does not state whether all planned samples were collected, how incomplete concentration profiles were treated, or how missing endpoint values were handled. It does not describe imputation, exclusions or sensitivity analyses.
The primary population is called the primary pharmacokinetic population, but its inclusion criteria and analysis rules are not reported. The enrollment count of 24 does not establish how many participants contributed to each condition-specific endpoint. Condition-level denominators and the handling of participants with incomplete observations are not reported in the registry record.
These omissions limit assessment of the analysis population, missingness and multiplicity. They also prevent a reader from determining whether the reported summaries, if available elsewhere, represent all enrolled participants or only those with evaluable measurements.
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 |
|---|---|---|---|
| AG200-15 Condition | 0 | 24 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| AG200-15 Condition | 0 of 24 |
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 |
|---|---|
| AG200-15 Condition | 23 of 24 |
Most frequent non-serious adverse event terms
| Event term | Organ system | AG200-15 Condition |
|---|---|---|
| Reproductive system and breast disorders | Reproductive system and breast disorders | 16 of 24 |
| Nervous system disorders | Nervous system disorders | 14 of 24 |
| General disorders and administration site conditions | General disorders | 13 of 24 |
| Gastrointestinal disorders | Gastrointestinal disorders | 12 of 24 |
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | 4 of 24 |
| Infections and infestations | Infections and infestations | 2 of 24 |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | 2 of 24 |
The registry record lists 24 participants at risk for serious adverse events and 0 affected. It lists 24 participants at risk for other adverse events and 23 affected. Deaths are listed as 0. These are counts associated with the AG200-15 condition; the record does not provide a separate untreated or control group for comparison.
These figures should be read as descriptive counts, not as evidence that an event is impossible or that the intervention caused or prevented an event. The record does not list serious adverse event terms. It also does not report the nature, severity, timing or duration of the other adverse events, or whether a participant could have experienced more than one event. The affected-participant counts do not provide event-level detail.
The registry record does not explain how adverse events were collected or define the categories used for serious and other adverse events. The figures therefore characterize what is listed in the record, but they do not support a detailed account of the events or a comparison with another treatment. The absence of a serious adverse event count in this listing should not be expanded into a broader safety conclusion.
12. What the Result Does, and Does Not, Mean
This study addresses a specific pharmacokinetic question: how the LNG AUC over 0–168 hours was characterized for AG200-15 under normal conditions and external conditions that included treadmill exercise, cold water, whirlpool and dry sauna. The record also identifies wearability and safety as study aims, with patch adhesion listed as a secondary outcome.
The record does not report numerical AUC estimates, standard deviations, confidence intervals or statistical tests. It therefore does not show the magnitude, direction or precision of any difference between conditions. It also does not provide condition-specific participant counts, the method used to allocate participants to conditions, or a detailed statistical analysis plan. Without those results and design details, claims about whether exposure differed across conditions are not supported by the registry entry.
The study is listed as phase 1, single group, and unmasked. It enrolled healthy female volunteers and evaluated a 7-day patch-wear period. These design and population details define the context of the investigation; they do not establish that results would apply to populations or settings not described in the record. The registry lists a 6-week timeframe for the primary outcome, but does not explain that timeframe in relation to the wear period.
The safety listing reports 0 serious adverse events among 24 participants at risk and 23 participants with other adverse events among 24 at risk. Those counts are descriptive and do not provide event details or a comparison group. They should not be interpreted as a complete account of safety beyond what is recorded.
In short, the registry entry documents the study question and the principal measurement approach, but it does not contain the numerical primary results needed to quantify exposure or compare conditions. The record supports describing what was studied and what was reported, not a conclusion about the effect of the patch or the external conditions.
13. Why This Trial Matters Statistically
This trial is statistically notable for its focus on repeated pharmacokinetic measurements over a defined interval. LNG AUC from 0–168 hours condenses a sequence of concentration observations into a continuous summary of exposure. The registry specifies a mean and standard deviation, which are useful descriptive quantities when interpreted together: one characterizes the average, while the other describes variability among measurements.
The multiple external conditions also make design information important. Normal conditions, treadmill exercise, cold water, whirlpool and dry sauna are all named, but the study is not listed as a randomized comparison. The record does not give condition-level counts or explain how participants entered each condition. Those gaps matter because the interpretation of between-condition differences depends not only on the endpoint but also on how the groups or observations were formed and analyzed.
The study also illustrates why an endpoint definition is not a substitute for a result. The sampling schedule and AUC interval are described, but the registry record does not include numerical AUC summaries or measures of uncertainty. Without them, readers cannot assess the observed exposure estimates or their precision. The record’s listing of 0 analyses reinforces that no inferential results are available in this entry to evaluate.
Finally, planning assumptions should be kept distinct from evidence generated by the completed study. The recorded planning illustration assumes equal allocation between two arms, while the trial is listed as a single-group study. Such illustrations are not observed power and do not supply missing endpoint results. Recognizing these distinctions helps prevent design assumptions, descriptive counts and unreported analyses from being treated as interchangeable evidence.
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 for interpreting the primary endpoint is that the registry record does not report its numerical results. Condition-specific means and standard deviations are not listed, and no confidence intervals, p-values or inferential comparisons are reported. The record therefore does not permit assessment of the size or precision of any differences in LNG exposure.
The study is described as single group and unmasked, with allocation listed as not applicable. Although the record names five external conditions, it does not report condition-level participant counts or how participants were allocated to those conditions. It also does not clarify whether the same participants contributed measurements under more than one condition. As a result, the structure of any condition comparisons cannot be reconstructed from the registry record.
The primary pharmacokinetic population is named but not defined. Enrollment is listed as 24, but the number with complete sampling or evaluable AUC data is not reported. The record does not explain how missing samples or incomplete concentration profiles were handled, nor does it describe exclusions or sensitivity analyses.
The record states a 6-week timeframe for the primary outcome and describes 7 days of patch wear, but does not explain the relation between those timeframes. It does not report the AUC calculation method, statistical model, analysis plan or multiplicity procedure. These omissions limit reproducibility and make it difficult to assess whether the listed outcome definition fully describes the analysis.
Safety information is also limited to participant counts. Serious adverse event terms are not listed, and details about other adverse events are not reported. The absence of a separate control group further limits comparative interpretation of the safety counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pharmacokinetic Study Of AGILE AG200-15 After Weekly Application Under Various Conditions in Healthy Female Volunteers — NCT01375946.
- Registry record last updated 2018-07-31; status last verified 2018-07.
- Results first posted 2017-12-21.
- 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.
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18. Record Summary
NCT01375946 is a completed phase 1, single-group study of AG200-15 in healthy female volunteers. The registry lists 24 participants enrolled and describes 7 days of patch wear under normal conditions, treadmill exercise, cold water, whirlpool or dry sauna. The primary outcome is mean LNG AUC over 0–168 hours, with standard deviation specified as the dispersion measure and a 6-week timeframe.
Blood sampling was scheduled from 0 hour before dosing through 168 hours after application. Patch adhesion is listed as a secondary outcome. The registry record does not report numerical AUC results, condition-level participant counts, inferential analyses, missing-data methods or a detailed analysis plan.
The safety listing reports 0 serious adverse events among 24 participants at risk, 23 participants with other adverse events among 24 at risk, and 0 deaths. These counts are descriptive and are not accompanied by event details or a separate control group.