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 Evaluation of Brisdelle™ (Formerly Known as Mesafem) Following Single & Repeat Oral Administration in Healthy Postmenopausal Women (NCT01829919), a na phase 1 study. The primary outcome is AUC (Hour*ng/mL) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01829919 |
| Phase | Phase 1 |
| Condition | Postmenopausal Symptoms |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 24 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Noven Therapeutics |
| Results posted | Yes |
2. Clinical Question
Population
Healthy postmenopausal women. The registry record lists 24 enrolled participants and describes the safety and evaluable pharmacokinetic populations as 24 randomized subjects.
Intervention
Brisdelle (paroxetine mesylate) capsules, taken orally with 240 mL of water for 20 days. The study purpose also describes assessment after a single dose and after multiple doses.
Comparator
There is no separate comparator group. The study is recorded as a single-group study with allocation listed as not applicable, so it does not provide a like-for-like controlled comparison.
Primary question
What is the single-dose pharmacokinetic profile of Brisdelle, as represented by mean AUC on Day 1, and how does the study assess pharmacokinetics, safety, and tolerability after single and repeat oral administration?
The primary endpoint is titled AUC (Hour*ng/mL) for single-dose pharmacokinetics of Brisdelle 7.5 mg. Its stated summary measure is the mean, with standard deviation as the dispersion measure. The record identifies the Day 1 timeframe and the safety and evaluable pharmacokinetic populations, but it does not include the numerical AUC result.
This is a descriptive pharmacokinetic question, not a comparison of Brisdelle with placebo or another treatment. The posted record therefore cannot establish a between-group difference. It also does not provide enough outcome detail to characterize the shape of the concentration profile or compare single-dose with repeat-dose exposure quantitatively. Those results are not reported in the registry record.
3. Trial Design
This is a completed Phase 1 study, recorded as a single-group study of Brisdelle (paroxetine mesylate) in healthy postmenopausal women. Enrollment was 24. Allocation is listed as not applicable, and masking is listed as none. The record's description of 24 randomized subjects in the safety and evaluable pharmacokinetic populations does not make this a randomized comparison: there is no separate control arm or allocation between treatment groups described.
The study purpose was to assess pharmacokinetics, safety, and tolerability following a single dose and multiple doses. The intervention description states that Brisdelle capsules were taken orally with 240 mL of water for 20 days. The primary endpoint is a Day 1 single-dose AUC measure. The record does not specify the dosing schedule in greater detail, the timing of pharmacokinetic sample collection, or how single-dose and repeat-dose observations were related in the analysis.
The study started in 2011-07, reached primary completion in 2011-08, and has completed status. Noven Therapeutics is listed as the sponsor. The registry record identifies 13 outcome measures and zero analyses, but does not report a statistical analysis plan, sample-size justification, interim analysis plan, or further design details. The record also does not describe a blinding procedure; masking is listed as none.
With no comparator arm, the design can describe measurements collected during treatment but cannot isolate a treatment effect against a concurrent control. Interpretation is therefore centered on the reported pharmacokinetic and safety observations, and on whether those observations are presented with enough detail to judge their precision.
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 | Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg |
|---|---|
| STARTED | 24 |
| COMPLETED | 24 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Safety and evaluable pharmacokinetic populations = 24 randomized subjects.
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: 24
| Characteristic | Unit | Brisdelle (Paroxetine Mesylate) Capsules |
|---|---|---|
| Participants analysed | 24 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 20 |
| Age, Categorical: >=65 years | Participants | 4 |
| Age, Continuous | years | 56.2 (SD 7.29) |
| 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 AUC (Hour*ng/mL) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg, measured over Day 1.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Hour*ng/mL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is mean AUC, measured in Hour*ng/mL, for single-dose Brisdelle (paroxetine mesylate) 7.5 mg on Day 1. AUC is a measure of exposure over time. General: It is commonly derived from drug concentration measurements across a specified time interval; a larger AUC represents greater total measured exposure over that interval. The exact sampling schedule and calculation procedures for this study are not reported in the registry record.
The endpoint uses the mean to describe the central value across the stated safety and evaluable pharmacokinetic populations, which the record identifies as 24 randomized subjects. Standard deviation is the specified dispersion measure. General: The standard deviation describes how spread out individual observations are around their mean, while the mean alone does not show that spread. AUC is useful in pharmacokinetic assessment because it condenses exposure across time into a single measure, rather than describing concentration at just one sampling time.
The registry record gives the endpoint definition and units but does not report the mean, standard deviation, confidence interval, or individual observations. It also does not state the AUC calculation method or the sampling window. Consequently, the endpoint's intended interpretation can be described, but its observed magnitude and precision cannot be evaluated from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record defines a primary Day 1 AUC endpoint and names mean and standard deviation as the summary statistics. It does not report a numerical mean or standard deviation. No confidence interval, test statistic, p-value, or numerical primary-endpoint result is reported in the registry record. As a result, the available information establishes what the study intended to summarize, but not the observed level or variability of single-dose exposure.
This distinction matters because an endpoint definition is not itself an outcome. A mean would describe the average AUC in the study population, while the standard deviation would indicate how dispersed participant values were. Neither statistic can be inferred from the enrollment count or the endpoint title. The record's statement that 24 subjects were in the safety and evaluable pharmacokinetic populations does not substitute for the outcome data.
The study includes a single group and no comparator. Its design therefore supports a descriptive account of the group’s measurements, rather than an estimate of a treatment difference against another group. The registry record does not provide a comparison of single-dose and repeat-dose AUC, nor does it report enough details to interpret repeat-dose pharmacokinetics quantitatively. Although repeat dosing is part of the study purpose and the intervention is described over 20 days, the available primary endpoint is specifically the Day 1 single-dose measure.
The safety counts are distinct from the missing pharmacokinetic result. The record lists zero participants with serious adverse events among 24 at risk and 23 participants with other adverse events among 24 at risk. Those counts describe reported adverse-event categories; they do not supply the missing AUC result or establish a comparison with an untreated group. The death count is not reported in the registry record.
The record lists 13 outcome measures but zero analyses. That means the posted registry information does not give analysis results from which to assess statistical uncertainty or the treatment of multiplicity. It is not appropriate to infer a positive or negative pharmacokinetic finding from the study's completion status, its sample size, or the existence of an endpoint definition. The quantitative result and its precision are not reported in the registry record.
9. Statistical Methods Explained
The registry identifies the primary measure as a continuous outcome summarized by a mean and standard deviation. General: A continuous outcome can take values along a measurement scale, rather than being limited to categories. The mean gives a central summary, while the standard deviation describes the dispersion of observations around that mean. These summaries are most informative when the endpoint's units, measurement procedure, and analyzed population are clear. The record gives the units, timeframe, and stated populations, but not the numerical summaries or measurement details.
What does AUC represent?
General: AUC, or area under the concentration-time curve, represents cumulative drug exposure across a specified time interval. It combines concentration and time information into one measure. Its interpretation depends on how concentrations were sampled, what time window was used, and how the area was calculated. Those study-specific procedures are not reported in the registry record. The named unit, Hour*ng/mL, indicates that the measure combines time and concentration units; it does not reveal the observed amount of exposure.
The primary endpoint is identified as a single-dose measure on Day 1. The registry record does not state the sampling times or report a separate numerical AUC for repeat dosing. It is therefore not possible to assess from the posted endpoint whether exposure changed over repeated administration, or how estimates across dosing conditions compare.
How should the mean and standard deviation be read?
General: The mean is a summary of the group's observed values. The standard deviation describes how far individual values tend to lie from that mean, with larger dispersion indicating more variability among observations. These statistics answer different questions: the mean concerns the central level, while the standard deviation concerns spread. Neither alone gives a complete account of uncertainty in an estimated population mean. A confidence interval can convey uncertainty around an estimate, but no confidence interval for the primary endpoint is reported in the registry record.
The record names 24 participants in the safety and evaluable pharmacokinetic populations. That count indicates the stated population size, but it does not reveal the distribution of AUC values or the precision of the mean. The number of participants is not a substitute for the endpoint estimate, its variability, or the details of missing observations.
What can the study design estimate?
General: A single-group design can describe outcomes observed in the group receiving an intervention. Without a concurrent comparator, it cannot directly estimate a between-group treatment contrast. Factors other than the intervention may also influence descriptive observations, and this design does not separate their contributions. In this record, allocation is listed as not applicable, masking as none, and the model as single-group. The record does not describe a separate control group.
The study purpose covers single and multiple oral administration, whereas the primary endpoint is specifically the Day 1 single-dose AUC. These are related but distinct questions. A single-dose exposure summary does not by itself provide a numerical account of repeat-dose exposure. The record does not report a primary endpoint result for repeat administration or an analysis contrasting the dosing conditions.
How does dispersion relate to precision?
General: A standard deviation describes variation among observations; it is not the same as the standard error or a confidence interval for a mean. Estimating precision requires information about both variability and the analyzed sample size, along with an appropriate analysis. Although the population is stated as 24 subjects, the record does not provide the AUC standard deviation or a confidence interval. Precision of the primary endpoint therefore cannot be assessed from the posted information.
General: When data vary more than a chosen statistical model expects, that is called over-dispersion. In count or other modeled data, over-dispersion can make model-based uncertainty too small if it is ignored. This endpoint is identified as continuous and summarized by a mean and standard deviation; the registry record does not describe a fitted model or report diagnostics, so no claim about over-dispersion or model adequacy can be made for this analysis.
What do the planning assumptions mean?
The planning assumptions describe an illustration based on an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The illustration is not the design of the registered study: this record describes a single-group study, not equal allocation between two arms. The numerical planning outputs and the observed effect used for such planning are not reported in the registry record. Such calculations are hypothetical planning illustrations, not observed power and not evidence of a treatment effect. They cannot replace the missing endpoint result or provide a direct assessment of this study's achieved precision.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 13 outcome measures and zero analyses. It does not report how the outcomes were ordered for inference, whether one outcome was designated as primary for statistical testing beyond the listed primary endpoint, or whether any adjustment for multiple testing was planned or performed. Those details are not reported in the registry record. Without an analysis plan or posted results, it is not possible to determine how multiple outcomes may have affected interpretation.
The stated primary population is the safety and evaluable pharmacokinetic populations, each described as 24 randomized subjects. The record does not explain how evaluability was defined, whether all participants contributed to the primary AUC summary, or how any incomplete pharmacokinetic measurements were handled. A missing-data method, imputation procedure, or sensitivity analysis is not reported in the registry record. The registry's population statement alone cannot establish that every participant had complete endpoint data.
The record does not report an analysis population for the 13 outcome measures separately, nor does it give participant flow or outcome-specific denominators. It also does not describe interim analyses or stopping rules. These absent details should not be inferred from the completed status or from the stated enrollment.
These gaps constrain interpretation rather than proving that a particular method was or was not used. The available record supports identifying the endpoints and stated population, but not reconstructing how missing observations or multiple outcomes were handled.
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 |
|---|---|---|---|
| Brisdelle (Paroxetine Mesylate) Capsules | 0 | 24 | 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 |
|---|---|
| Brisdelle (Paroxetine Mesylate) Capsules | 23 of 24 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Brisdelle (Paroxetine Mesylate) Capsules |
|---|---|---|
| Fatigue | General disorders | 6 of 24 |
| Constipation | Gastrointestinal disorders | 5 of 24 |
| Headache | Nervous system disorders | 4 of 24 |
| Abdominal pain | Gastrointestinal disorders | 3 of 24 |
| Diarrhoea | Gastrointestinal disorders | 3 of 24 |
| Back pain | Musculoskeletal and connective tissue disorders | 3 of 24 |
| Abnormal dreams | Psychiatric disorders | 3 of 24 |
| Insomnia | Psychiatric disorders | 3 of 24 |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 3 of 24 |
The registry reports one Brisdelle group, with 24 participants at risk for serious adverse events and zero affected by serious adverse events. It also reports 24 participants at risk for other adverse events and 23 affected. These are counts for the group as recorded; they do not provide a comparison against a control group, because the study has no separate comparator arm.
Serious adverse events and other adverse events are reported as separate categories. The record lists no top serious adverse-event terms. It does not provide the detailed event terms or event counts for the other-adverse-event category in the registry record for this analysis. The death count is not reported in the registry record.
These figures should be read as descriptive safety counts, not as evidence of comparative risk. The categories do not convey severity or clinical importance for each event unless event-level details are available, and the registry counts alone do not establish causation. The record's study purpose includes safety and tolerability, but a complete assessment requires details beyond these aggregate counts.
12. What the Result Does, and Does Not, Mean
This study is a Phase 1, single-group evaluation of Brisdelle pharmacokinetics, safety, and tolerability in healthy postmenopausal women. Its primary endpoint is defined as mean Day 1 AUC after a single dose, in Hour*ng/mL, with standard deviation as the dispersion measure. The registry record does not report the endpoint's numerical result. It therefore cannot establish the observed mean exposure, variability, or precision from the information recorded.
The design also limits the kinds of conclusions that can be drawn. There is no separate comparator group, so the study does not estimate a treatment contrast against placebo or another intervention. The record describes both single and multiple administration, but it does not provide a numerical comparison between those dosing conditions. A single-dose endpoint should not be treated as a reported repeat-dose result.
The safety record reports zero participants with serious adverse events among 24 at risk and 23 with other adverse events among 24 at risk. These are descriptive counts in the treated group. With no comparison group, they do not quantify a difference in adverse-event risk between treatments. The death count is not reported in the registry record.
More broadly, the registry does not report an analysis plan, handling of missing data, multiplicity procedures, or a numerical estimate with a measure of uncertainty for the primary endpoint. Those omissions prevent a detailed statistical appraisal of the endpoint findings. They do not justify assuming that a result was favorable or unfavorable. The record establishes the study question, the basic single-group design, and certain safety counts, while leaving the central quantitative pharmacokinetic result unreported.
13. Why This Trial Matters Statistically
The trial is statistically useful as an example of why a clearly named endpoint and a completed study status do not by themselves communicate the study's result. The registry identifies a Day 1 AUC measure, its units, summary statistic, dispersion measure, and stated population. Without the numerical mean and standard deviation, however, readers cannot judge the observed exposure or how much participant values varied.
The single-group design is also important to interpretation. It can describe pharmacokinetic observations in the participants who received Brisdelle, but it does not provide a concurrent control for estimating a comparative effect. The distinction between a descriptive estimate and a controlled contrast is fundamental when reading early-phase studies. A design's purpose and the result it can support are not interchangeable.
The record further separates two kinds of information: the primary endpoint is a single-dose AUC on Day 1, while the study purpose includes repeat administration as well. Without a reported repeat-dose estimate or an analysis comparing dosing conditions, the wider purpose cannot be treated as a quantitative finding. The safety counts similarly describe a single group and should not be read as comparative evidence.
Finally, the registry lists multiple outcome measures but no analyses. Without numerical estimates and details on missing data, multiplicity, and analysis populations, readers have limited basis for judging precision and robustness. The key statistical lesson is to distinguish what a registry records about design and intent from what it reports as analyzed outcomes.
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 primary limitation for statistical interpretation is that the registry record defines the Day 1 AUC endpoint but does not report its numerical mean or standard deviation. It also does not report a confidence interval or other measure of uncertainty. The endpoint's magnitude and precision therefore cannot be evaluated from the posted information.
The study is single-group, with allocation listed as not applicable and masking listed as none. There is no separate control group for a like-for-like comparison. This limits interpretation to descriptive observations in the treated group and prevents a direct estimate of a comparative treatment effect.
Although the study purpose includes both single and multiple dosing, the named primary endpoint concerns single-dose pharmacokinetics on Day 1. Numerical repeat-dose results and a comparison between single and repeat administration are not reported in the registry record. The intervention description states oral administration with 240 mL of water for 20 days, but does not give more detailed dosing or sampling schedules.
The record lists 13 outcome measures and zero analyses but does not describe a statistical analysis plan, missing-data methods, multiplicity handling, or participant flow by outcome. It does not explain the evaluability criteria or whether all participants contributed complete AUC measurements. The death count is also not reported in the registry record. These limitations leave important aspects of outcome estimation and uncertainty unresolved.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pharmacokinetic Evaluation of Brisdelle™ (Formerly Known as Mesafem) Following Single & Repeat Oral Administration in Healthy Postmenopausal Women — NCT01829919.
- Registry record last updated 2015-10-15; status last verified 2015-10.
- Results first posted 2014-02-24.
- 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
NCT01829919 is a completed Phase 1, single-group study sponsored by Noven Therapeutics. It enrolled 24 healthy postmenopausal women and evaluated Brisdelle (paroxetine mesylate) following single and repeat oral administration. The intervention description states that capsules were taken with 240 mL of water for 20 days. The study started in 2011-07 and reached primary completion in 2011-08.
The primary endpoint is mean Day 1 AUC in Hour*ng/mL for single-dose pharmacokinetics, with standard deviation specified as the dispersion measure. The safety and evaluable pharmacokinetic populations are described as 24 randomized subjects. The numerical endpoint result is not reported in the registry record. Safety counts include zero serious adverse events among 24 at risk and other adverse events in 23 of 24 participants. The record lists 13 outcome measures and zero analyses.