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 to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021 (NCT00544882), a randomized phase 3 study. The primary outcome is Serum Estradiol Levels by Cycle Day.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00544882 |
| Phase | Phase 3 |
| Condition | Healthy |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 61 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Healthy participants enrolled in a prospective, multicenter study. The registry record reports enrollment of 61 and describes the primary outcome population as the intent-to-treat population with available data at each time point.
Intervention
DR-1021, described as an oral regimen containing desogestrel and ethinyl estradiol, followed by an ethinyl estradiol tablet during Cycle 2.
Comparator
Mircette is identified as a randomized group and its Cycle 2 regimen is partly described. Kariva is also listed as an intervention, but the registry record does not report a complete description of its role or regimen.
Primary question
How do serum estradiol levels vary over the specified cycle days among participants receiving the study regimens?
The study focused on hormone patterns and ovarian follicular activity rather than a single clinical event. The primary outcome was serum estradiol by cycle day, expressed as a median with a full range. Measurements were scheduled at Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, and Cycle 3, Days 2, 4 and 6.
The registry also lists outcomes concerning follicles greater than 5 mm in diameter, change in maximum follicle size, and bleeding or spotting during scheduled and unscheduled periods. These outcomes describe different aspects of ovarian activity and bleeding patterns; they are not interchangeable measures of one underlying effect. Numerical results for these measures are not reported in the registry record in the registry record used for this account.
The question is therefore best read as a comparison of longitudinal hormone patterns across treatment groups, with additional measures of follicular activity and bleeding. The registry record does not report a single prespecified contrast that reduces all cycle-day measurements to one summary comparison. It also does not report the complete eligibility criteria, the allocation ratio, or a detailed account of how the listed interventions map to all study arms.
3. Trial Design
This was a Phase 3, prospective, multicenter, randomized, double-blind, parallel-group study. The registry record gives an enrollment of 61 and describes the enrolled participants as healthy. The study status is completed. It was sponsored by Teva Branded Pharmaceutical Products R&D, Inc.
The record identifies DR-1021, Mircette, and Kariva as drug interventions. Its description of the DR-1021 Cycle 2 regimen specifies a combination tablet containing 150 μg desogestrel and 20 μg ethinyl estradiol once daily for 21 days, followed by a 10 μg ethinyl estradiol tablet once daily for 7 days. The partial description of Mircette specifies a combination tablet containing 150 μg desogestrel and 20 μg ethinyl estradiol once daily for 21 days, followed by placebo for 2 days and a 10 μg ethinyl estradiol tablet once daily for 5 days. The descriptions are incomplete in the registry record; a complete account of all regimens and treatment sequences is not reported in the registry record.
Random allocation is intended to reduce systematic differences between treatment groups, while double masking is intended to limit influences on participant experience and outcome assessment. These design features support a comparative interpretation in principle, but they do not establish that groups were comparable in every respect or resolve concerns about missing observations and analysis choices. The allocation procedure, concealment details, masking procedures, and number of study centers are not reported in the registry record.
The primary outcome was measured repeatedly across cycle days, so the study has a longitudinal structure. The record identifies the intent-to-treat population with available data at each time point, with the number observed indicated by n. It does not report a detailed analysis plan, sample-size justification, interim-analysis plan, or rules for handling missing observations. Those omissions limit assessment of how the design translated into the reported 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.
Before assignment: 67 women were screened for participation in this study; 61 were enrolled and took at least 1 dose of their current regimen of oral contraceptive in Cycle 1 (the Run-in Cycle). Of the 61 enrolled, 3 participants discontinued the study prior to completing the Run-in Cycle and were therefore not randomly assigned to study drug in Cycle 2.
Cycle 1: Run-in Cycle
| Stage | Run-In Cycle - All Enrolled | DR-1021 | Mircette |
|---|---|---|---|
| STARTED | 61 | 0 | 0 |
| COMPLETED | 58 | 0 | 0 |
| NOT COMPLETED | 3 | 0 | 0 |
Reasons for not completing this period:
| Reason | Run-In Cycle - All Enrolled | DR-1021 | Mircette |
|---|---|---|---|
| Withdrawal by Subject | 2 | 0 | 0 |
| Adverse Event | 1 | 0 | 0 |
Cycle 2: Randomized Treatment Cycle
| Stage | Run-In Cycle - All Enrolled | DR-1021 | Mircette |
|---|---|---|---|
| STARTED | 0 | 29 | 29 |
| Treated | 0 | 28 | 28 |
| COMPLETED | 0 | 28 | 28 |
| NOT COMPLETED | 0 | 1 | 1 |
Reasons for not completing this period:
| Reason | Run-In Cycle - All Enrolled | DR-1021 | Mircette |
|---|---|---|---|
| Withdrawal by Subject | 0 | 1 | 0 |
| Noncompliance | 0 | 0 | 1 |
Cycle 3: Follow-up
| Stage | Run-In Cycle - All Enrolled | DR-1021 | Mircette |
|---|---|---|---|
| STARTED | 0 | 28 | 28 |
| COMPLETED | 0 | 26 | 28 |
| NOT COMPLETED | 0 | 2 | 0 |
Reasons for not completing this period:
| Reason | Run-In Cycle - All Enrolled | DR-1021 | Mircette |
|---|---|---|---|
| Noncompliance | 0 | 1 | 0 |
| Pregnancy | 0 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-treat population with available data at each time point (as indicated by n).
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: The Intent-to-treat (ITT) cohort consisted of all randomized participants who took at least one dose of randomized study medication and had at least one post-baseline efficacy measurement for at least one of the primary efficacy endpoints (FSH, inhibin-B, or estradiol).
| Characteristic | Unit | DR-1021 | Mircette | Total |
|---|---|---|---|---|
| Participants analysed | 28 | 28 | 56 | |
| Age, Continuous | years | 27.3 (SD 4.68) | 28.0 (SD 4.38) | 27.7 (SD 4.51) |
| Sex: Female, Male: Female | Participants | 28 | 28 | 56 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: African-American | participants | 4 | 6 | 10 |
| Race/Ethnicity, Customized: Asian | participants | 2 | 0 | 2 |
| Race/Ethnicity, Customized: Caucasian | participants | 20 | 20 | 40 |
| Race/Ethnicity, Customized: Hispanic | participants | 1 | 1 | 2 |
| Race/Ethnicity, Customized: Other | participants | 1 | 1 | 2 |
| Region of Enrollment: United States | participants | 28 | 28 | 56 |
6. Primary Endpoint
The registry lists the primary outcome as Serum Estradiol Levels by Cycle Day, measured over Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6..
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | pg/mL |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is serum estradiol level by cycle day, measured in pg/mL. Blood samples were used to measure estradiol over the study period. The record specifies a median and full range at each scheduled time point: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, and Cycle 3, Days 2, 4 and 6.
Estradiol is a hormone, so repeated measurements can describe how hormone levels vary over time in relation to a study regimen. In general, a pattern across scheduled days can provide more information about timing and variability than a single measurement. The study title and objectives connect these hormone patterns with ovarian follicular activity, but the registry record does not establish that any particular estradiol value has a specific clinical meaning.
A median describes the middle observation in an ordered set, while a full range reports the lowest and highest observed values. In general, this presentation emphasizes the distribution's center and span rather than its mean and standard deviation. A range can be sensitive to extreme observations, and a median alone does not show how tightly observations cluster around the center. The number of available observations can also vary by time point; the record says the population includes available data at each time point, with n indicating that count.
The endpoint is therefore descriptive unless accompanied by a specified between-group analysis. The registry record does not report the numerical estradiol summaries or a statistical test or model for comparing groups over time. It is not possible to characterize the size, direction, or precision of a treatment contrast from the endpoint description alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines a repeated-measures hormone outcome but does not include numerical estradiol results in the registry record for this account. Consequently, no statement can be made about which group had higher or lower median levels at a given cycle day, how broad the observed ranges were, or whether the groups differed statistically. Those conclusions require the actual results and, for a comparative claim, the analysis linking observations across groups and time.
The scheduled measurements span multiple points in Cycle 2 and Cycle 3. In general, looking across time points can help distinguish a pattern from a single isolated measurement. However, multiple time points also create several potential comparisons. A difference at one day would not by itself establish a consistent pattern across the study period, and a similar median would not prove that the underlying distributions or participant-level trajectories were the same. Neither the numerical pattern nor a formal group comparison is reported in the registry record.
The registry identifies the primary summary as a median with a full range. These statistics provide a description of observed values, not an estimate of a treatment effect with a confidence interval. In general, a confidence interval communicates the uncertainty around an estimated quantity under an analysis model; its width depends on the variability and amount of information in the data, among other factors. No confidence intervals, treatment-effect estimates, or p-values for the primary outcome are reported in the registry record.
The record specifies an intent-to-treat population with available data at each time point. That wording indicates that available observations are summarized at each scheduled measurement, but it does not reveal how many observations contributed at each time point in this account or why any data were unavailable. If availability differs across days or groups, the displayed summaries may represent different subsets of participants. The missing-data pattern and the assumptions used in any analysis are not reported in the registry record.
Several secondary outcomes concern follicle size and bleeding or spotting. These describe distinct outcomes and may have different units, distributions, and analysis requirements. The registry lists nine outcome measures and 36 analyses, but does not provide a multiplicity strategy or identify a hierarchy for interpreting all those analyses. In general, examining many outcomes or time points increases the chance of observing an apparently notable result by chance unless the analysis plan accounts for multiplicity. No numerical findings for the secondary outcomes are reported in the registry record in the registry record used for this account.
Overall, the record establishes the study question, the broad design, and the planned outcome structure. It does not establish the observed treatment differences, their precision, or their statistical significance. The completed status does not substitute for outcome estimates, and randomization and masking do not make absent results interpretable. Any conclusion about comparative hormone patterns would require the posted numerical results and a clearly described analysis.
9. Statistical Methods Explained
Statistical methods should be interpreted in relation to the type of outcome, the comparison being made, and the amount of available data. The registry record describes repeated estradiol measurements and reports medians with full ranges as the primary summary. It does not report the inferential model or test used for the primary outcome. The explanations below are general statistical context, not claims about methods used in this study.
What does a median and full range show?
In general, the median is the central observation after values are ordered. It is less affected by an unusually high or low observation than the mean, which can make it a useful descriptive statistic when a distribution is skewed. The full range gives the minimum and maximum observed values. It displays the span of observations, but does not indicate how many observations lie near either endpoint or whether most observations are tightly grouped. A range can change substantially when an extreme value is added or removed.
These summaries do not by themselves quantify the uncertainty in a group difference. For example, overlap between two ranges is not a formal test of whether groups differ, and non-overlap is not a complete substitute for an estimate and uncertainty interval. A suitable comparison would depend on the intended estimand, the distribution of estradiol values, and the repeated observations within participants. The registry record does not report that comparison method.
Why does the repeated-measures structure matter?
Measurements from the same participant are generally related: a person's level at one scheduled time may be associated with that person's level at another time. General statistical methods for repeated measurements account for that within-participant dependence. Treating every measurement as if it came from a different, unrelated person can understate uncertainty because the observations are not independent. The particular model, correlation structure, and assumptions used in this study are not reported in the registry record.
Repeated measurements can be analyzed in different ways. A model might estimate group differences at selected times, an overall pattern across time, or a group-by-time interaction. Those questions are not equivalent. A contrast at one day asks about a particular time; a group-by-time question asks whether the pattern changes differently across groups. The registry outcome title names levels by cycle day, but the exact estimand and inferential approach are not reported in the registry record. No single comparison should be assumed from the outcome title alone.
What does over-dispersion mean in general?
Over-dispersion occurs when the observed variability in data is greater than a statistical model assumes. It is particularly relevant to count outcomes when a simple model expects variability to follow a restrictive mean-variance relationship. If over-dispersion is ignored, standard errors may be too small and confidence intervals or tests may appear more certain than warranted. General remedies can include models with an additional dispersion parameter or robust uncertainty estimates. This is general context only; the registry record does not report an over-dispersion assessment or a model for the follicle or bleeding outcomes.
How should multiplicity be considered?
In general, the chance of at least one false-positive finding rises when many hypotheses are tested without adjustment. Here the record lists multiple outcome measures and analyses, and the primary outcome itself is measured on several cycle days. The registry record does not report whether comparisons were prespecified as a hierarchy, whether a multiplicity adjustment was used, or which analyses were considered confirmatory. Without that information, an individual result should not automatically be treated as definitive evidence of a broad pattern.
What do the planning illustrations mean?
The registry describes sample-size planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. These are planning assumptions, not a report of the trial's design rationale. In general, such illustrations estimate the number of participants per arm that a hypothetical study might require under specified assumptions. They are not observed power and do not show that the completed study had a particular probability of detecting an effect. The registry record does not report the trial's own sample-size justification. The numerical planning results and the effect fraction are not reported in the registry record used for this account.
For general sample-size interpretation, an assumed effect, outcome variability, significance level, allocation, and analysis method all influence the result. Planning calculations can be useful for considering a future study, but a calculation based on an observed effect can be unstable, especially when that estimate is imprecise. Any such illustration should therefore be read as conditional on its assumptions, not as a measure of the reliability or success of this completed trial.
What analysis details remain unknown?
The registry record does not report the statistical test or model, covariate adjustment, confidence-interval method, missing-data assumptions, handling of protocol deviations, or detailed analysis population rules. It also does not report interim analyses. These details affect how estimates should be interpreted and how reproducible the analysis is. They cannot be inferred from the randomized, double-blind design or from the use of medians and ranges as descriptive summaries.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is measured at several scheduled cycle days, and the registry lists secondary outcomes related to follicle size and bleeding or spotting. It reports nine outcome measures and 36 analyses. This breadth matters statistically because each additional outcome, time point, or subgroup comparison can create another opportunity for a chance finding. In general, multiplicity procedures can control the overall false-positive risk or organize testing through a prespecified hierarchy. The registry record does not report whether any such strategy was used, which outcomes were confirmatory, or how the analyses were prioritized.
The primary population is described as the intent-to-treat population with available data at each time point, with n indicating the number with data. This is not enough to assess missingness. The reasons observations may be absent, the number available at each time point, whether missingness differed by group, and any imputation or sensitivity analyses are not reported in the registry record. In general, a complete-case summary can be misleading if the available observations differ systematically from those that are missing. The effect of missingness depends on its pattern and on assumptions used to analyze it.
Randomization describes how treatment assignment is intended to occur; it does not guarantee that every randomized participant contributes data at every measurement. Nor does the intent-to-treat label alone specify how unavailable outcomes were handled. The record does not report exclusions after randomization, protocol deviations, or whether all randomized participants were included in each analysis.
The number of observations may vary across repeated measurements, and the record explicitly ties available-data counts to each time point. Without those counts and the missing-data methods, it is difficult to judge how comparable the time-specific summaries are. The statistical analysis plan, multiplicity approach, and detailed analysis-population definitions are not reported in the registry record.
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 |
|---|---|---|---|
| DR-1021 | 0 | 28 | 0.0% |
| Mircette | 1 | 28 | 3.6% |
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 |
|---|---|
| DR-1021 | 7 of 28 |
| Mircette | 7 of 28 |
Most frequent serious adverse event terms
| Event term | Organ system | DR-1021 | Mircette |
|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | 0 of 28 | 1 of 28 |
Most frequent non-serious adverse event terms
| Event term | Organ system | DR-1021 | Mircette |
|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | 1 of 28 | 4 of 28 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 2 of 28 | 1 of 28 |
| Nasopharyngitis | Infections and infestations | 0 of 28 | 2 of 28 |
| Urinary tract infection | Infections and infestations | 2 of 28 | 0 of 28 |
| Back pain | Musculoskeletal and connective tissue disorders | 2 of 28 | 0 of 28 |
| Headache | Nervous system disorders | 0 of 28 | 2 of 28 |
Serious events with the highest arm-level rate: asthma (3.6%).
The registry record reports serious adverse events for the DR-1021 and Mircette groups. For DR-1021, 28 participants were at risk and 0 were affected; for Mircette, 28 were at risk and 1 was affected. These are the counts recorded in the respective serious-adverse-event summaries. The record also reports 7 affected participants in each group for other adverse events, with 28 at risk in each group.
The registry lists asthma at 3.6% among the top serious adverse-event terms. The registry entries used for this account do not specify which group that term is associated with or provide additional detail about its cases. Death counts are not reported in the registry record.
These counts are descriptive. A small difference in observed event counts does not, by itself, establish a treatment-related difference or explain whether events were caused by a study drug. In general, safety comparisons depend on event definitions, follow-up duration, exposure, the number of participants observed, and uncertainty around the estimates. The registry record does not report the event definitions, exposure-adjusted analyses, or inferential comparisons needed to assess those issues. The event counts should therefore be read as reported observations, not as a stand-alone measure of comparative safety.
12. What the Result Does, and Does Not, Mean
This study addresses a focused statistical question: how serum estradiol levels vary by cycle day under the listed oral contraceptive regimens, alongside measures of ovarian follicular activity and bleeding or spotting. Its randomized, double-blind, parallel-group design is relevant to comparative interpretation. The record also specifies that estradiol was summarized using medians and full ranges and that the primary population included available data at each time point.
Those details do not reveal the direction or magnitude of the observed findings. The numerical primary-outcome summaries, between-group estimates, uncertainty intervals, and p-values are not reported in the registry record in the registry record used for this account. The completed status and the existence of scheduled measurements cannot substitute for those results. It is not possible to say from these registry entries whether estradiol patterns were similar or different, or how precisely any apparent difference was estimated.
In general, a descriptive difference is not necessarily evidence of a reliable treatment effect. Interpretation depends on the analysis method, the within-participant correlation across time, missing observations, and the number of comparisons. A result at one cycle day may not represent the overall pattern, while a broad summary can obscure time-specific variation. The registry record does not report enough analysis detail to determine how these issues were addressed.
The same caution applies to secondary outcomes and safety counts. The record names outcomes involving follicle size and bleeding, but their numerical results are not reported in the registry record used for this account. Serious and other adverse-event counts are reported for DR-1021 and Mircette, but those counts alone do not establish causation or provide a fully adjusted comparison. The listed asthma term has limited context in the record, and deaths are not reported.
Accordingly, this study's record documents a randomized evaluation of hormone patterns and related outcomes, but the registry entries do not support a conclusion about the comparative results. They also do not establish broader clinical implications beyond the measured outcomes and study population. No medical advice or treatment conclusion follows from the design description alone.
13. Why This Trial Matters Statistically
The trial is statistically notable for its repeated measurement of a biological outcome over scheduled cycle days. A single endpoint value can conceal changes over time; serial measurements instead raise questions about trajectories, timing, and whether groups follow different patterns. This makes the choice of estimand and analysis important. A time-specific comparison, an overall average contrast, and a test of whether groups change differently over time answer distinct questions.
The endpoint is summarized with medians and full ranges, which communicates the center and observed span without relying on a mean-and-standard-deviation description. That choice is useful to recognize when reading the results, but the summaries do not by themselves quantify uncertainty or establish a group difference. Inferential interpretation would require an analysis that accounts for the repeated observations and specifies the comparison of interest. The registry record does not report that method.
The study also illustrates why outcome multiplicity matters. Estradiol is assessed at multiple times, and the registry lists additional outcomes for follicles and bleeding or spotting. These measures address different aspects of the study question. Statistical interpretation benefits from knowing which comparisons were primary, how secondary analyses were prioritized, and whether multiplicity was addressed; those details are not reported in the registry record.
Finally, the record separates design information from evidence about results. Randomization and double masking describe safeguards in the study design, while effect estimates, uncertainty, missing-data handling, and analysis methods determine how confidently findings can be interpreted. The record provides the former but does not report many of the latter in the registry record used for this account. That distinction is central when reading a completed trial with a repeated-measures endpoint.
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 principal limitation for interpreting the primary outcome is that the numerical estradiol summaries are not reported in the registry record in the registry record used for this account. Without those values, it is not possible to describe the observed pattern, compare groups, or assess the range of measurements. The registry record also does not report a treatment-effect estimate, confidence interval, or p-value for the primary outcome.
The design and analysis are incompletely described. Although the study is identified as randomized, double-blind, and parallel-group, the allocation ratio, randomization procedure, masking procedures, and complete regimen descriptions are not reported in the registry record. Kariva is listed as an intervention, but its complete study role and regimen are not reported. The record does not report the statistical model, covariate adjustment, analysis plan, sample-size rationale, or interim-analysis plan.
The primary population is described as intent-to-treat with available data at each time point. The number of observations can be indicated for each measurement, but the missingness pattern, reasons for missing data, and handling of unavailable measurements are not reported in the registry record used for this account. This limits evaluation of whether time-specific summaries represent comparable populations.
Multiplicity is another concern because the study measures estradiol at multiple times and lists additional follicular and bleeding outcomes. The record does not report a prespecified hierarchy or adjustment strategy. The secondary-outcome results are not reported in the registry record used for this account, limiting interpretation beyond the primary outcome description.
Generalizability is also bounded by the registry description: the participants were characterized as healthy, and the study evaluated specified regimens and scheduled outcomes. The complete eligibility criteria and detailed study-center information are not reported in the registry record. The available adverse-event summaries are descriptive and do not include the methodological detail needed for a causal safety comparison.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With DR-1021 — NCT00544882.
- Registry record last updated 2021-11-18; status last verified 2021-11.
- Results first posted 2014-06-10.
- 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
NCT00544882 is a completed Phase 3, prospective, multicenter, randomized, double-blind, parallel-group study sponsored by Teva Branded Pharmaceutical Products R&D, Inc. The registry reports enrollment of 61 healthy participants. The listed interventions are DR-1021, Mircette, and Kariva.
The primary outcome is serum estradiol by cycle day, measured from blood samples and summarized as a median with full range. The record also lists outcomes concerning follicle size and bleeding or spotting. It describes the primary population as intent-to-treat participants with available data at each time point.
The registry record reports serious and other adverse-event counts for DR-1021 and Mircette, and lists asthma at 3.6% among the top serious-event terms. Numerical primary and secondary outcome results, detailed analysis methods, missing-data procedures, and a multiplicity plan are not reported in the registry record used for this account.