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 Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive) (NCT05309694), a na phase 4 study. The primary outcome is Overall Successful Insertions.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05309694 |
| Phase | Phase 4 |
| Condition | Contraception |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 119 |
| Arms in the primary outcome | n/a |
| Lead sponsor | CooperSurgical Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Females of reproductive potential, described in the registry record as including parous and non-parous participants. The record does not report detailed participant characteristics or outcomes by parity.
Intervention
Paragard® T380A intrauterine copper contraceptive used with the new inserter design. The study was intended to evaluate successful insertion and safety.
Comparator
There was no concurrent comparison group. The study summary refers to the currently approved inserter as the benchmark for comparability, but this trial used a single group and does not provide a like-for-like control comparison.
Primary question
Among participants with at least one successful or unsuccessful insertion attempt, what proportion had a successful insertion using the new inserter, and what safety events were recorded during follow-up? The primary endpoint covers the period from enrollment to the end of treatment at 3 months. The numerical primary result is not reported in the registry record.
The clinical question is therefore descriptive: the study was designed to document insertion success and safety with the new inserter in clinical use. Its registry summary states an aim of demonstrating successful and safe insertion comparable to the currently approved inserter. Because there is no concurrent control group, however, the study cannot directly estimate a between-group difference. Any comparison with the currently approved device would need evidence beyond a direct randomized comparison within this study, and the registry record does not report the method or results of such a comparison.
3. Trial Design
This is a post-marketing, prospective, multi-center, single-arm, open-label Phase 4 study of Paragard® T380A intrauterine copper contraceptive with a new inserter. The registry lists an enrollment of 119 and describes a group comprising parous and non-parous females of reproductive potential. The study is marked completed. Its recorded start date is 2022-03-04, and its primary completion date is 2022-12-08.
“Prospective” indicates that outcomes were intended to be followed forward during the study, while “open-label” means masking was not used. The record lists no allocation because there was no randomized allocation between study arms. With a single group, participant outcomes describe experience with the new inserter in the study setting; they do not provide an internal control group for separating device-related outcomes from other influences.
The primary endpoint concerns successful insertions from enrollment through the end of treatment at 3 months. The registry description defines success as at least one successful insertion attempt, allowing a maximum of two attempts, and defines the percentage using participants with at least one successful or unsuccessful attempt as the denominator. The numerical primary result and the analysis details are not reported in the registry record.
Secondary outcomes listed include uterine perforation and IUD embedment, IUS expulsions and dislocations, adverse events, procedure-related adverse events, vasovagal events, and pelvic infections. Their listing identifies areas of safety interest, but the registry record does not provide numerical results for each of these outcomes. The sponsor is CooperSurgical Inc. The record does not report a detailed statistical analysis plan, a sample-size justification, or interim-analysis procedures.
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 | Group 1 |
|---|---|
| STARTED | 117 |
| COMPLETED | 104 |
| NOT COMPLETED | 13 |
Reasons for not completing this period:
| Reason | Group 1 |
|---|---|
| Adverse Event | 8 |
| Physician Decision | 1 |
| Lost to Follow-up | 2 |
| Withdrawal by Subject | 2 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Group 1 |
|---|---|---|
| Participants analysed | 117 | |
| Age, Continuous | Years | 30.0 (18 to 49) |
| Sex: Female, Male: Female | Participants | 117 |
| Sex: Female, Male: Male | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 5 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 |
| Race (NIH/OMB): Black or African American | Participants | 12 |
| Race (NIH/OMB): White | Participants | 89 |
| Race (NIH/OMB): More than one race | Participants | 2 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 8 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 18 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 97 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 |
| Parity: Parous | Participants | 53 |
| Parity: Non-Parous | Participants | 64 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Successful Insertions, measured over From enrollment to end of treatment at 3 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “Overall Successful Insertions.” It measures the percentage of participants who had a successful insertion among participants with at least one successful or unsuccessful insertion attempt. Under the registry definition, success requires at least one successful attempt, with no more than two attempts. The observation period runs from enrollment to the end of treatment at 3 months.
This endpoint is clinically relevant to the device’s intended function: it records whether insertion was accomplished under the study’s stated definition. Reporting a proportion, rather than only an event count, can make the result easier to interpret because the denominator identifies how many participants with an insertion attempt contributed to the measure. The registry record does not report the numerical proportion, its uncertainty, or the underlying success count and denominator. Enrollment is recorded as 119, but the endpoint denominator is specifically defined by insertion attempts, so enrollment alone should not be treated as that denominator.
The endpoint does not by itself measure every aspect of device use or safety. The listed secondary outcomes address specific complications and adverse events. Nor does a single-group endpoint establish whether success is comparable to success with the currently approved inserter: that comparison would require a suitable comparator and an analysis of between-group results, neither of which is reported for this study.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study context and lists some safety counts, but it does not report the numerical primary insertion-success result. As a result, the key efficacy-style quantity in the study’s stated objective—the percentage of participants meeting the successful-insertion definition—cannot be interpreted from the registry information. The record also does not provide a confidence interval or other measure of precision for that endpoint. Without the endpoint numerator and denominator, it is not possible to assess how much uncertainty surrounds the observed success proportion.
The record lists 2 participants with serious adverse events among 117 participants at risk. It also lists 44 participants in the other adverse-event category among 117 at risk, and records 0 deaths. Uterine perforation and IUS embedment are each listed among the top serious terms at 0.9%. These are safety summaries, not a comparison of event risks between devices. The record does not provide a concurrent control group, and the listed percentages should not be read as evidence of comparative safety.
Counts and percentages answer different questions. A count records how many participants were classified as having an event; a percentage expresses a count relative to a denominator. Interpretation depends on the population and event definition used for each summary. The serious and other adverse-event summaries use 117 participants at risk, while the primary insertion endpoint has its own stated denominator based on participants with an insertion attempt. Those denominators should not be substituted for one another.
The lack of reported uncertainty measures also matters. In general, a confidence interval conveys the range of values reasonably compatible with the data under the analysis assumptions. Without a reported interval for the primary endpoint or safety measures, the precision of these estimates cannot be evaluated from the registry record. A count such as 2 serious adverse-event participants is descriptive; by itself it does not establish the rate that would occur in another population or show whether the device caused the events.
The stated objective refers to comparability with the currently approved inserter, but the design has no concurrent control arm and no comparative analysis is reported. The results therefore cannot establish equivalence, non-inferiority, or superiority. The registry record lists 0 analyses. It also does not report the statistical plan, criteria for declaring comparability, or how missing endpoint information was handled. Interpretation should remain limited to the design and the descriptive safety information that the record actually reports.
9. Statistical Methods Explained
The registry describes a single-group prospective study with no masking. In a single-group design, participants receive the study intervention and outcomes are described within that group. This can characterize observed experience, but it does not create a direct estimate of the difference between the intervention and a control. Differences from results in other studies can reflect differences in participants, clinical settings, follow-up, definitions, or measurement, as well as differences in the devices being studied.
What does the primary endpoint count?
The primary endpoint is a participant-level insertion-success measure. The registry definition counts participants with at least one successful attempt as successful, allowing a maximum of two attempts. The denominator is participants with at least one successful or unsuccessful insertion attempt. In general, specifying the denominator is essential: a percentage can change depending on whether it is calculated among all enrolled participants, those who began an attempt, or another analysis population. Here the record states the intended denominator but does not report the numerical count or percentage. The enrollment figure of 119 is not necessarily the endpoint denominator.
For a binary outcome such as success or failure, a proportion is a natural summary. Its estimate describes the share of the defined analysis population with the event of interest. The estimate alone does not show precision. In general, uncertainty depends on the number of observations and the observed proportion; a confidence interval can communicate that uncertainty. The registry record does not report a confidence interval for the primary endpoint.
Why does the single-arm design limit comparison?
A concurrent comparator helps distinguish the intervention’s observed outcomes from background factors that also affect outcomes. In this study, all reported intervention experience is in the group using the new inserter. The study summary mentions comparability with the currently approved inserter, but the design information does not describe a group using that device. Without such a group and a prespecified comparative analysis, the study cannot estimate a within-trial treatment difference or formally establish equivalence or non-inferiority.
Open-label status means masking was not used. For an objectively defined event, lack of masking may be less influential than for a subjective assessment, but open-label knowledge can still affect reporting, clinical decisions, or outcome classification. The registry record does not explain whether outcome adjudication was independent or whether any procedures were used to reduce assessment bias.
How should the safety summaries be read?
The registry lists participant counts for serious and other adverse events, with participants at risk as the denominator. These summaries are descriptive. A participant count is not necessarily the same as an event count: one participant may experience more than one event, and the record does not provide enough detail to reconstruct event-level totals. General interpretation of adverse-event frequencies also depends on follow-up duration, definitions, ascertainment, and whether events are judged related to the intervention. The primary endpoint’s timeframe is stated as ending at 3 months, but the record does not provide detailed follow-up information for each safety outcome.
The record lists uterine perforation and IUS embedment as serious terms, each with a percentage of 0.9%. These terms should be read as registry-listed safety summaries, not as proof of causation or as a comparative risk estimate. No treatment-comparison test or uncertainty interval is reported for them.
What can planning calculations tell readers?
In general, sample-size planning calculations estimate how much information a future study might need to detect a specified effect under stated assumptions. The registry’s planning description refers to a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects defined as fractions of an observed effect. It describes those calculations as planning illustrations, not as the original trial design. The record does not report a sample-size justification for this single-arm study, and numerical planning illustrations are not reported in the registry record.
Any such illustration is conditional on its assumptions and on the effect estimate used. A smaller target effect generally requires more information to detect than a larger target effect, all else equal; this is a general statistical principle, not a claim about this trial’s results. Planning figures are not observed power and do not establish that the study was adequately powered. Because the record does not report the primary endpoint result or a comparative effect estimate, readers cannot independently evaluate the effect assumptions underlying such an illustration from the registry information.
The registry record lists 0 analyses. It does not report a detailed model, uncertainty method, missing-data procedure, analysis-population definition beyond the endpoint denominator, or multiplicity adjustment. These omissions constrain reproducibility and the strength of conclusions that can be drawn from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary insertion-success endpoint and secondary safety outcomes addressing uterine perforation and IUD embedment, IUS expulsions and dislocations, adverse events, procedure-related adverse events, vasovagal events, and pelvic infections. Examining multiple outcomes can create a multiplicity issue when statistical tests are conducted: the chance of at least one apparently unusual finding can increase as more tests are considered. In general, a statistical plan may address this through a prespecified hierarchy, adjusted significance thresholds, or an explicitly exploratory interpretation.
The registry record does not report whether multiplicity was addressed, whether the secondary outcomes were intended for formal hypothesis testing, or what decision criteria would apply. It lists 0 analyses, so there are no reported inferential results to interpret as a family of tests. The absence of a reported adjustment should not be mistaken for evidence that an adjustment was or was not used outside the registry record.
Missing-data handling and analysis populations are also not reported in the registry record. The primary endpoint definition specifies a denominator of participants with at least one successful or unsuccessful insertion attempt, but it does not describe how participants without an attempt, incomplete records, or unavailable follow-up were handled. Enrollment is recorded as 119; the endpoint denominator is separately defined and its observed value is not reported. The registry also does not state whether safety summaries include all enrolled participants or another specified population beyond the reported at-risk count of 117.
These details matter because exclusions, missing outcomes, and different analysis populations can change what a result represents. Without a stated missing-data approach and a clear account of participant flow into each analysis, readers cannot assess the sensitivity of results to incomplete observations or determine whether the same population contributed to all endpoints. The registry record does not report these details.
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 |
|---|---|---|---|
| Group 1 | 2 | 117 | 1.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Group 1 | 0 of 117 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Group 1 | 44 of 117 |
Most frequent serious adverse event terms
| Event term | Organ system | Group 1 |
|---|---|---|
| Uterine Perforation | Reproductive system and breast disorders | 1 of 117 |
| IUS Embedment | Reproductive system and breast disorders | 1 of 117 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Group 1 |
|---|---|---|
| Heavy Menstrual Bleeding | Reproductive system and breast disorders | 13 of 117 |
| Dysmenorrhoea | Reproductive system and breast disorders | 10 of 117 |
| Muscle Spasms | Reproductive system and breast disorders | 5 of 117 |
| Intermenstrual Bleeding | Reproductive system and breast disorders | 4 of 117 |
| Abnormal Uterine Bleeding | Reproductive system and breast disorders | 3 of 117 |
| Vaginal Discharge | Reproductive system and breast disorders | 3 of 117 |
| Vaginal Haemorrhage | Reproductive system and breast disorders | 3 of 117 |
| Device Expulsion | Reproductive system and breast disorders | 3 of 117 |
Serious events with the highest arm-level rate: uterine perforation (0.9%), ius embedment (0.9%).
The registry lists 2 participants with serious adverse events among 117 at risk. It lists 44 participants in the other adverse-event category among 117 at risk and records 0 deaths. The top serious terms are uterine perforation and IUS embedment, each listed at 0.9%. These figures are descriptive entries in the registry record; they do not, on their own, establish that the intervention caused an event or permit a comparison with the currently approved inserter.
Participant counts and event counts should not be conflated. The reported serious-adverse-event figure concerns participants, while a participant may have more than one event; the record does not provide event-level detail needed to clarify that relationship. The “other” category is reported separately, but further classification detail is not reported in the registry record. The serious-term percentages should be interpreted as listed, without inferring an unreported denominator or translating them into additional counts.
The record does not report comparative safety estimates, confidence intervals, or a formal analysis of event rates. It also does not report enough detail to assess how safety events were collected, adjudicated, or attributed. These limitations mean that the figures describe the registry’s recorded safety summaries, rather than supplying a complete comparative assessment.
12. What the Result Does, and Does Not, Mean
The study addresses a practical post-marketing question: whether insertion with a new Paragard® inserter can be documented in prospective clinical use, alongside monitoring for safety events. Its registry record identifies the intended primary measure and records several safety summaries. Those details help define the study’s scope, but they do not supply the numerical primary insertion-success result.
Consequently, the record does not allow readers to determine the observed success proportion, how precisely it was estimated, or whether it met a prespecified target. No target or statistical decision criterion is reported. The stated goal of comparability with the currently approved inserter is not equivalent to a demonstrated comparison. A single-arm design without a concurrent control cannot establish that outcomes are the same as, better than, or worse than outcomes with that device.
The safety counts document reported events in the study group, including 2 participants with serious adverse events among 117 at risk and 0 deaths. They do not show what would have happened in a comparable group using another inserter. Nor do the counts establish causation. Rare or uncommon events are difficult to characterize precisely in a study of limited size, as a general statistical point; the registry record does not report uncertainty intervals that would quantify precision for these safety summaries.
The findings should therefore be read as a registry description of a completed single-arm study, not as definitive comparative evidence. The information that would help support stronger conclusions—primary endpoint results, uncertainty estimates, analysis methods, missing-data handling, and comparative results—is not reported in the registry record. This absence does not prove that analyses or information were unavailable elsewhere; it means they cannot be assessed from the registry record.
13. Why This Trial Matters Statistically
Insertion success is central to evaluating an inserter design because the device is intended to facilitate placement of the intrauterine contraceptive. A clearly defined endpoint can make the intended measure understandable: the registry specifies success as at least one successful attempt, with a maximum of two attempts, among participants with an insertion attempt. This definition is more informative than a broad statement of success because it identifies how repeat attempts are treated and who belongs in the denominator.
The study also illustrates why study design and outcome reporting must be considered together. Prospective, multi-center observation can describe use across the study’s clinical settings, and safety monitoring can identify events that warrant careful reporting. However, a single-arm study cannot supply a concurrent estimate of outcomes under another inserter. The stated interest in comparability therefore raises a design question: a claim of comparability needs a defined comparator, an analysis suited to that claim, and adequate precision. Those comparative elements are not reported in the registry record.
The available safety summaries also show why counts need context. Serious events, other adverse events, and deaths are distinct summaries, and the record gives an at-risk denominator for the reported participant counts. Interpretation still depends on event definitions, follow-up, attribution, and uncertainty. The registry record does not report all of those details.
Statistically, the record is useful for identifying the endpoint definition, design, follow-up timeframe, and safety counts. Its central limitation is that the numerical primary result and formal analyses are not reported. Without them, readers cannot quantify insertion success, judge its precision, or assess a formal comparison. The distinction between a study’s objective and the results actually reported is important when interpreting post-marketing 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 principal limitation for interpreting this study is that the numerical primary endpoint result is not reported in the registry record. The record gives the endpoint definition but not its success count, denominator, percentage, or uncertainty interval. The enrollment figure cannot replace the endpoint denominator, which is defined according to whether participants had an insertion attempt.
The single-arm design is a further limitation for the stated aim of comparability with the currently approved inserter. There is no concurrent control group, and no formal comparative result is reported. As a result, differences from outcomes reported elsewhere could not be attributed to the inserter alone using this study’s design.
The registry lists safety counts, but does not report confidence intervals, event-level detail, or a comparative safety analysis. The record also does not describe safety-event ascertainment, adjudication, or the basis for attributing events to the procedure or device. The primary endpoint timeframe is stated as ending at 3 months; detailed follow-up information for each safety outcome is not reported.
Additional analysis details are absent from the registry record: missing-data handling, analysis populations beyond the primary endpoint’s stated denominator, multiplicity procedures, a detailed statistical plan, interim analyses, and a sample-size justification. The record lists 0 analyses. These reporting gaps limit reproducibility and prevent assessment of how analytic choices may have influenced the findings. The study’s open-label design also means masking was not used; the record does not describe independent outcome adjudication or other safeguards against assessment bias.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive) — NCT05309694.
- Registry record last updated 2026-08-25; status last verified 2026-07.
- Results first posted 2026-08-25.
- 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
NCT05309694 is a completed Phase 4, post-marketing, prospective, multi-center, single-arm, open-label study sponsored by CooperSurgical Inc. It evaluated Paragard® T380A intrauterine copper contraceptive with a new inserter in females of reproductive potential. Enrollment is recorded as 119; the study began on 2022-03-04, with primary completion on 2022-12-08.
The primary outcome is overall successful insertions from enrollment to the end of treatment at 3 months. Its definition allows a maximum of two attempts and uses participants with an insertion attempt as the denominator. The numerical primary result is not reported in the registry record. Safety summaries list 2 participants with serious adverse events among 117 at risk, 44 participants in the other adverse-event category among 117 at risk, and 0 deaths. Uterine perforation and IUS embedment are each listed at 0.9% among the top serious terms. The record lists 0 analyses and does not report a concurrent comparator or a formal comparative analysis.