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 Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy (NCT04756037), a na phase 3 study. The primary outcome is Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the At-Risk Pearl Index (PI).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04756037 |
| Phase | Phase 3 |
| Condition | Contraception |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 1164 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sumitomo Pharma Switzerland GmbH |
| Results posted | Yes |
2. Clinical Question
Population
Women 18 to 50 years of age with uterine fibroids or endometriosis who were at risk for pregnancy. The primary endpoint was specified for a Restricted Intent-to-treat Population, described as a subset of the ITT population.
Intervention
Relugolix combination therapy, identified in the registry record as Relugolix/E2/NETA. Participants were to receive treatment for 1 year, consisting of 13 consecutive 28-day treatment cycles.
Comparator
There was no comparison group. The study is recorded as single-group, with allocation and masking listed as NA and NONE, respectively. The efficacy question is therefore about outcomes observed during treatment, not a difference between randomized treatments.
Primary question
What was the At-Risk Pearl Index during the treatment period? It is defined as on-treatment pregnancies per 100 woman-years, counting cycles considered at risk because there was no other contraceptive method and vaginal intercourse was affirmed.
The central statistical question is how many on-treatment pregnancies occurred in relation to the amount of eligible time at risk. The endpoint does not count every treatment cycle automatically: the registry definition restricts its denominator to consecutive 28-day periods meeting the stated at-risk conditions. A pregnancy is considered on treatment when its estimated conception date falls from the first day of study intervention intake through 7 days after the last medication intake.
This framing is useful for describing contraceptive efficacy over exposure time. It does not create a treatment comparison, because the record describes a single group receiving relugolix combination therapy. The registry record does not report the resulting index, its confidence interval, or the number of pregnancies used in its calculation. Consequently, the clinical question can be described from the endpoint definition, but its numerical answer is not reported in the registry record.
3. Trial Design
This was a Phase 3, single-arm, open-label study. The registry record lists an enrollment of 1164 and describes women with uterine fibroids or endometriosis who were at risk for pregnancy. Relugolix combination therapy was the only intervention listed. The treatment schedule was 1 year, or 13 consecutive 28-day treatment cycles.
A single-arm design observes outcomes in a treated group without a concurrent control group. It can describe event experience during treatment, but it cannot estimate a randomized contrast against another contraceptive method or no treatment. Allocation is listed as NA, consistent with the record’s single-group model, and masking is listed as NONE. Thus the study was open-label rather than masked.
The registry lists the study start as 2021-03-18, primary completion as 2025-02-25, and status as COMPLETED. These dates describe the recorded study timeline; they do not establish when individual participants began or completed treatment. The timing of individual enrollment, follow-up, and discontinuation is not reported in the registry record.
The primary endpoint was the At-Risk Pearl Index in the Restricted Intent-to-treat Population. Secondary outcomes include modified At-Risk, Gross, and Method Failure Pearl Indices; cumulative 1-year pregnancy rates; the number of participants who do not complete 13 treatment cycles; and percent change in bone mineral density from baseline to 6 and 12 months on-treatment. The registry also records 7 outcome measures and 0 analyses. No primary or secondary numerical efficacy results are reported in the registry record.
The design should be kept distinct from the planning assumptions used for sample-size illustrations. Those illustrations describe a hypothetical two-arm calculation with equal allocation, whereas the registered trial itself is single-arm. They do not turn the study into a randomized comparison and are not observed-power results. The registry record does not report a trial-specific sample-size justification.
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 | Relugolix/E2/NETA |
|---|---|
| STARTED | 1164 |
| COMPLETED | 497 |
| NOT COMPLETED | 667 |
Reasons for not completing this period:
| Reason | Relugolix/E2/NETA |
|---|---|
| Adverse Event | 93 |
| Lost to Follow-up | 94 |
| Physician Decision | 17 |
| Pregnancy | 6 |
| Protocol Violation | 44 |
| Withdrawal by Subject | 77 |
| Bone loss meeting the threshold for withdrawal per protocol | 193 |
| Other not specified in protocol | 27 |
| Withdrawal of consent | 77 |
| Patients who did not take any treatment | 39 |
Analysis population for the primary outcome, as defined in the registry: Restricted Intent-to-treat Population is defined as the subset of patients included in the ITT population (defined as all patients who have completed the informed consent process, completed screening procedures, and have been allocated to treatment and receive at least one dose of study intervention.) who have at least one at-risk treatment cycle or who have a treatment cycle (at-risk or not) in which a pregnancy has occurred. Patients are aged between \>= 18 years to \<=50 years.
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 ITT population is defined as all enrolled patients who receive at least one dose of study intervention.
| Characteristic | Unit | Relugolix/E2/NETA |
|---|---|---|
| Participants analysed | 1125 | |
| Age, Continuous | years | 38.6 (SD 6.77) |
| Age, Customized: <=35 years | Participants | 352 |
| Age, Customized: > 35 years | Participants | 773 |
| Sex: Female, Male: Female | Participants | 1125 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 317 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 798 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 10 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 3 |
| Race (NIH/OMB): Asian | Participants | 24 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 5 |
| Race (NIH/OMB): Black or African American | Participants | 575 |
| Race (NIH/OMB): White | Participants | 448 |
| Race (NIH/OMB): More than one race | Participants | 24 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 46 |
| Region of Enrollment: United States | Participants | 1125 |
| Body Mass Index (BMI) Category (kg/m2): < 30 | Participants | 564 |
| Body Mass Index (BMI) Category (kg/m2): >= 30 | Participants | 561 |
6. Primary Endpoint
The registry lists the primary outcome as Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the At-Risk Pearl Index (PI), measured over 13 consecutive 28-day treatment cycles.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Pregnancies per 100 woman-years |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the At-Risk Pearl Index (PI), expressed as pregnancies per 100 woman-years over 13 consecutive 28-day treatment cycles. The registry defines it as the number of on-treatment pregnancies per 100 women-years of treatment, based on cycles considered at risk of pregnancy. A cycle qualifies under the definition when no other contraceptive method is used and vaginal intercourse is affirmed.
The endpoint’s numerator is restricted to on-treatment pregnancies. The registry defines these as pregnancies with an estimated conception date between the first day of study intervention intake and up to and including 7 days after the last medication intake. The denominator is time contributed under the specified at-risk conditions, rather than simply the number of participants enrolled or all time on treatment.
As a general statistical concept, an incidence rate relates event counts to time at risk. This can be useful when participants contribute different amounts of eligible exposure time. The Pearl Index expresses that rate on a conventional scale of 100 woman-years. A confidence interval, when reported, would describe uncertainty around the estimated rate; it would not remove limitations caused by the study design or the number of observed events.
The registry record identifies a 95% Confidence Interval as the endpoint’s dispersion measure, but does not report the index estimate, interval limits, or underlying pregnancy count. The primary endpoint’s definition is available; its numerical result is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the structure of the efficacy question but does not provide the numerical result needed to answer it. The primary outcome is an At-Risk Pearl Index, with a stated 95% Confidence Interval, yet neither the point estimate nor the interval limits are reported. The number of pregnancies contributing to the primary calculation is also not reported in the registry record. It is therefore not possible to describe the observed rate, its precision, or whether the data were compatible with a wide range of possible rates.
The distinction between endpoint definition and endpoint result matters. A definition explains what would be counted and which exposure time would enter the denominator. It does not reveal how many pregnancies occurred or how much eligible person-time accumulated. Without those results, no quantitative conclusion about contraceptive efficacy can be drawn from this registry record.
The single-arm, open-label structure also sets the scope of interpretation. Results, if reported, would describe the treatment group under the study’s eligibility, exposure, and endpoint rules. They would not provide a randomized estimate of how outcomes differ from another method. Potential differences in participant characteristics, behavior, follow-up, or use of other methods cannot be separated through a concurrent randomized contrast in this design.
The planned treatment period was 1 year, described as 13 consecutive 28-day cycles. That schedule does not establish that every participant completed all cycles. The record lists non-completion as a secondary outcome, but does not report its result. It also lists cumulative 1-year pregnancy rates and other Pearl Index variants without numerical findings. Thus the primary and secondary efficacy outcomes cannot be compared with one another based on this record.
The registry records 1164 participants enrolled, while the adverse-event group lists 1125 participants at risk for the reported safety categories. These figures have different labels and roles; the record does not explain the relationship between them. They should not be treated as interchangeable denominators. The safety counts do not fill the gap in efficacy reporting, and they do not provide an estimate of the primary endpoint.
In general, a confidence interval communicates uncertainty around an estimate, and its width depends in part on the amount of information available. Here, because the estimate and interval are not reported, precision cannot be assessed. Any sample-size illustrations based on an observed effect are planning illustrations, not observed power, and no numerical illustration results are reported in the registry record.
9. Statistical Methods Explained
The central analysis measure is the At-Risk Pearl Index. Its numerator is the count of on-treatment pregnancies, while its denominator is eligible exposure time in woman-years. The registry specifies that exposure time is restricted to consecutive 28-day periods without another contraceptive method and with affirmed vaginal intercourse. This means the index is not simply the number of pregnancies divided by all participants enrolled. It depends on both the event count and the amount of qualifying time at risk.
Why express the outcome as a rate?
As a general statistical concept, a rate uses person-time to account for differing lengths of observation. Participants who contribute more eligible time contribute more to the denominator than participants who contribute less. Expressing the result per 100 woman-years makes the scale interpretable as a rate relative to a specified amount of exposure time. The registry defines the unit as pregnancies per 100 woman-years, but does not report the calculated rate.
The eligibility rules for the denominator are important because time outside the defined at-risk conditions is not part of the endpoint’s exposure basis. For example, the definition excludes cycles when another contraceptive method is used, and requires affirmed vaginal intercourse. This approach addresses the endpoint’s stated question about pregnancy risk during eligible periods. It also means the estimate depends on how those conditions are ascertained and how exposure time is recorded; details of those procedures are not reported in the registry record.
What does the confidence interval contribute?
As a general statistical explanation, a confidence interval presents a range of values compatible with the data under the method used to calculate it. It is a measure of statistical uncertainty around an estimate, not a guarantee that the true value lies within that particular interval. An interval is most informative when read together with the point estimate, event count, denominator, and analysis method. The registry identifies a 95% Confidence Interval for the primary endpoint, but does not report its limits, the point estimate, or the calculation method.
For a rate endpoint, the number of observed events and the amount of person-time are relevant to precision. A small event count can leave substantial uncertainty even when the rate appears numerically low. Conversely, the rate alone cannot show how much information supports it. Because the event count and eligible woman-time are not reported, the precision of the primary result cannot be assessed from this record.
How does the study design affect interpretation?
The trial is listed as single-group and open-label, with no comparator arm. As a general principle, a single-group analysis can describe the observed outcome in the group receiving the intervention, but it does not estimate a randomized difference between treatments. Open-label conduct means masking was not used, as the registry explicitly records. The registry does not report additional procedures intended to limit assessment or reporting effects.
The single-arm design is especially relevant when considering an outcome involving at-risk periods. Participants’ time in those periods depends on the endpoint conditions, including use of other contraceptive methods and affirmed intercourse. The registry states these endpoint rules but does not report the measured amount of qualifying exposure time or further details on its ascertainment. No assumptions about those procedures should be inferred.
The primary analysis population is described as the Restricted Intent-to-treat Population, defined as a subset of the ITT population. The registry’s definition of the ITT population refers to patients who completed informed consent, completed screening procedures, were allocated to treatment, and received at least one dose of study intervention. The remaining details of the restricted population and its analysis implementation are not reported in the registry record. This matters because analysis-population definitions specify which participants contribute to an estimate.
What do the planning illustrations mean?
The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They state that the effect to detect is a specified fraction of the observed effect. These are planning assumptions, not a description of the registered single-arm design. They do not establish that the trial used a two-arm test or that an observed effect was available for a comparative analysis.
Planning calculations answer a hypothetical design question: what sample size would be associated with stated assumptions about an effect and analysis? They do not report the study’s actual result and must not be described as observed power. The record does not report the numerical outputs of those illustrations, the effect value used, or a trial-specific design justification. The calculated planning values, if displayed with the statistical material, should therefore be read only as illustrations under their stated assumptions.
The registry reports 0 analyses. No analysis procedure for the primary endpoint, handling of incomplete exposure records, method for estimating the confidence interval, or sensitivity analysis is reported in the registry record. Without these details and the numerical result, readers can understand the endpoint’s intended construction but cannot reproduce or evaluate the analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple secondary outcomes, including modified At-Risk, Gross, and Method Failure Pearl Indices; cumulative 1-year pregnancy rates; treatment-cycle non-completion; and bone mineral density change from baseline to 6 and 12 months on-treatment. The record also reports 7 outcome measures and 0 analyses. Numerical results for these outcomes are not reported in the registry record.
When a study assesses several outcomes, the chance of at least one apparently notable result can increase if each is tested separately without an appropriate strategy. As a general statistical principle, a multiplicity plan may identify a primary outcome, order the testing, adjust thresholds, or distinguish confirmatory from exploratory analyses. No multiplicity approach is reported in the registry record. The existence of one named primary endpoint does not, by itself, establish how secondary outcomes were interpreted or whether any adjustment was planned.
The primary endpoint is defined for the Restricted Intent-to-treat Population. The registry describes the underlying ITT population as patients who completed informed consent and screening, were allocated to treatment, and received at least one dose. The further restrictions defining the primary analysis population are not reported in the registry record. The record does not state how participants with missing pregnancy status, incomplete at-risk exposure information, or early treatment discontinuation were handled.
Missing-data procedures can affect both the event numerator and exposure-time denominator for a rate. As a general matter, incomplete follow-up may reduce the information available, and assumptions used to address missing observations can influence an estimate. No imputation method, censoring rule, missingness summary, or sensitivity analysis is reported in the registry record. Accordingly, neither the impact of missing data nor the robustness of any efficacy estimate can be assessed from the recorded information.
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 |
|---|---|---|---|
| Relugolix/E2/NETA | 22 | 1125 | 2.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Relugolix/E2/NETA | 0 of 1125 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Relugolix/E2/NETA | 144 of 1125 |
Most frequent serious adverse event terms
| Event term | Organ system | Relugolix/E2/NETA |
|---|---|---|
| Suicidal ideation | Psychiatric disorders | 4 of 1125 |
| Cholelithiasis | Hepatobiliary disorders | 3 of 1125 |
| Gastrointestinal oedema | Gastrointestinal disorders | 1 of 1125 |
| Chest pain | General disorders | 1 of 1125 |
| Oedema peripheral | General disorders | 1 of 1125 |
| Cholecystitis acute | Hepatobiliary disorders | 1 of 1125 |
| Appendicitis | Infections and infestations | 1 of 1125 |
| COVID-19 pneumonia | Infections and infestations | 1 of 1125 |
| Gastrointestinal infection | Infections and infestations | 1 of 1125 |
| Rotavirus infection | Infections and infestations | 1 of 1125 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Relugolix/E2/NETA |
|---|---|---|
| Headache | Nervous system disorders | 75 of 1125 |
| Vaginal haemorrhage | Reproductive system and breast disorders | 51 of 1125 |
| Amenorrhoea | Reproductive system and breast disorders | 41 of 1125 |
Serious events with the highest arm-level rate: suicidal ideation (0.4%), cholelithiasis (0.3%), gastrointestinal oedema (0.1%), chest pain (0.1%), oedema peripheral (0.1%).
The safety record lists one Relugolix/E2/NETA group. For serious adverse events, it reports 1125 participants at risk and 22 affected. For other adverse events, it reports 1125 participants at risk and 144 affected. The record reports 0 deaths. These counts describe the safety entries and should not be confused with the enrollment figure or the primary efficacy analysis population.
The listed serious adverse-event terms with their reported percentages are suicidal ideation, 0.4%; cholelithiasis, 0.3%; gastrointestinal oedema, 0.1%; chest pain, 0.1%; oedema peripheral, 0.1%; and cholecystitis acute, 0.1%. These are the terms and percentages recorded; the registry does not provide further event-level detail in the registry record recorded for this analysis.
As a general statistical principle, an affected-participant count indicates how many participants were recorded as affected, while a count of events could include repeated events in an individual. The registry labels the values as affected participants, so they should not be interpreted as a count of all event episodes. The record does not report event timing, duration, outcome, attribution, or the number of events per affected participant. These data describe recorded safety observations and do not, on their own, establish whether an event was caused by treatment.
12. What the Result Does, and Does Not, Mean
The registry record provides a clearly described primary endpoint and a treatment schedule, but does not provide the numerical primary efficacy result. It therefore does not support a quantitative statement about the observed At-Risk Pearl Index or its precision. The endpoint definition explains which pregnancies and exposure periods were intended to contribute; it cannot substitute for the missing result.
The study’s single-arm design determines what a reported estimate could mean. It would describe the experience of the study group during treatment under the registry’s at-risk definition. There is no concurrent comparison group, so the design does not provide a randomized estimate of the difference between relugolix combination therapy and another approach. A description of a treated group is not equivalent to a comparative treatment effect.
The registry lists secondary pregnancy outcomes, treatment-cycle completion, and bone mineral density change, but does not report numerical findings for them. It is therefore not possible to use those outcomes to clarify the primary result, describe completion, or assess changes in bone mineral density from this record. The primary and secondary outcomes also should not be assumed to have been analyzed in a particular way when the analysis details are not reported.
The safety record gives affected-participant counts, a death count, and selected serious adverse-event terms with percentages. These are safety observations, not a substitute for the missing contraceptive efficacy estimate. They also do not provide a randomized comparison or prove that an event was caused by the intervention. As a general principle, observed counts should be interpreted in the context of the population observed, follow-up, event definitions, and ascertainment; several of those details are not reported in the registry record.
Overall, the record establishes the trial’s purpose, intervention, design, endpoint definitions, and selected safety counts. It does not report the numerical efficacy findings or enough analysis detail to evaluate their precision. Conclusions should therefore remain limited to what the record actually documents, rather than extending to comparative effects or unreported outcomes.
13. Why This Trial Matters Statistically
This trial is statistically notable because the primary outcome is defined through both pregnancy events and eligible time at risk. The At-Risk Pearl Index does not simply use all enrolled participants as its denominator. It restricts exposure to consecutive 28-day periods without another contraceptive method and with affirmed vaginal intercourse, and it defines the timing window for an on-treatment pregnancy. Those rules are central to understanding what the endpoint is intended to measure.
The study also illustrates the interpretive boundary of a single-arm design. A rate can describe the event experience in a treatment group, but a single group does not provide a randomized treatment contrast. The open-label designation and absence of a comparator should remain visible when interpreting any reported estimate. The registry record does not report an efficacy estimate, so even a descriptive numerical interpretation is unavailable.
Another statistical issue is the difference between planned treatment duration and actual participant follow-up. The intervention schedule is 1 year across 13 consecutive 28-day cycles, while the registry lists non-completion as a secondary outcome. Since the non-completion result is not reported, the schedule alone cannot establish how much exposure participants contributed or how many completed the planned cycles.
Finally, this record shows why endpoint definitions and results must be read separately. A well-specified measure can identify the intended numerator and denominator, but an estimate and its uncertainty are required to judge the observed data. The registry identifies a 95% Confidence Interval but gives neither its limits nor the point estimate. That absence prevents assessment of precision and leaves the primary efficacy question numerically unanswered in the registry record.
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 of the information recorded is that numerical efficacy results are absent. The At-Risk Pearl Index is defined and a 95% Confidence Interval is specified, but the estimate, interval limits, pregnancy count, and eligible woman-time are not reported in the registry record. The secondary outcome results are also not reported. Consequently, the magnitude and precision of contraceptive efficacy cannot be evaluated from this record.
The trial is single-arm and open-label, with no comparator. Any outcome estimate would be descriptive of the group studied rather than a randomized comparison. This design cannot separate treatment-associated observations from differences that might have arisen from participant characteristics, behavior, exposure patterns, or other factors. The registry does not report details that would allow these issues to be examined.
The primary endpoint depends on identifying at-risk cycles and estimating pregnancy conception dates relative to medication intake. The registry defines these conditions, but does not report how exposure and intercourse information were collected, how pregnancy dates were determined, or how incomplete information was handled. Details of adjudication and endpoint validation are not reported in the registry record.
The primary population is described as a Restricted Intent-to-treat Population, but the restrictions beyond the stated ITT definition are not fully specified in the record. Missing-data methods, analysis procedures, multiplicity handling, and sensitivity analyses are also not reported. These omissions limit assessment of reproducibility and of how dependent a result might be on analytic choices.
The enrollment figure is 1164, while the safety group reports 1125 at risk for both serious and other adverse events. The registry record does not explain the relationship between those figures. They should not be assumed to represent identical analysis sets. The record also does not report individual follow-up duration or treatment completion results, which limits interpretation of exposure and safety counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy — NCT04756037.
- Registry record last updated 2026-05-13; status last verified 2026-05.
- Results first posted 2026-05-13.
- 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
NCT04756037 is recorded as a completed Phase 3, single-arm, open-label study of relugolix combination therapy in women with uterine fibroids or endometriosis who were at risk for pregnancy. Enrollment is listed as 1164. The treatment schedule was 1 year, comprising 13 consecutive 28-day cycles. The study start is recorded as 2021-03-18 and primary completion as 2025-02-25.
The primary endpoint is the At-Risk Pearl Index, defined as on-treatment pregnancies per 100 woman-years during eligible periods without other contraceptive methods and with affirmed vaginal intercourse. A 95% Confidence Interval is specified, but the numerical estimate and interval are not reported in the registry record. Secondary outcomes cover other pregnancy measures, cycle completion, and bone mineral density change; their numerical results are not reported.
The safety record lists 22 participants affected by serious adverse events, 144 affected by other adverse events, and 0 deaths, with 1125 participants at risk for each adverse-event category. The study has no comparator group, and the registry reports 0 analyses. The main interpretive constraint is the absence of numerical efficacy findings and analysis details.