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 the Efficacy and Safety of DR-102 for the Prevention of Pregnancy (NCT01178125), a na phase 3 study. The primary outcome is All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01178125 |
| Phase | Phase 3 |
| Condition | Contraception, Female Contraception |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 2858 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The primary outcome population was the Pregnancy Intent-to-Treat Population, consisting of participants 18 to 35 years of age, inclusive, at the Screening Visit. For the All Users analysis, participants also had to complete at least one 28-day cycle. The study enrolled 2858 participants overall; the registry record does not report how many met each primary-outcome population criterion.
Intervention
Participants received DR-102, an oral regimen of desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days, followed by ethinyl estradiol 0.01 mg for 7 days. The study description specifies 12 months of therapy and daily participant diaries.
Comparator
There was no concurrent control group. This was an open-label, single-group study in which all participants received DR-102. Consequently, its primary outcome describes pregnancy rates during treatment under the study’s definition; it does not directly estimate a difference between DR-102 and another treatment or a control condition.
Primary question
The primary question was how many pregnancies occurred per 100 woman-years of exposure among All Users, calculated with the Pearl Index for thirteen 28-day cycles and classified using the 7-day rule. The outcome was broken out by participant-weight subpopulations. The registry record provides the endpoint definition and timeframe, but the numerical pregnancy-rate estimate and its confidence interval are not reported in the registry record.
3. Trial Design
This was a Phase 3, multicenter, open-label, single-group study of DR-102 for pregnancy prevention. The registry record lists an enrollment of 2858 and a completed study status. The recorded start was 2010-08, and primary completion was 2013-01. These are registry dates; they do not, by themselves, establish how long each participant was followed.
All participants received the same oral contraceptive regimen. DR-102 consisted of desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days, then ethinyl estradiol 0.01 mg for 7 days. The study description states that participants would receive 12 months of oral contraceptive therapy. It also describes physical and gynecological examinations, including a Pap smear, and daily diaries completed during the study.
Because the design was single-group, there was no randomized allocation between treatment arms and no concurrent like-for-like control comparison. The allocation field is listed as NA, and masking is listed as none. The registry record does not report a protocol-level sample-size justification, an interim-analysis plan, or a detailed statistical analysis plan. A numerical primary outcome result is not reported in the registry record, so the clinical question cannot be answered from the posted results as an estimated treatment-versus-control effect.
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: Of the 2858 enrolled, 93 participants withdrew from study before taking any investigational product, for the following reasons: lost to follow-up (n=34), consent withdrawn (n=17), sponsor request (n=13), withdrawn due to pregnancy (n=11), noncompliance (n=6), other (n=6), protocol violation (n=3), adverse event(n=2), investigator request (n=2).
Overall Study
| Stage | DR-102 |
|---|---|
| STARTED | 2858 |
| Safety Population | 2765 |
| Intent to Treat (ITT) Population | 2607 |
| Pregnancy ITT (PITT) Population | 2401 |
| COMPLETED | 1680 |
| NOT COMPLETED | 1178 |
Reasons for not completing this period:
| Reason | DR-102 |
|---|---|
| Lost to Follow-up | 397 |
| Adverse Event | 244 |
| Withdrawal by Subject | 209 |
| Noncompliance | 184 |
| Pregnancy | 55 |
| Other Reason | 39 |
| Sponsor Decision | 28 |
| Protocol Violation | 17 |
| Investigator Decision | 5 |
Analysis population for the primary outcome, as defined in the registry: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Safety Population
| Characteristic | Unit | DR-102 |
|---|---|---|
| Participants analysed | 2765 | |
| Age, Continuous | years | 26.7 (SD 5.44) |
| Sex: Female, Male: Female | Participants | 2765 |
| Sex: Female, Male: Male | Participants | 0 |
| Race/Ethnicity, Customized: White | participants | 1798 |
| Race/Ethnicity, Customized: Black | participants | 428 |
| Race/Ethnicity, Customized: Asian | participants | 72 |
| Race/Ethnicity, Customized: Hispanic | participants | 393 |
| Race/Ethnicity, Customized: Other | participants | 74 |
| Weight | kg | 72.4 (SD 18.62) |
| Body Mass Index (BMI) | kg/m^2 | 26.9 (SD 6.54) |
6. Primary Endpoint
The registry lists the primary outcome as All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule, measured over thirteen 28-day cycles.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | pregnancies / 100 woman years exposure |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is a pregnancy rate measured with the Pearl Index (PI), expressed as pregnancies per 100 woman-years of exposure. The stated calculation is (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). The outcome covers thirteen 28-day cycles and uses the All Users population, defined as members of the Pregnancy Intent-to-Treat Population who completed at least one 28-day cycle. The underlying Pregnancy Intent-to-Treat Population includes participants 18 to 35 years of age, inclusive, at the Screening Visit.
The PI counts pregnancies identified by a positive urine and/or serum pregnancy test, with exclusions for pregnancies dated before DR-102 was started or more than 7 days after the combination or EE treatment was stopped. Under the 7-day rule, a pregnancy is considered on drug if conception occurred on or after the first dose and no more than 7 days after the last tablet, including combination hormonal or EE tablets.
Exposure-based rates are used to express pregnancy events relative to time at risk, rather than simply reporting a raw count. This can help describe rates when participants contribute different amounts of exposure. The registry record gives the endpoint definition and a 95% confidence-interval dispersion measure, but the numerical rate and interval are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The study addresses pregnancy rates during DR-102 use in a single treated group. Its primary endpoint is defined as a Pearl Index for All Users, with pregnancies classified under the 7-day rule and the analysis divided into participant-weight subpopulations. The design and endpoint definition are clear enough to identify the intended quantity, but the registry record does not report the numerical primary pregnancy rate or its confidence interval. Without those results, the magnitude and precision of the observed rate cannot be assessed from the registry record.
The distinction between an outcome definition and an outcome result matters. The record specifies which pregnancies count, the exposure denominator, the analysis population, and the timeframe. It does not give the number of primary-outcome pregnancies, total exposure used in the calculation, or weight-stratified estimates. Those omissions prevent an independent reading of the observed pregnancy frequency and prevent assessment of how much the estimates might vary across the specified subpopulations.
The single-group design also limits interpretation. A rate among participants receiving DR-102 is not a randomized comparison with another regimen or with no treatment. The record therefore cannot establish a comparative treatment effect from the primary endpoint alone. Differences between enrolled participants and people outside the study, as well as changes in adherence or exposure, may also affect how descriptive results would generalize; the registry record does not give enough detail to quantify such influences.
The registry lists 13 outcome measures, including the primary PI outcome and secondary outcomes involving life-table pregnancy estimates, compliant use, typical use, participant weight, and BMI. These are distinct outcome definitions, not interchangeable measures. The registry record does not report numerical findings for them, and no analysis-level results are recorded. It is therefore not possible to assess patterns across outcomes or determine whether any apparent subgroup differences were estimated precisely.
Safety information is listed separately from the primary efficacy endpoint. The record reports serious adverse-event counts and selected serious-event terms, but these do not supply missing pregnancy-rate results or create a comparison group. Neither outcome definitions nor safety counts alone establish a causal treatment effect. The posted information supports describing the study structure, population criteria, endpoint construction, and recorded safety counts; it does not support conclusions about comparative efficacy or the precision of the primary estimate.
9. Statistical Methods Explained
The primary analysis uses the Pearl Index, an exposure-based rate. Its stated unit is pregnancies per 100 woman-years of exposure, while the calculation uses 28-day cycles and a factor of 13. The denominator represents the total number of 28-day cycles in the analysis population. In general, exposure-based rates are useful when participants contribute varying amounts of time under observation: they relate event counts to accumulated exposure rather than treating every participant as if they contributed identical follow-up. This rate does not show how events are distributed over time, and by itself it does not describe an individual participant’s probability of pregnancy.
Pregnancy classification depends on the 7-day rule. A pregnancy is counted as on drug when conception is on or after the first dose and no more than 7 days after the last tablet. The endpoint description excludes pregnancies dated before treatment began or more than 7 days after stopping treatment. Applying a prespecified timing rule makes the endpoint operational, but its interpretation depends on the accuracy of conception-date information and the pregnancy-test information used to identify events. The registry record describes the rule but does not report the underlying event dates or detailed handling of uncertain dates.
The primary population is also defined in stages. The Pregnancy Intent-to-Treat Population includes participants aged 18 to 35 years, inclusive, at screening. The primary All Users set further requires completion of at least one 28-day cycle. This means that the primary endpoint is not defined for every person counted in overall enrollment. The registry record does not report how many participants entered the Pregnancy Intent-to-Treat Population, how many completed at least one cycle, or how exclusions and incomplete follow-up were handled in the actual analysis.
A 95% confidence interval is identified as the measure of dispersion for the primary endpoint. General statistical context: a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the method used. A narrower interval generally indicates greater precision, while a wider interval indicates less precision. It does not correct for bias, incomplete outcome ascertainment, or the lack of a comparison group. Since the numerical interval is not reported in the registry record, its width and the resulting precision cannot be evaluated.
The outcome list distinguishes All Users, typical-use, and compliant-use measures, and describes life-table estimates for some secondary outcomes. General statistical context: life-table methods estimate event experience across successive time intervals while accounting for differing follow-up and censoring under the method’s assumptions. A compliant-use analysis asks about outcomes under a defined pattern of adherence, whereas an All Users analysis is broader. These analyses can answer different descriptive questions and may use different participant subsets or rules. The registry record lists these outcome types but does not provide numerical estimates, detailed adherence definitions, censoring rules, or the actual analysis methods used for each outcome.
Several outcomes are specified by participant weight or BMI group, including decile-based groupings for on-drug pregnancy percentages. Subgroup analyses can describe whether estimates differ across defined categories, but they often contain fewer observations than an overall analysis and may consequently be less precise. A difference between subgroup estimates is not, on its own, evidence that the treatment effect differs between groups. Here, numerical subgroup results and their uncertainty are not reported in the registry record. Nor does the record state whether subgroup analyses were prespecified in the protocol or how they were interpreted alongside the overall endpoint.
General statistical context: event rates can be more variable than a simple model assumes when events are clustered or when participants have meaningfully different underlying risks; this is commonly described as over-dispersion. Methods that account for extra variability can affect uncertainty estimates. The registry record does not report the model used to estimate the primary rate or whether over-dispersion was assessed, so no claim can be made about those choices for this study.
The record identifies a 95% confidence interval but does not provide a primary p-value or a numerical treatment-effect estimate. The single-group design does not supply a randomized between-group contrast for the primary endpoint. Any sample-size figures based on a fraction of an observed effect are planning illustrations under stated assumptions, not observed power. Those assumptions describe a hypothetical two-arm calculation with two-sided significance level 0.05, equal allocation, and a normal approximation; they are not the design of this single-group study. The registry record does not report the trial’s own sample-size justification.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 13 outcome measures, including the primary Pearl Index and secondary pregnancy-rate outcomes based on life-table methods, use patterns, weight, and BMI. When a study examines multiple outcomes or subgroups, the chance of finding an apparently notable pattern by chance can increase. General statistical context: multiplicity procedures are used in some analyses to control or describe this issue, but the suitable approach depends on which outcomes are confirmatory and how they relate to the study question. A multiplicity procedure or hierarchy is not reported in the registry record.
Missing-data handling is also not reported in the registry record. The record defines the All Users population as members of the Pregnancy Intent-to-Treat Population who completed at least one 28-day cycle, but it does not explain how participants who discontinued, missed visits, had incomplete diaries, or had unknown pregnancy status were handled. Nor does it describe censoring rules for the life-table outcomes. These details matter because incomplete follow-up can affect the amount of exposure counted and the ascertainment of pregnancies.
The registry record does not report an analysis plan describing interim looks, outcome adjudication, or sensitivity analyses. These items should not be inferred from the endpoint descriptions. The number enrolled overall does not establish the number included in each endpoint analysis, and the registry record does not provide those analysis denominators. Consequently, the extent to which missingness, multiple outcomes, or analysis-population choices could affect the reported findings cannot be assessed from the posted results.
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-102 | 46 | 2765 | 1.7% |
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 |
|---|---|
| DR-102 | 1319 of 2765 |
Most frequent serious adverse event terms
| Event term | Organ system | DR-102 |
|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | 5 of 2765 |
| Cholecystitis | Hepatobiliary disorders | 3 of 2765 |
| Appendicitis | Infections and infestations | 3 of 2765 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 3 of 2765 |
| Pneumonia | Infections and infestations | 2 of 2765 |
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2 of 2765 |
| Depression | Psychiatric disorders | 2 of 2765 |
| Cervical dysplasia | Reproductive system and breast disorders | 2 of 2765 |
| Anaemia | Blood and lymphatic system disorders | 1 of 2765 |
| Pancreatitis | Gastrointestinal disorders | 1 of 2765 |
Most frequent non-serious adverse event terms
| Event term | Organ system | DR-102 |
|---|---|---|
| Nasopharyngitis | Infections and infestations | 247 of 2765 |
| Upper respiratory infection | Infections and infestations | 172 of 2765 |
| Sinusitus | Infections and infestations | 152 of 2765 |
| Headache | Nervous system disorders | 132 of 2765 |
| Nausea | Gastrointestinal disorders | 130 of 2765 |
| Urinary tract infection | Infections and infestations | 130 of 2765 |
| Vulvovaginal mycotic infection | Infections and infestations | 128 of 2765 |
| Metrorrhagia | Reproductive system and breast disorders | 121 of 2765 |
| Cervical dysplasia | Reproductive system and breast disorders | 114 of 2765 |
| Weight increased | Investigations | 108 of 2765 |
Serious events with the highest arm-level rate: abortion spontaneous (0.2%), cholecystitis (0.1%), appendicitis (0.1%), pulmonary embolism (0.1%), pneumonia (0.1%).
The safety listing identifies 2765 participants at risk for the DR-102 group. Within that group, 46 participants are listed as affected by serious adverse events, and 1319 are listed as affected by other adverse events. These are separate registry counts and should not be interpreted as counts of unique event types or as a comparison with an untreated group. The registry record does not report a death count.
The selected serious adverse-event terms and recorded percentages are: Abortion spontaneous, 0.2%; Cholecystitis, 0.1%; Appendicitis, 0.1%; Pulmonary embolism, 0.1%; Pneumonia, 0.1%; and Cervix carcinoma stage 0, 0.1%. These are listed as the top serious terms; the registry record does not provide additional details about timing, severity grading, relatedness assessment, or the number of events per affected participant.
General statistical context: an at-risk count gives the denominator associated with the safety listing, while an affected-participant count describes how many participants were recorded with the specified category. Counts and percentages describe what was recorded during the study; they do not establish that treatment caused an event or provide a comparative risk estimate. Because this study has no concurrent control group, the safety counts are descriptive rather than a randomized comparison.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed Phase 3, open-label, single-group study enrolled 2858 participants and evaluated DR-102 using a pregnancy-rate endpoint. It specifies the treatment regimen, the age range for the Pregnancy Intent-to-Treat Population, the All Users completion criterion, the Pearl Index calculation, and the 7-day rule. Those details clarify what the primary outcome was intended to measure.
The primary numerical outcome is not reported in the registry record. As a result, readers cannot determine the observed pregnancy rate, its confidence interval, or the estimates across participant-weight subpopulations from the registry record. The secondary outcome definitions are listed, but numerical secondary results are also not reported. The available information therefore does not quantify the study’s observed pregnancy frequency or its statistical precision.
The single-group design means that the study describes outcomes among participants receiving DR-102, rather than estimating a randomized contrast with another treatment. An outcome rate in a treated group alone cannot isolate the contribution of treatment from other influences. It also cannot establish how the rate would compare with rates under a different regimen or in a different population.
The safety listing records serious and other adverse-event counts among participants at risk, along with selected serious-event terms and percentages. Those counts are useful as descriptive safety information, but they do not establish causation or comparative safety. Overall, the registry record supports understanding the study’s design and intended analyses, but the missing numerical efficacy results and lack of a control group prevent a comparative conclusion.
13. Why This Trial Matters Statistically
This study illustrates why endpoint definitions are essential when interpreting clinical-trial results. The primary outcome is not a raw pregnancy count alone: it is an exposure-based Pearl Index with a specified denominator, timeframe, population, and pregnancy-classification rule. Each component determines which events and exposure contribute to the estimate. Without a numerical estimate and its confidence interval, however, a detailed endpoint definition cannot answer how large or precise the observed rate was.
The record also demonstrates the distinction between a descriptive rate and a comparative effect. In a single-group, open-label study, the pregnancy rate describes the participants receiving DR-102 under the recorded rules. There is no concurrent randomized group against which to estimate a difference. Statistical interpretation must therefore stay aligned with the design, rather than treating a within-group rate as evidence of a comparative treatment effect.
Multiple outcome definitions add another layer of interpretation. All Users, typical-use, compliant-use, life-table, weight-group, and BMI-group outcomes address related but non-identical questions. Their denominators and assumptions may differ, and subgroup estimates may have different precision. The registry record lists these analyses without numerical results or a reported multiplicity approach, leaving their relationships and uncertainty unresolved.
Finally, safety counts and efficacy endpoints answer separate questions. The serious adverse-event listing describes recorded events among participants at risk, while the primary endpoint concerns pregnancy rates. A careful statistical reading keeps these quantities distinct and recognizes what the registry record does and does not report.
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 most consequential limitation for interpreting the primary endpoint is that its numerical result and 95% confidence interval are not reported in the registry record. The total pregnancy count and total 28-day-cycle exposure used in the PI are also not reported. The primary estimate’s magnitude and precision therefore cannot be assessed, and the calculation cannot be independently checked from the registry information.
The single-group, open-label design provides no concurrent randomized comparison. It cannot estimate a between-group treatment difference, and the absence of a control group limits causal interpretation of both pregnancy outcomes and safety events. The registry record does not report detailed adherence results, although the outcome set includes typical-use and compliant-use measures.
The primary population is restricted to participants 18 to 35 years of age, inclusive, at screening, and the All Users set requires at least one completed 28-day cycle. The record does not report the number included in that set or how withdrawals, incomplete diaries, missing pregnancy tests, or other incomplete follow-up were addressed. These omissions make it difficult to evaluate selection into the analysis and the completeness of outcome ascertainment.
Subgroup outcomes by participant weight and BMI are listed, but their numerical estimates and uncertainty are not reported. The registry record also does not describe multiplicity procedures, detailed statistical models, missing-data methods, interim analyses, or the trial’s own sample-size justification. These are specific limits on assessing analysis choices; their absence from the registry record does not establish what may have been specified elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy — NCT01178125.
- Registry record last updated 2021-11-09; status last verified 2021-11.
- Results first posted 2013-12-11.
- 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
NCT01178125, titled A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy, is listed as a completed Phase 3, multicenter, open-label, single-group study sponsored by Teva Branded Pharmaceutical Products R&D, Inc. Enrollment was 2858. The recorded start was 2010-08, and primary completion was 2013-01.
Participants received DR-102, described as desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days followed by ethinyl estradiol 0.01 mg for 7 days. The primary endpoint was an All Users Pearl Index for thirteen 28-day cycles, using a 7-day pregnancy-classification rule and weight subpopulations. The registry record lists 13 outcome measures but does not report numerical primary or secondary results. Safety information includes 2765 participants at risk, 46 affected by serious adverse events, and 1319 affected by other adverse events.