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 Oral Contraceptives in the Metabolic Syndrome (NCT00205504), a non-randomized phase 4 study. The primary outcome is Changes in Insulin Sensitivity Associated With Oral Contraceptive (OC) Use Compared Among (1) Obese Women and (2) Lean Women.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00205504 |
| Phase | Phase 4 |
| Condition | Metabolic Syndrome X, Insulin Resistance, Obesity |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 46 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Virginia Commonwealth University |
| Results posted | Yes |
2. Clinical Question
The study asks how insulin sensitivity changes during oral contraceptive use among women grouped by obesity and metabolic syndrome status, and how those changes compare between obese and lean women. The registry lists three groups: obese women with metabolic syndrome, obese women without metabolic syndrome, and lean women without metabolic syndrome. Its primary outcome is described as changes in insulin sensitivity associated with oral contraceptive use compared among obese and lean women.
The question reflects concern that obesity and the metabolic syndrome may be relevant to cardiovascular risk in oral contraceptive users. The registry background describes insulin resistance as a possible underlying feature of metabolic syndrome and states that the cardiovascular risks in oral contraceptive users with emerging risk factors had not been investigated in the way the investigators sought to address. The stated objective was to obtain pilot data on how metabolic syndrome and obesity affect glucose metabolism and cardiovascular risks in women.
The intervention listed is Ortho Tri Cyclen. However, the registry record does not give a detailed description of the treatment regimen, dose, adherence assessment, or whether every participant received the intervention. It also does not describe a separate untreated or alternative-treatment control group. Because allocation was non-randomized, comparisons among the groups are not like-for-like randomized comparisons.
The primary question is therefore descriptive and comparative: what changes in insulin sensitivity were observed from baseline to 6 months, and how did those changes differ across the listed groups? The registry record does not report the numerical outcome results, so the magnitude, direction, and precision of any differences are not reported in the registry record.
3. Trial Design
This completed Phase 4 study was registered as a parallel, non-randomized trial with no masking. The registry lists an enrollment of 46. Its groups were obese women with metabolic syndrome, obese women without metabolic syndrome, and lean women without metabolic syndrome. Group descriptions beyond those labels are not reported in the registry record.
The listed intervention is Ortho Tri Cyclen, a drug intervention. The study's primary outcome is framed around changes associated with oral contraceptive use and comparison among obese and lean women. The registry does not specify the regimen or clarify in the group descriptions how intervention exposure was handled across the groups. There is no randomized allocation, and the registry explicitly cautions that the arms are not a like-for-like control comparison.
The primary outcome was measured at baseline and 6 months. The study began in 2005-06, reached primary completion in 2009-06, and is marked completed. Virginia Commonwealth University is listed as the sponsor. The recorded conditions include metabolic syndrome X, insulin resistance, obesity, and cardiovascular diseases.
Non-randomized group comparisons can describe patterns in the observed participants, but group membership may coincide with other characteristics that also relate to the outcome. Without random allocation, an observed difference cannot be attributed to the intervention alone on the basis of design. The registry record does not report how participants entered each group, what eligibility criteria were applied, or whether the analysis adjusted for differences between groups.
The enrollment figure is not an outcome-specific analysis count. The registry record does not report how many participants contributed data to the primary endpoint at each time point, or whether all enrolled participants completed follow-up. It also does not report a sample-size justification or a prespecified statistical analysis plan.
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: Although 46 completed informed consent, only 36 initiated the study. Among The participants who did not begin the study were lost to follow-up prior to beginning the protocol, were no shows, or withdrew from the study before beginning study procedures.
Overall Study
| Stage | Obese Women | Lean Women |
|---|---|---|
| STARTED | 21 | 15 |
| COMPLETED | 14 | 15 |
| NOT COMPLETED | 7 | 0 |
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 | Obese Women | Lean Women | Total |
|---|---|---|---|---|
| Participants analysed | 21 | 15 | 36 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 21 | 15 | 36 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 25.3 (SD 6.9) | 21.4 (SD 2.3) | 23.4 (SD 5.8) |
| Sex: Female, Male: Female | Participants | 21 | 15 | 36 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 21 | 15 | 36 |
6. Primary Endpoint
The registry lists the primary outcome as Changes in Insulin Sensitivity Associated With Oral Contraceptive (OC) Use Compared Among (1) Obese Women and (2) Lean Women, measured over Baseline and 6 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mIU/L |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is described as changes in insulin sensitivity associated with oral contraceptive use, compared among obese and lean women. Measurement was scheduled at baseline and 6 months. The registry states that insulin sensitivity was assessed using a frequent sampling intravenous glucose tolerance test (FSIVGTT). The outcome is specified as a continuous measure summarized by a mean and standard deviation, with the unit listed as mIU/L.
As general background, insulin sensitivity concerns how responsive the body is to insulin in handling glucose. It is relevant to this study because the registry background identifies insulin resistance as a possible underlying feature of metabolic syndrome and names glucose metabolism as part of the pilot study objective. A measure of insulin sensitivity can therefore serve as a physiological outcome for examining metabolic patterns in the study groups.
The registry does not provide the operational calculation used to derive the endpoint from the FSIVGTT, nor does it state whether the analysis used a change score, a comparison of follow-up values adjusted for baseline, or another model. The precise interpretation of a higher or lower value is not defined in the registry record. No group means, standard deviations, between-group estimates, confidence intervals, or p-values for this endpoint are reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a relevant primary outcome and its measurement schedule, but it does not report numerical primary outcome results. Consequently, the direction and size of changes in insulin sensitivity, the differences among groups, and the uncertainty around those differences are not reported in the registry record. No conclusion about whether the groups had similar or different outcome patterns can be drawn from the information recorded.
The distinction between a within-group change and a between-group comparison matters. A change from baseline within one group describes what happened over time among the participants in that group. A difference in changes between groups asks whether the time pattern differed across groups. The registry's stated primary question concerns comparisons among obese and lean women, but the precise contrast used in the analysis is not reported in the registry record. In particular, the record does not state how the three listed groups were combined or compared for the primary analysis.
As general statistical explanation, an estimate describes the size and direction of an association or difference, while a confidence interval describes the range of values compatible with the data under the analysis assumptions. A narrow interval indicates greater precision than a wide interval, though precision does not establish that a finding is free from bias. Since the registry record does not report an estimate or confidence interval, neither the magnitude nor the precision of the primary result can be evaluated.
The record lists 10 outcome measures and 0 analyses. It names several secondary outcomes, including lipid profile, inflammatory markers, estrogen metabolites, waist-to-hip ratio, blood pressure, body mass index, and waist circumference. The absence of reported analyses means that the registry information does not establish which outcomes were analyzed or what results were obtained. It also does not report any p-values or adjustments for multiple outcome testing.
The study was non-randomized and unmasked. As general explanation, non-randomized group comparisons can be influenced by baseline differences, selection into groups, and other factors associated with both group membership and outcomes. Masking can reduce some forms of measurement or assessment bias, but no masking was used according to the record. These design features do not determine what the observed results were; they limit how confidently group differences could be attributed to the intervention if such differences were reported.
The enrollment was 46, but the number contributing primary outcome data is not reported in the registry record. The completion status refers to the study, not necessarily to complete outcome data for every participant. Without outcome counts, estimates, analysis details, and information about missing observations, the registry record supports a description of the study question and design, not a numerical assessment of its findings.
9. Statistical Methods Explained
The registry record identifies a continuous primary outcome, a mean and standard deviation summary, and measurements at baseline and 6 months. It does not report the statistical methods used to compare groups or time points. The explanations below describe general statistical concepts relevant to this design; they should not be read as a claim that a particular method was used in this study.
What does a continuous outcome mean?
A continuous outcome can take values across a measurement scale rather than falling into a small set of categories. Insulin sensitivity is treated as a continuous measure in this record. A mean describes the arithmetic average in a group, while a standard deviation describes how dispersed individual measurements are around that average. The mean alone does not show how variable participants' measurements were, and the standard deviation is not a measure of uncertainty in the mean.
For a comparison, an effect estimate would ordinarily describe a difference in means, a difference in changes over time, or another defined contrast. The registry record does not state which contrast or model was used. It does not report group means, standard deviations, or an effect estimate for the primary outcome. These omissions prevent readers from assessing the actual size and direction of any observed pattern.
How should baseline and follow-up measurements be considered?
Repeated measurements on the same participant are related. General methods for longitudinal data account for that relationship rather than treating each measurement as independent. One possible analytic approach is to compare changes from baseline; another is to model follow-up values while accounting for baseline values. These approaches answer related but not identical questions and can yield different estimates. The registry record does not report which approach, if any, was used.
Baseline values can also differ across non-randomized groups. Describing baseline measurements helps readers understand the groups being compared, while an adjusted analysis may account for measured differences. Adjustment cannot necessarily remove bias from unmeasured or poorly measured factors. The registry does not report baseline outcome values, covariates, or any adjusted analysis.
What does non-randomized allocation imply?
In a randomized comparison, assignment is determined by a random process. In a non-randomized study, group membership is not assigned that way. As general explanation, the groups may differ in characteristics related to the outcome, whether or not those characteristics were measured. Thus, a difference between groups may reflect the intervention, group composition, other exposures, or a combination of factors. Statistical adjustment can address some measured differences under assumptions, but it does not turn a non-randomized comparison into a randomized one.
The registry marks allocation as non-randomized and notes that the arms are not a like-for-like control comparison. It does not report the process that determined group membership or the variables used to address potential confounding. The group labels identify obesity and metabolic syndrome status, but do not provide enough detail to reconstruct the comparison strategy.
How should precision and statistical significance be assessed?
A confidence interval gives a range of estimates compatible with the observed data under the chosen model and its assumptions. Its width reflects statistical precision. A p-value is a measure, under a specified statistical model, of how compatible the data are with a null hypothesis. Neither a p-value nor an interval alone describes the practical importance of an effect or resolves bias in the study design. The registry record reports no primary outcome confidence interval, p-value, or other inferential statistic.
Small amounts of data can yield imprecise estimates, particularly when comparisons divide participants among several groups or when outcome data are incomplete. The registered enrollment is 46, but actual group-specific numbers contributing to the primary analysis are not reported in the registry record. Precision therefore cannot be assessed from enrollment alone.
What do planning assumptions tell readers?
The registry describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The illustration is described as detecting a stated fraction of the observed effect; for time-to-event outcomes, the stated convention is a total event count, while other outcomes use participants per arm. These are planning assumptions, not evidence that the trial had a particular power or that an effect was observed with certainty.
Sample-size calculations framed around an observed effect are retrospective planning illustrations. They are not observed power and do not replace estimates and confidence intervals. The registry record does not report the numerical effect or the resulting planning counts, and it does not report a prospective sample-size justification. The assumptions alone cannot establish whether the study was adequately sized for its primary question.
What is not established by the record?
The record lists 10 outcome measures but 0 analyses. It does not report the analysis population, handling of missing data, model specification, covariate selection, multiplicity procedures, or sensitivity analyses. Those details are important because they define which observations were analyzed and how uncertainty was quantified. In their absence, the statistical methods actually used and their implications cannot be reconstructed.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 10 outcome measures: one primary measure and multiple secondary measures. These include changes in lipid profile, inflammatory markers, estrogen metabolites, waist-to-hip ratio, blood pressure, body mass index, and waist circumference. The record lists 0 analyses and does not report whether the outcomes were tested, which comparisons were made, or whether any adjustment for multiple testing was used.
As general explanation, examining many outcomes or comparisons increases the opportunity for chance findings. A prespecified hierarchy, a family-wise error adjustment, a false-discovery approach, or a clear distinction between confirmatory and exploratory outcomes can help readers interpret a set of results. Which approach is appropriate depends on the scientific aims and analysis plan. The registry record does not report a multiplicity strategy, so the status of any possible secondary findings cannot be assessed.
Missing-data methods are also not reported in the registry record. The record does not give the number of participants with primary outcome measurements at baseline or 6 months, explain why any observations may be missing, or state whether missing values were excluded, imputed, or handled through a model. No analysis population definition is reported, such as whether analyses included all enrolled participants or only those with measurements at both time points.
As general explanation, missingness can affect both precision and validity. If the availability of a measurement is related to participant characteristics or outcomes, an analysis of observed measurements alone may not represent the full enrolled group. The appropriate interpretation depends on the amount, pattern, and likely reasons for missing data, none of which are reported. The completed status and enrollment figure do not establish complete outcome follow-up.
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 |
|---|---|---|---|
| Obese Women | 1 | 21 | 4.8% |
| Lean Women | 0 | 15 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Obese Women | 2 of 21 |
| Lean Women | 2 of 15 |
Most frequent serious adverse event terms
| Event term | Organ system | Obese Women | Lean Women |
|---|---|---|---|
| Gallstones removal | Gastrointestinal disorders | 1 of 21 | 0 of 15 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Obese Women | Lean Women |
|---|---|---|---|
| Tiredness | Injury, poisoning and procedural complications | 0 of 21 | 1 of 15 |
| Pain with venipuncture | Injury, poisoning and procedural complications | 0 of 21 | 1 of 15 |
| Phlebitis due to catheter insertion | Injury, poisoning and procedural complications | 1 of 21 | 0 of 15 |
| Dizziness due to Ortho Tricyclen | Injury, poisoning and procedural complications | 1 of 21 | 0 of 15 |
Serious events with the highest arm-level rate: gallstones removal (4.8%).
The registry lists serious and other adverse-event counts for obese women and lean women. In the obese women group, 21 were recorded at risk for serious events, with 1 affected; 21 were recorded at risk for other adverse events, with 2 affected. In the lean women group, 15 were recorded at risk for serious events, with 0 affected; 15 were recorded at risk for other adverse events, with 2 affected. These are registry counts, not evidence that the groups were comparable or that an event was caused by the intervention.
The registry also lists “Gallstones removal” as a top serious term with 4.8%. The record does not explain the denominator or the event-level details for that percentage, so it should not be converted into a participant count or assigned to a particular group from this information alone. Deaths are recorded as null, which does not establish that there were no deaths; the death information is not reported in the registry record.
Safety counts need to be interpreted alongside the observation period, exposure, event definitions, and completeness of reporting. These details are not reported in the registry record. The counts also do not provide a randomized comparison, and the listed adverse-event groups are not identified as like-for-like control arms. They describe recorded events in the listed groups without establishing a causal relationship.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was a completed, non-randomized study of oral contraceptive use in women grouped by obesity and metabolic syndrome status, with insulin sensitivity measured at baseline and 6 months as the primary outcome. It also identifies the outcome assessment method as FSIVGTT and lists secondary metabolic and cardiovascular-related measures. These details clarify the research question and the measurements planned or registered.
The record does not report primary outcome values, comparisons, confidence intervals, or p-values. It therefore does not establish whether insulin sensitivity increased, decreased, or remained similar in any group, nor whether changes differed among groups. It also does not report numerical results for the secondary outcomes. A study marked completed is not, by itself, evidence of a particular result.
Even if group differences were reported, the non-randomized design would require cautious interpretation. As general explanation, differences across groups can arise from characteristics that differ between participants, in addition to any association with oral contraceptive use. The registry record does not describe adjustment for such differences, and it explicitly notes that the arms are not a like-for-like control comparison. Thus, the design would not by itself support a causal conclusion.
The listed enrollment of 46 does not indicate how many participants contributed data to each analysis. Missing outcome counts, analysis populations, and statistical methods are not reported in the registry record. This prevents assessment of precision, attrition, or robustness. The safety counts are similarly descriptive and do not establish causation or comparative risk.
The study's stated aim was to obtain pilot data on metabolic syndrome, obesity, glucose metabolism, and cardiovascular risks in women. The registry record supports describing that aim and the study structure, but not a conclusion about the magnitude, clinical relevance, or reliability of an outcome effect. Those judgments require results and analysis details that are not reported in the registry record.
13. Why This Trial Matters Statistically
Statistically, the study addresses a question involving both a continuous metabolic measure and participant groups defined by obesity and metabolic syndrome status. That combination makes the exact comparison important: a change within a group is not the same quantity as a difference in change between groups, and comparisons between groups may reflect differences in participant characteristics as well as exposure.
The record identifies a baseline and 6-month assessment of insulin sensitivity and describes FSIVGTT as the measurement method. It also lists secondary outcomes spanning lipids, inflammatory markers, estrogen metabolites, body measurements, and blood pressure. This breadth makes clear why the analysis plan, outcome hierarchy, and handling of multiple comparisons matter. The registry record lists 10 outcomes but 0 analyses and does not report those procedures.
The non-randomized allocation is central to interpretation. As general statistical context, randomization can balance measured and unmeasured characteristics on average, while non-randomized group comparisons may retain confounding. The record's own caution that the arms are not a like-for-like control comparison is therefore important when considering any contrast. No numerical results are reported in the registry record, so the design's statistical implications cannot be weighed against observed estimates or their precision.
The study is identified as seeking pilot data. Pilot work can help characterize measurements and generate questions for further study, but its value depends on transparent estimates, uncertainty, and methods. Here, the registry record establishes the question and design but does not report the primary outcome findings, analysis populations, or missing-data handling. Those omissions limit what can be learned about the statistical evidence from the 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.
Several trial-specific limitations affect interpretation. Allocation was non-randomized and masking was absent. The registry itself cautions that the arms are not a like-for-like control comparison. The record does not report how participants were assigned to the groups or whether analyses adjusted for group differences, so the potential influence of confounding cannot be assessed.
The group descriptions identify obese women with metabolic syndrome, obese women without metabolic syndrome, and lean women without metabolic syndrome, but the arm-description entries contain no further detail. The primary outcome description does not specify the exact contrast among these groups, and the record does not define how insulin sensitivity values were calculated from the FSIVGTT. The primary population field is not reported in the registry record.
Although enrollment is listed as 46, the number of participants analyzed for the primary outcome, the number with measurements at each time point, and the group-specific outcome counts are not reported in the registry record. The record does not describe withdrawals, missing-data methods, or the analysis population. It also does not report a sample-size justification, a statistical analysis plan, adjustment for multiple outcomes, or sensitivity analyses.
Most importantly, the registry record lists 0 analyses and does not report numerical outcome findings. Without estimates and measures of uncertainty, the magnitude, direction, and precision of any observed differences cannot be evaluated. These are limitations of what the registry record reports; they do not establish that particular procedures or analyses were absent from all study documents.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Oral Contraceptives in the Metabolic Syndrome — NCT00205504.
- Registry record last updated 2018-08-08; status last verified 2018-07.
- Results first posted 2012-05-07.
- 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
NCT00205504, “Oral Contraceptives in the Metabolic Syndrome,” is a completed Phase 4, parallel, non-randomized study with no masking. Virginia Commonwealth University is listed as sponsor, and enrollment is recorded as 46. The study began in 2005-06 and reached primary completion in 2009-06.
The listed intervention is Ortho Tri Cyclen. Groups are described as obese women with metabolic syndrome, obese women without metabolic syndrome, and lean women without metabolic syndrome. The primary outcome is change in insulin sensitivity, assessed using FSIVGTT at baseline and 6 months, with a mean and standard deviation specified.
The registry lists 10 outcome measures and 0 analyses. Numerical primary and secondary outcome results, analysis methods, missing-data procedures, and the primary analysis population are not reported in the registry record. The record also lists adverse-event counts for obese and lean women, but these are not a randomized comparison.