Comparison · NCT00754065-sae
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) vs Ortho Tri-Cyclen Lo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) vs Ortho Tri-Cyclen Lo: serious adverse events. Trial comparisons, record NCT00754065-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00754065-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0105 | 0.00288 | 0.0374 | wilson | |
| Risk in group 2 | 0.0245 | 0.0105 | 0.0561 | wilson | |
| Risk difference, group 1 minus group 2 | -0.014 | -0.0465 | 0.0163 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.427 | 0.0839 | 2.18 | log | |
| Odds ratio, group 1 over group 2 | 0.421 | 0.0807 | 2.2 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) than on Ortho Tri-Cyclen Lo | 71.2 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles(treatment encapsulated) | 2 | 191 | EG000 |
| Group 2 | Ortho Tri-Cyclen Lo | Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) | 5 | 204 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)
- NCT number
- NCT00754065
- Phases
- PHASE3
- Conditions
- Contraception
- Interventions
- Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027), Ortho Tri Cyclen Lo
- Lead sponsor
- Bayer
- Results first posted
- 2012-08-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00754065?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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