Comparison · NCT00461305-dbad3ca2
DRSP 3 mg/EE 20 µg (6 Cycles) vs DRSP 3 mg/EE 30 µg (6 Cycles): Number of Participants With Intracyclic Bleeding at Cycle 6
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. DRSP 3 mg/EE 20 µg (6 Cycles) vs DRSP 3 mg/EE 30 µg (6 Cycles): Number of Participants With Intracyclic Bleeding at Cycle 6. Trial comparisons, record NCT00461305-dbad3ca2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00461305-dbad3ca2
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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 | 0.134 | 0.0998 | 0.177 | wilson | |
| Risk in group 2 | 0.0714 | 0.0281 | 0.17 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0624 | -0.0417 | 0.124 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.87 | 0.698 | 5.03 | log | |
| Odds ratio, group 1 over group 2 | 2.01 | 0.689 | 5.85 | log | |
| Number needed to treat, for one more participant with the outcome on DRSP 3 mg/EE 20 µg (6 Cycles) than on DRSP 3 mg/EE 30 µg (6 Cycles) | 16 | 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 | DRSP 3 mg/EE 20 µg (6 Cycles) | 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 40 | 299 | OG000 |
| Group 2 | DRSP 3 mg/EE 30 µg (6 Cycles) | 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 4 | 56 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Intracyclic Bleeding at Cycle 6
- Description
- Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
- Time frame
- Up to Cycle 6 (168 days) with 28 days per cycle
- Population
- FAS (Participants with data at Cycle 6)
Source ClinicalTrials.gov
Trial
- Title
- Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea
- NCT number
- NCT00461305
- Phases
- PHASE2, PHASE3
- Conditions
- Dysmenorrhea
- Interventions
- DRSP 3 mg/EE 20 µg (13 cycles), DRSP 3 mg/EE 30 µg (6 cycles)
- Lead sponsor
- Bayer
- Results first posted
- 2010-10-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00461305?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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