Comparison · NCT01306331-sae
Conceptrol vs Amphora: 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. Conceptrol vs Amphora: serious adverse events. Trial comparisons, record NCT01306331-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01306331-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 | 0.0129 | 0.00825 | 0.02 | wilson | |
| Risk in group 2 | 0.00754 | 0.00422 | 0.0135 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00532 | -0.00218 | 0.0132 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.71 | 0.814 | 3.57 | log | |
| Odds ratio, group 1 over group 2 | 1.71 | 0.813 | 3.61 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Conceptrol than on Amphora | 188 | 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 | Conceptrol | 100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel~Conceptrol: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel. | 19 | 1,477 | EG000 |
| Group 2 | Amphora | Citric acid USP, potassium bitartrate USP, and L-lactic acid USP~Amphora: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel. | 11 | 1,458 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 183 days
Source ClinicalTrials.gov
Trial
- Title
- Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel
- NCT number
- NCT01306331
- Phases
- PHASE3
- Conditions
- Contraception
- Interventions
- Conceptrol, Amphora
- Lead sponsor
- Evofem Inc.
- Results first posted
- 2020-07-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01306331?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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