Comparison · NCT03294538-67395897
Generic Estradiol Vaginal Cream USP, 0.01% vs Estrace Vaginal Cream USP, 0.01%: Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups
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. Generic Estradiol Vaginal Cream USP, 0.01% vs Estrace Vaginal Cream USP, 0.01%: Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups. Trial comparisons, record NCT03294538-67395897. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03294538-67395897
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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 | 0.201 | 0.155 | 0.256 | wilson | |
| Risk in group 2 | 0.194 | 0.148 | 0.25 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00699 | -0.0654 | 0.0786 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.719 | 1.49 | log | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.664 | 1.65 | log | |
| Number needed to treat, for one more participant with the outcome on Generic Estradiol Vaginal Cream USP, 0.01% than on Estrace Vaginal Cream USP, 0.01% | 143 | 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 | Generic Estradiol Vaginal Cream USP, 0.01% | Participants were to self-administer 2 g of generic Estradiol Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days. | 49 | 244 | OG000 |
| Group 2 | Estrace Vaginal Cream USP, 0.01% | Participants were to self-administer 2 g of Estrace Vaginal Cream USP, 0.01% once daily at approximately the same time of the day for 7 consecutive days. | 44 | 227 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups
- Description
Treatment comparison of the number of participants in the PP population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.
- Time frame
- Up to Day 9
- Population
Participants who met I/E criteria, didn't develop a concurrent vaginal infection, completed Day 8 visit, and took 6-8 doses and didn't miss \>1 dose of study drug (PP Population). As pre-specified in the protocol, only the active groups (Generic Estradiol Vaginal Cream USP, 0.01% and Estrace Vaginal Cream USP, 0.01%) were included in this analysis.
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate Equivalence of Estradiol Vaginal Cream 0.01% to Estrace® Cream 0.01% in Atrophic Vaginitis
- NCT number
- NCT03294538
- Phases
- PHASE3
- Conditions
- Atrophic Vaginitis
- Interventions
- Generic Estradiol Vaginal Cream USP, 0.01%, Estrace® Vaginal Cream USP, 0.01%, Vehicle Vaginal Cream
- Lead sponsor
- Actavis Inc.
- Results first posted
- 2019-12-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03294538?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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