Comparison · NCT04079218-e53fa81e
Estradiol Vaginal Insert vs No Treatment: Vaginal Microbiome - Detectable Lactobacillus Crispatus (L. Crispatus)
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 Vaginal Insert vs No Treatment: Vaginal Microbiome - Detectable Lactobacillus Crispatus (L. Crispatus). Trial comparisons, record NCT04079218-e53fa81e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04079218-e53fa81e
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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 | 0.136 | 0.0475 | 0.333 | wilson | |
| Risk in group 2 | 0.2 | 0.0886 | 0.391 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0636 | -0.275 | 0.163 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.682 | 0.184 | 2.53 | log | |
| Odds ratio, group 1 over group 2 | 0.632 | 0.132 | 3.01 | log | |
| Number needed to treat, for one fewer participant with the outcome on Estradiol Vaginal Insert than on No Treatment | 15.7 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: no treatment.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Estradiol Vaginal Insert | Using a pre-loaded single-use plastic applicator, participants will insert one 10 microgram estradiol tablet intravaginally daily for 2 weeks and then one tablet twice weekly for the remainder of the study for a total of 12 weeks.~Estradiol Vaginal Insert: Using a pre-loaded single-use plastic applicator, participants will insert one 10 microgram estradiol tablet intravaginally daily for 2 weeks and then one tablet twice weekly for the remainder of the study for a total of 12 weeks. | 3 | 22 | OG000 |
| Group 2 | No Treatment | No intervention | 5 | 25 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- POST_HOC
- Title
- Vaginal Microbiome - Detectable Lactobacillus Crispatus (L. Crispatus)
- Description
- The number/percentage of participants with detectable concentrations of the protective Lactobacillus species, L. crispatus, as quantified by lllumina MiSeq sequencing, is summarized by study arm.
- Time frame
- 12 weeks (Visit 5)
- Population
Data was not collected for 3 participants in the 'Estradiol' study arm and 1 participant in the 'No Treatment' study arm at Visit 5 (12 weeks) therefore data is not and will not be available. Samples were collected at 6 weeks however due to insufficient finding, sequencing was not performed at the 6 week timepoint and therefore is not available and will not be available in the future.
Source ClinicalTrials.gov
Trial
- Title
- Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial
- NCT number
- NCT04079218
- Phases
- PHASE4
- Conditions
- HIV Infection, Vaginal Atrophy, Menopause, Menopause Related Conditions, Aging, Premature Aging, Atrophic Vaginitis, Dysbiosis, Vaginitis
- Interventions
- Estradiol Vaginal Insert
- Lead sponsor
- Kerry Murphy
- Results first posted
- 2025-03-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04079218?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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