Trial · NCT04079218
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy | Between baseline (Visit 2) and 12 weeks (Visit 5) | Participants whose MBS reported at baseline changed during the follow-up visit at 12 weeks and participants who did not report a MBS during the baseline visit were excluded. The overall number of participants analyzed has been updated to reflect this. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Vaginal Microbiome - Relative Abundance of Lactobacillus Crispatus (L. Crispatus) | Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5) | Samples were not available for microbiome studies for 3 participants in the 'Estradiol' study arm and 1 participant in the 'No Treatment' study arm at both Visits 2 \& 5 therefore there is no microbiome data available nor will there be in the future for these participants. Vaginal swabs were also collected at 6 weeks for all participants however due to lack of funding, sequencing was not performed therefore the data is not available nor will it be in the future. | change in percentage of sequences | MEAN |
| PRIMARY | Vaginal Microbiome - Quantitative Determination of Protective Lactobacilli Species | Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5) | Though cervicovaginal lavage samples were collected and utilized for other outcome measures reported including cytokine levels, etc, the portion of the cervicovaginal lavage that was collected for qPCR for the quantitative determination of protective Lactobacilli species was not utilized as we did not have sufficient funding to run qPCR. Therefore qPCR was not performed on any sample at any time point. qPCR data is not available nor will it be available in the future. | ||
| SECONDARY | Vaginal Microbiome - Relative Abundance of Bacterial Vaginosis Associated Species | Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5) | Samples were not available for microbiome studies for 3 participants in the 'Estradiol' study arm and 1 participant in the 'No Treatment' study arm at both Visits 2 \& 5 therefore there is no microbiome data available nor will there be in the future for these participants. Vaginal swabs were also collected at 6 weeks for all participants however due to lack of funding, sequencing was not performed therefore the data is not available nor will it be in the future. | change in percentage of sequences | MEAN |
| SECONDARY | Vaginal Microbiome - Quantitative Determination of Bacterial Vaginosis Associated Species | Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5) | Though cervicovaginal lavage samples were collected and utilized for other outcome measures reported including cytokine levels, etc, the portion of the cervicovaginal lavage sample collected for qPCR for the quantitative determination of bacterial vaginosis associated species was not utilized as we did not have sufficient funding to run qPCR. Therefore qPCR was not performed on any sample at any time point. qPCR data for these species is not available nor will it be available in the future. | ||
| SECONDARY | Change in Vaginal Cytokine and Chemokine Concentrations | Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5) | CVL was collected at 6 weeks however due to insufficient funding, levels of cytokines and chemokines were not run at this time point. Therefore the data is not available nor will it be in the future. | pg/mL | MEAN |
| OTHER_PRE_SPECIFIED | HIV-1 RNA Levels in the Genital Tract | Baseline and 6 and 12 weeks | |||
| OTHER_PRE_SPECIFIED | Immunoglobulin (Ig)A and IgG Coated Bacteria | Baseline and 6 and 12 weeks | |||
| POST_HOC | Change in Vaginal Symptom Index (VSI) | Between Baseline (Visit 2) and 12 weeks (Visit 5) | score on a scale | MEAN | |
| POST_HOC | Vaginal Microbiome - Detectable Lactobacillus Crispatus (L. Crispatus) | 12 weeks (Visit 5) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Vaginal Microbiome - Detectable Bacterial Vaginosis-Associated Species | 12 weeks (Visit 5) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Change in Vaginal Microbiome - Detectable Lactobacillus Crispatus (L. Crispatus) | Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5) | 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. | percentage change detectable sequences | NUMBER |
| POST_HOC | Change in Vaginal Microbiome - Detectable Bacterial Vaginosis-Associated Species | Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5) | 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. | percentage change detectable sequences | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04079218/outcomes