Trial · NCT04079218
Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial
NCT04079218, Phase 4, Completed, Kerry Murphy; results first posted 2025-03-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial. Trials, record NCT04079218. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04079218
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial
- NCT number
- NCT04079218
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 60 participants, actual
- Lead sponsor
- Kerry Murphy
- Conditions
- HIV Infection, Vaginal Atrophy, Menopause, Menopause Related Conditions, Aging, Premature Aging, Atrophic Vaginitis, Dysbiosis, Vaginitis
- Interventions
- Estradiol Vaginal Insert
- First posted
- 2019-09-06
- Last updated
- 2025-03-14
- Results first posted
- 2025-03-14
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy | Between baseline (Visit 2) and 12 weeks (Visit 5) | Change in the severity of MBS of vaginal atrophy as reported during the baseline visit was assessed at 12 weeks (Visit 5). During the baseline visit, participants were asked to identify their MBS and assess the severity of the MBS on an ordinal scale of "None," "Mild," "Moderate," or "Severe." During the follow-up visit at 12 weeks participants were again asked to identify and assess the severity of their MBS. The degree of severity of the MBS reported at baseline was then compared to the severity of the MBS reported at 12 weeks and categorically summarized and reported as either "Severity Increased" "Severity Decreased" or "No change in Severity" for the given MBS. Participants whose MBS reported at baseline changed during the follow-up visit at 12 weeks were excluded from the analysis. Participants who did not report an MBS during the baseline visit were also excluded. Data for each possible type of MBS is summarized by study arm. |
| Primary | Vaginal Microbiome - Relative Abundance of Lactobacillus Crispatus (L. Crispatus) | Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5) | The relative abundance of the protective Lactobacillus species, L. crispatus, as quantified by lllumina MiSeq sequencing will be calculated by dividing the total number of L crispatus sequences detected in a sample by the total number of sequences from all bacterial species detected in the same sample. This proportion will be expressed as a percentage. The change in relative abundance between baseline (visit 2) and 12 weeks (visit 5) will be summarized by study arm. |
| Primary | Vaginal Microbiome - Quantitative Determination of Protective Lactobacilli Species | Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5) | Changes in the vaginal microbiome, specifically the quantities of protective Lactobacilli species (L. crispatus, L. jensenii and L. gasseri) as measured by quantitative PCR (qPCR) will be determined. The three Lactobacilli species will be identified and quantified in colony forming units per milliliter of sample (CFU/mL). Changes in abundance from baseline will be summarized by study arm using basic descriptive statistics. |
| Secondary | Vaginal Microbiome - Relative Abundance of Bacterial Vaginosis Associated Species | Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5) | The relative abundance of bacterial vaginosis (BV) associated bacterial species as quantified by lllumina MiSeq sequencing, will be calculated by dividing the total number of the individual BV-associated species sequences in a sample by the total number of sequences from all bacterial species detected in the same sample. This proportion will be expressed as a percentage. The change in relative abundance between baseline (visit 2) and 12 weeks (visit 5) will be summarized by study arm for the 3 most common BV-associated species; Gardnerella vaginalis (G. vaginalis); Fannyhessea vaginae (F. vaginae); and Prevotella bivia (P. bivia) |
| Secondary | Vaginal Microbiome - Quantitative Determination of Bacterial Vaginosis Associated Species | Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5) | Changes in quantities of BV-associated species as measured by quantitative PCR (qPCR) will be determined. BV-associated species will be detected and quantified in colony forming units per milliliter of sample (CFU/mL). Changes in abundance from baseline for each detected species will be summarized by study arm using basic descriptive statistics. |
| Secondary | Change in Vaginal Cytokine and Chemokine Concentrations | Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5) | Change in concentrations from baseline of vaginal cytokines and chemokines in cervicovaginal lavage (CVL) was determined. Following assay, concentrations for the following cytokines and chemokines, as individually expressed, were reported in picograms per milliliter (pg/mL): IL-1A, Interleukin-8 (IL8); Interferon-gamma inducible protein 10 (IP-10); Monocyte Chemoattractant Protein-1 (MCP-1); and Secretory Leukocyte Protease Inhibitor (SLPI). Change in concentrations for the respective cytokines and chemokines from baseline are summarized by study arm using basic descriptive statistics. |
| Other | HIV-1 RNA Levels in the Genital Tract | Baseline and 6 and 12 weeks | HIV-1 RNA testing from cervicovaginal lavage fluid will be used to assess HIV-1 concentrations in the genital tract. Concentrations will be summarized by study arm and subsequently analyzed by multivariate linear regression. Cervicovaginal lavage (CVL) fluid was collected for other measures however due to insufficient funding, CVL HIV-1 viral loads were not run at any time point therefore the data is not available, nor will it be available in the future. |
| Other | Immunoglobulin (Ig)A and IgG Coated Bacteria | Baseline and 6 and 12 weeks | Relative differences in levels of live IgA+IgG+ coated, live IgA+IgG- coated, live IgA-IgG-coated and dead bacteria will be summarized using basic descriptive statistics and subsequently analyzed by multivariate linear regression. Vaginal swabs were collected for quantification of subsets of IgA and IgG coated bacteria however due to insufficient funding, sequencing of these samples has not been performed and therefore data is not available. If we are able to secure additional funding, the sequencing may be performed in the future. |
Source ClinicalTrials.gov
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy | Estradiol Vaginal Insert | Itching / Severity Increased | 0 | Participants | |
| Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy | No Treatment | Itching / Severity Increased | 1 | Participants | |
| Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy | Estradiol Vaginal Insert | Itching / Severity Decreased | 8 | Participants | |
| Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy | No Treatment | Itching / Severity Decreased | 4 | Participants | |
| Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy | Estradiol Vaginal Insert | Itching / No change in Severity | 0 | Participants | |
| Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy | No Treatment | Itching / No change in Severity | 1 | Participants | |
| Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy | Estradiol Vaginal Insert | Dryness / Severity Increased | 0 | Participants | |
| Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy | No Treatment | Dryness / Severity Increased | 1 | Participants | |
| Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy | Estradiol Vaginal Insert | Dryness / Severity Decreased | 9 | Participants | |
| Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy | No Treatment | Dryness / Severity Decreased | 3 | Participants |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Estradiol Vaginal Insert | 33 | |
| Overall Study | STARTED | No Treatment | 27 | |
| Overall Study | COMPLETED | Estradiol Vaginal Insert | 25 | |
| Overall Study | COMPLETED | No Treatment | 26 | |
| Overall Study | NOT COMPLETED | Estradiol Vaginal Insert | 8 | |
| Overall Study | NOT COMPLETED | No Treatment | 1 |
Source ClinicalTrials.gov
Adverse events72
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pigmentation loss | Reproductive system and breast disorders | Estradiol Vaginal Insert | 1 | 33 | |
| other | Pigmentation loss | Reproductive system and breast disorders | No Treatment | 0 | 27 | |
| other | Hemoglobin Decreased | Blood and lymphatic system disorders | Estradiol Vaginal Insert | 1 | 33 | |
| other | Hemoglobin Decreased | Blood and lymphatic system disorders | No Treatment | 2 | 27 | |
| other | Leg weakness | Musculoskeletal and connective tissue disorders | Estradiol Vaginal Insert | 1 | 33 | |
| other | Leg weakness | Musculoskeletal and connective tissue disorders | No Treatment | 0 | 27 | |
| other | Groin Pain | Renal and urinary disorders | Estradiol Vaginal Insert | 1 | 33 | |
| other | Groin Pain | Renal and urinary disorders | No Treatment | 0 | 27 | |
| other | Vaginal Discharge | Reproductive system and breast disorders | Estradiol Vaginal Insert | 1 | 33 | |
| other | Vaginal Discharge | Reproductive system and breast disorders | No Treatment | 1 | 27 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Estradiol Vaginal Insert | 1 | 33 |
| Total, all-cause mortality | No Treatment | 0 | 27 |
| Total, other adverse events | Estradiol Vaginal Insert | 20 | 33 |
| Total, other adverse events | No Treatment | 10 | 27 |
| Total, serious adverse events | Estradiol Vaginal Insert | 4 | 33 |
| Total, serious adverse events | No Treatment | 2 | 27 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| K23AG062400 | The impact of HIV on accelerated aging in the female genital tract: a pilot trial of topical estradiol to improve the vaginal microbiome and symptoms of vaginal atrophy in menopausal women with HIV | MURPHY, KERRY JEANNE | ALBERT EINSTEIN COLLEGE OF MEDICINE | NATIONAL INSTITUTE ON AGING | 2020 to 2023 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Estradiol Vaginal Insert vs No Treatment: deaths from any cause | Trial comparisons |
| Estradiol Vaginal Insert vs No Treatment: Vaginal Microbiome - Detectable Lactobacillus Crispatus (L. Crispatus) | Trial comparisons |
| Estradiol Vaginal Insert vs No Treatment: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04079218
GET https://conductscience.org/api/trials/v1/NCT04079218/results?page=2