HIV InfectionPhase 4NCT04079218

Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial

A Phase 4 study testing Estradiol Vaginal Insert in people with HIV Infection and Vaginal Atrophy, run by Kerry Murphy at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for: HIV Infection, Vaginal Atrophy, Menopause
What is being tested?: Estradiol Vaginal Insert
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2020to 9 Aug 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 70 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

HIV infection
Females aged 45-70
Menopause defined by having no menstrual periods for 12 consecutive months, confirmed with serum follicle-stimulating hormone (FSH) level >40 IU/ml and serum estradiol level <20 pg/ml
Symptomatic vaginal atrophy defined as reporting at least once per week in the past 30 days, 1 or more of the following symptoms of moderate or severe intensity: Dryness, Itching, Irritation, Soreness or pain OR Pain associated with sexual activity at least once
Evidence of atrophy on exam, including thin, pale and dry vaginal and vulvar surfaces
Agrees not to use vaginal products other than vaginal estradiol tablet during the clinical trial

Who cannot join

Current or previous history of breast cancer or estrogen dependent neoplasia
Current or past thromboembolic disease (deep vein thrombosis or pulmonary embolism, not including thrombophlebitis)
Current or previous history of myocardial infarction or stroke
Known blood clotting disorders including Protein C, Protein S and antithrombin deficiency, Factor V Leiden or prothrombin mutations
Known severe liver disease including cirrhosis or active Hepatitis B
History of adverse reaction to vaginal estradiol

Show all 17Show fewer

Current unexplained or unevaluated abnormal genital bleeding
Current or suspected pregnancy
If < age 55, had a hysterectomy and has at least one ovary
Pelvic or vaginal surgery in the prior 60 days
Use of systemic reproductive hormones in the past 2 months
Antibiotic use in the past 30 days
Use of immunosuppressive medications in the prior 60 days including biologics, chemotherapeutics or post-transplant immunosuppressive medications
Use of any vaginal or vulvar preparations 1 month prior to enrollment
Current active vaginal infection (diagnosed by wet mount at Visit 1 or 2)
Any serious disease or chronic condition that might interfere with study compliance
Unwilling to agree to the provisions of the protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

Albert Einstein College of Medicine
The Bronx, New York, 10461

Other trials in United States

About this study

Official title: 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

During menopause, there is a decrease in a hormone estrogen, which leads to aging of the vagina. Vaginal aging includes changes in the type and amount of healthy bacteria in the vagina, inflammation and a breakdown of natural barriers that keep the vagina healthy and protected from infections. Some menopausal women develop a condition called vaginal atrophy, which causes vaginal dryness, irritation, pain with sex, and itching. We are testing whether an estradiol tablet placed inside the vagina will lead to fewer changes in the types of bacteria present in the vagina, improve vaginal atrophy symptoms and ultimately keep the vagina healthier for a longer. This is important for women with HIV as they are living longer, healthier, sexually active lives due to successful treatment with antiretrovirals.

Read the detailed description

HIV may be associated with premature aging in the female genital tract including alterations in the vaginal microbiome and mucosal inflammation, which may increase risk for vaginal atrophy, urinary tract infections (UTI) and other genital tract infections. This study will determine whether use of vaginal estradiol for 12 weeks in menopausal women living with HIV with symptomatic vaginal atrophy will improve atrophy symptoms and the vaginal microbiome and reduce mucosal inflammation thereby improving vaginal health. This study will include 50 participants randomized to treatment with a vaginal estradiol insert or no therapy for 12 weeks and will have 4 study visits.

Conditions: HIV Infection, Vaginal Atrophy, Menopause, Menopause Related Conditions, Aging, Premature Aging
Being tested: Estradiol Vaginal Insert
Keywords: HIV Infection, Vaginal Atrophy, Menopause, Vaginal Microbiome, Microbiome, Dysbiosis, Aging, Premature Aging, Atrophic Vaginitis
Medical subject headings: HIV Infections, Aging, Premature, Atrophic Vaginitis, Dysbiosis, Vaginitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Estradiol Vaginal InsertDrug
Also called Vagifem®, Vagifem (estradiol vaginal tablet)
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.

Study groups in NCT04079218
Study group	Role	What they receive
Estradiol Vaginal Insert	Experimental	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. Receives: Drug: Estradiol Vaginal Insert
No treatment	No intervention	No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy
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.
Measured: Between baseline (Visit 2) and 12 weeks (Visit 5)
Vaginal Microbiome - Relative Abundance of Lactobacillus Crispatus (L. Crispatus)
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.
Measured: Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5)
Vaginal Microbiome - Quantitative Determination of Protective Lactobacilli Species
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.
Measured: Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5)

Secondary outcomes (3)

Vaginal Microbiome - Relative Abundance of Bacterial Vaginosis Associated Species
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)
Measured: Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5)
Vaginal Microbiome - Quantitative Determination of Bacterial Vaginosis Associated Species
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.
Measured: Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5)
Change in Vaginal Cytokine and Chemokine Concentrations
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.
Measured: Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20209 Aug 2023

First posted6 Sep 2019
Study start1 Sep 2020
Primary completion9 Aug 2023
Study completion9 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HIV InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomly assigned to receive treatment with estradiol vaginal tablets or no treatment.
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04079218
Sponsor's protocol ID: 2019-10529
Other IDs: 1K23AG062400-01A1, 2019
Status last verified: Feb 2025
First submitted: 3 Sep 2019
Last updated: 14 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: After publication of the main study findings, external investigators may contact the Principal Investigator Dr. Kerry Murphy for de-identified datasets.

Publications

Murphy K, Keller MJ, Anastos K, Sinclair S, Devlin JC, Shi Q, Hoover DR, Starkman B, McGillick J, Mullis C, Minkoff H, Dominguez-Bello MG, Herold BC. Impact of reproductive aging on the vaginal microbiome and soluble immune mediators in women living with and at-risk for HIV infection. PLoS One. 2019 Apr 26;14(4):e0216049. doi: 10.1371/journal.pone.0216049. eCollection 2019.
PubMed 31026271
Shen J, Song N, Williams CJ, Brown CJ, Yan Z, Xu C, Forney LJ. Effects of low dose estrogen therapy on the vaginal microbiomes of women with atrophic vaginitis. Sci Rep. 2016 Apr 22;6:24380. doi: 10.1038/srep24380.
PubMed 27103314
Hummelen R, Macklaim JM, Bisanz JE, Hammond JA, McMillan A, Vongsa R, Koenig D, Gloor GB, Reid G. Vaginal microbiome and epithelial gene array in post-menopausal women with moderate to severe dryness. PLoS One. 2011;6(11):e26602. doi: 10.1371/journal.pone.0026602. Epub 2011 Nov 2.
PubMed 22073175
Brotman RM, Shardell MD, Gajer P, Fadrosh D, Chang K, Silver MI, Viscidi RP, Burke AE, Ravel J, Gravitt PE. Association between the vaginal microbiota, menopause status, and signs of vulvovaginal atrophy. Menopause. 2018 Nov;25(11):1321-1330. doi: 10.1097/GME.0000000000001236.
PubMed 30358729
Mitchell CM, Reed SD, Diem S, Larson JC, Newton KM, Ensrud KE, LaCroix AZ, Caan B, Guthrie KA. Efficacy of Vaginal Estradiol or Vaginal Moisturizer vs Placebo for Treating Postmenopausal Vulvovaginal Symptoms: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):681-690. doi: 10.1001/jamainternmed.2018.0116.
PubMed 29554173

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04079218
Acronym / sponsor ID: 2019-10529
Conditions: HIV Infection, Vaginal Atrophy, Menopause, Menopause Related Conditions, Aging, Premature Aging
Keywords: HIV Infection, Vaginal Atrophy, Menopause, Vaginal Microbiome, Microbiome, Dysbiosis, Aging, Premature Aging
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Kerry MurphyUniversity, hospital or other
Collaborators: National Institute on Aging (NIA), Novo Nordisk A/S, Irma L and Abram S Croll Charitable Trust
Study start: 1 Sep 2020 (actual)
Primary completion: 9 Aug 2023 (actual)
Study completion: 9 Aug 2023 (actual)
First posted: 6 Sep 2019 (actual)
Results: Posted 14 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants will be randomly assigned to receive treatment with estradiol vaginal tablets or no treatment.

Arm	Type	Receives
Estradiol Vaginal Insert	Experimental	Drug: Estradiol Vaginal InsertUsing 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.
No treatment	No intervention	–No intervention

Who may qualify

Ages: 45 to 70 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

HIV infection
Females aged 45-70
Menopause defined by having no menstrual periods for 12 consecutive months, confirmed with serum follicle-stimulating hormone (FSH) level >40 IU/ml and serum estradiol level <20 pg/ml
Symptomatic vaginal atrophy defined as reporting at least once per week in the past 30 days, 1 or more of the following symptoms of moderate or severe intensity: Dryness, Itching, Irritation, Soreness or pain OR Pain associated with sexual activity at least once
Evidence of atrophy on exam, including thin, pale and dry vaginal and vulvar surfaces

Key exclusion criteria (17 listed)

Current or previous history of breast cancer or estrogen dependent neoplasia
Current or past thromboembolic disease (deep vein thrombosis or pulmonary embolism, not including thrombophlebitis)
Current or previous history of myocardial infarction or stroke
Known blood clotting disorders including Protein C, Protein S and antithrombin deficiency, Factor V Leiden or prothrombin mutations
Known severe liver disease including cirrhosis or active Hepatitis B

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Estradiol Vaginal InsertAlso: Vagifem®, Vagifem (estradiol vaginal tablet)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.	Drug	Estradiol Vaginal Insert

Primary outcome

Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy
Time frame: 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.
Vaginal Microbiome - Relative Abundance of Lactobacillus Crispatus (L. Crispatus)
Time frame: 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.
Vaginal Microbiome - Quantitative Determination of Protective Lactobacilli Species
Time frame: 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.

3 secondary outcomes

Vaginal Microbiome - Relative Abundance of Bacterial Vaginosis Associated Species
Time frame: Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5)
Vaginal Microbiome - Quantitative Determination of Bacterial Vaginosis Associated Species
Time frame: Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5)
Change in Vaginal Cytokine and Chemokine Concentrations
Time frame: Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5)

Results and safety

Results posted to the registry on 14 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Estradiol Vaginal Insert	33	25
No Treatment	27	26

Primary outcome: Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy

Time frame: Between baseline (Visit 2) and 12 weeks (Visit 5). Count of participants. Unit: Participants

Measure	Estradiol Vaginal Insert n = 21	No Treatment n = 16
Itching: Severity Increased	0	1
Itching: Severity Decreased	8	4
Itching: No change in Severity	0	1
Dryness: Severity Increased	0	1
Dryness: Severity Decreased	9	3
Dryness: No change in Severity	1	6
Soreness: Severity Increased	0	0
Soreness: Severity Decreased	1	0

Population analysed: 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.

Primary outcome: Vaginal Microbiome - Relative Abundance of Lactobacillus Crispatus (L. Crispatus)

Time frame: Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5). Mean (Standard Deviation). Unit: change in percentage of sequences

Measure	Estradiol Vaginal Insert n = 22	No Treatment n = 25
Value	-1.37 (4.25)	-6.9 (25.14)

Population analysed: 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.

Primary outcome: Vaginal Microbiome - Quantitative Determination of Protective Lactobacilli Species

Time frame: Between baseline (Visit 2) and 6 weeks and 12 weeks (Visit 5)

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 13 weeks following randomization. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Estradiol Vaginal Insert	4 of 33 (12.1%)	20 of 33 (60.6%)	1 of 33
No Treatment	2 of 27 (7.4%)	10 of 27 (37%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31026271Murphy K, Keller MJ, Anastos K, Sinclair S, Devlin JC, Shi Q, Hoover DR, Starkman B, McGillick J, Mullis C, Minkoff H, Dominguez-Bello MG, Herold BC. Impact of reproductive aging on the vaginal microbiome and soluble immune mediators in women living with and at-risk for HIV infection. PLoS One. 2019 Apr 26;14(4):e0216049. doi: 10.1371/journal.pone.0216049. eCollection 2019.
Background: PubMed 27103314Shen J, Song N, Williams CJ, Brown CJ, Yan Z, Xu C, Forney LJ. Effects of low dose estrogen therapy on the vaginal microbiomes of women with atrophic vaginitis. Sci Rep. 2016 Apr 22;6:24380. doi: 10.1038/srep24380.
Background: PubMed 22073175Hummelen R, Macklaim JM, Bisanz JE, Hammond JA, McMillan A, Vongsa R, Koenig D, Gloor GB, Reid G. Vaginal microbiome and epithelial gene array in post-menopausal women with moderate to severe dryness. PLoS One. 2011;6(11):e26602. doi: 10.1371/journal.pone.0026602. Epub 2011 Nov 2.
Background: PubMed 30358729Brotman RM, Shardell MD, Gajer P, Fadrosh D, Chang K, Silver MI, Viscidi RP, Burke AE, Ravel J, Gravitt PE. Association between the vaginal microbiota, menopause status, and signs of vulvovaginal atrophy. Menopause. 2018 Nov;25(11):1321-1330. doi: 10.1097/GME.0000000000001236.
Background: PubMed 29554173Mitchell CM, Reed SD, Diem S, Larson JC, Newton KM, Ensrud KE, LaCroix AZ, Caan B, Guthrie KA. Efficacy of Vaginal Estradiol or Vaginal Moisturizer vs Placebo for Treating Postmenopausal Vulvovaginal Symptoms: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):681-690. doi: 10.1001/jamainternmed.2018.0116.
Individual participant dataSharing planned: Yes. After publication of the main study findings, external investigators may contact the Principal Investigator Dr. Kerry Murphy for de-identified datasets.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kerry J Murphy, MD principal investigator

Albert Einstein College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Estradiol Vaginal Insert in people with HIV Infection and Vaginal Atrophy, run by Kerry Murphy at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Most Bothersome Symptom (MBS) of Vaginal Atrophy (time frame: Between baseline (Visit 2) and 12 weeks (Visit 5)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04079218, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.