Menopausal ComplaintsPhase 4NCT07526948
Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
A Phase 4 study testing Vaginal estradiol tablets and Vaginal moisturizer in people with Menopausal Complaints and Vaginal Atrophy, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
This is a research study about the effects of vaginal estradiol compared to moisturizer on vaginal symptoms of menopause and the microbiome in women with HIV. This research study aims to understand how vaginal products affect the aging of the female genital tract in women living with HIV who are menopausal or… Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Complaints, Vaginal Atrophy, Genitourinary Symptoms
- What is being tested?
- Vaginal estradiol tablets and Vaginal moisturizer
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to 14 Oct 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female
- at least 40 years old
- menopausal (no menses in 12 months) within 2 years of last menstrual period or perimenopausal in the late menopausal transition, defined as an interval of amenorrhea greater than or equal to 60 days
- have symptoms of the genitourinary syndrome of menopause (GSM) which developed within the prior 2 years. Symptoms of GSM include vaginal symptoms including dryness, soreness, itching, irritation and dyspareunia and/or urinary symptoms including urgency, frequency and recurrent urinary tract infections (UTIs)
Who cannot join
- Unexplained or unevaluated abnormal genital bleeding
- Current or suspected pregnancy
- Desired pregnancy
- If less than 55 years old, have had a hysterectomy and have at least one ovary (as menopause cannot be determined in this case by amenorrhea alone)
- Pelvic or vaginal surgery in the prior 60 days
- Used systemic reproductive hormones in the last 2 months
Show all 17Show fewer
- Used antibiotics in the last 30 days
- Used immunosuppressive medications in the prior 60 days including biologics, chemotherapeutics or post transplant immunosuppressive medications
- Used any vaginal or vulvar preparations in the last month
- Current active vaginal infection diagnosed at study entry
- Any serious disease or condition that may interfere with study compliance
- Current or previous history of breast cancer or estrogen dependent cancer (e.g., ovarian, endometrial)
- Current or previous history of deep vein thrombosis or pulmonary embolism
- Current or previous history of myocardial infarction or stroke
- Known clotting disorder including Protein C, Protein S and antithrombin deficiency, Factor V Leiden or prothrombin mutations
- Known severe liver disease including cirrhosis or active Hepatitis B
- Known allergic reaction to Vagifem (estradiol vaginal tablet) or Replens
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
Kerry J Murphy, MD, 718-839-7885, kerry.murphy@einsteinmed.edu
About this study
Official title: Vaginal Estradiol Versus Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms, Dysbiosis and Markers of Latency Reversal in Menopausal Women Living With HIV
This is a research study about the effects of vaginal estradiol compared to moisturizer on vaginal symptoms of menopause and the microbiome in women with HIV. This research study aims to understand how vaginal products affect the aging of the female genital tract in women living with HIV who are menopausal or perimenopausal and have vaginal or urinary symptoms. There is a comparison group of women who are living without HIV. Participants with HIV and vaginal or urinary menopausal symptoms (e.g., dryness, irritation, soreness, itching, pain with sex, dysuria, urgency, or frequent urinary tract infections) will be asked to apply vaginal estradiol or a vaginal moisturizer (Replens). Participants who have vaginal or urinary menopausal symptoms and do not have HIV will receive vaginal estradiol.
- Conditions
- Menopausal Complaints, Vaginal Atrophy, Genitourinary Symptoms, HIV (Human Immunodeficiency Virus), Menopause Related Conditions, Vaginitis
- Being tested
- Vaginal estradiol tablets, Vaginal moisturizer
- Keywords
- Pain with sex, Vaginal dryness, Symptoms of menopause, HIV Infection, Menopause, Vaginal microbiome, Dysbiosis, Aging, Premature aging, Atrophic vaginitis, Genitourinary syndrome of menopause (GSM), Symptoms of perimenopause
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Vaginitis, HIV Infections, Dysbiosis, Aging, Premature, Atrophic Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal estradiol tabletsDrug
Also called Vagifem
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 16 weeks.
Vaginal moisturizerOther
Also called Replens
Using a pre-loaded single-use plastic applicator, participants will insert one vaginal moisturizer applicator intravaginally twice weekly for the duration of the study for a total of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Estradiol, Participants Living With HIV | Experimental | Participants living with HIV randomized to this arm will use vaginal estradiol tablets for the duration of the study (16 weeks) Receives: Drug: Vaginal estradiol tablets |
| Vaginal Estradiol, Participants without HIV | Active comparator | Participants without HIV enrolled in the study will use vaginal estradiol tablets for the duration of the study (16 weeks).
A control group of women without HIV with GSM (n=12) will be treated with vaginal estradiol for 16 weeks but will not be randomized to moisturizer as topical estrogen has already been shown (and is FDA approved) to improve symptoms and the vaginal microbiome in women without HIV infection. Receives: Drug: Vaginal estradiol tablets |
| Vaginal Moisturizer, Participants Living with HIV | Active comparator | Participants living with HIV randomized to this group will use vaginal moisturizer for the duration of the study (16 weeks) Receives: Other: Vaginal moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the vaginal microbiome (bacteria) as defined by the change in alpha diversity
Changes in the vaginal microbiome as defined by the change in alpha diversity from baseline to 16 weeks will be assessed. It is hypothesized that this may be a biomarker for improvement in vaginal health. Lower alpha diversity would indicate a favorable change in the microbiome.
Measured: From Baseline to 16 weeks
Secondary outcomes (1)
Change in genitourinary syndrome of menopause (GSM) symptoms as defined by the composite GSM symptom index
Using a survey administered at each visit, participants will rate the severity of five vaginal (dryness, itching, irritation, soreness, and dyspareunia) and three urinary (frequency, urgency, recurrent UTIs) symptoms based on a four-point scale (0=none, 1=mild, 2=moderate, 3=severe). A composite GSM symptom index will be calculated as the mean severity of the corresponding symptoms at each visit. A higher score indicates increased severity of symptoms.
It is anticipated that both vaginal estradiol and the vaginal moisturizer will lead to improvement in the symptoms of the genitourinary syndrome of menopause.
Measured: From Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startSep 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion14 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Menopausal ComplaintsStudies 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 living with HIV will be randomly assigned to receive treatment with estradiol vaginal tablets or to vaginal moisturizer (Replens). Participants without HIV will receive treatment with estradiol vaginal tablets.
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Zymo Research, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Kerry J Murphy, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526948
- Sponsor's protocol ID
- 2026-17642
- Other IDs
- R01AG102277
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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
Srinivasan S, Hua X, Wu MC, Proll S, Valint DJ, Reed SD, Guthrie KA, LaCroix AZ, Larson JC, Pepin R, Bhasin S, Raftery D, Fredricks DN, Mitchell CM. Impact of Topical Interventions on the Vaginal Microbiota and Metabolome in Postmenopausal Women: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e225032. doi: 10.1001/jamanetworkopen.2022.5032.
PubMed 35353163Murphy 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 31026271Shen 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 27103314Hummelen 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 22073175Brotman 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 30358729Mitchell 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 29554173Murphy K, Gromisch M, Connolly J, Wang T, McWalters J, Atrio J, Mahant AM, Gera S, Colanta A, Cajigas A, Kelly L, Estrella H, Gustafson D, Minkoff H, Anastos K, Keller MJ, Herold BC. Impact of Vaginal Estradiol on the Genitourinary Syndrome of Menopause, Vaginal Microbiome and Mucosal Immune Mediators in Women With HIV. Clin Infect Dis. 2026 Apr 30;82(4):e710-e719. doi: 10.1093/cid/ciaf669.
PubMed 41355723
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Estradiol Versus Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms, Dysbiosis and Markers of Latency Reversal in Menopausal Women Living With HIV
- ClinicalTrials.gov ID
- NCT07526948
- Acronym / sponsor ID
- 2026-17642
- Conditions
- Menopausal Complaints, Vaginal Atrophy, Genitourinary Symptoms, HIV (Human Immunodeficiency Virus), Menopause Related Conditions, Vaginitis
- Keywords
- Pain with sex, Vaginal dryness, Symptoms of menopause, HIV Infection, Menopause, Vaginal microbiome, Dysbiosis, Aging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Yale University, Zymo Research, National Institute on Aging (NIA)
- Study start
- Sep 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 14 Oct 2029 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study about the effects of vaginal estradiol compared to moisturizer on vaginal symptoms of menopause and the microbiome in women with HIV. This research study aims to understand how vaginal products affect the aging of the female genital tract in women living with HIV who are menopausal or perimenopausal and have vaginal or urinary symptoms. There is a comparison group of women who are living without HIV. Participants with HIV and vaginal or urinary menopausal symptoms (e.g., dryness, irritation, soreness, itching, pain with sex, dysuria, urgency, or frequent urinary tract infections) will be asked to apply vaginal estradiol or a vaginal moisturizer (Replens). Participants who have vaginal or urinary menopausal symptoms and do not have HIV will receive vaginal estradiol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants living with HIV will be randomly assigned to receive treatment with estradiol vaginal tablets or to vaginal moisturizer (Replens). Participants without HIV will receive treatment with estradiol vaginal tablets.
| Arm | Type | Receives |
|---|---|---|
| Vaginal Estradiol, Participants Living With HIV | Experimental | Drug: Vaginal estradiol tabletsParticipants living with HIV randomized to this arm will use vaginal estradiol tablets for the duration of the study (16 weeks) |
| Vaginal Estradiol, Participants without HIV | Active comparator | Drug: Vaginal estradiol tabletsParticipants without HIV enrolled in the study will use vaginal estradiol tablets for the duration of the study (16 weeks). A control group of women without HIV with GSM (n=12) will be treated with vaginal estradiol for 16 weeks but will not be randomized to moisturizer as topical estrogen has already been shown (and is FDA approved) to improve symptoms and the vaginal microbiome in women without HIV infection. |
| Vaginal Moisturizer, Participants Living with HIV | Active comparator | Other: Vaginal moisturizerParticipants living with HIV randomized to this group will use vaginal moisturizer for the duration of the study (16 weeks) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female
- at least 40 years old
- menopausal (no menses in 12 months) within 2 years of last menstrual period or perimenopausal in the late menopausal transition, defined as an interval of amenorrhea greater than or equal to 60 days
- have symptoms of the genitourinary syndrome of menopause (GSM) which developed within the prior 2 years. Symptoms of GSM include vaginal symptoms including dryness, soreness, itching, irritation and dyspareunia and/or urinary symptoms including urgency, frequency and recurrent urinary tract infections (UTIs)
Key exclusion criteria (17 listed)
- Unexplained or unevaluated abnormal genital bleeding
- Current or suspected pregnancy
- Desired pregnancy
- If less than 55 years old, have had a hysterectomy and have at least one ovary (as menopause cannot be determined in this case by amenorrhea alone)
- Pelvic or vaginal surgery in the prior 60 days
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 |
|---|---|---|
| Vaginal estradiol tabletsAlso: VagifemUsing 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 16 weeks. | Drug | Vaginal Estradiol, Participants Living With HIV, Vaginal Estradiol, Participants without HIV |
| Vaginal moisturizerAlso: ReplensUsing a pre-loaded single-use plastic applicator, participants will insert one vaginal moisturizer applicator intravaginally twice weekly for the duration of the study for a total of 12 weeks. | Other | Vaginal Moisturizer, Participants Living with HIV |
Primary outcome
Change in the vaginal microbiome (bacteria) as defined by the change in alpha diversity
Time frame: From Baseline to 16 weeks
Changes in the vaginal microbiome as defined by the change in alpha diversity from baseline to 16 weeks will be assessed. It is hypothesized that this may be a biomarker for improvement in vaginal health. Lower alpha diversity would indicate a favorable change in the microbiome.
1 secondary outcome
Change in genitourinary syndrome of menopause (GSM) symptoms as defined by the composite GSM symptom index
Time frame: From Baseline to 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Background: PubMed 35353163Srinivasan S, Hua X, Wu MC, Proll S, Valint DJ, Reed SD, Guthrie KA, LaCroix AZ, Larson JC, Pepin R, Bhasin S, Raftery D, Fredricks DN, Mitchell CM. Impact of Topical Interventions on the Vaginal Microbiota and Metabolome in Postmenopausal Women: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e225032. doi: 10.1001/jamanetworkopen.2022.5032.
- 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.
- Background: PubMed 41355723Murphy K, Gromisch M, Connolly J, Wang T, McWalters J, Atrio J, Mahant AM, Gera S, Colanta A, Cajigas A, Kelly L, Estrella H, Gustafson D, Minkoff H, Anastos K, Keller MJ, Herold BC. Impact of Vaginal Estradiol on the Genitourinary Syndrome of Menopause, Vaginal Microbiome and Mucosal Immune Mediators in Women With HIV. Clin Infect Dis. 2026 Apr 30;82(4):e710-e719. doi: 10.1093/cid/ciaf669.
- 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.
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 Vaginal estradiol tablets and Vaginal moisturizer in people with Menopausal Complaints and Vaginal Atrophy, run by Albert Einstein College of Medicine 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 4 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: opening soon, as of the sponsor's last update on 28 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kerry J Murphy, MD (718-839-7885, kerry.murphy@einsteinmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the vaginal microbiome (bacteria) as defined by the change in alpha diversity (time frame: From Baseline to 16 weeks). 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 NCT07526948, which also lists 7 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 28 Jul 2026.