A Phase 4 interventional study of Vaginal estradiol tablets and Vaginal moisturizer in Menopausal Complaints, Vaginal Atrophy and Genitourinary Symptoms, sponsored by Albert Einstein College of Medicine. Not yet recruiting at 1 site in United States. Open to female participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Albert Einstein College of Medicine · Phase 4, Interventional, and Treatment
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.
98 studies on the registry are indexed under Vaginitis; 12 are open to participants now.
This study's planned enrollment of 62 is below the median of 108 across 71 interventional studies indexed under Vaginitis.
Browse Vaginitis studies →Albert Einstein College of Medicine is the lead sponsor of 201 studies on the registry; 21 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 37 (80%) have results posted.
Compared within Vaginitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants living with HIV randomized to this arm will use vaginal estradiol tablets for the duration of the study (16 weeks)
Drug: Vaginal estradiol tablets
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.
Drug: Vaginal estradiol tablets
Participants living with HIV randomized to this group will use vaginal moisturizer for the duration of the study (16 weeks)
Other: Vaginal moisturizer
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.
Also known as: Vagifem
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.
Also known as: Replens
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.
Time frame: From Baseline to 16 weeks
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.
Time frame: From Baseline to 16 weeks
Plan to share: Yes — After publication of the main study findings, external investigators may contact the Principal Investigator Dr. Kerry Murphy for de-identified datasets.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Within 12 months after publication
Access criteria: De-identified electronic datasets of published results will be made available to external investigators in a format in which subsequent statistical analyses can be performed.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Estradiol
Albert Einstein College of Medicine →