HIV Infection study: Transdermal estradiol gel vs Micronized Progesterone
Official title Menopausal HT for Women Living With HIV (HoT)
ClinicalTrials.gov ID: NCT06856174
What this study is testing
What is Transdermal estradiol gel?
An investigational hormone therapy being studied to treat hot flashes, night sweats, and related symptoms in women living with HIV. It is designed to deliver estradiol through the skin, where it binds estrogen receptors and helps regulate hormonal pathways that influence vasomotor symptoms.
Also referred to as estradiol gel.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if hormone therapy (estradiol with or without progesterone) helps reduce hot flashes and night sweats and improves mood, sleep, mental function, quality of life, bone and heart health, and safety in women with HIV.
- Who it's for
- Women who have HIV and are going through menopause.
- What's involved
- Participants will take hormone therapy pills or patches and attend study visits where they will have questionnaires, blood tests, and possibly bone or heart scans.
- Time commitment
- The trial lasts several months with regular clinic visits, typically every few weeks to months.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 60, women only
You may be able to join if
- Living with HIV
- Assigned female sex at birth
- Between the ages of 40 and 60 years
- In the late menopausal transition (perimenopause) or early postmenopause
- Experiencing hot flashes and/or night sweats
See the full eligibility criteria
- Living with HIV
- Assigned female sex at birth
- Between the ages of 40 and 60 years
- In the late menopausal transition (perimenopause) or early postmenopause
- Experiencing hot flashes and/or night sweats
- Willing and able to complete a daily diary
- Does not have medical condition that would contraindicate hormone therapy
- Not taking medications to treat hot flashes
- Not taking medications that cannot be combined with hormone therapy
- Receiving antiretrovirals (HIV medication) for more than 1 year
- Not pregnant and willing and able to use at least non-hormonal birth control to prevent pregnancy
- Willing and able to provide informed consent after discussion with the research staff
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Torrance, California, United States
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Newark, New Jersey, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Greensboro, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Los Angeles, California, United States; San Diego, California, United States; San Francisco, California, United States; Torrance, California, United States; Aurora, Colorado, United States and 15 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.