Menopausal HT for Women Living With HIV (HoT)
Public ClinicalTrials.gov record NCT06856174. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Menopausal Hormone Therapy for Women Living With HIV (HoT)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Women living with HIV have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without HIV. This correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function, interference with activities of daily living including work, and worse overall quality of life. Hormone therapy is considered to be the most effective therapy for hot flashes and night sweats and the most appropriate choice to prevent bone loss at the time of menopause for women without HIV. However, the usefulness of hormone therapy has not been specifically studied in women living with HIV. This trial is being done to see if: * There is evidence to support the use of hormone therapy (estradiol with or without progesterone) for the treatment of hot flashes and night sweats in women living with HIV * Hormone therapy improves mental function, mood, sleep, quality of life, bone health, heart health, and inflammation in women living with HIV * Hormone therapy is safe and tolerable for women living with HIV
Study identification
- NCT ID
- NCT06856174
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 105 participants
Conditions and interventions
Conditions
Interventions
- Transdermal estradiol gel Drug
- Micronized Progesterone Drug
- Placebo for estradiol gel Drug
- Placebo for micronized progesterone Drug
Drug
Eligibility (public fields only)
- Age range
- 40 Years to 60 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 8, 2026
- Primary completion
- Sep 19, 2027
- Completion
- Sep 19, 2027
- Last update posted
- May 21, 2026
2026 – 2027
United States locations
- U.S. sites
- 23
- U.S. states
- 14
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 31788 Alabama CRS | Birmingham | Alabama | 35294 | Recruiting |
| University of California, Los Angeles CARE Center CRS (601) | Los Angeles | California | 90035 | Recruiting |
| UCSD Antiviral Research Center CRS (701) | San Diego | California | 92103 | Recruiting |
| 801 University of California, San Francisco HIV/AIDS CRS | San Francisco | California | 94110 | Recruiting |
| Harbor - UCLA Med. Ctr. CRS | Torrance | California | 90502 | Recruiting |
| University of Colorado Hospital CRS (6101) | Aurora | Colorado | 80045 | Recruiting |
| The Ponce de Leon Center CRS (5802) | Atlanta | Georgia | 30308 | Recruiting |
| Northwestern University CRS (2701) | Chicago | Illinois | 60611 | Recruiting |
| 201 Johns Hopkins University CRS | Baltimore | Maryland | 21205 | Recruiting |
| 101 Massachusetts General Hospital (MGH) CRS | Boston | Massachusetts | 02114 | Recruiting |
| Brigham and Women's Hosp. ACTG CRS (107) | Boston | Massachusetts | 02115 | Recruiting |
| 2101 Washington University Therapeutics (WT) CRS | St Louis | Missouri | 63110 | Recruiting |
| New Jersey Medical School Clinical Research Center CRS (31786) | Newark | New Jersey | 07103 | Recruiting |
| Weill Cornell Chelsea CRS (7804) | New York | New York | 10010 | Recruiting |
| Columbia Physicians and Surgeons (P&S) CRS (30329) | New York | New York | 10032 | Recruiting |
| 3201 Chapel Hill CRS | Chapel Hill | North Carolina | 27516 | Recruiting |
| 3203 Greensboro CRS | Greensboro | North Carolina | 27401 | Recruiting |
| 2401 Cincinnati CRS | Cincinnati | Ohio | 45267-0405 | Recruiting |
| Case CRS (2501) | Cleveland | Ohio | 44106 | Recruiting |
| Ohio State University CRS (2301) | Columbus | Ohio | 43210 | Recruiting |
| 6201 Penn Therapeutics CRS | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Univ of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | Recruiting |
| Houston AIDS Research Team CRS (31473) | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06856174, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 21, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06856174 live on ClinicalTrials.gov.