Clinical Research Directory
Browse clinical research sites, groups, and studies.
Menopausal HT for Women Living With HIV (HoT)
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Summary
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
Official title: Menopausal Hormone Therapy for Women Living With HIV (HoT)
Key Details
Gender
FEMALE
Age Range
40 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
105
Start Date
2026-04-09
Completion Date
2027-09-20
Last Updated
2026-05-22
Healthy Volunteers
No
Conditions
Interventions
Transdermal estradiol gel
All participants: Estradiol gel 0.1%, 0.75 grams (corresponding to estradiol 0.75 mg) applied to the skin of the upper thigh once daily for 12 weeks.
Micronized Progesterone
Participants with intact uterus: Encapsulated micronized progesterone 100 mg orally once daily for 12 weeks.
Placebo for estradiol gel
All participants: Placebo for estradiol gel 0.1%, 0.75 grams applied to the skin of the upper thigh once daily for 12 weeks.
Placebo for micronized progesterone
• Participants with intact uterus: Encapsulated placebo for micronized progesterone 100 mg orally once daily for 12 weeks.
Locations (23)
31788 Alabama CRS
Birmingham, Alabama, United States
University of California, Los Angeles CARE Center CRS (601)
Los Angeles, California, United States
UCSD Antiviral Research Center CRS (701)
San Diego, California, United States
801 University of California, San Francisco HIV/AIDS CRS
San Francisco, California, United States
Harbor - UCLA Med. Ctr. CRS
Torrance, California, United States
University of Colorado Hospital CRS (6101)
Aurora, Colorado, United States
The Ponce de Leon Center CRS (5802)
Atlanta, Georgia, United States
Northwestern University CRS (2701)
Chicago, Illinois, United States
201 Johns Hopkins University CRS
Baltimore, Maryland, United States
101 Massachusetts General Hospital (MGH) CRS
Boston, Massachusetts, United States
Brigham and Women's Hosp. ACTG CRS (107)
Boston, Massachusetts, United States
2101 Washington University Therapeutics (WT) CRS
St Louis, Missouri, United States
New Jersey Medical School Clinical Research Center CRS (31786)
Newark, New Jersey, United States
Weill Cornell Chelsea CRS (7804)
New York, New York, United States
Columbia Physicians and Surgeons (P&S) CRS (30329)
New York, New York, United States
3201 Chapel Hill CRS
Chapel Hill, North Carolina, United States
3203 Greensboro CRS
Greensboro, North Carolina, United States
2401 Cincinnati CRS
Cincinnati, Ohio, United States
Case CRS (2501)
Cleveland, Ohio, United States
Ohio State University CRS (2301)
Columbus, Ohio, United States
6201 Penn Therapeutics CRS
Philadelphia, Pennsylvania, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States
Houston AIDS Research Team CRS (31473)
Houston, Texas, United States