Menopausal HT for Women Living With HIV (HoT)
Start Date
4/9/2026
Completion Date
9/20/2027
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
Eligibility Criteria
Age Range: 40 years to 60 years
Interventions
Transdermal estradiol gel
Micronized Progesterone
Placebo for estradiol gel
Placebo for micronized progesterone
Conditions
Locations
31788 Alabama CRS
Birmingham, Alabama 35294
United States
University of California, Los Angeles CARE Center CRS (601)
Los Angeles, California 90035
United States
UCSD Antiviral Research Center CRS (701)
San Diego, California 92103
United States
801 University of California, San Francisco HIV/AIDS CRS
San Francisco, California 94110
United States
Harbor - UCLA Med. Ctr. CRS
Torrance, California 90502
United States
University of Colorado Hospital CRS (6101)
Aurora, Colorado 80045
United States
The Ponce de Leon Center CRS (5802)
Atlanta, Georgia 30308
United States
Northwestern University CRS (2701)
Chicago, Illinois 60611
United States
201 Johns Hopkins University CRS
Baltimore, Maryland 21205
United States
101 Massachusetts General Hospital (MGH) CRS
Boston, Massachusetts 02114
United States
Brigham and Women's Hosp. ACTG CRS (107)
Boston, Massachusetts 02115
United States
2101 Washington University Therapeutics (WT) CRS
St Louis, Missouri 63110
United States
New Jersey Medical School Clinical Research Center CRS (31786)
Newark, New Jersey 07103
United States
Weill Cornell Chelsea CRS (7804)
New York, New York 10010
United States
Columbia Physicians and Surgeons (P&S) CRS (30329)
New York, New York 10032
United States
3201 Chapel Hill CRS
Chapel Hill, North Carolina 27516
United States
3203 Greensboro CRS
Greensboro, North Carolina 27401
United States
2401 Cincinnati CRS
Cincinnati, Ohio 45267-0405
United States
Case CRS (2501)
Cleveland, Ohio 44106
United States
Ohio State University CRS (2301)
Columbus, Ohio 43210
United States
6201 Penn Therapeutics CRS
Philadelphia, Pennsylvania 19104
United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania 15213
United States
Houston AIDS Research Team CRS (31473)
Houston, Texas 77030
United States