Hormone therapy for hot flashes in women living with HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 trial will evaluate the safety and effectiveness of transdermal estradiol gel with or without micronized progesterone compared with placebos in women living with HIV who are late perimenopausal or early postmenopausal and experience hot flashes or night sweats. Participants will use daily diaries to track symptoms and daily functioning, sleep, mood, and bone health measures. The study aims to determine if hormone therapy offers benefits beyond symptom relief, including improvements in mood, sleep, mental function, and bone health, without unacceptable risks. The trial is conducted at multiple centers in the United States and is sponsored with collaborators from NIAID, NIA, and Exeltis.

Why it matters

Who can join: the full rules

* 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

Where it's running

• 31788 Alabama CRS
  Birmingham, Alabama, United States Recruiting
• University of California, Los Angeles CARE Center CRS (601)
  Los Angeles, California, United States Recruiting
• UCSD Antiviral Research Center CRS (701)
  San Diego, California, United States Recruiting
• 801 University of California, San Francisco HIV/AIDS CRS
  San Francisco, California, United States Recruiting
• Harbor - UCLA Med. Ctr. CRS
  Torrance, California, United States Recruiting
• University of Colorado Hospital CRS (6101)
  Aurora, Colorado, United States Recruiting

Study contacts

• Study coordinator: ACTG ClinicalTrials.gov Coordinator
• Email: ACTGCT.gov@dlhcorp.com
• Phone: 301-628-3348

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Hop extract vs soy isoflavone for menopausal symptoms

  This study tests whether a full-spectrum hop extract helps reduce menopausal mood symptoms better than soy isoflavones in peri- and postmenopausal women.

  Recruiting Menoclinica by Palacios · Madrid, Madrid · NCT07904390

• Resveratrol and Estrogen Receptors in Postmenopausal Women with CAD

  This study tests whether taking resveratrol is safe and can change estrogen-related markers in postmenopausal women with coronary artery disease.

  Recruiting InCor Heart Institute · São Paulo, São Paulo · NCT07865377

• Ashoka Bark and Shatavari for Menopause

  This 12-week study tests whether a daily Ashoka Bark and Shatavari supplement helps reduce menopausal symptoms in postmenopausal women compared with a placebo.

  Recruiting Vidya USA Corporation · New Port Richey, Florida · NCT07861295

• Lifestyle changes to ease menopausal symptoms, sleep problems, and anxiety

  Researchers are testing whether a structured lifestyle education program helps perimenopausal and postmenopausal women see fewer menopausal symptoms, better sleep, and less anxiety compared to usual care.

  Recruiting Konya Beyhekim Training and Research Hospital · Konya, Konya · NCT07860645

• Pain and period life: does menstrual cycle or menopause change pain during root canals?

  This study will see if pain during a root canal varies with menstrual cycle phase or menopausal status in adult patients.

  Recruiting Nigde Omer Halisdemir University · Niğde · NCT07850167

• Sex hormones, menopause, and exercise in aging women

  This study tests how hormonal status and resistance training affect age-related muscle and nerve function in postmenopausal women.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT07848438

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.