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Recruiting NCT06856174

Menopausal HT for Women Living With HIV (HoT)

Phase IV Interventional HIV Infection Menopause

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transdermal estradiol gel, Micronized Progesterone, Placebo for estradiol gel, Placebo for micronized progesterone.
Who it may be relevant to
Registry conditions: HIV Infection, Menopause. Basic parameters: 40 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Menopausal Hormone Therapy for Women Living With HIV (HoT)

Overview

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

Interventions

  • Drug 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.
  • Drug Micronized Progesterone
    Participants with intact uterus: Encapsulated micronized progesterone 100 mg orally once daily for 12 weeks.
  • Drug 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.
  • Drug Placebo for micronized progesterone
    • Participants with intact uterus: Encapsulated placebo for micronized progesterone 100 mg orally once daily for 12 weeks.

Primary outcome measures

  • Change in vasomotor symptoms (VMS) frequency [Time frame: From 5 weeks prior to randomization to Week 12]
Secondary outcome measures (12)
  • Change in vasomotor symptom (VMS) severity [Time frame: From 5 weeks prior to randomization to week 12]
  • Change in sleep [Time frame: From randomization to week 12]
  • Change in insomnia [Time frame: From randomization to week 12]
  • Change in quality of life [Time frame: From randomization to week 12]
  • Percentage of participants with adverse events associated with hormone therapy [Time frame: From randomization to week 12]
  • Percentage of participants with occurrence of abnormal vaginal bleeding [Time frame: From randomization to week 12]
  • Percentage of participants with intolerance of hormone therapy [Time frame: From randomization to week 12]
  • Change in neurocognitive test results [Time frame: From randomization to week 12]
  • Change in depression symptoms [Time frame: From randomization to week 12]
  • Change in anxiety symptoms [Time frame: From randomization to week 12]
  • Change in weight [Time frame: From randomization to week 12]
  • Change in body mass index (BMI) [Time frame: From randomization to week 12]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 23 centers
  • 31788 Alabama CRS — Birmingham
  • University of California, Los Angeles CARE Center CRS (601) — Los Angeles
  • UCSD Antiviral Research Center CRS (701) — San Diego
  • 801 University of California, San Francisco HIV/AIDS CRS — San Francisco
  • Harbor - UCLA Med. Ctr. CRS — Torrance
  • University of Colorado Hospital CRS (6101) — Aurora
  • The Ponce de Leon Center CRS (5802) — Atlanta
  • Northwestern University CRS (2701) — Chicago
  • … and 15 more centers

Identifiers

NCT: NCT06856174 · ACTG A5424 · UM1AI068636

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗