Menopausal Hormone Therapy for Women Living With HIV (HoT)

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

Age range

40–60 years

Sex

Female

Healthy volunteers

No

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.

Locations (23)