Menopause
Conditions
Interventions
Estradiol estradiol gel plus oral micronized progesterone daily for 12 weeks
Progesterone 100 mg capsules
Placebo for Progesterone
Sponsors
National Institutes of allergy and Infectious Diseases
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Assigned female sex at birth. 2. Age 40 to 60 years. 3. Late menopausal transition or early postmenopause 4. Participant self-report an average of two or more occurrences of moderate or severe menopausal VMS (i.e., hot flashes or night sweats) per day. 5. HIV-1
Exclusion criteria
Exclusion criteria: 1. Unexplained abnormal vaginal bleeding 2. Active use of a prohibited medication 3. Presence of active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in self-reported mean VMS frequency per day from Step 1 observation phase to the one-week period prior to week R + 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in self-reported mean severity of VMS from Step 1 observation phase to the one-week period prior to week R + 12. | — |
Countries
Uganda
Contacts
Public ContactLinda Naini
Clinical Trial Specialist
Outcome results
None listed