VEDA Study (DHEA vs Estradiol)

Sponsor
University of Arizona
Study ID
NCT07574216
Status
Not Yet Recruiting

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Conditions

  • Menopause
  • Painful Intercourse
  • Post-menopause
  • Pre-menopause
  • Sexual Function
  • Vaginal Dryness

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • DHEA ovals — DRUG
    DHEA (dehydroepiandrosterone) is an inactive hormone precursor naturally produced by the body. When placed locally in the vagina, it is converted by vaginal cells into small amounts of estrogen and androgens exactly where the tissues need them. This helps restore the vaginal lining, improve moisture, and reduce pain.
  • Estradiol 0.01% Vag Cream — DRUG
    Estradiol 0.01% vaginal cream is a local (vaginal) estrogen therapy used to treat symptoms of genitourinary syndrome of menopause (GSM)-the thinning, dryness, and inflammation of vaginal and urinary tissues caused by postmenopausal estrogen decline.

Study Details

This study is being done to compare two vaginal treatments, vaginal estrogen and vaginal DHEA, that are used to treat vaginal and urinary symptoms related to menopause. These symptoms may include vaginal dryness, discomfort, painful intercourse, or urinary problems and can affect quality of life and sexual health. Women who choose to participate will be randomly assigned to use one of the two treatments for a set period of time. Participants will complete questionnaires about their symptoms and sexual health and have simple vaginal testing at the beginning and end of the study. The goal of this research is to better understand how these treatments affect vaginal health and sexual function so healthcare providers can make informed treatment decisions and improve care for postmenopausal women.

Key Dates

First listed
May 7, 2026
Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
324 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: DHEA suppository
  • Active Comparator: Estradiol 0.01% vaginal cream

Primary Outcome Measure

Genitourinary Symptoms [ Time Frame: Baseline/post treatment (6 month follow up) ]

Central Contacts

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