Recruiting

Vaginal Estrogen & DHEA

Sponsor:

University of Arizona

Code:

NCT07574216

Conditions

Post-menopause

Pre-menopause

Sexual Function

Menopause

Vaginal Dryness

Eligibility Criteria

Sex: Female

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

DHEA ovals

Estradiol 0.01% Vag Cream

Study Details

Brief summary:

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.

Conditions

Post-menopause

Pre-menopause

Sexual Function

Menopause

Vaginal Dryness

Study ID

NCT07574216

Start date

Aug 4, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Dec 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Peri- or post-menopausal status
  • Presence of any genitourinary or vaginal symptom (e.g., dryness, itching, discomfort, dyspareunia)
  • Willingness and ability to use vaginal therapy
  • Ability to provide informed consent
  • English speaker
  • Ages 40-90

Exclusion Criteria:

  • Use of systemic hormone therapy within the last 6 months
  • Gynecologic malignancy
  • Known allergy to study medications
  • Active vaginal infection at enrollment
  • Prior pelvic radiation

Study Design

Enrollment

324 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: DHEA suppository

active comparator: Estradiol 0.01% vaginal cream

Interventions

DHEA ovals

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Iridian (Iris) Jaramillo, M.S.

602-827-2078iyjaramillo@arizona.edu

Pamela C Garcia-Filion, MD

602-827-2882pgarciafilion@arizona.edu

Locations

Banner University Medical Center Phoenix

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Iris Jaramillo

602-827-2078iyjarami@arizona.edu

Pamela C Garcia-Filion, MD

602-827-2882pgarciafilion@arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Keywords

  • DHEA
  • vaginal estrogen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of Arizona on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.