VEDA Study (DHEA vs Estradiol)

University of Arizona

Status

Begins enrollment this month

Conditions

Painful Intercourse

Pre-menopause

Menopause

Vaginal Dryness

Sexual Function

Post-menopause

Treatments

Drug: Estradiol 0.01% Vag Cream

Drug: DHEA ovals

Study type

Interventional

Funder types

Other

Identifiers

NCT07574216

STUDY00007779

Details and patient eligibility

About

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.

Full description

This research study is being conducted to compare two commonly used vaginal therapies vaginal estrogen and vaginal DHEA for the treatment of vaginal and urinary symptoms that occur after menopause. Many postmenopausal women experience symptoms such as vaginal dryness, irritation, painful intercourse, decreased sexual comfort, or urinary symptoms including burning, urgency, or recurrent urinary discomfort. These symptoms, often related to decreased estrogen levels, can significantly affect daily activities, intimate relationships, and overall quality of life.

In this study, women who choose to participate will be randomly assigned (like the flip of a coin) to use either vaginal estrogen or vaginal DHEA for a defined treatment period. Randomization ensures that each participant has an equal chance of receiving either treatment, which helps researchers make fair and unbiased comparisons between the two options.

Participants will complete questionnaires at several time points throughout the study to report on their symptoms, sexual health, comfort, and overall satisfaction with treatment. At the beginning and end of the study, participants will also undergo simple vaginal assessments, which may include vaginal pH testing, collection of vaginal swabs, or other non-invasive measurements to evaluate changes in vaginal health over time.

The goal of this research is to gain a deeper understanding of how each treatment affects vaginal tissue health, sexual function, urinary symptoms, and overall well-being. By comparing these two therapies directly, the study aims to provide healthcare providers with clearer evidence about which treatment may be more effective for specific symptoms or patient needs. Ultimately, the findings may help improve clinical care and offer women more tailored, evidence-based options for managing postmenopausal vaginal and urinary symptoms.

Enrollment

324 estimated patients

Sex

Female

Ages

40 to 90 years old

Volunteers

Accepts Healthy Volunteers

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