VEDA Study (DHEA vs Estradiol)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-90
SponsorUniversity of Arizona
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Use of systemic hormone therapy within the last 6 months
Gynecologic malignancy
Known allergy to study medications
Active vaginal infection at enrollment
Trial design
Design model
Parallel
Treatments tested in this trial
DHEA ovals
DrugDHEA (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
DrugEstradiol 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.
Treatment groups
324 Participants
are divided into 2 treatment groupsGroup A: DHEA suppositoryActive comparator 1 intervention
Group B: Estradiol 0.01% vaginal creamActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Genitourinary Symptoms
To compare the change in FSFI scores from baseline visit to post-treatment visit with vaginal DHEA versus vaginal estrogen among postmenopausal women with genitourinary symptoms.
Time frame
Baseline/post treatment (6 month follow up)Secondary outcomes
1
Recurrent urinary tract infections
To compare changes from baseline-visit to post-treatment visit in: vaginal pH and recurrent urinary tract infections before and after treatment with vaginal DHEA vs Vaginal estrogen. Data will show if vaginal pH is greater than 4.5 indicating a UTI.
Time frame
Baseline/post treatment (6 month follow up)Other outcomes
1
Vaginal microbiome and metabolome
To compare changes from baseline-visit to post-treatment visit in: vaginal microbiome (16S rRNA gene sequencing) and metabolome \[Liquid Chromatography-Mass Spectrometry (LC-MS/MS)\].
Time frame
Baseline/post treatment (6 month follow up)Sponsors and contacts
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Source ClinicalTrials.gov