VEDA Study (DHEA vs Estradiol)

NCT07574216 | Not Yet Recruiting

• 1 other identifier: STUDY00007779
• Study Type: interventional
• Target: 324
• Locations: 0 countries
• Sites: N/A

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; Painful Intercourse

Keywords

DHEA; vaginal estrogen

Outcome Measures

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.

  Baseline/post treatment (6 month follow up)

Secondary Outcomes (1)

• Recurrent urinary tract infections

  Baseline/post treatment (6 month follow up)

Other Outcomes (1)

• Vaginal microbiome and metabolome

  Baseline/post treatment (6 month follow up)

Study Arms (2)

DHEA suppository

ACTIVE COMPARATOR

Drug: DHEA ovals

Estradiol 0.01% vaginal cream

ACTIVE COMPARATOR

Drug: Estradiol 0.01% Vag Cream

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.

DHEA suppository

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.

Estradiol 0.01% vaginal cream

Eligibility Criteria

• Age: 40 Years - 90 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

Related Publications (8)

• Kaufman MR, Ackerman AL, Amin KA, Coffey M, Danan E, Faubion SS, Hardart A, Goldstein I, Ippolito GM, Northington GM, Powell CR, Rubin RS, Westney OL, Wilson TS, Lee UJ. The AUA/SUFU/AUGS Guideline on Genitourinary Syndrome of Menopause. J Urol. 2025 Sep;214(3):242-250. doi: 10.1097/JU.0000000000004589. Epub 2025 Apr 29.

  PMID: 40298120 BACKGROUND

• Pieta W, Smolarczyk R. Vaginal dehydroepiandrosterone compared to other methods of treating vaginal and vulvar atrophy associated with menopause. Prz Menopauzalny. 2020 Dec;19(4):195-199. doi: 10.5114/pm.2020.101943. Epub 2021 Jan 7.

  PMID: 33488333 BACKGROUND

• Bouchard C, Labrie F, Archer DF, Portman DJ, Koltun W, Elfassi E, Grainger DA, Ayotte N, Cooper TA, Martens M, Waldbaum AS, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Decreased efficacy of twice-weekly intravaginal dehydroepiandrosterone on vulvovaginal atrophy. Climacteric. 2015;18(4):590-607. doi: 10.3109/13697137.2014.992012. Epub 2015 Mar 3.

  PMID: 25511551 BACKGROUND

• Porcari I, Uccella S, Casprini C, Bosco M, Zorzato PC, Garzon S. Vulvovaginal estrogen therapy for urinary symptoms in postmenopausal women: a review and meta-analysis. Climacteric. 2026 Feb;29(1):13-22. doi: 10.1080/13697137.2025.2517138. Epub 2025 Jun 26.

  PMID: 40569036 BACKGROUND

• Danan ER, Sowerby C, Ullman KE, Ensrud K, Forte ML, Zerzan N, Anthony M, Kalinowski C, Abdi HI, Friedman JK, Landsteiner A, Greer N, Nardos R, Fok C, Dahm P, Butler M, Wilt TJ, Diem S. Hormonal Treatments and Vaginal Moisturizers for Genitourinary Syndrome of Menopause : A Systematic Review. Ann Intern Med. 2024 Oct;177(10):1400-1414. doi: 10.7326/ANNALS-24-00610. Epub 2024 Sep 10.

  PMID: 39250810 BACKGROUND

• Simon JA, Goldstein I, Kim NN, Davis SR, Kellogg-Spadt S, Lowenstein L, Pinkerton JV, Stuenkel CA, Traish AM, Archer DF, Bachmann G, Goldstein AT, Nappi RE, Vignozzi L. The role of androgens in the treatment of genitourinary syndrome of menopause (GSM): International Society for the Study of Women's Sexual Health (ISSWSH) expert consensus panel review. Menopause. 2018 Jul;25(7):837-847. doi: 10.1097/GME.0000000000001138.

  PMID: 29870471 BACKGROUND

• Misasi G, Russo E, Montt Guevara MM, Tomatis V, Fidecicchi T, Luisi S, Giannini A, Mannella P, Caretto M, Pomara G, Simoncini T. Effects of vaginal DHEA on stress urinary incontinence in postmenopausal women with vulvovaginal atrophy. Maturitas. 2025 May;196:108232. doi: 10.1016/j.maturitas.2025.108232. Epub 2025 Mar 1.

  PMID: 40068355 BACKGROUND

• Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. J Sex Med. 2014 Dec;11(12):2865-72. doi: 10.1111/jsm.12686. Epub 2014 Aug 25.

  PMID: 25155380 BACKGROUND

MeSH Terms

Conditions

Dyspareunia

Interventions

Estradiol; Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Molloy Shaida

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Valencia, MPH

CONTACT

520-780-8241; atvalencia@email.arizona.edu

Stephanie Marsh, MPH

CONTACT

602-255-7552; slmarsh@email.arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share