- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07574216
VEDA Study (DHEA vs Estradiol)
The Use of Vaginal Estrogen vs DHEA in Perimenopausal and Menopausal Women
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Iridian (Iris) Jaramillo, M.S.
- Telefonnummer: 602-827-2078
- E-post: iyjaramillo@arizona.edu
Studer Kontakt Backup
- Navn: Pamela C Garcia-Filion, MD
- Telefonnummer: 602-827-2882
- E-post: pgarciafilion@arizona.edu
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: DHEA suppository
|
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.
|
|
Aktiv komparator: Estradiol 0.01% vaginal 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Genitourinary Symptoms
Tidsramme: Baseline/post treatment (6 month follow up)
|
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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Recurrent urinary tract infections
Tidsramme: Baseline/post treatment (6 month follow up)
|
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.
|
Baseline/post treatment (6 month follow up)
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Vaginal microbiome and metabolome
Tidsramme: Baseline/post treatment (6 month follow up)
|
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)].
|
Baseline/post treatment (6 month follow up)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Molloy Shaida, University of Arizona
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Psykiske lidelser
- Kjønnssykdommer, mannlige
- Mannlige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Kjønnssykdommer, kvinner
- Seksuell dysfunksjon, fysiologisk
- Seksuelle dysfunksjoner, psykologiske
- Dyspareuni
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Farmasøytiske preparater
- Doseringsformer
- Polysykliske forbindelser
- Utstyr og forsyninger
- Steroider
- Smeltede ringforbindelser
- Estrenes
- Østraner
- Estradiol -kongener
- Gonadal steroidhormoner
- Gonadalhormoner
- Feminine Hygiene Products
- Østradiol
- Vaginal kremer, skum og gelé
Andre studie-ID-numre
- STUDY00007779
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .