- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07574216
VEDA Study (DHEA vs Estradiol)
The Use of Vaginal Estrogen vs DHEA in Perimenopausal and Menopausal Women
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Iridian (Iris) Jaramillo, M.S.
- 전화번호: 602-827-2078
- 이메일: iyjaramillo@arizona.edu
연구 연락처 백업
- 이름: Pamela C Garcia-Filion, MD
- 전화번호: 602-827-2882
- 이메일: pgarciafilion@arizona.edu
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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.
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활성 비교기: Estradiol 0.01% vaginal cream
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Genitourinary Symptoms
기간: Baseline/post treatment (6 month follow up)
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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.
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Baseline/post treatment (6 month follow up)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recurrent urinary tract infections
기간: Baseline/post treatment (6 month follow up)
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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.
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Baseline/post treatment (6 month follow up)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Vaginal microbiome and metabolome
기간: 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)].
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Baseline/post treatment (6 month follow up)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Molloy Shaida, University of Arizona
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00007779
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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