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临床试验/NCT07574216
NCT07574216招募中不适用

The Use of Vaginal Estrogen vs DHEA in Perimenopausal and Menopausal Women

University of Arizona1 个研究点 分布在 1 个国家目标入组 324 人开始时间: 2026年8月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
324
试验地点
1
主要终点
Genitourinary Symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Estradiol 0.01% vaginal cream

Active Comparator

干预措施: Estradiol 0.01% Vag Cream (Drug)

DHEA suppository

Active Comparator

干预措施: DHEA ovals (Drug)

结局指标

主要结局

Genitourinary Symptoms

时间窗: 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.

次要结局

  • Recurrent urinary tract infections(Baseline/post treatment (6 month follow up))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shaida Molloy

Principal Investigator

University of Arizona

研究点 (1)

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