Menopause, Painful Intercourse, Post-menopause, Pre-menopause, Sexual Function, Vaginal Dryness
Conditions
Keywords
DHEA, vaginal estrogen
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.
Detailed description
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.
Interventions
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.
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Genitourinary Symptoms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent urinary tract infections | 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. |
Contacts
University of Arizona