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NCT05723601 · ClinicalTrials.gov registry record · Phase 4
Preference of Women With Recurrent Urinary Tract Infection for Vaginal Estradiol Tablet vs Cream
A Phase 4 study of Recurrent Urinary Tract Infection, sponsored by Wake Forest University Health Sciences.
- Active
- Registry status
- Phase 4
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT05723601: Active Phase 4 study of Recurrent Urinary Tract Infection, sponsored by Wake Forest University Health Sciences.
NCT05723601 is a Phase 4 study of Recurrent Urinary Tract Infection that is active but no longer recruiting, run by Wake Forest University Health Sciences. The registered enrollment target is 21 participants, below the 109-participant average among 4 other Recurrent Urinary Tract Infection trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05723601, a Phase 4 study of Recurrent Urinary Tract Infection, is active but no longer recruiting, sponsored by Wake Forest University Health Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Vaginally applied estrogen has been shown to decrease the incidence of Recurrent Urinary Tract Infection (rUTI) in post-menopausal women. However, prior studies have shown the compliance rate for topical estrogen cream is low. The vaginal estradiol tablet has been shown to be preferred by patients being treated for genitourinary syndrome of menopause and has improved compliance. There are no studies looking at the preference of post-menopausal women with rUTI for vaginal estradiol tablet as an alternative to vaginal estradiol cream.
Primary Outcome
Preference will be assess at 6 months or at the time of withdrawal, by asking participants: "Which route of vaginal estrogen do you prefer: Vaginal estradiol tablet or vaginal estradiol cream?"
Conditions Studied
Interventions
- DRUG Estradiol vaginal cream
- DRUG Estradiol Vaginal Tablet
Study Locations (1)
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2024-01-12 |
| Est. Completion | 2027-01 |
| Phase | Phase 4 |
What the registry record for NCT05723601 still lists
NCT05723601 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 109-participant average among 4 other Recurrent Urinary Tract Infection trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Recurrent Urinary Tract Infection appearing as the primary indexed condition, and to 2 interventions - of which Estradiol vaginal cream is the first listed.
NCT05723601 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05723601 about?
NCT05723601 is a clinical study titled "Preference of Women With Recurrent Urinary Tract Infection for Vaginal Estradiol Tablet vs Cream". Vaginally applied estrogen has been shown to decrease the incidence of Recurrent Urinary Tract Infection (rUTI) in post-menopausal women. However, prior studies have shown the compliance rate for topical estrogen cream is low. The vaginal estradiol tablet has been shown to be preferred by patients b...
What is the current status of trial NCT05723601?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2024-01-12. Estimated completion is 2027-01.
What conditions does trial NCT05723601 study?
This clinical trial studies the following conditions: Recurrent Urinary Tract Infection.
What interventions are being tested in trial NCT05723601?
The interventions under investigation include: Estradiol vaginal cream (DRUG), Estradiol Vaginal Tablet (DRUG).
Who is sponsoring clinical trial NCT05723601?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05723601 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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