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NCT04807894 · ClinicalTrials.gov registry record · Phase 4
Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo
A Phase 4 study of Vaginal Atrophy and Recurrent Urinary Tract Infection, sponsored by Maimonides Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT04807894: Recruiting Phase 4 study of Vaginal Atrophy and Recurrent Urinary Tract Infection, sponsored by Maimonides Medical Center.
NCT04807894 is a Phase 4 study of Vaginal Atrophy and Recurrent Urinary Tract Infection that is actively recruiting participants, run by Maimonides Medical Center. The registered enrollment target is 100 participants, below the 345-participant average among 9 other Vaginal Atrophy trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04807894, a Phase 4 study of Vaginal Atrophy and Recurrent Urinary Tract Infection, is actively recruiting participants, sponsored by Maimonides Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Women over the age of 60 years have an estimated 10 to 15 % risk of recurrent urinary tract infections (UTI). This is believed to be due to hormonally induced changes in the vaginal flora associated with menopause. After menopause, there is a chemical changes in the vagina that may predispose to bacterial infections. The role of vaginal estrogen creams to restore vaginal atrophy and prevent urinary tract infections has been well characterized. Vaginal testosterone (VT) application use in postmenopausal breast cancer patients on aromatase inhibitors have been shown to improve vaginal pH, vaginal atrophy symptom scores, dyspareunia, and vaginal dryness. Although testosterone has been used to improve sexual function in postmenopausal women, the effects of VT on vaginal flora and recurrent UTIs are unknown. The purpose of this study is to determine whether topically applied vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections and to ascertain the effects of topical estrogen on the vaginal pH and flora.
Primary Outcome
Patients will receive months phone calls to assess for symptoms of UTI and urine will be collected in study visits at 1 month to check for presence of UTI.
Conditions Studied
Interventions
- DRUG Vaginal Cream with Applicator
Study Locations (1)
New York
- Maimonides Medical Center - Brooklyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-11-01 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 4 |
What NCT04807894 shows while recruiting
NCT04807894 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 345-participant average among 9 other Vaginal Atrophy trials with a reported enrollment target (71% lower).
The record links to 3 conditions, with Vaginal Atrophy appearing as the primary indexed condition, and to 1 intervention - of which Vaginal Cream with Applicator is the first listed.
NCT04807894 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04807894 about?
NCT04807894 is a clinical study titled "Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo". Women over the age of 60 years have an estimated 10 to 15 % risk of recurrent urinary tract infections (UTI). This is believed to be due to hormonally induced changes in the vaginal flora associated with menopause. After menopause, there is a chemical changes in the vagina that may predispose to bac...
What is the current status of trial NCT04807894?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2020-11-01. Estimated completion is 2026-12-31.
What conditions does trial NCT04807894 study?
This clinical trial studies the following conditions: Vaginal Atrophy, Recurrent Urinary Tract Infection, Postmenopausal Disorder.
What interventions are being tested in trial NCT04807894?
The interventions under investigation include: Vaginal Cream with Applicator (DRUG).
Who is sponsoring clinical trial NCT04807894?
This trial is sponsored by Maimonides Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04807894 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04807894's enrollment target sits among peer trials
100 4th of 9 higher than 5 of 9 other Vaginal Atrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Vaginal Atrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Postpartum Vaginal Estrogen for Breastfeeding Patients
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ASSIST-VLA: Assessment of Symptom-Specific Improvement in Diagnosed Vaginal Atrophy Following Laser Therapy
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