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NCT01958073 · ClinicalTrials.gov registry record · Phase 4
Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women
A Phase 4 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 4
- Development phase
- 35
- Enrollment target
NCT01958073: Completed Phase 4 study, sponsored by University of California, San Diego.
NCT01958073 is a Phase 4 study that has completed, run by University of California, San Diego. The registered enrollment target is 35 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01958073, a Phase 4 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 35 participants
- Enrollment target
Study Summary
The investigators would like to know if the use of vaginally applied estrogen can prevent the problem of repeated urinary tract infections (UTI) in women who have gone through menopause. The investigators will use two forms of vaginal estrogen that are available by prescription (a ring and a cream) and compare their efficacy to that of a placebo (without any active ingredient). The investigators are going to look at if the vaginal estrogen can prevent UTIs altogether and also the number of UTIs each group experiences over a 6 month period. After 6 months, all subjects will receive vaginal estrogen and the women on the non-active treatment will be able to choose whether they would like to use either the estrogen ring or cream. The investigators will then be able to compare the number of UTIs on and off active vaginal estrogen treatment within those subjects who started on the placebo. The investigators are also going to look at quality of life before and during treatment using questionnaires and whether subjects stop using the treatments or do not use them as directed (compliance).
Primary Outcome
The primary purpose of this study is to assess the efficacy of vaginal estrogen versus placebo at 6 months on the prevention of urinary tract infections (UTI) in postmenopausal women with history of recurrent UTI.
Interventions
- DRUG Placebo
- DRUG Conjugated Estrogen Vaginal Cream
- DRUG Estradiol Ring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2013-10 |
| Est. Completion | 2017-12 |
| Phase | Phase 4 |
What the finished NCT01958073 record still lists
NCT01958073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01958073 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01958073 about?
NCT01958073 is a clinical study titled "Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women". The investigators would like to know if the use of vaginally applied estrogen can prevent the problem of repeated urinary tract infections (UTI) in women who have gone through menopause. The investigators will use two forms of vaginal estrogen that are available by prescription (a ring and a cream) ...
What is the current status of trial NCT01958073?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 35 participants. The study started on 2013-10. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01958073?
The interventions under investigation include: Placebo (DRUG), Conjugated Estrogen Vaginal Cream (DRUG), Estradiol Ring (DRUG).
Who is sponsoring clinical trial NCT01958073?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01958073's enrollment target sits among peer trials
35 1506th of 2000 higher than 481 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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