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Compares treatment options for Recurrent Urinary Tract Infection
Official title Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo
ClinicalTrials.gov ID: NCT04807894
What this study is testing
What is Vaginal Cream with Applicator?
Vaginal Cream with Applicator is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for recurrent urinary tract infection.
Also referred to as Testosterone Cream.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 90, women only. Healthy volunteers may be eligible.
You may be able to join if
- 60-90 yo Female
- Postmenopausal
- Recurrent UTIs (three or more culture confirmed symptomatic episodes of UTI or two or more in the past 6 months).
- English Proficiency
- Unable or unwilling to use topical estrogen.
You likely can't join if
- Current UTI/ Dipstick and culture positive (\> trace leukocytes or nitrites)
- Antibiotic (vaginal or oral) use in the last 4 weeks
- Current sexually transmitted infection
- Chronic Foley catheter use or chronic ureteral stent placement.
- Vaginal probiotic use in the last 4 weeks
- Patient currently using vaginal estrogen.
See the full eligibility criteria
- 60-90 yo Female
- Postmenopausal
- Recurrent UTIs (three or more culture confirmed symptomatic episodes of UTI or two or more in the past 6 months).
- English Proficiency
- Unable or unwilling to use topical estrogen.
- Patients with history of or current endometrial or breast cancer and current aromatase inhibitor therapy may also be included in study.
- Patient on oral estrogen therapy may be included.
- Patient with slings, prior vaginal surgery or pessary may be included.
- Current UTI/ Dipstick and culture positive (\> trace leukocytes or nitrites)
- Antibiotic (vaginal or oral) use in the last 4 weeks
- Current sexually transmitted infection
- Chronic Foley catheter use or chronic ureteral stent placement.
- Vaginal probiotic use in the last 4 weeks
- Patient currently using vaginal estrogen.
- Post-void Residual Volume \>150 mL or current diagnosis of urinary retention
- Non-evaluated hematuria (\> trace on dipstick, microscopic, gross)
- Unable to complete study tasks or comply with follow up.
The study team makes the final eligibility decision.
Where it's taking place
- Brooklyn, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 60 years to 90 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brooklyn, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.