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Hormone Therapy

Vaginal Testosterone for Recurrent Urinary Tract Infections (PIVoT Trial)

Phase 4

Recruiting

Research Sponsored by Maimonides Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unable or unwilling to use topical estrogen

Recurrent UTIs (three or more culture confirmed symptomatic episodes of UTI or two or more in the past 6 months)

Must not have

Unable to complete study tasks or comply with follow up

Post-void Residual Volume >150 mL or current diagnosis of urinary retention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial will compare the effects of vaginal testosterone cream to placebo in postmenopausal women with recurrent UTIs. It will also look at the effects of vaginal estrogen on the vaginal pH and flora.

Who is the study for?

This trial is for postmenopausal women aged 60-90 with recurrent UTIs, who are not using vaginal estrogen but may be on oral estrogen or have a history of breast/endometrial cancer and taking aromatase inhibitors. Women with prior vaginal surgeries can join, but those with current UTI, recent antibiotic/probiotic use, large post-void residual volume, untreated hematuria or chronic catheter/stent use cannot participate.

What is being tested?

The study tests if applying vaginal testosterone cream reduces urinary tract infections in postmenopausal women more effectively than a placebo. It also examines the impact on vaginal pH and flora. Participants will receive either the testosterone cream or placebo through an applicator to apply themselves.

What are the potential side effects?

Potential side effects are not detailed here; however, similar hormonal treatments often include local irritation or infection risk increase due to changes in natural flora. Systemic side effects from topical hormones are rare but could involve mood swings or skin changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I cannot or do not want to use topical estrogen.

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I have had 3 or more UTIs in the last year.

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I am a woman aged between 60 and 90 years old.

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I have gone through menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am able to follow the study's requirements and attend all follow-ups.

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I have trouble fully emptying my bladder or have been diagnosed with urinary retention.

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I am currently using vaginal estrogen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Testosterone

To determine whether topically applied vaginal testosterone cream is more effective than placebo cream in changing vaginal flora and pH in postmenopausal women with recurrent urinary tract infections.

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Vaginal Testosterone Cream ArmExperimental Treatment1 Intervention

Women enrolled in this arm will receive vaginal testosterone cream to be applied once each night for two weeks followed by twice-weekly applications for a total duration of nine months.

Group II: Vaginal Placebo Cream ArmPlacebo Group1 Intervention

Women enrolled in this arm will receive vaginal placebo cream to be applied once each night for two weeks followed by twice-weekly applications for a total duration of nine months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vaginal Cream with Applicator

2023

Completed Phase 4

~40

0 / 7Eligibility criteria met