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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

PIVoT Trial 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.Check my eligibility

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.See study design

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.

PIVoT Trial 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.

PIVoT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Side effects data

From 2012 Phase 4 trial • 22 Patients • NCT01208038

19%

Skin irritation

10%

Increased facial hair

Blepharitis

Acne

per vagina spotting

100%

80%

60%

40%

20%

Study treatment Arm

Testosterone

PIVoT 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.

0 / 4Eligibility criteria met