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NCT Number: NCT04807894

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 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.

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Key information

Conditions

Recurrent Urinary Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Postmenopausal Disorder Urinary Tract Infections Urogenital Diseases Urologic Diseases Vaginal Atrophy

Age range

60 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location status: Recruiting

Location contact

Alison Polland, MD

CONTACT

[email protected]

718-283-7770

Alison Polland, MD

PRINCIPAL_INVESTIGATOR

About this study

Background:

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.

Methods:

This will be a multi-center randomized, double- blind placebo-controlled study. Participating clinic sites include Maimonides Medical Center and Northwell Health. Subjects will be one hundred postmenopausal women presenting to a gynecology, urogynecology or female urology clinic with a history of three or more microbiologically confirmed symptomatic episodes of urinary tract infection during the either the previous year or two or more within six months.

Patients will randomly assigned to one of two regimens: one group will receive VT cream to be used once each night for two weeks followed by twice-weekly applications for eight months, and the other group will receive a placebo cream to be used in the same manner. Demographic data, vaginal exam including vaginal swab to assess vaginal flora, vaginal pH measurement and vaginal atrophy index measurement will be collected at the initial study visit, again at a study visit at 4.5 months and another at 9 months.

Anticipated Results and Conclusion:

It is anticipated that vaginal testosterone cream will reduce the incidence of urinary tract infections in postmenopausal women when compared to placebo. It is expected that vaginal testosterone will improve vaginal atrophy and flora, thus, decreasing the frequency of urinary tract infections. Future aims of the study will focus on immune-dynamics associated with vaginal testosterone administration.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion 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.

Exclusion criteria

  • 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.

Treatment and study plan

Vaginal Cream with Applicator

Drug

Vaginal testosterone 300-μg dose will be compounded with 13.5 mg of testosterone propionate in 0.45 mL of polysorbate National Formulary liquid and sufficient emollient cream base to make 45 g total. A calibrated vaginal applicator will be supplied to measure out doses of 1 g each. All study medications will be compounded by a single pharmacy so as to avoid variation in compounding between pharmacies and allow for control of compounding. Randomization will be conducted by the compounding pharmacy to allow for double-blinding of patients and clinicians.

Other names: Testosterone Cream

Primary outcomes

  1. To assess whether topical vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections.

    Time frame: 1 month

    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.

  2. To assess whether topical vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections.

    Time frame: 4.5 months

    Patients will receive months phone calls to assess for symptoms of UTI and urine will be collected in study visits at 4.5 months to check for presence of UTI.

  3. To assess whether topical vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections.

    Time frame: 9 months

    Patients will receive months phone calls to assess for symptoms of UTI and urine will be collected in study visits at 9 months to check for presence of UTI.

  4. 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.

    Time frame: 1 month

    The vaginal pH, vaginal atrophy score, and vaginal swabs for participants will be collected at 1 month to assess whether there is improvement in pH and vaginal atrophy scores as well as normalization of vaginal flora.

  5. 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.

    Time frame: 4.5 months

    The vaginal pH, vaginal atrophy score, and vaginal swabs for participants will be collected at 4.5 months to assess whether there is improvement in pH and vaginal atrophy scores as well as normalization of vaginal flora.

  6. 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.

    Time frame: 9 months

    The vaginal pH, vaginal atrophy score, and vaginal swabs for participants will be collected at 9 months to assess whether there is improvement in pH and vaginal atrophy scores as well as normalization of vaginal flora.

Study contacts

Contact information is provided by the study sponsor or research team.

Alison Polland, MD

CONTACT

[email protected]

(718) 283-7770

Mariela Martinez, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Maimonides Medical Center

Other

Collaborators

  • American Urological Association

Registry information

Official study title

Prevention of Recurrent Urinary Tract Infection Using Vaginal Testosterone Versus Placebo

Acronym: PIVoT

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2021
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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