Recurrent Urinary Tract InfectionPhase 4PIVoTNCT04807894
Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo
A Phase 4 study testing Vaginal Cream with Applicator in people with Recurrent Urinary Tract Infection and Vaginal Atrophy, run by Jefferson Drapkin at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Urinary Tract Infection, Vaginal Atrophy, Postmenopausal Disorder
- What is being tested?
- Vaginal Cream with Applicator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 31 Aug 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Recurrent Urinary Tract Infection Using Vaginal Testosterone Versus 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.
Read the detailed description
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.
- Being tested
- Vaginal Cream with Applicator
- Keywords
- urinary tract infections,, postmenopausal women, vaginal atrophy,, vaginal flora
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Cream with ApplicatorDrug
Also called Testosterone Cream
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.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Testosterone Cream Arm | Experimental | 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. Receives: Drug: Vaginal Cream with Applicator |
| Vaginal Placebo Cream Arm | Placebo comparator | 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. Receives: Drug: Vaginal Cream with Applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 1 month
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.
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.
Measured: 4.5 months
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.
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.
Measured: 9 months
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.
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.
Measured: 1 month
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.
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.
Measured: 4.5 months
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.
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Nov 2020
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Why it stopped: High rates of loss to follow up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jefferson Drapkin
- Sponsor type
- University, hospital or other
- Collaborators
- American Urological Association
- Responsible party
- Sponsor-investigator, Jefferson Drapkin, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807894
- Sponsor's protocol ID
- 702576
- Acronym
- PIVoT
- Status last verified
- Sep 2026
- First submitted
- 19 Oct 2020
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Recurrent Urinary Tract Infection Using Vaginal Testosterone Versus Placebo
- ClinicalTrials.gov ID
- NCT04807894
- Acronym / sponsor ID
- PIVoT / 702576
- Keywords
- urinary tract infections,, postmenopausal women, vaginal atrophy,, vaginal flora
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: High rates of loss to follow up
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Jefferson DrapkinUniversity, hospital or other
- Collaborators
- American Urological Association
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Testosterone Cream Arm | Experimental | Drug: Vaginal Cream with ApplicatorWomen 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. |
| Vaginal Placebo Cream Arm | Placebo comparator | Drug: Vaginal Cream with ApplicatorWomen 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. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal Cream with ApplicatorAlso: Testosterone CreamVaginal 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. | Drug | Vaginal Placebo Cream Arm, Vaginal Testosterone Cream Arm |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study was stopped early (reason given: High rates of loss to follow up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaginal Cream with Applicator in people with Recurrent Urinary Tract Infection and Vaginal Atrophy, run by Jefferson Drapkin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: High rates of loss to follow up). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.