Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04807894
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2020-10-19
Brief Title:
Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo
Sponsor:
Maimonides Medical Center
Organization:
Maimonides Medical Center
Study Overview
Official Title:
Prevention of Recurrent Urinary Tract Infection Using Vaginal Testosterone Versus Placebo
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIVoT
Brief 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
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
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 45 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
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 45 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None