Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04807894
Study type Interventional
Source Maimonides Medical Center
Contact Alison Polland, MD
Phone (718) 283-7770
Email apolland@maimonidesmed.org
Status Recruiting
Phase Phase 4
Start date November 1, 2020
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Completed NCT06136975 - Low-level Laser Therapy for Genitourinary Syndromes and Stress Urinary Incontinence
Recruiting NCT04081805 - LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2) N/A
Completed NCT04039555 - Clinical Study to Compare the Efficacy of Erbium-Yag Laser or CO2RE Intimate Laser With Sham (COER) N/A
Active, not recruiting NCT02704741 - Clinical Study of the CO2RE Laser Device Performance for Vaginal Atrophy Treatments N/A
Completed NCT01975129 - A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin Phase 2
Completed NCT04735549 - Vulvovaginal Atrophy Correction Using Neodymium Laser N/A
Completed NCT04079218 - Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial Phase 4
Completed NCT03063684 - Fractional / Pixel CO2 Laser Treatment of Vulvar Atrophy and Lichen Sclerosus N/A
Recruiting NCT05953090 - VALOR: Vaginal Atrophy & Long-term Observation of Recovery N/A
Not yet recruiting NCT05483634 - Compare Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause
Completed NCT04717245 - Comparative Study: Vaginal Promestriene Use, Fractional CO2 LASER and Radiofrequency in the Vaginal Atrophy Treatment N/A
Completed NCT02937805 - Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes N/A
Completed NCT02967510 - Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy Phase 2
Not yet recruiting NCT02571127 - Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness. Phase 4
Completed NCT00238732 - Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause Phase 3
Completed NCT02413008 - A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting Phase 2
Completed NCT03493126 - Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function Phase 4
Not yet recruiting NCT03238053 - Laser Treatment of Genito-urinary Syndrome in Women N/A
Terminated NCT01753102 - Efficacy and Safety Of Spil's Estradiol Vaginal Tablet Phase 3
Terminated NCT05627791 - Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman Phase 2/Phase 3