Ignite Creation Date:
2024-05-06 @ 12:48 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03854396
Status:
WITHDRAWN
Last Update Posted:
2021-06-30
First Post:
2019-02-24
Brief Title:
Clinical Trial on the Preventive Effect of Intravaginal Prasterone on Recurrent Urinary Tract Infections in Postmenopausal Women
Sponsor:
Olivia Cardenas-Trowers MD
Organization:
University of Louisville
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Trial on the Preventive Effect of Intravaginal Prasterone DHEA Intrarosa on Recurrent Urinary Tract Infections in Women With Genitourinary Syndrome of Menopause
Status:
WITHDRAWN
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to termination of ISR by PI with agreement by grant sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Urinary tract infections UTIs are bothersome and more likely to occur in postmenopausal women Frequent UTIs as well as other problems with the urinary and genital systems such as painful sex and urinary frequencyurgency are part of a symptom complex called genitourinary syndrome of menopause GSM Prasterone Intrarosa is a man-made steroid that helps with painful sex in postmenopausal women Because previous studies have shown prasterone to help with other GSM problems this study was designed to investigate if prasterone used in the vagina decreases the number of UTIs in postmenopausal women
Detailed Description:
Urinary tract infections UTIs are costly contributing to more than 8 million ambulatory visits 84 women in the United States in 2007 Recurrent urinary tract infections rUTIs are UTIs diagnosed on at least 2 urine cultures in 6 months or at least 3 in 1 year The incidence of rUTIs increases in menopause with an estimated 10-15 of women 60 years old having rUTIs rUTIs contribute to a constellation of bothersome genitourinary symptoms in some postmenopausal women called genitourinary syndrome of menopause GSM Thus menopause rUTIs and GSM are intimately linked
Prasterone Intrarosa is a synthetic version of the steroid dehydroepiandrosterone DHEA approved by the US Food and Drug Administration in 2016 for the treatment of moderate to severe dyspareunia due to GSM Large prospective studies have shown prasterone to safely decrease vaginal pH decrease parabasal cells increase superficial cells and decrease symptoms related to atrophy like dyspareunia in women with GSM Given prasterones favorable treatment effects on some GSM symptoms investigation of prasterone as a possible treatment option for rUTIs in the setting of GSM is warranted
This is a single center double-blind placebo-controlled randomized trial comparing the efficacy of nightly intravaginal prasterone for 24 weeks to intravaginal placebo in decreasing rUTIs in women with GSM The study hypothesis is that intravaginal prasterone decreases UTI incidence in women with GSM compared to placebo
Prasterone Intrarosa is a synthetic version of the steroid dehydroepiandrosterone DHEA approved by the US Food and Drug Administration in 2016 for the treatment of moderate to severe dyspareunia due to GSM Large prospective studies have shown prasterone to safely decrease vaginal pH decrease parabasal cells increase superficial cells and decrease symptoms related to atrophy like dyspareunia in women with GSM Given prasterones favorable treatment effects on some GSM symptoms investigation of prasterone as a possible treatment option for rUTIs in the setting of GSM is warranted
This is a single center double-blind placebo-controlled randomized trial comparing the efficacy of nightly intravaginal prasterone for 24 weeks to intravaginal placebo in decreasing rUTIs in women with GSM The study hypothesis is that intravaginal prasterone decreases UTI incidence in women with GSM compared to placebo
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