Clinical Trial on the Preventive Effect of Intravaginal Prasterone on Recurrent Urinary Tract Infections in Postmenopausal Women
Clinical Trial on the Preventive Effect of Intravaginal Prasterone on Recurrent Urinary Tract Infections in Postmenopausal Women
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 frequency/urgency, 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.
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 prasterone's 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.
Inclusion Criteria:

 -  Women aged 18 years or older who are ≥ 1 year after spontaneous or surgical (bilateral
 oophorectomy) menopause

 -  Presence of ≤ 5% of superficial cells on vaginal smear and vaginal pH > 5.0

 -  History of ≥ 2 UTIs in 6 months or ≥ 3 UTIs in 12 months (with documentation of a UTI
 confirmed on urine culture within the past 1 year)

 -  Negative urine culture prior to treatment randomization

 Exclusion Criteria:

 -  Known allergy/hypersensitivity to prasterone or its constituents

 -  Contraindications to estrogen: acute thrombophlebitis, history of blood clotting
 disorder, and/or personal history of thromboembolic disorder associated with estrogen
 use

 -  Known or suspected estrogen-dependent neoplasms or mammary, ovarian, cervical, or
 vaginal malignancies

 -  Known congenital urologic or gynecologic abnormality

 -  Chronic immunosuppression

 -  Need for chronic catheterization

 -  Vaginal bleeding of origin other than vaginal mucosal atrophy

 -  Vaginal infection requiring treatment

 -  Use of systemic hormone replacement therapy or estrogen within past 6 months

 -  Use of topical estrogen within past 3 months

 -  Consistent use of vaginal products (lubricants, douches)

 -  Ongoing antibiotic treatment

 -  Ongoing treatment with Lactobacillus

 -  Inability to comply with protocol or place vaginal insert with applicator
 appropriately

 -  Less than 3 months status post urinary incontinence and/or pelvic organ prolapse
 surgery

 -  Unable to speak or read English

 -  If an exclusion condition is resolved, the patient may be re-approached later for
 study recruitment (ie., genitourinary infection, use of antibiotics, etc)