Clinical Trial on the Preventive Effect of Intravaginal Prasterone on Recurrent Urinary Tract Infections in Postmenopausal Women
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Postmenopausal Syndrome, Postmenopausal Syndrome, Infectious Disease, Women's Studies, Women's Studies, Urology |
| Therapuetic Areas: | Endocrinology, Immunology / Infectious Diseases, Nephrology / Urology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2019 |
| Start Date: | April 2019 |
| End Date: | February 2020 |
| Contact: | Alyce Goodman-Abraham, A.P.R.N. |
| Email: | contactus@ulp.org |
| Phone: | 502-588-7660 |
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
Urinary tract infections (UTIs) are bothersome and more likely to occur in post-menopausal
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 post-menopausal 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 post-menopausal women.
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 post-menopausal 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 post-menopausal 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 post-menopausal 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 12 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.
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 post-menopausal 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 12 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 the third UTI confirmed
on urine culture (and done within the past 1 year)) and 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)
We found this trial at
1
site
Louisville, Kentucky 40205
Principal Investigator: Olivia Cardenas-Trowers, M.D.
Phone: 502-588-7660
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