Status:
WITHDRAWN
Clinical Trial on the Preventive Effect of Intravaginal Prasterone on Recurrent Urinary Tract Infections in Postmenopausal Women
Lead Sponsor:
Olivia Cardenas-Trowers, M.D.
Collaborating Sponsors:
AMAG Pharmaceuticals, Inc.
Conditions:
Recurrent Urinary Tract Infection
Postmenopause
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 u...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03854396
Start Date
May 1 2020
End Date
February 1 2021
Last Update
June 30 2021
Active Locations (1)
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1
University of Louisville Urogynecology at Springs Medical Center
Louisville, Kentucky, United States, 40205