Clinical Trial on the Preventive Effect of Intravaginal Prasterone on Recurrent Urinary Tract Infections in Postmenopausal Women

• Status: Withdrawn
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Olivia Cardenas-Trowers, M.D.
• Collaborator: AMAG Pharmaceuticals, Inc.
• Treatments: Dehydroepiandrosterone

Criteria

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)