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

NCT03854396 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-06-30

No results posted yet for this study

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.

Conditions

  • Recurrent Urinary Tract Infection
  • Postmenopause
  • Postmenopausal Syndrome
  • Postmenopausal Symptoms
  • Menopause

Interventions

DRUG

Prasterone

Nightly intravaginal prasterone insert (6.5 mg prasterone at a concentration of 0.50%) for 24 weeks.

DRUG

Placebo

Nightly intravaginal placebo insert (Witepsol H-15, a mix of synthetic triglycerides) for 24 weeks.

Sponsors & Collaborators

  • AMAG Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Olivia Cardenas-Trowers, M.D.

    lead OTHER

Principal Investigators

  • Olivia Cardenas-Trowers, M.D. · University of Louisville

  • Sean L. Francis, M.D. · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-31
Primary Completion
2021-02-28
Completion
2021-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03854396 on ClinicalTrials.gov