Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
Status:
Active, not recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning
native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued
postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic
science investigation are designed to understand the mechanisms by which local estrogen
treatment affects connective tissues of the pelvic floor and determine whether its use before
and after prolapse repair will (i) improve success rates of the surgical intervention and
minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor
disorders.
Phase:
Phase 4
Details
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborators:
Pfizer University of Alabama at Birmingham Women and Infants Hospital of Rhode Island