NCT02431897 - Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen | Biotech Hunter

Enrollment

206

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

November 29, 2021

Study Completion Date

May 17, 2023

Conditions

Pelvic Organ ProlapseUrogenital ProlapseVaginal Vault ProlapseCystoceleUterine ProlapseVaginal ProlapsePelvic Floor Disorders

Interventions

DRUG

Conjugated Estrogens Cream

0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for \>5 weeks before surgery, then 2x/week for 1 year after surgery.

DRUG

Placebo Cream

1g applied vaginally nightly for 2 weeks then 2x/week for \>5 weeks before surgery, then 2x/week for 1 year after surgery.

Trial Locations (3)

University of Alabama at Birmingham, Birmingham

University of Texas Southwestern Medical Center, Dallas

Women & Infants Hospital of Rhode Island, Providence