The Effect of Neoadjuvant DMPA on Glandular Cellularity in Women Awaiting Hysterectomy
Status:
Unknown status
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
Objective: To compare pre- and post-treatment glandular cellularity in women with complex
atypical hyperplasia or grade 1-2 endometrial adenocarcinoma who are treated with
intramuscular depot medroxyprogesterone acetate (DMPA) versus placebo injection prior to
hysterectomy. The secondary objective is to compare various other outcomes including
molecular, histologic, pathologic and clinical endpoints in women treated with DMPA versus
placebo prior to hysterectomy.
Hypothesis: Patients treated with DMPA will have significantly decreased glandular
cellularity post-treatment when compared to patients treated with placebo injection. Patients
treated with DMPA will exhibit previously described changes in molecular tumor marker
expression patterns and other characteristic histologic changes. Patients treated with DMPA
will report less bothersome vaginal bleeding prior to surgery when compared to patients
treated with placebo injection.
Study Design: Double blinded randomized controlled trial
Population: Women being treated at the Women and Infants Program in Women's Oncology who have
a biopsy-proven diagnosis of complex atypical hyperplasia or grade 1-2 endometrial
adenocarcinoma with disease clinically confined to the uterus, with a plan to undergo
hysterectomy.
Study Period: February 2015 to June 2016