The Effect of Neoadjuvant DMPA on Glandular Cellularity in Women Awaiting Hysterectomy

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Women and Infants Hospital of Rhode Island
• Treatments: Medroxyprogesterone; Medroxyprogesterone Acetate

Criteria

Inclusion Criteria:

• Patient at the Women and Infants Program in Women's Oncology

• Biopsy-proven complex atypical hyperplasia or grade 1 or grade 2 endometrial adenocarcinoma with endometrioid histology

• Disease clinically confined to the uterus (no physical exam findings or imaging to suggest extrauterine disease)

• Ages 18 and older

• Plan for hysterectomy at Women and Infants Hospital of Rhode Island

• Able to read English or Spanish

• Able to give informed consent for involvement in the study

Exclusion Criteria:

• Allergic to medroxyprogesterone acetate

• Known sensitivity to any component of depot medroxyprogesterone acetate

• History of breast cancer, hepatic disease, uncontrolled hypertension, osteoporosis or strong osteoporotic risk factors including anorexia nervosa, rheumatoid arthritis and chronic glucocorticoid use

• Treatment with any progesterone or progesterone analogue in past 12 months