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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Grade 1 Endometrial Endometrioid Adenocarcinoma, Grade 2 Endometrial Endometrioid Adenocarcinoma, Complex Atypical Endometrial Hyperplasia

In brief

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

Key facts

Study ID

NCT02335203

Run by

Women and Infants Hospital of Rhode Island

People needed

76

Starts

2015-02-01

Expected to finish

2018-06-01

Last updated by the study team

2016-09-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Women and Infants Hospital, Program in Women's Oncology — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.