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

NCT02335203 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2016-09-20

No results posted yet for this study

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

Conditions

  • Grade 1 Endometrial Endometrioid Adenocarcinoma
  • Grade 2 Endometrial Endometrioid Adenocarcinoma
  • Complex Atypical Endometrial Hyperplasia

Interventions

DRUG

Depot medroxyprogesterone acetate

One injection intragluteally of 400mg depot medroxyprogesterone acetate at the time of the patient's first visit with the Program in Womens' Oncology

OTHER

Placebo

One injection intragluteally of 1mL Normal Saline (0.9% Sodium Chloride) at the time of the patient's first visit with the Program in Womens' Oncology

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Stephen Fiascone, MD · Department of medical education

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-03-31
Completion
2018-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02335203 on ClinicalTrials.gov