The Effect of Neoadjuvant DMPA on Glandular Cellularity in Women Awaiting Hysterectomy (NCT02335203) | Clinical Trial Compass
UnknownPhase 2
The Effect of Neoadjuvant DMPA on Glandular Cellularity in Women Awaiting Hysterectomy
United States76 participantsStarted 2015-02
Plain-language 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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.