Metformin With the Levonorgestrel-Releasing Intrauterine Device for the Treatment of Complex Atyp… (NCT02035787) | Clinical Trial Compass
CompletedPhase 2
Metformin With the Levonorgestrel-Releasing Intrauterine Device for the Treatment of Complex Atypical Hyperplasia (CAH) and Endometrial Cancer (EC) in Non-surgical Patients
United States20 participantsStarted 2014-02-27
Plain-language summary
Purpose: This is an open label, single-arm, single-center study of the addition of metformin to standard levonorgestrel-releasing intrauterine device (LR-IUD) treatment of 30 evaluable non-surgical patients with either complex atypical hyperplasia (CAH; n=15) or grade 1 endometrial adenocarcinoma (EC; n=15).
Participants:Women, over the age of 18 years, with biopsy-proven CAH/EC who are not candidates for surgical management, and therefore are planned to start standard of care treatment with the LR-IUD
Procedures (methods): subjects will be given oral metformin therapy for 12 months, or until disease progression occurs (whichever occurs first), in addition to LR-IUD treatment. Serial endometrial biopsies will be performed, as per standard of care, to assess disease status.
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:
Subjects must meet all of the inclusion criteria to participate in this study:
* Histologically confirmed CAH or grade 1 EC
* Females age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 4
* Non-surgical candidates due to:
* Desire for fertility preserving treatment
* Unacceptable surgical risk as defined by:
* American Society of Anesthesiologists Physical Status (ASA) ≥ 4 and/or Perioperative Cardiac Risk \> 5%(45) and/or Perioperative Respiratory Failure Risk \> 5%(46)
AND
oIndependent medicine or cardiology pre-op consultation concluding 'high' surgical risk.
* Planned treatment with the LR-IUD for CAH or grade 1 EC by primary physician
* Women of childbearing potential (WOCBP) must have negative pregnancy test within 7 days of D1 of treatment
* Understand study design, risks, and benefits and have signed informed consent
Exclusion Criteria Any patient meeting any of the exclusion criteria at baseline will be excluded from study participation.
* Evidence of renal dysfunction (Cr \> 1.5mg/dL or Cr clearance \< 60 mL/m2) or liver dysfunction (AST/alanine aminotransferase (ALT) \> 2x upper limit of normal (ULN))
* Currently receiving progestin therapy (local, topical, or systemic)
* Myometrial invasion \>50% or evidence of nodal or metastatic disease on baseline MRI (MRI only to be done for EC patients) or tumor size \> 2cm on MRI or pelvic ultrasound
* Mixed histology including clear cell, serous, undifferent…
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.