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 range18 Years
SexFEMALE
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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…