NCT02035787CompletedPhase 2
Metformin With the Levonorgestrel-Releasing Intrauterine Device for the Treatment of Complex Atypical Hyperplasia (CAH) and Endometrial Cancer (EC) in Non-surgical Patients
Source: ClinicalTrials.gov · Last updated 18 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 10 Jan 2014
- Start date
- 27 Feb 2014
- Primary completion date
- 12 Oct 2023
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Endometrial cancer
- NCT number
- NCT02035787
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 20
- From 27 Feb 2014 to the primary completion date, 12 Oct 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving progestin therapy (local, topical, or systemic)
- Prior or current use of metformin within the past 3 months
- Iodinated contrast agents used in prior 48 hours (significant increase in metformin concentration and risk of lactic acidosis)
Other illness
- 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
- History of hypersensitivity to metformin or history of discontinuation secondary to attributed adverse effects
- Recent (\< 4 weeks) active, documented, cervical infection
Lab values
- 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))
Other
- Mixed histology including clear cell, serous, undifferentiated or sarcomatous elements
- Chronic (daily use for \> 1 month) use of cimetidine (significant increase in metformin concentration and risk of lactic acidosis)
- Pregnant or lactating
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| TriHealth Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.