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Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer
NCT02397083 · View on ClinicalTrials.gov ↗
Study Summary
This randomized phase II trial studies how well levonorgestrel-releasing intrauterine system works when given alone or with everolimus in treating patients with atypical hyperplasia (a pre-cancerous growth of the lining of the uterus) or stage IA grade 1 endometrial cancer. The levonorgestrel-releasing intrauterine system is designed to prevent pregnancy by releasing a hormone called levonorgestrel, which is a type of progesterone. Progesterone is a common type of hormone that is used to prevent pregnancy and may prevent or slow tumor cell growth. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether the levonorgestrel-releasing intrauterine system works better with or without everolimus in treating patients with atypical hyperplasia or stage IA grade 1 endometrial cancer.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Everolimus
- DEVICE Levonorgestrel-Releasing Intrauterine System
Study Locations (18)
Texas
- MD Anderson in The Woodlands — Conroe
- Memorial Hermann Memorial City Medical Center — Houston
- Lyndon Baines Johnson General Hospital — Houston
- M D Anderson Cancer Center — Houston
- The Woman's Hospital of Texas — Houston
- MD Anderson West Houston — Houston
- MD Anderson League City — League City
- MD Anderson in Sugar Land — Sugar Land
Colorado
- North Colorado Medical Center — Greeley
- McKee Medical Center — Loveland
New Jersey
- Cooper Hospital University Medical Center — Camden
- MD Anderson Cancer Center at Cooper-Voorhees — Voorhees Township
Hawaii
- Queen's Medical Center — Honolulu
Michigan
- Covenant HealthCare Mackinaw — Saginaw
New York
- Northwell Health — New Hyde Park
Ohio
- OhioHealth Mansfield Hospital — Mansfield
Oklahoma
- University of Oklahoma Health Sciences Center — Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2015-09-23 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02397083
The ClinicalTrials.gov registry entry for NCT02397083 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,992 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions — of which Laboratory Biomarker Analysis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02397083 reports 18 study locations spanning 9 distinct geographic areas — top geographies include Texas, Colorado, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02397083 about?
NCT02397083 is a clinical study titled "Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer". This randomized phase II trial studies how well levonorgestrel-releasing intrauterine system works when given alone or with everolimus in treating patients with atypical hyperplasia (a pre-cancerous growth of the lining of the uterus) or stage IA grade 1 endometrial cancer. The levonorgestrel-releas...
What is the current status of trial NCT02397083?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2015-09-23. Estimated completion is 2026-09-30.
What conditions does trial NCT02397083 study?
This clinical trial studies the following conditions: FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, Atypical Endometrial Hyperplasia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02397083?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Everolimus (DRUG), Levonorgestrel-Releasing Intrauterine System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02397083?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,992 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02397083 being conducted?
This trial has 18 study locations across Colorado, Hawaii, Michigan, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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