MedTrace Logo

Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia

NCT04897217 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-07-05

No results posted yet for this study

Summary

The purpose of this research study is to compare the uterus tissue of women who receive an intrauterine system to treat their endometrial hyperplasia with the uterine tissue of women who receive megestrol acetate to treat their hyperplasia. While both methods are commonly used in practice, investigators would like to see what effects each treatment has on uterine tissue.

Conditions

  • Endometrial Hyperplasia

Interventions

DRUG

Megestrol Acetate

The control arm will consist of oral progesterone therapy (megestrol acetate 160mg po daily). The intervention will be administered on an outpatient basis.

DRUG

Levonorgestrel Drug Implant

Participants in the comparison arm will have a levonorgestrel intrauterine device placed in the office or in the operating room if the office procedure not tolerated or if they have not had a prior dilation and curettage.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Janelle Darby, MD · Wake Forest Baptist Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-10-31
Completion
2026-11-30
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04897217 on ClinicalTrials.gov