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Medroxyprogesterone Acetate vs LNG-IUS in Early-stage Endometrioid Carcinoma and Atypical Hyperplasia Patients

NCT05565573 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2022-10-04

No results posted yet for this study

Summary

In modern society, endometrial cancer (EC) and atypical hyperplasia is the most frequent desease which can affect the fertility of young patients. For young patients, there is a growing need to treat tumors and fertility sparing. Advaced studies have confirmed thatfertility preservation therapy has better tumor and pregnancy outcomes in specific patients with early gynecological tumors. Clinically, evidence-based guidelines are urgently needed to guide the screening and treatment of women who are suitable for fertility preservation. Fertility-sparing treatment predominantly involves the use of oral progestins and levonorgestrel-releasing intrauterine devices, which have been shown to be feasible and safe in women with early stage EC and minimal or no myometrial invasion. However, data on the efficacy and safety of conservative management strategies are primarily based on retrospective studies.The present study aims to compared the therapeutic effect of Medroxyprogesterone acetate (MPA) and Levonorgestrel-releasing intrauterine system (LNG-IUS) in early-stage endometrioid carcinoma and atypical hyperplasia patients

Conditions

  • Fertility Sparing

Interventions

DRUG

Medroxyprogesterone Acetate 500 MG Oral Tablet

500mg/ Pfizer Active ingredient: Medroxyprogesterone Acetate At a dosage of 500 mg/day

DEVICE

Levonorgestrel-Releasing Intrauterine System

Uterine cavity insertion

Sponsors & Collaborators

  • Hua Li

    lead OTHER

Principal Investigators

  • Hua Li, Ph.D · Beijing Chao Yang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2024-07-01
Completion
2025-11-01

Countries

  • China

Study Locations

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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 NCT05565573 on ClinicalTrials.gov