The Therapeutic Effect of Medroxyprogesterone Acetate vs. LNG-IUS in Early-stage Endometrioid Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 45
Healthy Volunteers: f
View:

• Age ≤ 45 years old;

• Diagnostic curettage pathology is highly differentiated endometrioid adenocarcinoma;

• pelvic augmentation MRI or / and vaginal color ultrasound Doppler examination, tumor confined endometrium;

• No suspicious metastatic lesions;

• Endometrial pathological tissue specimens with strong positive expression of estrogen and progesterone receptors;

• Blood CA125 is normal;

• no progesterone therapy and contraindications to pregnancy;

• The patient himself has a strong desire to preserve fertility, and the patient should fully understand that fertility preservation treatment is not the standard treatment method;

• Conditional acceptance of close follow-up.

Locations
Other Locations
China
Bei Jing Chao-Yang Hospital
RECRUITING
Beijing
Contact Information
Primary
Hengzi Sun, Ph.D
summerel1990@163.com
+86 18811151901
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 148
Treatments
Experimental: Medroxyprogesterone acetate
Administered MPA at a dosage of 500 mg/d concurrently
Experimental: LNG-IUS
Go through LNG-IUS insertion
Sponsors
Leads: Hua Li

This content was sourced from clinicaltrials.gov