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

NCT ID: NCT05565573

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2025-11-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medroxyprogesterone acetate

Administered MPA at a dosage of 500 mg/d concurrently

Group Type: EXPERIMENTAL

Medroxyprogesterone Acetate 500 MG Oral Tablet

Intervention Type: DRUG

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

LNG-IUS

Go through LNG-IUS insertion

Group Type: EXPERIMENTAL

Levonorgestrel-Releasing Intrauterine System

Intervention Type: DEVICE

Uterine cavity insertion

Interventions

Medroxyprogesterone Acetate 500 MG Oral Tablet

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

Intervention Type: DRUG

Levonorgestrel-Releasing Intrauterine System

Uterine cavity insertion

Intervention Type: DEVICE

Other Intervention Names

MPA; LNG-IUS, 52-mg LNG-IUS，Mirena

Eligibility Criteria

Inclusion Criteria

1. Age ≤ 45 years old;

2. Diagnostic curettage pathology is highly differentiated endometrioid adenocarcinoma;

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

4. No suspicious metastatic lesions;

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

6. Blood CA125 is normal;

7. no progesterone therapy and contraindications to pregnancy;

8. 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;

9. Conditional acceptance of close follow-up.

Exclusion Criteria

1. type II endometrial cancer;

2. Patients with abnormal liver and kidney function and other contraindications to progesterone therapy;

3. Other parts of the body are concurrent or successively complicated by other malignant tumors;

4. The patient and his/her family are unable to sign the informed consent form for any reason;

5. Unconditional follow-up.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hua Li

OTHER

Sponsor Role: lead

Responsible Party

Hua Li

Department of Obstetrics and Gynecology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hua Li, Ph.D

Role: STUDY_CHAIR

Beijing Chao Yang Hospital

Locations

Bei Jing Chao-Yang Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hengzi Sun, Ph.D

Role: CONTACT

summerel1990@163.com

+86 18811151901

Facility Contacts

Hua Li, Ph.D

Role: primary

+86 010 85231831

Other Identifiers

LH0930

Identifier Type: -

Identifier Source: org_study_id