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

NCT05565573 | Unknown Phase 2

• 1 other identifier: LH0930
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  The 24-week CR rate will be calculated in two groups.

  24-week

Secondary Outcomes (3)

• Time to achieve complete response

  From date of randomization until the date of CR, assessed up to 24 weeks

• The pregnancy rate

  Up to 2 years after the treatment

• The live-birth rate

  Up to 2 years after the treatment

Study Arms (2)

Medroxyprogesterone acetate

EXPERIMENTAL

Administered MPA at a dosage of 500 mg/d concurrently

Drug: Medroxyprogesterone Acetate 500 MG Oral Tablet

LNG-IUS

EXPERIMENTAL

Go through LNG-IUS insertion

Device: Levonorgestrel-Releasing Intrauterine System

Interventions

Medroxyprogesterone Acetate 500 MG Oral Tablet DRUG

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

Also known as: MPA

Medroxyprogesterone acetate

Levonorgestrel-Releasing Intrauterine System DEVICE

Uterine cavity insertion

Also known as: LNG-IUS, 52-mg LNG-IUS，Mirena

LNG-IUS

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• type II endometrial cancer;
• Patients with abnormal liver and kidney function and other contraindications to progesterone therapy;
• Other parts of the body are concurrent or successively complicated by other malignant tumors;
• The patient and his/her family are unable to sign the informed consent form for any reason;
• Unconditional follow-up.

Sponsors & Collaborators

• Hua Li: lead

Study Sites (1)

Bei Jing Chao-Yang Hospital

Beijing, Beijing Municipality, 100025, China

RECRUITING

MeSH Terms

Interventions

Medroxyprogesterone Acetate; Tablets

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Hua Li, Ph.D

  Beijing Chao Yang Hospital

  STUDY CHAIR

Central Study Contacts

Hengzi Sun, Ph.D

CONTACT

+86 18811151901; summerel1990@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 4, 2022
• Study Start: November 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: November 1, 2025
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)