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

October 3, 2022 updated by: Hua Li

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

148

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100025
        • Recruiting
        • Bei Jing Chao-Yang Hospital
        • Contact:
          • Hua Li, Ph.D
          • Phone Number: +86 010 85231831

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medroxyprogesterone acetate
Administered MPA at a dosage of 500 mg/d concurrently
Drug: Medroxyprogesterone Acetate 500 MG Oral Tablet
500mg/ Pfizer Active ingredient: Medroxyprogesterone Acetate At a dosage of 500 mg/day
Other Names:
  • MPA
Experimental: LNG-IUS
Go through LNG-IUS insertion
Device: Levonorgestrel-Releasing Intrauterine System
Uterine cavity insertion
Other Names:
  • LNG-IUS, 52-mg LNG-IUS，Mirena

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate
Time Frame: 24-week
The 24-week CR rate will be calculated in two groups.
24-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to achieve complete response
Time Frame: From date of randomization until the date of CR, assessed up to 24 weeks
The median CR time will be calculated in two groups
From date of randomization until the date of CR, assessed up to 24 weeks
The pregnancy rate
Time Frame: Up to 2 years after the treatment
Rate of fertility outcomes
Up to 2 years after the treatment
The live-birth rate
Time Frame: Up to 2 years after the treatment
Rate of fertility outcomes
Up to 2 years after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hua Li

Investigators

  • Study Chair: Hua Li, Ph.D, Beijing Chao Yang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

November 1, 2025

Study Registration Dates

First Submitted

September 29, 2022

First Submitted That Met QC Criteria

October 3, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LH0930

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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