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

Primary Purpose

Fertility Sparing

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Medroxyprogesterone Acetate 500 MG Oral Tablet
Levonorgestrel-Releasing Intrauterine System
Sponsored by
Hua Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fertility Sparing

Eligibility Criteria

21 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Bei Jing Chao-Yang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Medroxyprogesterone acetate

LNG-IUS

Arm Description

Administered MPA at a dosage of 500 mg/d concurrently

Go through LNG-IUS insertion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to achieve complete response
The median CR time will be calculated in two groups
The pregnancy rate
Rate of fertility outcomes
The live-birth rate
Rate of fertility outcomes

Full Information

First Posted
September 29, 2022
Last Updated
October 3, 2022
Sponsor
Hua Li
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1. Study Identification

Unique Protocol Identification Number
NCT05565573
Brief Title
Medroxyprogesterone Acetate vs LNG-IUS in Early-stage Endometrioid Carcinoma and Atypical Hyperplasia Patients
Official Title
The Therapeutic Effect of Medroxyprogesterone Acetate vs. LNG-IUS in Early-stage Endometrioid Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hua Li

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fertility Sparing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medroxyprogesterone acetate
Arm Type
Experimental
Arm Description
Administered MPA at a dosage of 500 mg/d concurrently
Arm Title
LNG-IUS
Arm Type
Experimental
Arm Description
Go through LNG-IUS insertion
Intervention Type
Drug
Intervention Name(s)
Medroxyprogesterone Acetate 500 MG Oral Tablet
Other Intervention Name(s)
MPA
Intervention Description
500mg/ Pfizer Active ingredient: Medroxyprogesterone Acetate At a dosage of 500 mg/day
Intervention Type
Device
Intervention Name(s)
Levonorgestrel-Releasing Intrauterine System
Other Intervention Name(s)
LNG-IUS, 52-mg LNG-IUS,Mirena
Intervention Description
Uterine cavity insertion
Primary Outcome Measure Information:
Title
Complete response rate
Description
The 24-week CR rate will be calculated in two groups.
Time Frame
24-week
Secondary Outcome Measure Information:
Title
Time to achieve complete response
Description
The median CR time will be calculated in two groups
Time Frame
From date of randomization until the date of CR, assessed up to 24 weeks
Title
The pregnancy rate
Description
Rate of fertility outcomes
Time Frame
Up to 2 years after the treatment
Title
The live-birth rate
Description
Rate of fertility outcomes
Time Frame
Up to 2 years after the treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hengzi Sun, Ph.D
Phone
+86 18811151901
Email
summerel1990@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hua Li, Ph.D
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Bei Jing Chao-Yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Li, Ph.D
Phone
+86 010 85231831

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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