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

Sponsor
Hua Li (Other)
Overall Status
Recruiting
CT.gov ID
NCT05565573
Collaborator
(none)
148
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Medroxyprogesterone Acetate 500 MG Oral Tablet
  • Device: Levonorgestrel-Releasing Intrauterine System
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
148 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Therapeutic Effect of Medroxyprogesterone Acetate vs. LNG-IUS in Early-stage Endometrioid Carcinoma
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Complete response rate [24-week]

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

    Secondary Outcome Measures

    1. Time to achieve complete response [From date of randomization until the date of CR, assessed up to 24 weeks]

      The median CR time will be calculated in two groups

    2. The pregnancy rate [Up to 2 years after the treatment]

      Rate of fertility outcomes

    3. The live-birth rate [Up to 2 years after the treatment]

      Rate of fertility outcomes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bei Jing Chao-Yang Hospital Beijing Beijing China 100025

    Sponsors and Collaborators

    • Hua Li

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hua Li, Department of Obstetrics and Gynecology, Beijing Chao Yang Hospital
    ClinicalTrials.gov Identifier:
    NCT05565573
    Other Study ID Numbers:
    • LH0930
    First Posted:
    Oct 4, 2022
    Last Update Posted:
    Oct 4, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Carcinoma, Endometrioid
    Medroxyprogesterone Acetate
    Levonorgestrel
    Medroxyprogesterone

    Study Results

    No Results Posted as of Oct 4, 2022