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Trial Title:
Medroxyprogesterone Acetate vs LNG-IUS in Early-stage Endometrioid Carcinoma and Atypical Hyperplasia Patients
NCT ID:
NCT05565573
Condition:
Fertility Sparing
Conditions: Official terms:
Carcinoma, Endometrioid
Medroxyprogesterone Acetate
Levonorgestrel
Medroxyprogesterone
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Medroxyprogesterone Acetate 500 MG Oral Tablet
Description:
500mg/ Pfizer Active ingredient: Medroxyprogesterone Acetate At a dosage of 500 mg/day
Arm group label:
Medroxyprogesterone acetate
Other name:
MPA
Intervention type:
Device
Intervention name:
Levonorgestrel-Releasing Intrauterine System
Description:
Uterine cavity insertion
Arm group label:
LNG-IUS
Other name:
LNG-IUS, 52-mg LNG-IUS，Mirena
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
Criteria for 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.
Gender:
Female
Minimum age:
21 Years
Maximum age:
45 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Bei Jing Chao-Yang Hospital
Address:
City:
Beijing
Zip:
100025
Country:
China
Status:
Recruiting
Contact:
Last name:
Hua Li, Ph.D
Phone:
+86 010 85231831
Start date:
November 1, 2022
Completion date:
November 1, 2025
Lead sponsor:
Agency:
Hua Li
Agency class:
Other
Source:
Beijing Chao Yang Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05565573
