Status:
RECRUITING
Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC
Lead Sponsor:
West China Second University Hospital
Conditions:
Endometrial Cancer
Atypical Endometrial Hyperplasia
Eligibility:
FEMALE
Up to 40 years
Phase:
PHASE2
PHASE3
Brief Summary
Primary end points: This clinical trial is aimed to analyze the effectiveness of Levonorgestrel-Releasing Intrauterine System (LNG-IUS, Mirena®) in the fertility-sparing treatment of atypical endomet...
Eligibility Criteria
Inclusion
- For Patients With Endometrial Cancer：
- ≤40 years of age:
- Having a strong desire for fertility preservation;
- Histological diagnosis is confirmed as well-differentiated (grade 1) endometrioid adenocarcinoma by the designated gynecological pathologists, and the progesterone receptors (PgRs) is positive in immunohistochemistry;
- Disease limited to the endometrium (stage 1A) on MRI;
- Serum CA125/199 level is within normal limit (Laparoscopic exploration to rule out ovarian tumor or another metastasis if necessary);
- Patients should have undergone counseling to learn fertility-preserving treatment is not standard of care for the treatment of EC, volunteered to participate in this study, signed the informed consent form, and agreed to participated in clinical follow-up.
Exclusion
- Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs;
- Patients have lynch syndrome (LS);
- Patients have contraindications for pregnancy;
- Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute liver or kidney diseases, acute or subacute genital tract infections and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible);
- Patients refuse to participate in clinical follow-up or sign the informed consent form.
- For Patients With Endometrial atypical hyperplasia：
- Inclusion Criteria:
- ≤ 40 years of age
- Having a strong desire for fertility preservation
- Histological diagnosis is confirmed as atypical endometrial hyperplasia (EAH) by the designated gynecological pathologists
- Having volunteered to participate in this study, signed the informed consent form, and agreed to participate in clinical follow-up
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2030
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT03463252
Start Date
April 1 2018
End Date
December 30 2030
Last Update
September 13 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
West China Second University Hospital
Chengdu, Sichuan, China, 610000