Brief Title
Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC
Official Title
Value of Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Fertility-preserving Treatment of Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma
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
endometrial hyperplasia and early endometrial carcinoma, including pathology response and
pregnancy outcome.
Second end points:
To analyze the appearances of side-effects.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Pathologic Response
Secondary Outcome
Side-Affects Rate
Condition
Endometrial Cancer
Intervention
Progesterone
Study Arms / Comparison Groups
MPA for EC without progesterone contraindication
Description: The enrolled patient (endometrial cancer without contraindication of oral high dose progesterone) is allocated to one of three groups, MPA only, MPA+LNG-IUS, LNG-IUS only, by randomization. Continuous treatment for 3 months is one cycle. Hysteroscopic evaluation and biopsy will procedure every cycle. Patients with partial response or in stable condition, after 2 cycles, will receive continuous treatment for one more cycle again. Patients with complete response after 2 or 3 cycles are encouraged to pregnancy. The consideration of giving up fertility-sparing treatment is recommended: 1) if patient have documented progression on the biopsies; 2) if endometrial cancer is still present after 3 cycles.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
224
Start Date
April 1, 2018
Completion Date
December 30, 2030
Primary Completion Date
December 30, 2025
Eligibility Criteria
For Patients With Endometrial Cancer：
Inclusion Criteria:
- ≤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 Criteria:
- 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
Exclusion Criteria:
- Patients have allergies or contraindications (except for thromboembolic disease, liver
dysfunction, hypertension, and diabetes) for the involved drugs
- Patients have contraindications for pregnancy
- Patients have serious underlying disease, malignancies at other site(s), acute liver
or kidney disease, 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.
Gender
Female
Ages
N/A - 40 Years
Accepts Healthy Volunteers
No
Contacts
, +8613018256012, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03463252
Organization ID
ZHENG Ying
Responsible Party
Principal Investigator
Study Sponsor
West China Second University Hospital
Study Sponsor
, ,
Verification Date
July 2020