Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
AgeUp to 40
SponsorWest China Second University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Progesterone
- Mirena®
- GnRH agonist
Treatment groups
224 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov