NCT03463252 Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC
| NCT ID | NCT03463252 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | West China Second University Hospital |
| Condition | Endometrial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 224 participants |
| Start Date | 2018-04-01 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 224 participants in total. It began in 2018-04-01 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03463252 clinical trial?
This trial is open to female participants only, up to 40 Years, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03463252 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03463252 currently recruiting?
Yes, NCT03463252 is actively recruiting participants. Contact the research team at 935398163@qq.com for enrollment information.
Where is the NCT03463252 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT03463252 clinical trial?
NCT03463252 is sponsored by West China Second University Hospital. The trial plans to enroll 224 participants.
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