Clinical trial · Interventional
Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC
Value of Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Fertility-preserving Treatment of Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma
NCT03463252CI-TRIAL-00053862recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atypical Endometrial Hyperplasia | Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia | ALIAS | 0.90 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GnRH agonist | Drug | — | UNRESOLVED |
| Mirena® | Device | — | UNRESOLVED |
| Progesterone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- ACTIVE_COMPARATOR
- label
- 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.
- interventionNames
- Drug: Progesterone
- type
- EXPERIMENTAL
- label
- MPA+Mirena® for EC without 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (22)
- BACKGROUNDUshijima K, Yahata H, Yoshikawa H, Konishi I, Yasugi T, Saito T, Nakanishi T, Sasaki H, Saji F, Iwasaka T, Hatae M, Kodama S, Saito T, Terakawa N, Yaegashi N, Hiura M, Sakamoto A, Tsuda H, Fukunaga M, Kamura T. Multicenter phase II study of fertility-sparing treatment with medroxyprogesterone acetate for endometrial carcinoma and atypical hyperplasia in young women. J Clin Oncol. 2007 Jul 1;25(19):2798-803. doi: 10.1200/JCO.2006.08.8344. PMID 17602085
- BACKGROUNDRodolakis A, Biliatis I, Morice P, Reed N, Mangler M, Kesic V, Denschlag D. European Society of Gynecological Oncology Task Force for Fertility Preservation: Clinical Recommendations for Fertility-Sparing Management in Young Endometrial Cancer Patients. Int J Gynecol Cancer. 2015 Sep;25(7):1258-65. doi: 10.1097/IGC.0000000000000493. PMID 26186070
- BACKGROUNDMinig L, Franchi D, Boveri S, Casadio C, Bocciolone L, Sideri M. Progestin intrauterine device and GnRH analogue for uterus-sparing treatment of endometrial precancers and well-differentiated early endometrial carcinoma in young women. Ann Oncol. 2011 Mar;22(3):643-649. doi: 10.1093/annonc/mdq463. Epub 2010 Sep 28. PMID 20876910
- BACKGROUNDKELLEY RM, BAKER WH. Progestational agents in the treatment of carcinoma of the endometrium. N Engl J Med. 1961 Feb 2;264:216-22. doi: 10.1056/NEJM196102022640503. No abstract available. PMID 13752346
- BACKGROUNDZhang Q, Qi G, Kanis MJ, Dong R, Cui B, Yang X, Kong B. Comparison among fertility-sparing therapies for well differentiated early-stage endometrial carcinoma and complex atypical hyperplasia. Oncotarget. 2017 May 3;8(34):57642-57653. doi: 10.18632/oncotarget.17588. eCollection 2017 Aug 22. PMID 28915701
- BACKGROUNDWildemeersch D, Andrade A, Goldstuck N. Femilis((R)) 60 Levonorgestrel-Releasing Intrauterine System-A Review of 10 Years of Clinical Experience. Clin Med Insights Reprod Health. 2016 Aug 9;10:19-27. doi: 10.4137/CMRH.S40087. eCollection 2016.