Clinical trial · Interventional
Megestrol Acetate Plus LNG-IUS in Young Women With Early Endometrial Cancer
Megestrol Acetate Plus LNG-IUS to Megestrol Acetate in Young Women With Early Endometrial Cancer
NCT03241914CI-TRIAL-00048395completedPhase 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)
To see if megestrol acetate plus Levonorgestrel-releasing intrauterine system (LNG-IUS) will not be inferior to returning the endometrial tissue to a normal state than megestrol acetate alone in patients with early endometrial cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Neoplasm Malignant Stage I | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Levonorgestrel-releasing Intrauterine System(LNG-IUS) | Device | — | UNRESOLVED |
| Megestrol Acetate | Drug | Megestrol | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- MA
- description
- Patients will receive megestrol acetate 160 mg by mouth daily for at least 3 months.Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.
- interventionNames
- Drug: Megestrol Acetate
- type
- EXPERIMENTAL
- label
- MA+LNG-IUS
- description
- Patients will receive MA (160mg po qd) plus LNG- IUS insertion for at least 3 months. Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.
- interventionNames
- Drug: Megestrol Acetate
- Device: Levonorgestrel-releasing Intrauterine System(LNG-IUS)
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Primarily have a confirmed diagnosis of endometrioid endometrial cancer based upon hysteroscopy * MRI parameters shows there's no myometrial invasion, extension beyond corpus, or enlarged lymph nodes * Have a desire for remaining reproductive function or uterus * Need to be able to undergo correlative treatment and follow-up Exclusion Criteria: * Acute liver disease or liver tumor (benign or malignant) or renal dysfunction * Pregnancy or suspicion of pregnancy * Have a history of EAH or EC and have disease relapse during Merina insertion * Under treatment of high-dose progestin therapy more than 3 months in recent 6 months * Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity * Confirmed diagnosis of malignant tumor in genital system * Acute severe disease such as stroke or heart infarction or a history of thrombosis disease * Hypersensitivity or contradiction to any component of this product * Ask for removal of the uterus or other conservative treatment * Smoker(\>15 cigarettes a day)
References
Publications (1)
- DERIVEDXu Z, Yang B, Guan J, Shan W, Liao J, Shao W, Chen X. Comparison of the effect of oral megestrol acetate with or without levonorgestrel-intrauterine system on fertility-preserving treatment in patients with early-stage endometrial cancer: a prospective, open-label, randomized controlled phase II trial (ClinicalTrials.gov NCT03241914). J Gynecol Oncol. 2023 Jan;34(1):e32. doi: 10.3802/jgo.2023.34.e32. Epub 2022 Dec 15. PMID 36562136