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NCT03241914

Megestrol Acetate Plus LNG-IUS in Young Women With Early Endometrial Cancer

Completed Phase 2, PHASE3 Last updated 20 November 2020
What this trial tests

Phase 2, PHASE3 trial testing Megestrol Acetate in Endometrial Neoplasm Malignant Stage I in 64 participants. Completed in 18 June 2020.

Timeline
4 July 2017
Primary endpoint
18 June 2020
18 June 2020

Quick facts

Lead sponsorFudan University
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment64
Start date4 July 2017
Primary completion18 June 2020
Estimated completion18 June 2020
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Fudan University

Who can join

Adults 18 to 45, female only, with Endometrial Neoplasm Malignant Stage I. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Fertility-sparing treatment in early endometrial cancer: current state and future strategies.
    Obermair A, Baxter E, Brennan DJ, McAlpine JN, et al · · 2020 · cited 62× · PMID 32689770 · DOI 10.5468/ogs.19169
  2. Fertility-Sparing Approaches in Atypical Endometrial Hyperplasia and Endometrial Cancer Patients: Current Evidence and Future Directions.
    Contreras NA, Sabadell J, Verdaguer P, Julià C, et al · · 2022 · cited 60× · PMID 35269674 · DOI 10.3390/ijms23052531
  3. Biomolecular and Genetic Prognostic Factors That Can Facilitate Fertility-Sparing Treatment (FST) Decision Making in Early Stage Endometrial Cancer (ES-EC): A Systematic Review.
    Tanos P, Dimitriou S, Gullo G, Tanos V. · · 2022 · cited 46× · PMID 35269800 · DOI 10.3390/ijms23052653
  4. The Perspectives of Fertility Preservation in Women with Endometrial Cancer.
    Knez J, Al Mahdawi L, Takač I, Sobočan M. · · 2021 · cited 22× · PMID 33546293 · DOI 10.3390/cancers13040602
  5. Fertility-preserving treatment in women with early endometrial cancer: the Chinese experience.
    Wang Y, Yang JX. · · 2018 · cited 21× · PMID 30584372 · DOI 10.2147/cmar.s188087
  6. Efficacy of the LNG-IUS for treatment of endometrial hyperplasia and early stage endometrial cancer: Can biomarkers predict response?
    Dore M, Filoche S, Danielson K, Henry C. · · 2021 · cited 19× · PMID 33718563 · DOI 10.1016/j.gore.2021.100732
  7. Asian Society of Gynecologic Oncology International Workshop 2018.
    Kong TW, Ryu HS, Kim SC, Enomoto T, et al · · 2019 · cited 10× · PMID 30740961 · DOI 10.3802/jgo.2019.30.e39
  8. 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
    Xu Z, Yang B, Guan J, Shan W, et al · · 2023 · cited 8× · PMID 36562136 · DOI 10.3802/jgo.2023.34.e32

Verify or expand the search:

Other trials of Megestrol Acetate

Trials testing the same drug.

Other recruiting trials for Endometrial Neoplasm Malignant Stage I

Currently open trials in the same condition.

Other Fudan University trials

Trials by the same sponsor.

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