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NCT03241914
Megestrol Acetate Plus LNG-IUS in Young Women With Early Endometrial Cancer
Phase 2, PHASE3 trial testing Megestrol Acetate in Endometrial Neoplasm Malignant Stage I in 64 participants. Completed in 18 June 2020.
18 June 2020
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 4 July 2017 |
| Primary completion | 18 June 2020 |
| Estimated completion | 18 June 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- Megestrol Acetate (MEGESTROL ACETATE) — full drug profile →
- Levonorgestrel-releasing Intrauterine System(LNG-IUS)
Conditions studied
- Endometrial Neoplasm Malignant Stage I — all drugs for Endometrial Neoplasm Malignant Stage I →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT03241914
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Megestrol Acetate
Trials testing the same drug.
- NCT07436793 — Progestins for the Treatment of Endometrial Cancer or Precancers of the Uterus Before Surgery, The Pro-Window Trial · Phase 2 · not yet recruiting
- NCT07254416 — A Study on Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients · Phase 4 · not yet recruiting
- NCT06998758 — Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Locally Advanced CRC · Phase 3 · recruiting
- NCT05538897 — Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recur · Phase 1, PHASE2 · active not recruiting
- NCT05332483 — Study of Megestrol Acetate in Grade 2 Endometrioid Endometrial Cancer · Phase 1 · terminated
Other recruiting trials for Endometrial Neoplasm Malignant Stage I
Currently open trials in the same condition.
- NCT05247268 — Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer · Phase 2 · recruiting
- NCT05945407 — Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer · NA · recruiting
Other Fudan University trials
Trials by the same sponsor.
- NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
- NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
- NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
- NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
- NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03241914 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fudan University
- Last refreshed: 20 November 2020
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