Prospective Study for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women

Endometrial Hyperplasia Clinical Trial

Official title:

Prospective Clinical Study of Fertility-sparing Treatment With a Membrane-inhibiting Formula Combined With Oral Progestins for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06417736
• Other study ID #: PRO2023-3614
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Yang Li, Doctor
• Phone: 0086-18268165386
• Email: 5516015[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the effect and adverse side effects of membrane-inhibiting formula plus oral progestins as fertility-preserving treatment in patients with early-stage endometrial cancer and endometrial hyperplasia research questions：When taken with oral progestins, does the drug membrane-inhibiting formula shorten the time required for complete endometrial remission? What medical problems do participants have when taking drug membrane-inhibiting formula plus oral progestins? Efficacy, side effects, recurrence, pregnancy, and time to obtain pregnancy in different molecular classifications of POLE-mutated, mismatch repair-deficient(MMRd), p53 wild type(p53wt), and p53-abnormal(p53abn).

Participants will: Take drug membrane-inhibiting formula plus oral progestins every day Visit the clinic once every 3 months for checkups, tests, and hysteroscopy Keep a diary of examination results and pathology

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2026
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 1.18-45 years old with a strong desire to preserve fertility; 2. pathologically diagnosed with primary grade1 or grade2 endometrioid endometrial carcinoma and hyperplasia 3.no signs of suspicious myometrial invasion by enhanced magnetic resonance imaging (MRI) 4. no signs of suspicious extrauterine metastasis by enhanced computed tomography and CT scan of the Lungs

Exclusion Criteria:

• 1.have contraindication for pregnancy. 2.no fertility requiremen 3.have myometrial invasion or extrauterine metastasis 4.pathologically diagnosed with primary grade3 endometrioid endometrial carcinoma or non-endometrioid endometrial carcinoma 5.Any disease or symptom that may affect the implementation of the study or the interpretation of the results

Related Conditions & MeSH terms

• Endometrial Cancer Stage I
• Endometrial Hyperplasia
• Endometrial Neoplasms
• Hyperplasia

Intervention

Drug:
• Megestrol Acetate 40 MG
160mg/one time/day

Locations

Country	Name	City	State
China	Women's Hospital School of Medicine Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CR in different molecular classification	Efficacy in different molecular classification of POLE-mutated, mismatch repair-deficient(MMRd), p53 wild type(p53wt),and p53-abnormal(p53abn)	baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment
Primary	24-week complete response(CR) rate	The treatment response:complete response,no endometrial lesion	baseline,12 weeks after treatment,and 24 weeks of treatment
Secondary	36-week CR rate	The treatment response:complete response,no endometrial lesion	baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment
Secondary	48-week CR rate	The treatment response:complete response,no endometrial lesion	baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment
Secondary	treatment-related adverse events	analyze the safety of the drug	baseline,12 weeks after treatment,and 24 weeks of treatment
Secondary	recurrent rate	cumulative recurrent rate	baseline,12 weeks after treatment,24 weeks of treatment,36 weeks of treatment,48 weeks of treatment
Secondary	pregnancy rate	long term fertility results	1-year after CR