NCT06417736

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Women's Hospital School Of Medicine Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Conditions

• Endometrial Cancer Stage I
• Endometrial Hyperplasia

Interventions

Type	Name	Description
DRUG	Megestrol Acetate 40 MG	160mg/one time/day

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-07-31
• Completion: 2026-12-31
• First posted: 2024-05-16
• Last updated: 2024-05-16

Locations

1 site across 1 country: China