Actively Recruiting

Phase 2
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT05247268

Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer

Led by Fudan University · Updated on 2025-04-06

104

Participants Needed

1

Research Sites

287 weeks

Total Duration

On this page

Sponsors

F

Fudan University

Lead Sponsor

P

Peking Union Medical College Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

To see if Gonadotropin-releasing hormone analogue (GnRHa) combined with aromatase inhibitors (AIs) will achieve better complete response rate than megestrol acetate or medroxyprogesterone acetate (MA/MPA) alone as fertility-sparing treatment for patients with early endometrial carcinoma.

CONDITIONS

Official Title

Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Confirmed diagnosis of early-stage endometrial cancer (endometrioid, grade I, without myometrial invasion) by biopsy, curettage, or hysteroscopy
  • No signs of suspicious myometrial invasion or spread outside the uterus by MRI, CT, or transvaginal ultrasound
  • Strong desire to preserve fertility or keep the uterus
  • Good compliance and willingness to follow up at Obstetrics and Gynecology Hospital of Fudan University on time
Not Eligible

You will not qualify if you...

  • Endometrial cancer with suspicious myometrial invasion or spread outside the uterus
  • Recurrent endometrial cancer
  • Severe medical diseases or severely impaired liver or kidney function
  • Other types of endometrial cancer or malignant reproductive system tumors; breast cancer or other hormone-dependent tumors where progesterone cannot be used
  • Need for hysterectomy or treatments other than drug therapy
  • Known or suspected pregnancy
  • Contraindications to Medroxyprogesterone Acetate, Megestrol Acetate, Triprorelin Acetate, Letrozole, or pregnancy
  • Hormone treatment within 3 months before the trial
  • Acute severe diseases such as stroke, heart attack, or history of thrombosis
  • Smoking more than 15 cigarettes per day

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, China, 200011

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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