Status:

WITHDRAWN

Liraglutide Plus Megestrol Acetate in Endometrial Atypical Hyperplasia

Lead Sponsor:

Xiaojun Chen

Collaborating Sponsors:

Huashan Hospital

Conditions:

Atypical Endometrial Hyperplasia

Obese

Eligibility:

FEMALE

18-45 years

Phase:

PHASE2

PHASE3

Brief Summary

To investigate the efficacy of liraglutide plus megestrol acetate in obesity patients with atypical endometrial hyperplasia (AEH)

Detailed Description

Backgrounds: High-dose progesterone (MA/MPA) or LNG-IUS is the first-line treatment for women with atypical endometrial hyperplasia (AEH) or early endometrioid cancer who want to preserve fertility. A...

Eligibility Criteria

Inclusion

  • BMI (body mass index) ≥28kg/m2
  • Consent informed and signed
  • Pathologically confirmed as endometrial atypical hyperplasia
  • Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements
  • Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time

Exclusion

  • Diagnosed as type 2 diabetes
  • Diabetic ketoacidosis
  • History of acute pancreatitis
  • Have a history or family history of medullary thyroid carcinoma; multiple endocrine neoplasia syndrome type 2 (MEN2)
  • Combined with severe medical disease or severely impaired liver and kidney function
  • Patients with other types of endometrial cancer or other malignant tumors of the reproductive system; patients with breast cancer or other hormone-dependent tumors that cannot be used with progesterone
  • Those who require hysterectomy or other methods other than conservative treatment with drugs
  • Deep vein thrombosis, stroke, myocardial infarction
  • Smokers (≥15 cigarettes/day)

Key Trial Info

Start Date :

March 20 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 30 2026

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04683237

Start Date

March 20 2021

End Date

November 30 2026

Last Update

September 26 2024

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Liraglutide Plus Megestrol Acetate in Endometrial Atypical Hyperplasia | DecenTrialz