Liraglutide Plus Megestrol Acetate in Endometrial Atypical Hyperplasia

• Status: Withdrawn
• Trial end date: 2024-11-30
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiaojun Chen
• Collaborator: Huashan Hospital
• Treatments: Liraglutide; Megestrol; Megestrol Acetate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)