Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to see if megestrol acetate plus metformin will be more effective in returning the endometrial tissue to a normal state than megestrol acetate alone in patients with endometrial atypical hyperplasia or early stage endometrial adenocarcinoma.

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

Details

• Lead Sponsor: Xiaojun Chen
• Collaborators: Fudan University; Shanghai 6th People's Hospital; Shanghai Changning Maternity & Infant Health Hospital; Zhejiang Cancer Hospital
• Treatments: Megestrol; Megestrol Acetate; Metformin

Criteria

Inclusion Criteria:

• Be between the ages of 18-45 years old

• Primarily have a confirmed diagnosis of endometrial atypical hyperplasia based upon D&C or hysteroscopy

• OR primarily have a confirmed diagnosis of endometrial adenocarcinoma(G1, low tumor grade), based upon D&C or hysteroscopy, and three MRI parameters shows there's no myometrial invasion, extension beyond corpus, or enlarged lymph nodes

• Have a desire for remaining reproductive function or uterus

• Need to be able to undergo correlative treatment and follow-up

Exclusion Criteria:

• Have a history of serious liver or renal dysfunction

• Have a confirmed diagnosis of malignant tumor in genital system

• Have taken oral contraceptive or other medicine for the treatment of endometrial hyperplasia in the past 6 months

• Ask for removal of the uterus or other conservative treatment

• serum CA-125 > 35 Um/L