Liraglutide Plus Megestrol Acetate in Endometrial Atypical Hyperplasia (NCT04683237) | Clinical Trial Compass
WithdrawnPhase 2/3
Liraglutide Plus Megestrol Acetate in Endometrial Atypical Hyperplasia
Stopped: Based on our latest research results, we will revise the protocol and design a better study. Since no participants are enrolled till now, we withdraw this study.
0Started 2021-03-20
Plain-language summary
To investigate the efficacy of liraglutide plus megestrol acetate in obesity patients with atypical endometrial hyperplasia (AEH)
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Pathological complete response (CR) rates
Timeframe: From date of randomization until the date of CR, assessed up to 28 weeks.