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Clinical trial

A Randomized Controlled Pilot Study of Polyethylene Glycol Loxenatide Plus LNG-IUS in Women With Endometrial Atypical Hyperplasia

ID
Name
53211033
Description
To study if polyethylene glycol loxenatide plus levonorgestrel-releasing intrauterine system (LNG-IUS) will improve response rates in patients with endometrial atypical hyperplasia.
Trial arms
Trial start
2022-01-08
Estimated PCD
2024-12-01
Trial end
2026-06-30
Status
Recruiting
Phase
Early phase I
Treatment
levonorgestrel-releasing intrauterine system
Enrolled patients will be inserted this device for treating AEH to preserve fertility for 3-6 months or longer till complete response or operation if treatment fails, and the device may be removed if treatment changes.
Arms:
LNG-IUS, LOX+LNG-IUS
Other names:
MIRENA
Polyethylene Glycol Loxenatide
Initiate injection of Loxenatide will be 0.1mg per week, if the patient can tolerate, the dose will be increased to 0.2mg per week, or else 0.1mg per week will be injected and the injection will last for no more than 28 weeks. If the patient cannot tolerate the least 0.1mg/week, she must be excluded from this trial.
Arms:
LOX+LNG-IUS
Other names:
Fulaimei, PEX168
Size
28
Primary endpoint
Pathological complete response (CR) rates
From date of randomization until the date of CR, assessed up to 16 weeks.
Eligibility 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 * Known or suspected pregnancy * Currently suffering from pelvic inflammatory disease or diagnosed as pelvic inflammatory disease * Lower reproductive system infection * abnormal cervical dysplasia * Congenital or acquired uterine abnormalities, including fibroids that deform the uterine cavity * Allergic to any parts of LNG-IUS components * The uterine cavity is too large (average diameter is over 7cm) or the history of LNG-IUS falling off
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 28, 'type': 'ESTIMATED'}}
Updated at
2024-02-22

1 organization

1 product

3 indications

Organization
Fudan University
Product
Polyethylene Glycol Loxenatide
Indication
Atypical Endometrial Hyperplasia
Indication
Obesity
Indication
Infertility