Megestrol Acetate Plus LNG-IUS in Young Women With Endometrial Atypical Hyperplasia

Fudan University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Atypical Endometrial Hyperplasia

Treatments: Drug: Megestrol Acetate; Device: Levonorgestrel-releasing Intrauterine System(LNG-IUS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03241888

2017-30-1

Details and patient eligibility

About

To see if megestrol acetate plus Levonorgestrel-releasing intrauterine system (LNG-IUS) will not be inferior to returning the endometrial tissue to a normal state than megestrol acetate or LNG-IUS alone in patients with endometrial atypical hyperplasia.

Full description

After diagnosed of endometrial atypical hyperplasia (EAH) by hysteroscopy, patients will be enrolled. Age, waist circumstances, blood pressure, basic history of infertility, blood pressure, serum lipid level and side effects will be collected. Blood tests, including fasting blood glucose (FBG), postprandial blood glucose (PBG), fasting insulin (FINS), SHBG, sex hormone levels, blood lipids and anti-müllerian hormone(AMH) will be performed before treatment to evacuate their metabolic conditions.

Patients are randomized to 1 of 3 treatment groups. Patients will receive MA (megestrol acetate) 160 mg by mouth daily for at least 3 months on Arm I. Patients will receive LNG-IUS insertion on Arm II and MA 160 mg plus LNG-IUS insertion on Arm III. Then an hysteroscope will be used to evaluate the endometrial condition every 3 months, and the findings will be recorded. For patients with EAH, complete response (CR) is defined as the reversion of endometrial atypical hyperplasia to proliferative or secretory endometrium; partial response (PR) is defined as regression to simple or complex hyperplasia without atypia; no response (NR) is defined as the persistence of the disease; and progressive disease (PD) is defined as the appearance of endometrial cancer in patients. Continuous therapies will be needed in PR, NR or PD.

After completion of study treatment, 2 months of maintenance treatment will be recommended for patients with CR, and participants will be followed up for 2 years.

Enrollment: 180 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primarily have a confirmed diagnosis of endometrial atypical hyperplasia based upon hysteroscopy
• Have a desire for remaining reproductive function or uterus
• Need to be able to undergo correlative treatment and follow-up

Exclusion criteria

• Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
• Pregnancy or suspicion of pregnancy
• Have a history of EAH and have disease relapse during Merina insertion
• Under treatment of high-dose progestin therapy more than 3 months in recent 6 months
• Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
• Confirmed diagnosis of malignant tumor in genital system
• Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
• Hypersensitivity or contradiction to any component of this product
• Ask for removal of the uterus or other conservative treatment
• Smoker(>15 cigarettes a day)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups

MA

Active Comparator group

Description:

Patients will receive megestrol acetate 160 mg by mouth daily for at least 3 months.Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.

Treatment:

Drug: Megestrol Acetate

LNG-IUS

Active Comparator group

Description:

Patients will receive LNG-IUS insertion for at least 3 months. Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.

Treatment:

Device: Levonorgestrel-releasing Intrauterine System(LNG-IUS)

MA+LNG-IUS

Experimental group

Description:

Patients will receive MA (160mg po qd) plus LNG-IUS insertion for at least 3 months. Then every 3 months, an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.

Treatment:

Device: Levonorgestrel-releasing Intrauterine System(LNG-IUS)

Drug: Megestrol Acetate