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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-04

Study Completion Date

2020-06-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atypical Endometrial Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MA

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.

Group Type ACTIVE_COMPARATOR

Megestrol Acetate

Intervention Type DRUG

At a dosage of 160 mg/day

LNG-IUS

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.

Group Type ACTIVE_COMPARATOR

Levonorgestrel-releasing Intrauterine System(LNG-IUS)

Intervention Type DEVICE

Active ingredient: levonorgestrel 52mg. It is a hormone-releasing T-shaped intrauterine system.

MA+LNG-IUS

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.

Group Type EXPERIMENTAL

Megestrol Acetate

Intervention Type DRUG

At a dosage of 160 mg/day

Levonorgestrel-releasing Intrauterine System(LNG-IUS)

Intervention Type DEVICE

Active ingredient: levonorgestrel 52mg. It is a hormone-releasing T-shaped intrauterine system.

Interventions

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Megestrol Acetate

At a dosage of 160 mg/day

Intervention Type DRUG

Levonorgestrel-releasing Intrauterine System(LNG-IUS)

Active ingredient: levonorgestrel 52mg. It is a hormone-releasing T-shaped intrauterine system.

Intervention Type DEVICE

Other Intervention Names

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Megace Mirena Intrauterine Device Mirena

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No