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

June 18, 2020 updated by: Xiaojun Chen, Fudan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Obstetrics and Gynecology Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Megestrol Acetate
At a dosage of 160 mg/day
Other Names:
  • Megace
Active Comparator: 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.
Device: Levonorgestrel-releasing Intrauterine System(LNG-IUS)
Active ingredient: levonorgestrel 52mg. It is a hormone-releasing T-shaped intrauterine system.
Other Names:
  • Mirena
  • Mirena Intrauterine Device
Experimental: 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.
Drug: Megestrol Acetate
At a dosage of 160 mg/day
Other Names:
  • Megace
Device: Levonorgestrel-releasing Intrauterine System(LNG-IUS)
Active ingredient: levonorgestrel 52mg. It is a hormone-releasing T-shaped intrauterine system.
Other Names:
  • Mirena
  • Mirena Intrauterine Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological response rate
Time Frame: From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months
From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months
Pathological response time
Time Frame: From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months
time of histologic regression from endometrial atypical hyperplasia to benign endometrium
From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: up to 2 years after the treatment for each patient
Common side effects from these drugs include weight gain, vaginal spotting and descent of sexuality. Severe side effects include thrombus and diseases related. The investigators will record any mental or body symptoms and evaluate the correlation.
up to 2 years after the treatment for each patient
Rate of relapse
Time Frame: up to 2 years after the treatment for each patient
up to 2 years after the treatment for each patient
Rate of pregnancy
Time Frame: up to 2 years after the treatment for each patient
up to 2 years after the treatment for each patient
Compliance
Time Frame: up to 2 years after the treatment for each patient
The investigators designed a questionnaire to evaluate the compliance through treatment as side effects of oral megestrol acetate may be more common than LNG-IUS. Self Efficacy, physical activity and social support will be scored (1 to 5) and compared among each arm.
up to 2 years after the treatment for each patient

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Economic consequences through study completion
Time Frame: From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months
The investigators will evaluate whether the combination could shorten the therapeutic period, so that bring economic benefits.
From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Zhejiang Cancer Hospital
Shanghai 6th People's Hospital
Shanghai Changning Maternity & Infant Health Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2017

Primary Completion (Actual)

June 18, 2020

Study Completion (Actual)

June 18, 2020

Study Registration Dates

First Submitted

July 12, 2017

First Submitted That Met QC Criteria

August 5, 2017

First Posted (Actual)

August 8, 2017

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 18, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-30-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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