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NCT Number: NCT03241888

Megestrol Acetate Plus 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.

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Key information

Conditions

Atypical Endometrial Hyperplasia Endometrial Hyperplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Uterine Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, Shanghai Municipality, 200011, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Megestrol acetate

Drug

At a dosage of 160 mg/day

Other names: Megace

Levonorgestrel-releasing Intrauterine System(LNG-IUS)

Device

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

Other names: Mirena Intrauterine Device, Mirena

Primary outcomes

  1. 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

    the proportion of histologic regression from endometrial atypical hyperplasia to benign endometrium

  2. 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

Secondary outcomes

  1. 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.

  2. Rate of relapse

    Time frame: up to 2 years after the treatment for each patient

    the proportion of experiencing recurrence after regression

  3. Rate of pregnancy

    Time frame: up to 2 years after the treatment for each patient

    the proportion of getting pregnancy after regression

  4. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 8, 2017
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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