Atypical Endometrial Hyperplasia
Conditions
Keywords
Levonorgestrel-releasing intrauterine system, megestrol acetate, Atypical Endometrial Hyperplasia
Brief summary
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.
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.
Interventions
DRUGMegestrol Acetate
At a dosage of 160 mg/day
Active ingredient: levonorgestrel 52mg. It is a hormone-releasing T-shaped intrauterine system.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological response time | 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 |
| Pathological response rate | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of relapse | up to 2 years after the treatment for each patient | the proportion of experiencing recurrence after regression |
| Compliance | 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. |
| Rate of pregnancy | up to 2 years after the treatment for each patient | the proportion of getting pregnancy after regression |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Economic consequences through study completion | 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. |
Countries
China
Outcome results
None listed