Megestrol Acetate 160 MG Oral Tablet: enrolled participants will take Megestrol Acetate 160mg daily
Levonorgestrel-Releasing Intrauterine Contraceptive System (Mirena), 52 Mg: enrolled patients will be treated with LNG-IUS.
Study summary
To investigate the efficacy of weight management plus levonorgestrel intrauterine system (LNG-IUS) or megestrol acetate (MA) in obese patients with endometrial atypical hyperplasia (EAH) asking for conservative therapy.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria:
1.18 years≤age≤45years 2.BMI (body mass index) ≥24kg/m2 3.Consent informed and signed 4.Pathologically confirmed as endometrial atypical hyperplasia. Patients with endometrial specimens obtained by endometrial biopsy, diagnostic curettage or hysteroscopy and diagnosed histologically as endometrial atypical hyperplasia. If specimens are from other hospitals, they must be counseled or reconfirmed by the Department of Pathology of the Obstetrics and Gynecology Hospital of Fudan University.
5.Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements.
6.Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time.
Exclusion Criteria:
1. Combined with severe medical disease or liver or kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level elevates to 3 times or more of the upper limit of normal, kidney dysfunction (creatinine clearance \< 30 mL/min)
2. Patients are diagnosed with other malignant tumors of the reproductive system; patients with breast cancer or other hormone-dependent tumors that cannot be used with progesterone.
3. Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication).
4. Those who require hysterectomy or other methods other than conservative treatment.
5. Known or suspected pregnancy.
6. Those who has contraindications to use progestin.
7. Deep vein thrombosis, stroke, myocardial infarction.
8. Severe joint lesions that prevent walking or movement.
9. untreated or recurrent pelvic inflammatory disease (PID)
10. an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine);
11. Cervical dysplasia
12. Congenital or acquired uterine abnormalities, including uterine fibroid tumors or conditions that affect the shape of the uterus
13. allergic to the LNG-IUS components
14. uterine cavity is too large (average uterine diameter is over 7 cm) or have a history of LNG-IUS falling out.
Notes: the last 6 criteria are only applied for patients with LNG-IUS.
Primary outcome measure(s)
Pathological complete response (CR) rates — From date of recruitment until the date of CR, assessed up to 28 weeks. The 28-week CR rates will be calculated in four arms
Trial sites (1)
Facility
City
Region
Status
Obstetrics and Gynecology Hospital of Fudan University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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