Overview

Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia

Status:
Not yet recruiting
Trial end date:
2026-02-28
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xiaojun Chen
Treatments:
Contraceptive Agents
Levonorgestrel
Megestrol
Megestrol Acetate
Criteria
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.