Weight Management With Hormone Treatment for Endometrial Atypical Hyperplasia
Tests weight management with an intrauterine device or megestrol in women with endometrial hyperplasia.
Plain-language title generated from the registry record
Registry title: Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT05316493, who can take part
Where in China
- Obstetrics and Gynecology Hospital of Fudan UniversityShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xiaojun Chen
- Trial code
- NCT05316493
- Record updated
- 4 June 2026
- Original description
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.Read full original descriptionShow less
Weight Management Plus Levonorgestrel Intrauterine System or Megestrol Acetate in Endometrial Atypical Hyperplasia: Multiple Single-arm, Prospective and Open-label Clinical Study
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.
Inclusion: 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: Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication); 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; Deep vein thrombosis, stroke, myocardial infarction; untreated or recurrent pelvic inflammatory disease (PID); an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine); Congenital or acquired uterine abnormalities, including uterine fibroid tumors or conditions that affect the shape of the uterus; allergic to the LNG-IUS components; 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; 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); Those who require hysterectomy or other methods other than conservative treatment; Known or suspected pregnancy; Those who has contraindications to use progestin; Severe joint lesions that prevent walking or movement; Cervical dysplasia.