Clinical trial

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

Recruiting now · Phase 2, Phase 3 · 1 countries · Registry ID NCT05316493

Recruiting nowPhase 2, Phase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 45 Years
SexFemale
Healthy volunteersNot accepted
ConditionAtypical Endometrial Hyperplasia, Fertility Issues, Overweight and Obesity

Full registry 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.

Treatments and study arms

Intensive Lifestyle Intervention (ILI)

Behavioral

dietary guidance, exercise guidance, lifestyle intervention

Megestrol Acetate 160 MG Oral Tablet

Drug

enrolled participants will take Megestrol Acetate 160mg daily

Levonorgestrel-Releasing Intrauterine Contraceptive System (Mirena), 52 Mg

Drug

enrolled patients will be treated with LNG-IUS.

Primary outcomes

Pathological complete response (CR) ratesFrom date of recruitment until the date of CR, assessed up to 28 weeks.

The 28-week CR rates will be calculated in four arms

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Obstetrics and Gynecology Hospital of Fudan University🇨🇳 Shanghai, China
WEIWEI SHAN, PhDContact
DANDAN JU, MDContact