RecruitingPhase 2Phase 3NCT05316493

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

Weight Management Plus Levonorgestrel Intrauterine System or Megestrol Acetate in Endometrial Atypical Hyperplasia: Multiple Single-arm, Prospective and Open-label Clinical Study


Sponsor

Xiaojun Chen

Enrollment

172 participants

Start Date

Jun 13, 2022

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria3

  • 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.
  • Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements.
  • 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 Criteria15

  • 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)
  • 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.
  • Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication).
  • Those who require hysterectomy or other methods other than conservative treatment.
  • Known or suspected pregnancy.
  • Those who has contraindications to use progestin.
  • Deep vein thrombosis, stroke, myocardial infarction.
  • Severe joint lesions that prevent walking or movement.
  • untreated or recurrent pelvic inflammatory disease (PID)
  • an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine);
  • Cervical dysplasia
  • 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.

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Interventions

BEHAVIORALIntensive Lifestyle Intervention (ILI)

dietary guidance, exercise guidance, lifestyle intervention

DRUGMegestrol Acetate 160 MG Oral Tablet

enrolled participants will take Megestrol Acetate 160mg daily

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

enrolled patients will be treated with LNG-IUS.


Locations(1)

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, China

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NCT05316493


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