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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Obstetrics and Gynecology Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
WEIWEI SHAN, PhD
danweiwei7468@fckyy.org.cn
8613817813106
Backup
XIAOJUN CHEN, PhD
cxjlhjj@163.com
8613601680784
Time Frame
Start Date: 2022-06-13
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 172
Treatments
Experimental: overweight MA+ILI
enrolled overweight (24kg/m2≤BMI\<28kg/m2) patients will receive megestrol acetate 160mg po qd plus weight management
Experimental: overweight LNG-IUS+ILI
enrolled overweight (24kg/m2≤BMI\<28kg/m2) patients will be treated with LNG-IUS plus weight management
Experimental: obese MA+ILI
enrolled obese (BMI≥28kg/m2) patients will receive megestrol acetate 160mg po qd plus weight management
Experimental: obese LNG-IUS+ILI
enrolled obese (BMI≥28kg/m2) patients will be treated with LNG-IUS plus weight management
Related Therapeutic Areas
Sponsors
Leads: Xiaojun Chen

This content was sourced from clinicaltrials.gov

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