Liraglutide Plus Megestrol Acetate in Endometrial Atypical Hyperplasia

Sponsor
Xiaojun Chen
Study ID
NCT04683237
Phase
PHASE2/PHASE3
Status
Withdrawn

Conditions

  • Atypical Endometrial Hyperplasia
  • Fertility Issues
  • Obese

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide Injection — DRUG
    Initiate liraglutide with a dose of 0.6 mg daily for one week. After one week at 0.6 mg per day, increase the dose to 1.2 mg daily in a week, and increase the dose to 1.8 mg daily after at least one week of treatment with the 1.2 mg daily dose. If the patients can not tolerate 1.8mg per day, decrease the dose to the max tolerable dose.
  • Megestrol Acetate 160 MG — DRUG
    160mg po qd

Study Details

To investigate the efficacy of liraglutide plus megestrol acetate in obesity patients with atypical endometrial hyperplasia (AEH)

Key Dates

Start date
Mar 20, 2021
Status verified
Sep 2024
Primary completion
Nov 30, 2025
Completion
Nov 30, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: MA alone
    enrolled patients will receive megestrol acetate 160mg po qd
  • Experimental: MA+liraglutide
    enrolled patients will receive megestrol acetate 160mg po qd plus liraglutide (1.8mg/d or the max tolerable dosage)

Primary Outcome Measure

Pathological complete response (CR) rates [ Time Frame: From date of randomization until the date of CR, assessed up to 28 weeks. ]

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