Liraglutide Plus Megestrol Acetate in Endometrial Atypical Hyperplasia

NCT04683237 | Withdrawn Phase 2

• 1 other identifier: 53211031
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Atypical Endometrial Hyperplasia; Obese; Fertility Issues

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (CR) rates

  The 28-week CR rates will be calculated in two groups

  From date of randomization until the date of CR, assessed up to 28 weeks.

Secondary Outcomes (7)

• weight lose

  From date of randomization until the date of CR, assessed up to 28 weeks

• changing of insulin resistance

  From date of randomization until the date of CR, assessed up to 28 weeks.

• improvement of chronic inflammation

  From date of randomization until the date of CR, assessed up to 28 weeks

• Time of pathological complete response (CR)

  From date of randomization until the date of CR, assessed up to 2 years.

• safety and side effects

  From date of randomization until the date of CR, assessed up to 2 years.

Study Arms (2)

MA alone

OTHER

enrolled patients will receive megestrol acetate 160mg po qd

Drug: Megestrol Acetate 160 MG

MA+liraglutide

EXPERIMENTAL

enrolled patients will receive megestrol acetate 160mg po qd plus liraglutide (1.8mg/d or the max tolerable dosage)

Drug: Liraglutide Injection; Drug: Megestrol Acetate 160 MG

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.

Also known as: victoza, Nuo he li

MA+liraglutide

Megestrol Acetate 160 MG DRUG

160mg po qd

Also known as: Yi li zhi, Megace

MA alone; MA+liraglutide

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI (body mass index) ≥28kg/m2
• Consent informed and signed
• Pathologically confirmed as endometrial atypical hyperplasia
• 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

You may not qualify if:

• Diagnosed as type 2 diabetes
• Diabetic ketoacidosis
• History of acute pancreatitis
• Have a history or family history of medullary thyroid carcinoma; multiple endocrine neoplasia syndrome type 2 (MEN2)
• Combined with severe medical disease or severely impaired liver and kidney function
• Patients with other types of endometrial cancer or other malignant tumors of the reproductive system; patients with breast cancer or other hormone-dependent tumors that cannot be used with progesterone
• Those who require hysterectomy or other methods other than conservative treatment with drugs
• Deep vein thrombosis, stroke, myocardial infarction
• Smokers (≥15 cigarettes/day)

Sponsors & Collaborators

• Xiaojun Chen: lead
• Huashan Hospital: collaborator

MeSH Terms

Conditions

Endometrial Hyperplasia; Obesity; Infertility

Interventions

Liraglutide; Megestrol Acetate

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• xiaojun chen

  Obstetrics & Gynecology Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 24, 2020
• Study Start: March 20, 2021
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share