NCT04607252

Metformin Plus Megestrol Acetate As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia

Comparing Metformin Plus Megestrol Acetate with Megestrol Acetate Alone As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

To verify whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH).

Detailed description

Whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH) is still not clear. Our previous finding from subgroup analysis in a phase II randomized controlled trial showed that 39.6% of AEH patients in metformin plus megestrol acetate group achieved complete response, compared with 20.4% in group of megestrol acetate alone. This trial aim to fully testify the effect of metformin in fertility-sparing treatment for AEH patients with adequate sample size.

Conditions

• Atypical Endometrial Hyperplasia

Interventions

Type	Name	Description
DRUG	Metformin plus Megestrol acetate	metformin 1500mg, per day, oral; megestrol acetate 160mg per day, oral
DRUG	Megestrol Acetate	megestrol acetate 160mg per day, oral

Timeline

• Start date: 2021-01-11
• Primary completion: 2021-06-03
• Completion: 2021-06-03
• First posted: 2020-10-29
• Last updated: 2024-09-26

Locations

1 site across 1 country: China