NCT05898321

To Prevent Type I-II Myoma After TCRM Recurrence by Gonadotropin-releasing Hormone (GnRH )Analogues or Mifepristone

A Multicenter，Prospective Clinical Trial for Reducing Remaining Submucous Fibroids Volume and Preventing Recurrence by Treating With GnRH Analogues or Mifepristone After Transcervical Resection of Type I-II Myoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 294 (estimated)
• Sponsor: Women's Hospital School Of Medicine Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Transcervical resection of myoma(TCRM) has a good therapeutic effect while the probability of complete resection of type I and II fibroids is only 55% per procedure on average and a significant number of patients have fibroid remained.At present, there is no standardized treatment option for reducing the remaining submucous fibroids volume and preventing its recurrence after TCRM.The present prospective,multicentre,randomised controlled clinical trial will enrol women after TCRM and treat them with mifepristone(10mg)or GnRHa(3.60mg)for 3 to 6 months,investigating the effective and cost-effective treatment options after fibroids with TCRM，thus to provide evidence and effectual regiments for reducing remaining fibroids volume and preventing its recurrence.

Conditions

• Submucous Leiomyoma of Uterus

Interventions

Type	Name	Description
DRUG	Zoladex	Patients with fibroid remained will be enrolled and divided into three groups. one group wii be administrated with Zoladex (3.60mg/28 days) for three to six months.
DRUG	Mifepristone Oral Tablet	Patients with fibroid remained will be enrolled and divided into three groups. one group will be administrated with mifepristone(10.0mg/d) for three to six months.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-12-30
• Completion: 2025-12-30
• First posted: 2023-06-12
• Last updated: 2023-06-12

Locations

1 site across 1 country: China