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

Submucous Leiomyoma of Uterus Clinical Trial

— TCRM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05898321
• Other study ID #: IRB-20230046-R
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: June 2023
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: WU zaigui
• Phone: 15957193058
• Email: 411773[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 294
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Age more than 18 years and less than 45 years old, no childbirth requirements in the next 3 years;

2. Type I and II submucosal fibroids diagnosed by ultrasound, and the diameter of them are greater than 3cm;

3. Type I or II submucosal fibroids confirmed by TCRM and no degeneration confirmed pathologically;

4. A MRI test will be done to evaluate the residual submucosal fibroids and calculate the residual fibroid volume after 1 month of surgery;

5. Patients would not had used drugs such as mifepristone and GnRHa 3 months before surgery;

6. Participate in this trial and sign the informed consent form voluntarily .

Exclusion Criteria:

1. Combined with congenital uterine malformations such as double uterus, unicornuate uterus, etc;

2. Have fertility requirements within 3 years after surgery;

3. Estrogen-dependent diseases such as adenomyosis and endometriosis;

4. Drugs such as mifepristone or GnRHa have been used before surgery;

5. Mifepristone or GnRHa drug treatment is contraindicated or cannot tolerate TCRM surgery.

Related Conditions & MeSH terms

• Leiomyoma
• Recurrence
• Submucous Leiomyoma of Uterus

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Women's Hospital School of Medicine Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the remaining submucous fibroids volume	The change of residual fibroid volume is compared to residual fibroid volume measured by ultrasound and /or MRI one month after surgery;	one to three years after TCRM
Secondary	the recurrence rate of remaining submucous fibroids and time	recurrent submucosal fibroids include increased menstrual flow and continued growth of residual submucosal fibroids.	one to three years after TCRM
Secondary	the recurrence time of remaining submucous fibroids	the time interval between recurrent submucosal fibroids and TCRM	one to three years after TCRM