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

NCT ID: NCT05898321

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-12-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GnRHa group

Patients with fibroid remained will be enrolled and one third of them will be administrated with Zoladex (3.60mg/28 days) for three to six months,.

Group Type: EXPERIMENTAL

Zoladex

Intervention Type: DRUG

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 group

Patients with fibroid remained will be enrolled and one third of them will be administrated with mifepristone(10.0mg/d) for three to six months.

Group Type: EXPERIMENTAL

Mifepristone Oral Tablet

Intervention Type: DRUG

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.

control group

Patients with fibroid remained will be enrolled and the third group was serviced as controls and no drugs will be used.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lv weiguo

Role: STUDY_DIRECTOR

Women's Hospital School Of Medicine Zhejiang University

Locations

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

WU zaigui

Role: CONTACT

411773@zju.edu.cn

15957193058

RUAN fei

Role: CONTACT

849742095@qq.com

057189992125

Other Identifiers

IRB-20230046-R

Identifier Type: -

Identifier Source: org_study_id