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

Women's Hospital School Of Medicine Zhejiang University

Status: Not yet enrolling

Conditions: Submucous Leiomyoma of Uterus

Treatments: Drug: Zoladex; Drug: Mifepristone Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05898321

IRB-20230046-R

Details and patient eligibility

About

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.

Enrollment: 294 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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294 participants in 3 patient groups

GnRHa group

Experimental group

Description:

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,.

Treatment:

Drug: Zoladex

mifepristone group

Experimental group

Description:

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.

Treatment:

Drug: Mifepristone Oral Tablet

control group

No Intervention group

Description:

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