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

Sponsor

Women's Hospital School Of Medicine Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05898321

Collaborator

(none)

294

Enrollment

Location

Arms

Anticipated Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Submucous Leiomyoma of Uterus	Drug: Zoladex Drug: Mifepristone Oral Tablet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

294 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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,.	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.
Experimental: 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.	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.
No Intervention: control group Patients with fibroid remained will be enrolled and the third group was serviced as controls and no drugs will be used.

Arm

Intervention/Treatment

Experimental: 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,.

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.

Experimental: 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.

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.

No Intervention: control group

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

Outcome Measures

Primary Outcome Measures

the remaining submucous fibroids volume [one to three years after TCRM]
The change of residual fibroid volume is compared to residual fibroid volume measured by ultrasound and /or MRI one month after surgery;

Secondary Outcome Measures

the recurrence rate of remaining submucous fibroids and time [one to three years after TCRM]
recurrent submucosal fibroids include increased menstrual flow and continued growth of residual submucosal fibroids.
the recurrence time of remaining submucous fibroids [one to three years after TCRM]
the time interval between recurrent submucosal fibroids and TCRM

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age more than 18 years and less than 45 years old, no childbirth requirements in the next 3 years;
Type I and II submucosal fibroids diagnosed by ultrasound, and the diameter of them are greater than 3cm;
Type I or II submucosal fibroids confirmed by TCRM and no degeneration confirmed pathologically;
A MRI test will be done to evaluate the residual submucosal fibroids and calculate the residual fibroid volume after 1 month of surgery;
Patients would not had used drugs such as mifepristone and GnRHa 3 months before surgery;
Participate in this trial and sign the informed consent form voluntarily .

Exclusion Criteria:

Combined with congenital uterine malformations such as double uterus, unicornuate uterus, etc;
Have fertility requirements within 3 years after surgery;
Estrogen-dependent diseases such as adenomyosis and endometriosis;
Drugs such as mifepristone or GnRHa have been used before surgery;
Mifepristone or GnRHa drug treatment is contraindicated or cannot tolerate TCRM surgery.