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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Submucous Leiomyoma of Uterus

Intervention / Treatment
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* Drug: Zoladex
* Drug: Mifepristone Oral Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRHa group<br>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<br>* 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.<br>|
| Experimental: mifepristone group<br>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<br>* 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.<br>|
| No Intervention: control group<br>Patients with fibroid remained will be enrolled and the third group was serviced as controls and no drugs will be used. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| the recurrence time of remaining submucous fibroids | the time interval between recurrent submucosal fibroids and TCRM | one to three years after TCRM | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GnRH analogues, Submucous leiomyoma, Transcervical resection of myoma