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

Primary Purpose

Submucous Leiomyoma of Uterus

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Zoladex
Mifepristone Oral Tablet
Sponsored by
Women's Hospital School Of Medicine Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Submucous Leiomyoma of Uterus focused on measuring Submucous leiomyoma, Transcervical resection of myoma, GnRH analogues

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Women's Hospital School of Medicine Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

GnRHa group

mifepristone group

control group

Arm 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,.

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.

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

Outcomes

Primary Outcome Measures

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;

Secondary Outcome Measures

the recurrence rate of remaining submucous fibroids and time
recurrent submucosal fibroids include increased menstrual flow and continued growth of residual submucosal fibroids.
the recurrence time of remaining submucous fibroids
the time interval between recurrent submucosal fibroids and TCRM

Full Information

First Posted
February 10, 2023
Last Updated
June 7, 2023
Sponsor
Women's Hospital School Of Medicine Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05898321
Brief Title
To Prevent Type I-II Myoma After TCRM Recurrence by Gonadotropin-releasing Hormone (GnRH )Analogues or Mifepristone
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's Hospital School Of Medicine Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Submucous Leiomyoma of Uterus
Keywords
Submucous leiomyoma, Transcervical resection of myoma, GnRH analogues

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
294 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GnRHa group
Arm Type
Experimental
Arm 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,.
Arm Title
mifepristone group
Arm Type
Experimental
Arm 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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Patients with fibroid remained will be enrolled and the third group was serviced as controls and no drugs will be used.
Intervention Type
Drug
Intervention Name(s)
Zoladex
Intervention Description
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
Intervention Name(s)
Mifepristone Oral Tablet
Intervention Description
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.
Primary Outcome Measure Information:
Title
the remaining submucous fibroids volume
Description
The change of residual fibroid volume is compared to residual fibroid volume measured by ultrasound and /or MRI one month after surgery;
Time Frame
one to three years after TCRM
Secondary Outcome Measure Information:
Title
the recurrence rate of remaining submucous fibroids and time
Description
recurrent submucosal fibroids include increased menstrual flow and continued growth of residual submucosal fibroids.
Time Frame
one to three years after TCRM
Title
the recurrence time of remaining submucous fibroids
Description
the time interval between recurrent submucosal fibroids and TCRM
Time Frame
one to three years after TCRM

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
WU zaigui
Phone
15957193058
Email
411773@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
RUAN fei
Phone
057189992125
Email
849742095@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lv weiguo
Organizational Affiliation
Women's Hospital School Of Medicine Zhejiang University
Official's Role
Study Director
Facility Information:
Facility Name
Women's Hospital School of Medicine Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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