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

June 7, 2023 updated by: Women's Hospital School Of Medicine Zhejiang University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

294

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Women's Hospital School of Medicine Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the remaining submucous fibroids volume
Time Frame: 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;
one to three years after TCRM

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Investigators

  • Study Director: Lv weiguo, Women's Hospital School of Medicine Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-20230046-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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