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

NCT05898321 | Unknown

• 1 other identifier: IRB-20230046-R
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

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.

Conditions

Submucous Leiomyoma of Uterus

Keywords

Submucous leiomyoma; Transcervical resection of myoma; GnRH analogues

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• the recurrence rate of remaining submucous fibroids and time

  one to three years after TCRM

• the recurrence time of remaining submucous fibroids

  one to three years after TCRM

Study Arms (3)

GnRHa group

EXPERIMENTAL

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

mifepristone group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

Zoladex DRUG

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.

GnRHa group

Mifepristone Oral Tablet DRUG

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.

mifepristone group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Interventions

Goserelin; Mifepristone

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lv weiguo

  Women's Hospital School Of Medicine Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

WU zaigui

CONTACT

15957193058; 411773@zju.edu.cn

RUAN fei

CONTACT

057189992125; 849742095@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: June 12, 2023
• Study Start: June 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)