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

Not Applicable

Not yet recruiting

• Conditions: Submucous Leiomyoma of Uterus
• Interventions: Drug: Mifepristone Oral Tablet; Drug: Zoladex

• Registration Number: NCT05898321
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-10
• Status Verified: 2023-06
• Study Start: 2023-06-01
• Study First Submitted QC: 2023-06-07
• Last Update Submitted: 2023-06-07
• Study First Posted: 2023-06-12
• Last Update Posted: 2023-06-12
• Primary Completion: 2024-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 294

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mifepristone group	Mifepristone Oral Tablet	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.
GnRHa group	Zoladex	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,.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Women's Hospital School of Medicine Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China