To hear about similar clinical trials, please enter your email below
Trial Title:
To Prevent Type I-II Myoma After TCRM Recurrence by Gonadotropin-releasing Hormone (GnRH )Analogues or Mifepristone
NCT ID:
NCT05898321
Condition:
Submucous Leiomyoma of Uterus
Conditions: Official terms:
Leiomyoma
Myofibroma
Recurrence
Goserelin
Mifepristone
Conditions: Keywords:
Submucous leiomyoma
Transcervical resection of myoma
GnRH analogues
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Zoladex
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.
Arm group label:
GnRHa group
Intervention type:
Drug
Intervention name:
Mifepristone Oral Tablet
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.
Arm group label:
mifepristone group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Women's Hospital School of Medicine Zhejiang University
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Start date:
June 1, 2023
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Women's Hospital School Of Medicine Zhejiang University
Agency class:
Other
Source:
Women's Hospital School Of Medicine Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05898321
