Submucous Leiomyoma of UterusTCRMNCT05898321
To Prevent Type I-II Myoma After TCRM Recurrence by Gonadotropin-releasing Hormone (GnRH )Analogues or Mifepristone
A study testing Zoladex and Mifepristone Oral Tablet in people with Submucous Leiomyoma of Uterus, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Submucous Leiomyoma of Uterus
- What is being tested?
- Zoladex and Mifepristone Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
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
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
- Being tested
- Zoladex, Mifepristone Oral Tablet
- Keywords
- Submucous leiomyoma, Transcervical resection of myoma, GnRH analogues
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZoladexDrug
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.
Mifepristone Oral TabletDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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,. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: one to three years after TCRM
Secondary outcomes (2)
the recurrence rate of remaining submucous fibroids and time
recurrent submucosal fibroids include increased menstrual flow and continued growth of residual submucosal fibroids.
Measured: one to three years after TCRM
the recurrence time of remaining submucous fibroids
the time interval between recurrent submucosal fibroids and TCRM
Measured: one to three years after TCRM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jun 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Submucous Leiomyoma of UterusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lv weiguo, Study director, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898321
- Sponsor's protocol ID
- IRB-20230046-R
- Acronym
- TCRM
- Status last verified
- Jun 2023
- First submitted
- 10 Feb 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05898321
- Acronym / sponsor ID
- TCRM / IRB-20230046-R
- Conditions
- Submucous Leiomyoma of Uterus
- Keywords
- Submucous leiomyoma, Transcervical resection of myoma, GnRH analogues
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GnRHa group | Experimental | Drug: ZoladexPatients 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,. |
| mifepristone group | Experimental | Drug: Mifepristone Oral TabletPatients with fibroid remained will be enrolled and one third of them will be administrated with mifepristone(10.0mg/d) for three to six months. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZoladexPatients 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. | Drug | GnRHa group |
| Mifepristone Oral TabletPatients 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. | Drug | mifepristone group |
Primary outcome
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;
2 secondary outcomes
the recurrence rate of remaining submucous fibroids and time
Time frame: one to three years after TCRM
the recurrence time of remaining submucous fibroids
Time frame: one to three years after TCRM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lv weiguo study director
Women's Hospital School Of Medicine Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zoladex and Mifepristone Oral Tablet in people with Submucous Leiomyoma of Uterus, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WU zaigui (15957193058, 411773@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the remaining submucous fibroids volume (time frame: one to three years after TCRM). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.