LeiomyomaPhase 2/3NCT00821275
Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma
A Phase 2/3 study testing Interventional radiological or surgical management in people with Leiomyoma, run by Sun Yat-sen University at 4 sites in China.
Trial summary
The efficacy and safety of uterine artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. The purpose of this trial is to evaluate the uterine volume and tumor size reduction, symptomatic relief, complication, fertility, ovarian function and… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Leiomyoma
- What is being tested?
- Interventional radiological or surgical management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 4 sitesChina
- Study dates
- Jan 2008to Dec 2018
- Phase
- Phase 2/3
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of symptomatic uterine leiomyoma
Who cannot join
- pregnancy
- iodine agent allergy
- patient refuse to take part in this trial
- tumour size is less than 3cm or beyond 10cm
- with endometriosis
- with malignant diseases
Show all 9Show fewer
- with abnormal coagulation function which can't restore
- with acute inflammatory diseases or acute episode of chronic inflammatory diseases
- with severe heart, lung, liver and kidney, et al. organ diseases.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Nanfang Hospital of Nanfang medical University
Guangzhou, Guangdong, 510000
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
the first Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510089
Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
Official title: Multi-Center Clinical Trial of Uterine Artery Embolization Treatment of Uterine Leiomyoma
The efficacy and safety of uterine artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. The purpose of this trial is to evaluate the uterine volume and tumor size reduction, symptomatic relief, complication, fertility, ovarian function and quality of life with uterine artery embolization for uterine fibroids comparing with standard surgical methods.
- Conditions
- Leiomyoma
- Being tested
- Interventional radiological or surgical management
- Keywords
- Uterine Artery Embolization, Leiomyoma, myomectomy, hysterectomy, pregnancy, complication, ovarian function, quality of life
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional radiological or surgical managementProcedure or surgery
Uterine artery embolization will be done for the patients who enroll into UAE group and desire for future pregancy and reserving uterus.Myomectomy will be performed for the patients who enroll into SURGERY group and desire for future pregancy and reserving uterus.Hysterectomy will be done for the patients who enroll into SURGERY group and don't desire for reserving uterus and/or future pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| pregnancy expectation | Active comparator | The patients who desire for future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group. Receives: Procedure: Interventional radiological or surgical management |
| No pregnancy expectation | Active comparator | The patients who don't desire for reserving uterus and/ or future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group. Receives: Procedure: Interventional radiological or surgical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
Measured: 1,3,5,10 year.
pregnant
Measured: 3 years
Secondary outcomes (5)
tumor recurrence
Measured: 1,3,5,10 years
complications
Measured: 3,6,12,24 months
ovarian functions
Measured: 3,6,12 months, 2,3,5 and 10 years
symptom relief
Measured: 3,6,12,24 months
tumour volume
Measured: 3,6,12 18 24 months and 3,5,10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeiomyomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Investigators
- Hong Shan, M.D., PHD., Study director, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821275
- Sponsor's protocol ID
- 2007026
- Status last verified
- Jan 2009
- First submitted
- 9 Jan 2009
- Last updated
- 13 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Clinical Trial of Uterine Artery Embolization Treatment of Uterine Leiomyoma
- ClinicalTrials.gov ID
- NCT00821275
- Acronym / sponsor ID
- 2007026
- Conditions
- Leiomyoma
- Keywords
- Uterine Artery Embolization, Leiomyoma, myomectomy, hysterectomy, pregnancy, complication, ovarian function, quality of life
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Jan 2009 (estimated)
- 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.
The efficacy and safety of uterine artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. The purpose of this trial is to evaluate the uterine volume and tumor size reduction, symptomatic relief, complication, fertility, ovarian function and quality of life with uterine artery embolization for uterine fibroids comparing with standard surgical methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnancy expectation | Active comparator | Procedure: Interventional radiological or surgical managementThe patients who desire for future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group. |
| No pregnancy expectation | Active comparator | Procedure: Interventional radiological or surgical managementThe patients who don't desire for reserving uterus and/ or future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of symptomatic uterine leiomyoma
Key exclusion criteria (9 listed)
- pregnancy
- iodine agent allergy
- patient refuse to take part in this trial
- tumour size is less than 3cm or beyond 10cm
- with endometriosis
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 |
|---|---|---|
| Interventional radiological or surgical managementUterine artery embolization will be done for the patients who enroll into UAE group and desire for future pregancy and reserving uterus.Myomectomy will be performed for the patients who enroll into SURGERY group and desire for future pregancy and reserving uterus.Hysterectomy will be done for the patients who enroll into SURGERY group and don't desire for reserving uterus and/or future pregnancy. | Procedure or surgery | No pregnancy expectation, pregnancy expectation |
Primary outcome
quality of life
Time frame: 1,3,5,10 year.
pregnant
Time frame: 3 years
5 secondary outcomes
tumor recurrence
Time frame: 1,3,5,10 years
complications
Time frame: 3,6,12,24 months
ovarian functions
Time frame: 3,6,12 months, 2,3,5 and 10 years
symptom relief
Time frame: 3,6,12,24 months
tumour volume
Time frame: 3,6,12 18 24 months and 3,5,10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2009.
- The Third Affiliated Hospital of Sun Yat-sen UniversityLink provided by the sponsor.
Related trials for Leiomyoma
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Renal Tumor Histology, Cutaneous Leiomyoma
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Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
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Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
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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.
Hong Shan, M.D., PHD. study director
Third Affiliated Hospital, Sun Yat-Sen University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Interventional radiological or surgical management in people with Leiomyoma, run by Sun Yat-sen University at 4 sites 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 1 inclusion and 9 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 13 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life (time frame: 1,3,5,10 year.). The study lists 2 primary outcomes in all. 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 13 Jan 2009.