MenorrhagiaPhase 3NCT00100191
Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids
A Phase 3 study testing uterine artery embolization and hysterectomy in people with Menorrhagia and Leiomyoma, run by ZonMw: The Netherlands Organisation for Health Research and Development at 2 sites in Netherlands.
Trial summary
The Emmy trial is set up to evaluate the safety and efficacy of uterine artery embolization (UAE) in comparison to hysterectomy for the treatment of symptomatic uterine fibroids. UAE was considered equivalent to hysterectomy when at least 75% of patients had normalization of heavy menstrual blood loss after treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menorrhagia, Leiomyoma, Uterine Neoplasms
- What is being tested?
- uterine artery embolization and hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 2 sitesNetherlands
- Study dates
- Feb 2002to Apr 2006
- Phase
- Phase 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uterine fibroids
- Menorrhagia
- Scheduled for hysterectomy
- Pre-menopausal
Who cannot join
- Childwish (planning to conceive)
- Pregnancy
- Suspected malignancy
- Untreated pelvic inflammatory disease (PID)
- Clotting disorders
- Contrast fluid allergy
- Presence of intrauterine device (IUD)
- Renal failure (creatinine > 150 mmol/l)
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Academic Medical Centre Amsterdam
Amsterdam, 1105 AZ
27 Other Participating Hospitals of Varying Sizes Throughout the Country
Amsterdam
About this study
Official title: EMMY Trial: a Randomized Comparison of Uterine Artery Embolization and Hysterectomy for the Treatment of Symptomatic Uterine Fibroids
The Emmy trial is set up to evaluate the safety and efficacy of uterine artery embolization (UAE) in comparison to hysterectomy for the treatment of symptomatic uterine fibroids. UAE was considered equivalent to hysterectomy when at least 75% of patients had normalization of heavy menstrual blood loss after treatment.
Read the detailed description
Uterine Artery Embolization (UAE) is a new treatment for heavy menstrual bleeding caused by uterine fibroids. UAE is already being performed on a regular basis, without profound evidence: no good quality randomized controlled trials have been conducted. The EMMY trial evaluates the safety and efficacy of UAE in a randomized comparison to hysterectomy. Patients were included when they had uterine fibroids and menorrhagia, and were eligible for hysterectomy. The primary endpoint is the elimination of menorrhagia after a two-year follow-up period. Secondary endpoints comprise: effect on complaints of pain and pressure, quality of life issues, uterine volume reduction, effect on ovarian function and cost-effectiveness. Patients were randomly assigned to either UAE or hysterectomy (1:1). All patients were followed for two years after treatment. Whether UAE can be an alternative to hysterectomy as treatment of first choice depends on the balance of efficacy, costs, and quality of life.
- Conditions
- Menorrhagia, Leiomyoma, Uterine Neoplasms
- Being tested
- uterine artery embolization, hysterectomy
- Keywords
- hysterectomy, fibroids, uterine artery embolization, therapeutic embolization, uterus, menorrhagia
- Medical subject headings
- Menorrhagia, Leiomyoma, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterine artery embolizationProcedure or surgery
hysterectomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the normalization of menorrhagia after a two-year follow-up period
Secondary outcomes (7)
Effect on complaints of pain and pressure
Technical failure
Complications
Quality of life issues
Uterine volume reduction
Effect on ovarian function
Cost-effectiveness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2004 (estimated)
- Study startFeb 2002
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MenorrhagiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- ZonMw: The Netherlands Organisation for Health Research and Development
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Investigators
- J.A. Reekers, MD, PhD, Principal investigator, Academic Medical Centre, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100191
- Sponsor's protocol ID
- NWO-DO 945-01-17
- Status last verified
- Dec 2004
- First submitted
- 23 Dec 2004
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Hehenkamp WJ, Volkers NA, Van Swijndregt AD, De Blok S, Reekers JA, Ankum WM. Myoma expulsion after uterine artery embolization: complication or cure? Am J Obstet Gynecol. 2004 Nov;191(5):1713-5. doi: 10.1016/j.ajog.2004.02.001.
PubMed 15547547Hehenkamp WJ, Volkers NA, Bartholomeus W, de Blok S, Birnie E, Reekers JA, Ankum WM. Sexuality and body image after uterine artery embolization and hysterectomy in the treatment of uterine fibroids: a randomized comparison. Cardiovasc Intervent Radiol. 2007 Sep-Oct;30(5):866-75. doi: 10.1007/s00270-007-9121-7.
PubMed 17671809
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMMY Trial: a Randomized Comparison of Uterine Artery Embolization and Hysterectomy for the Treatment of Symptomatic Uterine Fibroids
- ClinicalTrials.gov ID
- NCT00100191
- Acronym / sponsor ID
- NWO-DO 945-01-17
- Conditions
- Menorrhagia, Leiomyoma, Uterine Neoplasms
- Keywords
- hysterectomy, fibroids, uterine artery embolization, therapeutic embolization, uterus, menorrhagia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- ZonMw: The Netherlands Organisation for Health Research and DevelopmentUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Feb 2002
- Study completion
- Apr 2006
- First posted
- 24 Dec 2004 (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 Emmy trial is set up to evaluate the safety and efficacy of uterine artery embolization (UAE) in comparison to hysterectomy for the treatment of symptomatic uterine fibroids. UAE was considered equivalent to hysterectomy when at least 75% of patients had normalization of heavy menstrual blood loss after treatment.
Detailed description
Uterine Artery Embolization (UAE) is a new treatment for heavy menstrual bleeding caused by uterine fibroids. UAE is already being performed on a regular basis, without profound evidence: no good quality randomized controlled trials have been conducted. The EMMY trial evaluates the safety and efficacy of UAE in a randomized comparison to hysterectomy. Patients were included when they had uterine fibroids and menorrhagia, and were eligible for hysterectomy. The primary endpoint is the elimination of menorrhagia after a two-year follow-up period. Secondary endpoints comprise: effect on complaints of pain and pressure, quality of life issues, uterine volume reduction, effect on ovarian function and cost-effectiveness. Patients were randomly assigned to either UAE or hysterectomy (1:1). All patients were followed for two years after treatment. Whether UAE can be an alternative to hysterectomy as treatment of first choice depends on the balance of efficacy, costs, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Uterine fibroids
- Menorrhagia
- Scheduled for hysterectomy
- Pre-menopausal
Key exclusion criteria (8 listed)
- Childwish (planning to conceive)
- Pregnancy
- Suspected malignancy
- Untreated pelvic inflammatory disease (PID)
- Clotting disorders
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 |
|---|---|---|
| uterine artery embolization | Procedure or surgery | – |
| hysterectomy | Procedure or surgery | – |
Primary outcome
The primary endpoint is the normalization of menorrhagia after a two-year follow-up period
7 secondary outcomes
Effect on complaints of pain and pressure
Technical failure
Complications
Quality of life issues
Uterine volume reduction
Effect on ovarian function
Cost-effectiveness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Results publication: PubMed 15547547Hehenkamp WJ, Volkers NA, Van Swijndregt AD, De Blok S, Reekers JA, Ankum WM. Myoma expulsion after uterine artery embolization: complication or cure? Am J Obstet Gynecol. 2004 Nov;191(5):1713-5. doi: 10.1016/j.ajog.2004.02.001.
- Derived from this study: PubMed 17671809Hehenkamp WJ, Volkers NA, Bartholomeus W, de Blok S, Birnie E, Reekers JA, Ankum WM. Sexuality and body image after uterine artery embolization and hysterectomy in the treatment of uterine fibroids: a randomized comparison. Cardiovasc Intervent Radiol. 2007 Sep-Oct;30(5):866-75. doi: 10.1007/s00270-007-9121-7.
- Information site of the Emmy trial for patients (in Dutch)Link provided by the sponsor.
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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.
J.A. Reekers, MD, PhD principal investigator
Academic Medical Centre, Department of Radiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing uterine artery embolization and hysterectomy in people with Menorrhagia and Leiomyoma, run by ZonMw: The Netherlands Organisation for Health Research and Development at 2 sites in Netherlands.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint is the normalization of menorrhagia after a two-year follow-up period. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00100191, which also lists 2 linked publications.
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 24 Jun 2005.