MenorrhagiaPhase 3NCT00215618
Uterine Balloon Treatment for Heavy Period Bleeding.
A Phase 3 study testing Uterine Balloon Therapy in people with Menorrhagia, run by Ethicon, Inc..
Trial summary
The purpose of this research is to determine the proportion of women who achieve permanent cessation of bleeding after Uterine Balloon Therapy (UBT) for the treatment of heavy uterine bleeding. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Uterine Balloon Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Sep 2008
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female at least 30 years of age who is premenopausal and for whom childbearing is complete.
- Excessive menstrual bleeding documented by a diary score of at least 150.
- Have documented 3 months failed medical therapy or either a) contraindicated for or b) refused medical therapy.
- Have an anatomically normal uterine cavity sounding at least 4cm, but not greater than 12cm.
- Have a normal pap smear and no unexplained abnormal pap smears within 1 year of the procedure.
- Agree not to switch from hormonal to non-hormonal contraception or vice versa during or just prior to the study.
- Agree to use reliable contraception throughout the study.
- Freely agree to participate in the study, including all study related procedures and evaluations, and document this agreement by signing informed consent documentation.
Who cannot join
- Active pelvic inflammatory disease (PID) or recurrent chronic PID.
- Active genital or urinary tract infection at the time of the procedure.
- History of malignancy of the reproductive system within 5 years of the procedure or have ever had malignancy of the endometrium.
- Endometrial neoplasia, determined by endometrial biopsy taken within 6 months of procedure.
- Cavity distorting submucous myoma(s) determined by preoperative hysterogram, hysteroscopy, or transvaginal sonography within 6 months of the procedure.
- Previous endometrial ablation procedure.
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- Previous uterine surgeries (such as full thickness myomectomy, subserosal myomectomy, uterine reconstruction, or any surgery in which thinning of the uterine musculature could occur) except for low transverse caesarean section.
- Pregnant or desirous of future pregnancy.
- Taken endometrial suppression medication, except for oral contraceptives, within 3 months of the procedure.
- Concurrent open or laparoscopic surgery.
About this study
Official title: Clinical Evaluation of Uterine Balloon Therapy System for Menorrhagia
The purpose of this research is to determine the proportion of women who achieve permanent cessation of bleeding after Uterine Balloon Therapy (UBT) for the treatment of heavy uterine bleeding.
Read the detailed description
This study was also designed to determine the effect of a post procedure curettage on bleeding patterns and post-operative discharge and pain.
- Conditions
- Menorrhagia
- Being tested
- Uterine Balloon Therapy
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine Balloon TherapyDevice
Also called with post procedure curettage
UBT with post procedure curettage
Uterine Balloon TherapyDevice
Also called without post procedure curettage
UBT without post procedure curettage
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Uterine Balloon Therapy with post procedure curettage Receives: Device: Uterine Balloon Therapy |
| 2 | Experimental | Uterine Balloon Therapy without post-procedure curettage Receives: Device: Uterine Balloon Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-procedure amenorrhea in women treated with uterine balloon therapy.
Measured: 6 and 12 mo
Secondary outcomes (3)
Post-procedure bleeding levels
Measured: 2 and 3 yrs
Effect of post-procedure curettage on bleeding patterns, post-operative discharge and post-operative pain.
Measured: 2 and 3 yrs
System utility as indicated by equipment events that require intervention.
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2003
- Primary completionAug 2006
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Charles T Cash, MD, Principal investigator, Oakwood Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215618
- Sponsor's protocol ID
- 2003-010
- Status last verified
- Jan 2009
- First submitted
- 19 Sep 2005
- Last updated
- 14 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Cash C Jr, Garza-Leal J, Donovan A, Guidry C, Romanowski C, Patel B. Clinical evaluation of long-term safety and effectiveness of a third-generation thermal uterine balloon therapy system for heavy menstrual bleeding. J Minim Invasive Gynecol. 2012 Jul-Aug;19(4):469-76. doi: 10.1016/j.jmig.2012.03.015.
PubMed 22748952
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Uterine Balloon Therapy System for Menorrhagia
- ClinicalTrials.gov ID
- NCT00215618
- Acronym / sponsor ID
- 2003-010
- Conditions
- Menorrhagia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Aug 2006 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 22 Sep 2005 (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 purpose of this research is to determine the proportion of women who achieve permanent cessation of bleeding after Uterine Balloon Therapy (UBT) for the treatment of heavy uterine bleeding.
Detailed description
This study was also designed to determine the effect of a post procedure curettage on bleeding patterns and post-operative discharge and pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Uterine Balloon TherapyUterine Balloon Therapy with post procedure curettage |
| 2 | Experimental | Device: Uterine Balloon TherapyUterine Balloon Therapy without post-procedure curettage |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female at least 30 years of age who is premenopausal and for whom childbearing is complete.
- Excessive menstrual bleeding documented by a diary score of at least 150.
- Have documented 3 months failed medical therapy or either a) contraindicated for or b) refused medical therapy.
- Have an anatomically normal uterine cavity sounding at least 4cm, but not greater than 12cm.
- Have a normal pap smear and no unexplained abnormal pap smears within 1 year of the procedure.
Key exclusion criteria (10 listed)
- Active pelvic inflammatory disease (PID) or recurrent chronic PID.
- Active genital or urinary tract infection at the time of the procedure.
- History of malignancy of the reproductive system within 5 years of the procedure or have ever had malignancy of the endometrium.
- Endometrial neoplasia, determined by endometrial biopsy taken within 6 months of procedure.
- Cavity distorting submucous myoma(s) determined by preoperative hysterogram, hysteroscopy, or transvaginal sonography within 6 months of the procedure.
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 Balloon TherapyAlso: with post procedure curettageUBT with post procedure curettage | Device | 1 |
| Uterine Balloon TherapyAlso: without post procedure curettageUBT without post procedure curettage | Device | 2 |
Primary outcome
Incidence of post-procedure amenorrhea in women treated with uterine balloon therapy.
Time frame: 6 and 12 mo
3 secondary outcomes
Post-procedure bleeding levels
Time frame: 2 and 3 yrs
Effect of post-procedure curettage on bleeding patterns, post-operative discharge and post-operative pain.
Time frame: 2 and 3 yrs
System utility as indicated by equipment events that require intervention.
Time frame: perioperative
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 14 Jan 2009.
- Derived from this study: PubMed 22748952Cash C Jr, Garza-Leal J, Donovan A, Guidry C, Romanowski C, Patel B. Clinical evaluation of long-term safety and effectiveness of a third-generation thermal uterine balloon therapy system for heavy menstrual bleeding. J Minim Invasive Gynecol. 2012 Jul-Aug;19(4):469-76. doi: 10.1016/j.jmig.2012.03.015.
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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.
Charles T Cash, MD principal investigator
Oakwood Hospital and Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Uterine Balloon Therapy in people with Menorrhagia, run by Ethicon, Inc..
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 8 inclusion and 10 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 14 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of post-procedure amenorrhea in women treated with uterine balloon therapy. (time frame: 6 and 12 mo). 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 NCT00215618, which also lists 1 linked publication.
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 14 Jan 2009.