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uterine artery embolization, hysterectomy

Phase 3

Menorrhagia | Unknown | Oncology |Boston Scientific Corporation|Last Updated: Jun 24, 2005

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00100191Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine FibroidsPHASE3 COMPLETED 120 — — Feb 1, 2002Apr 1, 2006Jun 24, 20052 Netherlands
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Study Endpoints
Primary Endpoints
The primary endpoint is the normalization of menorrhagia after a two-year follow-up period
Secondary Endpoints
Effect on complaints of pain and pressure
Technical failure
Complications
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
uterine artery embolizationPROCEDURE -
hysterectomyPROCEDURE -
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Uterine fibroids * Menorrhagia * Scheduled for hysterectomy * Pre-menopausal Exclusion Criteria: * Childwish (planning to conceive) * Pregnancy * Suspected malignancy * Untreated pelvic inflammatory disease (PID) * Clotting disorders * Contrast fluid allergy * Presence of in...

Countries:Netherlands
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