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ERB-041

Phase 2

Endometriosis | Small molecule | Other |Pfizer, Inc.|Last Updated: May 1, 2015

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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00110487Study Evaluating ERB-041 in Endometriosis in Reproductive-Age WomenPHASE2 COMPLETED 200 — — Jan 1, 2005Dec 1, 2006May 1, 201546 United States
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Study Endpoints
Primary Endpoints
To assess the effects and to compare the safety profile of an investigational
medication on the relief of endometriosis-related symptoms.
Secondary Endpoints
Clinical and subject assessment of symptoms related to endometriosis and the
use of analgesia to relieve symptoms.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
ERB-041DRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexFEMALE
Healthy VolunteersNo
Study Sites46

Inclusion Criteria: * Surgical diagnosis of endometriosis within 5 years * Not pregnant and not lactating * Willing to use non-hormonal contraception, history of regular menstrual cycles Exclusion Criteria: * Hysterectomy, surgical treatment for endometriosis within 3 months * Certain medications...

Countries:United States
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