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VA2914

Phase 2

Contraception | Small molecule | Other |Perrigo Company plc|Last Updated: Jun 17, 2010

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 Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00456924Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914PHASE2 COMPLETED 48Jan 1, 2004Dec 1, 2004Jun 17, 20104 Belgium, France
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Study Endpoints
Primary Endpoints
ovarian hormones
follicular development
endometrial histology
Secondary Endpoints
menstural bleeding patterns
cervical mucus
VA2914 concentration
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
VA2914DRUG -
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Eligibility Criteria
Age Range18 Years — 35 Years
SexFEMALE
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * women in good general health with regular, ovulatory menstrual cycles * age 18-35 * not pregnant * not sexually active or reliably use barrier methods of contraception * normal liver and renal functions and normal laboratory exams Exclusion Criteria: * pregnant or breastfeed...

Countries:BelgiumFrance
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