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Oxybutinyn Vaginal Ring

Phase 3

Overactive Bladder | Small molecule | Nephrology |Teva Pharmaceutical Industries Limited|Last Updated: Mar 16, 2023

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-BlindCONTROLLED
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00782769A Safety Extension Study of DR-OXY-301PHASE3 COMPLETED 240 — — Sep 1, 2008Jul 1, 2010Mar 16, 202335 United States
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Study Endpoints
Primary Endpoints
Safety, by investigating post void residual volume, physical exams, vital signs, and clinical laboratory values. The outcome of any pregnancy will be followed and reported
Duration of Study
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Oxybutinyn Vaginal Ring 4mgEXPERIMENTALinserted daily and replaced every 4 weeks
Oxybutinyn Vaginal Ring 6mgEXPERIMENTALinserted daily and replaced every 4 weeks
Interventions
NameTypeDescription
Oxybutinyn Vaginal Ring 4mgDRUG -
Oxybutinyn Vaginal Ring 6mgDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * Completed the 12 weeks of treatment in the DR-OXY-301 study * Willing to limit medications for overactive bladder to investigational product only * Able to understand and complete all study procedures including the required diary

Countries:United States
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