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Divigel

Phase 3

Postmenopausal Symptoms | Small molecule | Other |Smith & Nephew SNATS, Inc.|Last Updated: Sep 26, 2008

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment495
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00727129Study to Evaluate Divigel for the Treatment of Postmenoupausal SymptomsPHASE3 COMPLETED 495Jul 1, 2004Aug 1, 2005Sep 26, 2008 -
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Study Endpoints
Primary Endpoints
Daily frequency and severity of moderate to severe vasomotor symptoms
Secondary Endpoints
vulvar and vaginal atrophy
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
DivigelDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Postmenopausal women * Have moderate to severe hot flashes * Normal Pap Smear Exclusion Criteria: * Abnormal mammogram * Abnormal clinical breast exam * BMI \>35

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