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Cenestin

Phase 3

Hot Flashes | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Jul 3, 2012

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment400
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00272935A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot FlashesPHASE3 COMPLETED 400 — — Dec 1, 2005May 1, 2007Jul 3, 201249 United States
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Study Endpoints
Primary Endpoints
Mean change in average frequency of moderate to severe hot flashes
Baseline to Day 28 and to Day 84
Mean change in severity of moderate to severe hot flashes
Baseline to Day 28 and to Day 84
Secondary Endpoints
Safety and tolerability of Cenestin 0.3mg
Throughout study
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Cenestin 0.3 mg TabletsDRUG1 tablet daily
PlaceboOTHER1 tablet daily
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Eligibility Criteria
Age Range30 Years — 80 Years
SexFEMALE
Healthy VolunteersNo
Study Sites49

Inclusion Criteria: * Naturally or surgically postmenopausal * At least 12 months since last menses or 6 weeks past surgery * Minimum of 7 daily or 50 weekly moderate to severe hot flashes Exclusion Criteria: * Any contraindication to natural or synthetic estrogens

Countries:United States
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