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DVS-233

Phase 3

Vasomotor Symptoms | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 11, 2007

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 Enrollment540
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00421031Study Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With MenopausePHASE3 COMPLETED 540Dec 1, 2003Apr 1, 2004Jan 11, 200741 United States
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Study Endpoints
Primary Endpoints
The primary objective is to assess the efficacy and safety of 4 doses of DVS-233 SR as compared to placebo for the treatment of moderate to severe VMS associated with menopause.
Secondary Endpoints
The secondary objectives are to assess the effects of DVS-233 SR as compared to placebo on sleep parameters and on health outcomes indicators
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
DVS-233 SRDRUG -
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Eligibility Criteria
SexFEMALE
Healthy VolunteersYes
Study Sites41

Inclusion Criteria: 1. Generally healthy, postmenopausal women; at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL or at least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). 2. Minimum of 7 mode...

Countries:United States
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