Recent Updates
Recently added Catalysts

PVC

Phase 3

Atrophic Vaginitis | Small molecule | Other |Pfizer, Inc.|Last Updated: Dec 10, 2007

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment480
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00137371Study Evaluating Conjugated Estrogen Cream for Atrophic VaginitisPHASE3 COMPLETED 480 — — Aug 1, 2005Sep 1, 2007Dec 10, 200749 United States, Canada
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks.
Secondary Endpoints
To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
PVC (daily for 21 days, 7 days off)DRUG -
PVC (twice weekly)DRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range45 Years — 80 Years
SexFEMALE
Healthy VolunteersNo
Study Sites49

Inclusion Criteria: Generally healthy postmenopausal women with symptoms of atrophic vaginitis including vaginal dryness, vaginal itching, vaginal burning, and/or painful intercourse. The subject must have a clinical diagnosis of atrophic vaginitis and an intact uterus. Exclusion Criteria: Women...

Countries:United StatesCanada
Unlock Eligibility Criteria