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Synthetic Conjugated estrogens, B

Phase 3

Menopause | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Sep 2, 2013

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00196378A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal AtrophyPHASE3 COMPLETED 300Nov 1, 2004Feb 1, 2006Sep 2, 201338 United States
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Study Endpoints
Primary Endpoints
Mean change in the symptom identified by the patient to be most bothersome
Randomization to Week 12
Mean change in vaginal pH
Randomization to Week 12
Mean change in maturation index
Randomization to Week 12
Secondary Endpoints
Safety and tolerability of Enjuvia
Duration of study
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Synthetic Conjugated estrogens, BDRUG1 (0.3mg) tablet daily
PlaceboOTHER1 tablet daily
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Eligibility Criteria
Age Range30 Years — 80 Years
SexFEMALE
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: * Naturally or surgically postmenopausal * Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse) Exclusion Criteria: * Known sensitivity or contraindication to estrogens or progestins * History or current diagnosis of endometria...

Countries:United States
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