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Mylan Estradiol System /day

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 1, 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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment76
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00649896Evaluation of Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System 0.025 mg/Day and Climara® Transdermal System 0.025 mg/DayPHASE1 COMPLETED 76Aug 1, 2003Sep 1, 2003Apr 1, 20081 United States
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Study Endpoints
Primary Endpoints
Dermal Safety
within 30 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
1EXPERIMENTALMylan Estradiol Transdermal System 0.025 mg/day
2ACTIVE_COMPARATORClimara® Transdermal System 0.025 mg/day
Interventions
NameTypeDescription
Mylan Estradiol Transdermal System 0.025 mg/dayDRUG -
Climara® Transdermal System 0.025 mg/dayDRUG -
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Eligibility Criteria
Age Range40 Years — 69 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 40-69 years. 2. Sex: Females only. 3. Weight: At least 52 kg (115 lbs) and within 30% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" from Metropolitan Life Insurance Company, 1999 (See Part II: ADMINISTRATIVE ASPECTS OF HUMAN BIOA...

Countries:United States
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