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Levonorgestrel /Ethinyl Estradiol

Phase 3

Contraception | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 8, 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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment2,000
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00245921Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral ContraceptionPHASE3 COMPLETED 2,000 — — Feb 1, 2003Oct 1, 2005Feb 8, 2013 - —
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Study Endpoints
Primary Endpoints
To evaluate safety and contraceptive efficacy
Secondary Endpoints
To evaluate the effects of this LNG/EE combination on bleeding profile, endometrial histology, hemostasis measures, hemoglobin levels, discontinuation rates, subject satisfaction, and cycle-related symptoms and work productivity at baseline.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
Interventions
NameTypeDescription
Levonorgestrel 90 mg/Ethinyl Estradiol 20 mgDRUG -
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Eligibility Criteria
Age Range18 Years — 49 Years
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Healthy women aged 18 to 49 years * Regular (21- to 35- day) menstrual cycles for the 3-month period preceding visit 1 * Must be sexually active and at risk for becoming pregnant. Exclusion Criteria: * Planned use of any other form of birth control other than the test articl...

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