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Levonorgestrel and Ethinyl Estradiol

Phase 3

Oral Contraceptive | Small molecule | Other |Pfizer, Inc.|Last Updated: May 19, 2006

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment600
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00248963Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral ContraceptionPHASE3 COMPLETED 600 — — -Oct 1, 2004May 19, 2006 - —
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Study Endpoints
Primary Endpoints
To evaluate the contraceptive efficacy of an OC containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and the safety compared to LNG 100 mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen
Secondary Endpoints
To evaluate the effects on vaginal bleeding profile, hemostatic balance, lipid, carbohydrate, bone metabolism measures, hemoglobin levels, discontinuation rates, compliance with respect to pill taking, subject satisfaction
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeECT
Interventions
NameTypeDescription
Levonorgestrel 90 mg and Ethinyl Estradiol 20 mgDRUG -
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Eligibility Criteria
Age Range18 Years — 49 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Healthy women aged 18 to 49 years who are willing to rely upon a combination birth control pill as their only method of contraception. * Women must be sexually active and at risk for becoming pregnant. * Women must have had regular (21- to 35- day) menstrual cycles for the 3-m...

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