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Levonorgestrel

Phase 2

Ovulation | 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00254189Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on OvulationPHASE2 COMPLETED 60 — — Dec 1, 2002Oct 1, 2004May 19, 2006 - —
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Study Endpoints
Primary Endpoints
To determine the ability of a monophasic oral contraceptive (OC) regimen of Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg to inhibit ovulation during 84 days of continuous therapy.
Secondary Endpoints
To assess the safety profile. To assess the ovarian activity, as measured by the Hoogland and Skouby 6-point grading system, during 84 days of continuous therapy. To evaluate the time to return of ovulation after cessation of treatment.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
LevonorgestrelDRUG -
Ethinyl EstradiolDRUG -
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Eligibility Criteria
Age Range0 Years — 36 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Healthy women of legal age of consent who are willing to use a combination OC. * Subjects must be under the age of 36 at the time of enrollment (visit 3). * Subjects must have had regular (24 to 32 day) menstrual cycles for the 3-month period preceding entry into the pretreatm...

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