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Norgestimate; Ethinyl Estradiol; Folic acid.

Phase 1

Pharmacokinetics | Small molecule | Other |Johnson & Johnson|Last Updated: Jun 8, 2011

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 Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00709644Bioequivalence Study of the Oral Contraceptive (OC) Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.PHASE1 COMPLETED 54 — — Apr 1, 2005Aug 1, 2005Jun 8, 2011 - —
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Study Endpoints
Primary Endpoints
Determine the bioequivalence of NGM (as measured by the pharmacokinetics of its active breakdown product NGMN) and EE in 2 formulations of 250 mcg NGM/25 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid.
Secondary Endpoints
Determine the pharmacokinetics of NG in these 2 formulations; and to characterize the pharmacokinetics of plasma folate after the administration of folic acid alone or in combination with 250 mcg NGM/25 mcg EE. Safety also was assessed.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposePREVENTION
Interventions
NameTypeDescription
Norgestimate; Ethinyl Estradiol; Folic acid.DRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Healthy * nonpregnant * nonlactating * nonsmoking women * weighing at least 110 pounds * With regular menstrual cycles * A body mass index between 16 and 29.9 kg/m2 * And a hematocrit of at least 36%. Exclusion Criteria: * History or presence of disorders commonly accepted a...

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